Prediabetic StateNCT03208010
Diabetes Prevention for Mexican Americans
A study testing Diabetes Prevention Intervention in people with Prediabetic State and Overweight and Obesity, run by University of Texas at Austin at 1 site in United States.
Trial summary
This study tests a culturally tailored lifestyle intervention designed to prevent, or delay onset of, T2DM in Mexican Americans with prediabetes. Half the participants take part in a lifestyle program that emphasizes preparing and eating healthy Mexican American foods and increasing physical activity; the other half… Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Prediabetic State, Overweight and Obesity
- What is being tested?
- Diabetes Prevention Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2017to 31 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- no prior diabetes diagnosis (except gestational)
- impaired fasting glucose (fasting glucose between 100 and 125 mg/dL) OR impaired glucose tolerance (between 140 and 199 mg/dL on a 2-hour post-load glucose tolerance test) OR A1C between 5.7% and 6.4%)
- have not previously participated in diabetes self-management education studies
- Mexican American
Who cannot join
- diagnosed with diabetes at baseline
- fasting glucose greater than or equal to 126 mg/dL
- ever used hypoglycemic medication (except during pregnancy)
- are currently pregnant or within 3 months postpartum
- are migrant farmworkers who migrate for more than 2 weeks
- take medications that could confound a diabetes diagnosis (e.g., steroids)
- have medical conditions for which changes in diet and/or physical activity would be contraindicated
Trial locations and contacts
1 site in 1 country.
United States1 site
Starr County Research Field Office
Rio Grande City, Texas, 78582
About this study
Official title: Diabetes Prevention Culturally Tailored for Mexican Americans
This study tests a culturally tailored lifestyle intervention designed to prevent, or delay onset of, T2DM in Mexican Americans with prediabetes. Half the participants take part in a lifestyle program that emphasizes preparing and eating healthy Mexican American foods and increasing physical activity; the other half take part in an "enhanced" usual care control group.
Read the detailed description
The main purpose of this study is to test a culturally tailored lifestyle intervention that incorporates motivational interviewing and is designed to prevent, or delay onset of, T2DM in Mexican Americans with prediabetes. Groups of participants are randomly assigned to: a) an experimental group that receives a lifestyle program (12 2-hour weekly educational group sessions) that emphasizes preparing and eating healthy Mexican American foods and increasing physical activity, followed by 14 biweekly support group sessions to problem solve remaining barriers to adopting recommended behaviors and 3 booster sessions to enhance maintenance of behavioral changes; OR b) an "enhanced" usual care control group that receives lab results with individualized guidance and referrals. A secondary goal of the study is to examine the influence of genetic variation at selected candidate genes for glucose regulation on response to the lifestyle intervention.
The specific aims of the study are to:
- Test a culturally tailored lifestyle intervention that incorporates motivational interviewing and is designed to prevent, or delay onset of, T2DM in Mexican Americans with prediabetes. Groups of participants are randomly assigned to: a) an experimental group that receives a lifestyle program (12 2-hour weekly educational group sessions) that emphasizes preparing and eating healthy Mexican American foods and increasing physical activity, followed by 14 biweekly support group sessions to problem solve remaining barriers to adopting recommended behaviors and 3 booster sessions to enhance maintenance of behavioral changes; OR b) an "enhanced" usual care control group that receives lab results with individualized guidance and referrals. H1: The experimental group, compared to the control group, will have better health outcomes at 3, 6, 12, 24, and 36 months post baseline: 2-hour OGTT, A1C, FBG, lipids, blood pressure, health behaviors (physical activity, dietary intake), health beliefs: barriers, and anthropometrics (BMI [primary outcome], waist circumference). Other baseline measures - demographics and acculturation - characterize the population and correct for any baseline imbalances between groups.
- Prior to testing the intervention, we conduct focus groups in Starr County with participants of our previous DSMES studies, physicians from both sides of the border, local health officials, and key authority figures (Catholic priests, county officials) to fine tune intervention aspects in the context of diabetes prevention.
- Exploratory Aim: Examine the influence of genetic variation at selected candidate genes for glucose regulation on response to the lifestyle intervention.
The study addresses THE major public health problem of U.S.-Mexico border communities.
Note: In response to the COVID-19 pandemic, a remote version of the intervention was designed to provide the program remotely instead of via the usual in-person group format. A series of augmented text messages were developed that included 5 to 10-minute videos of a project dietitian or nurse talking about previously-learned content and demonstrating a simple, healthier method of preparing favorite recipe(s). The URLs of other related Spanish-language videos from the Internet are included and the text messages with videos are supplemented with phone calls from community workers to provide follow-up coaching for motivation. This alternative strategy is designed to replace the biweekly support groups, which in the past focused on similar content, i.e., reviewing key educational content, demonstrations of healthy Mexican American recipes.
- Conditions
- Prediabetic State, Overweight and Obesity
- Being tested
- Diabetes Prevention Intervention, Enhanced Usual Care
- Keywords
- health disparities, lifestyle behaviors, diabetes prevention, Hispanic health
- Medical subject headings
- Prediabetic State, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diabetes Prevention InterventionBehavioural
Also called Culturally Tailored Diabetes Prevention
- Educational sessions with emphasis on physical activity, healthy cultural diets, and strategies to promote positive behavioral changes.
- Specific goals set for weight loss and physical activities
- Fitbits provided for monitoring physical activity goals
- Weekly review of and feedback on effects of physical activity (Fitbits) and dietary changes (checklists)
- 15 biweekly support group sessions plus 3 booster sessions every 6 months thereafter
Note: In response to the COVID-19 pandemic, a remote version of the intervention was designed to provide the program remotely instead of via the usual in-person group format. This alternative strategy is designed to replace the biweekly support groups, which in the past focused on similar content, i.e., reviewing key educational content, demonstrations of healthy Mexican American recipes.
Enhanced Usual CareOther
- Monitoring by existing personal physicians
- Feedback on lab results
- Referrals to physicians or clinics, if needed
- Diabetes prevention educational materials
| Study group | Role | What they receive |
|---|---|---|
| Diabetes Prevention Intervention | Experimental | The intervention is 12 weeks of education on diet and physical activity, followed by 15 biweekly support groups for problem solving. Then, 3 booster sessions are scheduled, each one at 6-month intervals. Further, motivational interviewing is infused into all group sessions. Receives: Behavioral: Diabetes Prevention Intervention |
| Enhanced Usual Care | Active comparator | The comparator is an "enhanced" usual care control group that receives health care from personal physicians plus has access to: a) data collection sessions; b) individualized exit interviews with program staff after each data collection session to receive immediate feedback on lab results and trends in personal health indicators (e.g., BMI, A1C) and to ask questions; c) referral to a local physician or clinic, if needed; and d) Spanish-language materials on diabetes prevention. Receives: Other: Enhanced Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in glycosylated hemoglobin (A1C) at 3 months
A1C, an indicator of long-term glucose control, is measured as the percentage of red blood cells that are glycosylated (have a glucose molecule connected) and is analyzed onsite using a point-of-care device (Siemens DCA Vantage Analyzer, Malvern, PA).
Measured: Baseline and 3 months
Change from baseline in glycosylated hemoglobin (A1C) at 6 months
A1C, an indicator of long-term glucose control, is measured as the percentage of red blood cells that are glycosylated (have a glucose molecule connected) and is analyzed onsite using a point-of-care device (Siemens DCA Vantage Analyzer, Malvern, PA).
Measured: Baseline and 6 months
Change from baseline in glycosylated hemoglobin (A1C) at 12 months
A1C, an indicator of long-term glucose control, is measured as the percentage of red blood cells that are glycosylated (have a glucose molecule connected) and is analyzed onsite using a point-of-care device (Siemens DCA Vantage Analyzer, Malvern, PA).
Measured: Baseline and 12 months
Change from baseline in glycosylated hemoglobin (A1C) at 24 months
A1C, an indicator of long-term glucose control, is measured as the percentage of red blood cells that are glycosylated (have a glucose molecule connected) and is analyzed onsite using a point-of-care device (Siemens DCA Vantage Analyzer, Malvern, PA).
Measured: Baseline and 24 months
Change from baseline in glycosylated hemoglobin (A1C) at 36 months
A1C, an indicator of long-term glucose control, is measured as the percentage of red blood cells that are glycosylated (have a glucose molecule connected) and is analyzed onsite using a point-of-care device (Siemens DCA Vantage Analyzer, Malvern, PA).
Measured: Baseline and 36 months
Change from baseline in body mass index (BMI) at 3 months
Body weights are measured with a balance beam scale with individuals in street clothing and without shoes. Heights are obtained using a secured stadiometer. BMI is calculated (weight(kg)/height/meters^2).
Measured: Baseline and 3 months
Change from baseline in body mass index (BMI) at 6 months
Body weights are measured with a balance beam scale with individuals in street clothing and without shoes. Heights are obtained using a secured stadiometer. BMI is calculated (weight(kg)/height/meters^2).
Measured: Baseline and 6 months
Change from baseline in body mass index (BMI) at 12 months
Body weights are measured with a balance beam scale with individuals in street clothing and without shoes. Heights are obtained using a secured stadiometer. BMI is calculated (weight(kg)/height/meters^2).
Measured: Baseline and 12 months
Change from baseline in body mass index (BMI) at 24 months
Body weights are measured with a balance beam scale with individuals in street clothing and without shoes. Heights are obtained using a secured stadiometer. BMI is calculated (weight(kg)/height/meters^2).
Measured: Baseline and 24 months
Change from baseline in body mass index (BMI) at 36 months
Body weights are measured with a balance beam scale with individuals in street clothing and without shoes. Heights are obtained using a secured stadiometer. BMI is calculated (weight(kg)/height/meters^2).
Measured: Baseline and 36 months
Secondary outcomes (50)
Change from baseline to 3 months in quality of life as measured with 1 researcher-developed item
Measured with 1 item developed by the research team. The participants respond to the following statement -- "In general, my well being is..." Item responses range from 1-7, with 7 indicating as good as it possibly could be and 1 indicating as bad as it possibly could be. The item employs a 1-7 Likert-type scale with higher numbers indicating a more favorable perceived quality of life.
Measured: Baseline and 3 months
Change from baseline to 12 months in quality of life as measured with 1 researcher-developed item
Measured with 1 item developed by the research team. The participants respond to the following statement -- "In general, my well being is..." Item responses range from 1-7, with 7 indicating as good as it possibly could be and 1 indicating as bad as it possibly could be. The item employs a 1-7 Likert-type scale with higher numbers indicating a more favorable perceived quality of life.
Measured: Baseline and 12 months
Change from baseline to 24 months in quality of life as measured with 1 researcher-developed item
Measured with 1 item developed by the research team. The participants respond to the following statement -- "In general, my well being is..." Item responses range from 1-7, with 7 indicating as good as it possibly could be and 1 indicating as bad as it possibly could be. The item employs a 1-7 Likert-type scale with higher numbers indicating a more favorable perceived quality of life.
Measured: Baseline and 24 months
Change from baseline to 36 months in quality of life as measured with 1 researcher-developed item
Measured with 1 item developed by the research team. The participants respond to the following statement -- "In general, my well being is..." Item responses range from 1-7, with 7 indicating as good as it possibly could be and 1 indicating as bad as it possibly could be. The item employs a 1-7 Likert-type scale with higher numbers indicating a more favorable perceived quality of life.
Measured: Baseline and 36 months
Changes from baseline to 12 months in number/amount of times foods were eaten during the previous month using the questionnaire entitled, Food Frequency Questionnaire for Starr County Health Studies (see McPherson et al., Ann Epidemiol, 1995).
The Food Frequency Questionnaire for Starr County Studies lists 106 specific food items. The participants indicate the frequency a specific food item, including cultural foods, was eaten during the past month, as well as the portion size. For example, for the item "Cheetos," the respondent answers "yes" or "no" regarding whether the item was eaten during the past month. If "yes," then the individual is asked how many times and then asked to estimate portion size using food models available during the administration of the questionnaire. Special software enables converting frequency data to raw intake as well as nutrient densities for analysis. Macro- and micro-nutrients that will be quantified are: total caloric intake, protein, fat, saturated fat, mono-unsaturated fat, poly-unsaturated fat, cholesterol, carbohydrate intake, vitamins A, and E, carotene, calcium, and iron.
Measured: Baseline and 12 months
Changes from baseline to 24 months in number/amount of times foods were eaten during the previous month using the questionnaire entitled, Food Frequency Questionnaire for Starr County Health Studies (see McPherson et al., Ann Epidemiol, 1995)
The Food Frequency Questionnaire for Starr County Studies lists 106 specific food items. The participants indicate the frequency a specific food item, including cultural foods, was eaten during the past month, as well as the portion size. For example, for the item "Cheetos," the respondent answers "yes" or "no" regarding whether the item was eaten during the past month. If "yes," then the individual is asked how many times and then asked to estimate portion size using food models available during the administration of the questionnaire. Special software enables converting frequency data to raw intake as well as nutrient densities for analysis. Macro- and micro-nutrients that will be quantified are: total caloric intake, protein, fat, saturated fat, mono-unsaturated fat, poly-unsaturated fat, cholesterol, carbohydrate intake, vitamins A, and E, carotene, calcium, and iron.
Measured: Baseline and 24 months
Changes from baseline to 36 months in number/amount of times foods were eaten during the previous month using the questionnaire entitled, Food Frequency Questionnaire for Starr County Health Studies (see McPherson et al., Ann Epidemiol, 1995)
The Food Frequency Questionnaire for Starr County Studies lists 106 specific food items. The participants indicate the frequency a specific food item, including cultural foods, was eaten during the past month, as well as the portion size. For example, for the item "Cheetos," the respondent answers "yes" or "no" regarding whether the item was eaten during the past month. If "yes," then the individual is asked how many times and then asked to estimate portion size using food models available during the administration of the questionnaire. Special software enables converting frequency data to raw intake as well as nutrient densities for analysis. Macro- and micro-nutrients that will be quantified are: total caloric intake, protein, fat, saturated fat, mono-unsaturated fat, poly-unsaturated fat, cholesterol, carbohydrate intake, vitamins A, and E, carotene, calcium, and iron.
Measured: Baseline and 36 months
Changes from baseline to 3 months in the number of times high-fat foods were eaten during the previous month using the Saturated Fat/Cholesterol Avoidance Scale, a culturally-tailored instrument developed in Starr County
The Saturated Fat/Cholesterol Avoidance Scale is a brief 7-item scale that collects information on intake and use of saturated fat in the diet during the previous month. A major emphasis in the diet instruction is how to reduce lard when preparing Mexican-American recipes. Questions on the Scale are specific to Mexican-American foods, e.g., "When you eat refried beans, what type of fat are they made with?" The Scale is a brief 7-item scale and item responses range from 1 to 4, representing never to always. Higher scores reflect higher intake of high-fat foods.
Measured: Baseline and 3 months
Changes from baseline to 6 months in the number of times high-fat foods were eaten during the previous month using the Saturated Fat/Cholesterol Avoidance Scale, a culturally-tailored instrument developed in Starr County
The Saturated Fat/Cholesterol Avoidance Scale is a brief 7-item scale that collects information on intake and use of saturated fat in the diet during the previous month. A major emphasis in the diet instruction is how to reduce lard when preparing Mexican-American recipes. Questions on the Scale are specific to Mexican-American foods, e.g., "When you eat refried beans, what type of fat are they made with?" The Scale is a brief 7-item scale and item responses range from 1 to 4, representing never to always. Higher scores reflect higher intake of high-fat foods.
Measured: Baseline and 6 months
Changes from baseline to 12 months in the number of times high-fat foods were eaten during the previous month using the Saturated Fat/Cholesterol Avoidance Scale, a culturally-tailored instrument developed in Starr County
The Saturated Fat/Cholesterol Avoidance Scale is a brief 7-item scale that collects information on intake and use of saturated fat in the diet during the previous month. A major emphasis in the diet instruction is how to reduce lard when preparing Mexican-American recipes. Questions on the Scale are specific to Mexican-American foods, e.g., "When you eat refried beans, what type of fat are they made with?" The Scale is a brief 7-item scale and item responses range from 1 to 4, representing never to always. Higher scores reflect higher intake of high-fat foods.
Measured: Baseline and 12 months
Changes from baseline to 24 months in the number of times high-fat foods were eaten during the previous month using the Saturated Fat/Cholesterol Avoidance Scale, a culturally-tailored instrument developed in Starr County
The Saturated Fat/Cholesterol Avoidance Scale is a brief 7-item scale that collects information on intake and use of saturated fat in the diet during the previous month. A major emphasis in the diet instruction is how to reduce lard when preparing Mexican-American recipes. Questions on the Scale are specific to Mexican-American foods, e.g., "When you eat refried beans, what type of fat are they made with?" The Scale is a brief 7-item scale and item responses range from 1 to 4, representing never to always. Higher scores reflect higher intake of high-fat foods.
Measured: Baseline and 24 months
Changes from baseline to 36 months in the number of times high-fat foods were eaten during the previous month using the Saturated Fat/Cholesterol Avoidance Scale, a culturally-tailored instrument developed in Starr County
The Saturated Fat/Cholesterol Avoidance Scale is a brief 7-item scale that collects information on intake and use of saturated fat in the diet during the previous month. A major emphasis in the diet instruction is how to reduce lard when preparing Mexican-American recipes. Questions on the Scale are specific to Mexican-American foods, e.g., "When you eat refried beans, what type of fat are they made with?" The Scale is a brief 7-item scale and item responses range from 1 to 4, representing never to always. Higher scores reflect higher intake of high-fat foods.
Measured: Baseline and 36 months
Change from baseline to 3 months in weekly average of daily steps walked using a Fitbit activity tracker
Each participant in the experimental group receives a free Fitbit activity tracker to monitor daily steps. An individual walking prescription is negotiated with each participant, with the general goal of individuals walking 10,000 steps per day. Walking data are automatically downloaded into secured software (Fitabase) for tracking.
Measured: Baseline and 3 months
Change from baseline to 6 months in weekly average of daily steps walked using a Fitbit activity tracker
Each participant in the experimental group receives a free Fitbit activity tracker to monitor daily steps. An individual walking prescription is negotiated with each participant, with the general goal of individuals walking 10,000 steps per day. Walking data are automatically downloaded into secured software (Fitabase) for tracking.
Measured: Baseline and 6 months
Change from baseline to 12 months in weekly average of daily steps walked using a Fitbit activity tracker
Each participant in the experimental group receives a free Fitbit activity tracker to monitor daily steps. An individual walking prescription is negotiated with each participant, with the general goal of individuals walking 10,000 steps per day. Walking data are automatically downloaded into secured software (Fitabase) for tracking.
Measured: Baseline and 12 months
Change from baseline to 24 months in weekly average of daily steps walked using a Fitbit activity tracker
Each participant in the experimental group receives a free Fitbit activity tracker to monitor daily steps. An individual walking prescription is negotiated with each participant, with the general goal of individuals walking 10,000 steps per day. Walking data are automatically downloaded into secured software (Fitabase) for tracking.
Measured: Baseline and 24 months
Change from baseline to 36 months in weekly average of daily steps walked using a Fitbit activity tracker
Each participant in the experimental group receives a free Fitbit activity tracker to monitor daily steps. An individual walking prescription is negotiated with each participant, with the general goal of individuals walking 10,000 steps per day. Walking data are automatically downloaded into secured software (Fitabase) for tracking.
Measured: Baseline and 36 months
Change from baseline to 3 months in perceived barriers to improving dietary habits using the Givens & Givens health beliefs: barriers subscale adapted for Starr County studies
The Health Beliefs: Barriers questionnaire is a subscale from the health belief instrument adapted from the Givens \& Givens Health Belief Scale. The instrument focuses on the barriers to following a prescribed diet. The instrument is a 12-item questionnaire and involves a Likert-type scale of 1-5; total scores range from 12 to 60 with higher scores indicating more barriers.
Measured: Baseline and 3 months
Change from baseline to 6 months in perceived barriers to improving dietary habits using the Givens & Givens health beliefs: barriers subscale adapted for Starr County studies
The Health Beliefs: Barriers questionnaire is a subscale from the health belief instrument adapted from the Givens \& Givens Health Belief Scale. The instrument focuses on the barriers to following a prescribed diet. The instrument is a 12-item questionnaire and involves a Likert-type scale of 1-5; total scores range from 12 to 60 with higher scores indicating more barriers.
Measured: Baseline and 6 months
Change from baseline to 12 months in perceived barriers to improving dietary habits using the Givens & Givens health beliefs: barriers subscale adapted for Starr County studies
The Health Beliefs: Barriers questionnaire is a subscale from the health belief instrument adapted from the Givens \& Givens Health Belief Scale. The instrument focuses on the barriers to following a prescribed diet. The instrument is a 12-item questionnaire and involves a Likert-type scale of 1-5; total scores range from 12 to 60 with higher scores indicating more barriers.
Measured: Baseline and 12 months
Change from baseline to 24 months in perceived barriers to improving dietary habits using the Givens & Givens health beliefs: barriers subscale adapted for Starr County studies
The Health Beliefs: Barriers questionnaire is a subscale from the health belief instrument adapted from the Givens \& Givens Health Belief Scale. The instrument focuses on the barriers to following a prescribed diet. The instrument is a 12-item questionnaire and involves a Likert-type scale of 1-5; total scores range from 12 to 60 with higher scores indicating more barriers.
Measured: Baseline and 24 months
Change from baseline to 36 months in perceived barriers to improving dietary habits using the Givens & Givens health beliefs: barriers subscale adapted for Starr County studies
The Health Beliefs: Barriers questionnaire is a subscale from the health belief instrument adapted from the Givens \& Givens Health Belief Scale. The instrument focuses on the barriers to following a prescribed diet. The instrument is a 12-item questionnaire and involves a Likert-type scale of 1-5; total scores range from 12 to 60 with higher scores indicating more barriers.
Measured: Baseline and 36 months
Change from baseline in blood cholesterol levels at 12 months
Standard procedures for measuring cholesterol include the use of the Monotest Cholesterol procedure. The test is adapted to automatic analysis using the Hitachi 911 analyzer, a totally self-contained computerized, programmable, fully automated chemistry analyzer.
Measured: Baseline and 12 months
Change from baseline in blood cholesterol levels at 24 months
Standard procedures for measuring cholesterol include the use of the Monotest Cholesterol procedure. The test is adapted to automatic analysis using the Hitachi 911 analyzer, a totally self-contained computerized, programmable, fully automated chemistry analyzer.
Measured: Baseline and 24 months
Change from baseline in blood cholesterol levels at 36 months
Standard procedures for measuring cholesterol include the use of the Monotest Cholesterol procedure. The test is adapted to automatic analysis using the Hitachi 911 analyzer, a totally self-contained computerized, programmable, fully automated chemistry analyzer.
Measured: Baseline and 36 months
Change from baseline in blood triglyceride levels at 12 months
Standard procedures for measuring triglycerides include the GPO Triglyceride procedure of Boehringer Mannheim. The test is adapted to automatic analysis using the Hitachi 911 analyzer. The Hitachi 911 analyzer is a totally self-contained computerized, programmable, fully automated chemistry analyzer.
Measured: Baseline and 12 months
Change from baseline in blood triglyceride levels at 24 months
Standard procedures for measuring triglycerides include the GPO Triglyceride procedure of Boehringer Mannheim. The test is adapted to automatic analysis using the Hitachi 911 analyzer. The Hitachi 911 analyzer is a totally self-contained computerized, programmable, fully automated chemistry analyzer.
Measured: Baseline and 24 months
Change from baseline in blood triglyceride levels at 36 months
Standard procedures for measuring triglycerides include the GPO Triglyceride procedure of Boehringer Mannheim. The test is adapted to automatic analysis using the Hitachi 911 analyzer. The Hitachi 911 analyzer is a totally self-contained computerized, programmable, fully automated chemistry analyzer.
Measured: Baseline and 36 months
Change from baseline in 2 hr.-Oral Glucose Tolerance Test (OGTT) at 12 months
A simplified 2-hour OGTT is used with blood collection while fasting and 120 minutes following a 75-gram liquid glucose challenge. These procedures enable classification of prediabetes and diabetes according to all current recommendations.
Measured: Baseline and 12 months
Change from baseline in 2 hr.-Oral Glucose Tolerance Test (OGTT) at 24 months
A simplified 2-hour OGTT is used with blood collection while fasting and 120 minutes following a 75-gram liquid glucose challenge. These procedures enable classification of prediabetes and diabetes according to all current recommendations.
Measured: Baseline and 24 months
Change from baseline in 2 hr.-Oral Glucose Tolerance Test (OGTT) at 36 months
A simplified 2-hour OGTT is used with blood collection while fasting and 120 minutes following a 75-gram liquid glucose challenge. These procedures enable classification of prediabetes and diabetes according to all current recommendations.
Measured: Baseline and 36 months
Change from baseline in blood pressure at 3 months
Blood pressure readings are taken using an automated device (Critikon Dinamap, Tampa, FL) following 5 minutes of sitting quietly. Measures of systolic (SBP) and diastolic (DBP) blood pressures involve averaging the second and third measures.
Measured: Baseline and 3 months
Change from baseline in blood pressure at 6 months
Blood pressure readings are taken using an automated device (Critikon Dinamap, Tampa, FL) following 5 minutes of sitting quietly. Measures of systolic (SBP) and diastolic (DBP) blood pressures involve averaging the second and third measures.
Measured: Baseline and 6 months
Change from baseline in blood pressure at 12 months
Blood pressure readings are taken using an automated device (Critikon Dinamap, Tampa, FL) following 5 minutes of sitting quietly. Measures of systolic (SBP) and diastolic (DBP) blood pressures involve averaging the second and third measures.
Measured: Baseline and 12 months
Change from baseline in blood pressure at 24 months
Blood pressure readings are taken using an automated device (Critikon Dinamap, Tampa, FL) following 5 minutes of sitting quietly. Measures of systolic (SBP) and diastolic (DBP) blood pressures involve averaging the second and third measures.
Measured: Baseline and 24 months
Change from baseline in blood pressure at 36 months
Blood pressure readings are taken using an automated device (Critikon Dinamap, Tampa, FL) following 5 minutes of sitting quietly. Measures of systolic (SBP) and diastolic (DBP) blood pressures involve averaging the second and third measures.
Measured: Baseline and 36 months
Change from baseline in depression measured with the Patient Health Questionnaire (PHQ-9) at 3 months
The Patient Health Questionnaire (PHQ-9) is a brief, 9-item instrument to screen for depression. It employs a 0 to 3 scale: not at all, several days, more than half the days, and nearly every day. A composite score of 5-9 indicates mild depression; 10-14 moderate depression; 15-19 moderately severe depression; and 20-17 severe depression.
Measured: Baseline and 3 months
Change from baseline in depression measured with the Patient Health Questionnaire (PHQ-9) at 6 months
The Patient Health Questionnaire (PHQ-9) is a brief, 9-item instrument to screen for depression. It employs a 0 to 3 scale: not at all, several days, more than half the days, and nearly every day. A composite score of 5-9 indicates mild depression; 10-14 moderate depression; 15-19 moderately severe depression; and 20-17 severe depression.
Measured: Baseline and 6 months
Change from baseline in depression measured with the Patient Health Questionnaire (PHQ-9) at 12 months
The Patient Health Questionnaire (PHQ-9) is a brief, 9-item instrument to screen for depression. It employs a 0 to 3 scale: not at all, several days, more than half the days, and nearly every day. A composite score of 5-9 indicates mild depression; 10-14 moderate depression; 15-19 moderately severe depression; and 20-17 severe depression.
Measured: Baseline and 12 months
Change from baseline in depression measured with the Patient Health Questionnaire (PHQ-9) at 24 months
The Patient Health Questionnaire (PHQ-9) is a brief, 9-item instrument to screen for depression. It employs a 0 to 3 scale: not at all, several days, more than half the days, and nearly every day. A composite score of 5-9 indicates mild depression; 10-14 moderate depression; 15-19 moderately severe depression; and 20-17 severe depression.
Measured: Baseline and 24 months
Change from baseline in depression measured with the Patient Health Questionnaire (PHQ-9) at 36 months
The Patient Health Questionnaire (PHQ-9) is a brief, 9-item instrument to screen for depression. It employs a 0 to 3 scale: not at all, several days, more than half the days, and nearly every day. A composite score of 5-9 indicates mild depression; 10-14 moderate depression; 15-19 moderately severe depression; and 20-17 severe depression.
Measured: Baseline and 36 months
Change from baseline in confidence to improve dietary behaviors, using the Weight Efficacy Lifestyle Questionnaire Short Form (WEL-SF) at 3 months
The Weight Efficacy Lifestyle Questionnaire, an 8-item instrument, measures how confident (or certain) one is that he/she will be able to resist overeating in a number of difficult situations, such as in social settings or watching TV. The scale is a Likert-type scale of 0 (not confident) to 10 (very confident). Total scores range from 0-80 and higher scores indicate higher self-efficacy.
Measured: Baseline and 3 months
Change from baseline in confidence to improve dietary behaviors, using the Weight Efficacy Lifestyle Questionnaire Short Form (WEL-SF) at 6 months
The Weight Efficacy Lifestyle Questionnaire, an 8-item instrument, measures how confident (or certain) one is that he/she will be able to resist overeating in a number of difficult situations, such as in social settings or watching TV. The scale is a Likert-type scale of 0 (not confident) to 10 (very confident). Total scores range from 0-80 and higher scores indicate higher self-efficacy.
Measured: Baseline and 6 months
Change from baseline in confidence to improve dietary behaviors, using the Weight Efficacy Lifestyle Questionnaire Short Form (WEL-SF) at 12 months
The Weight Efficacy Lifestyle Questionnaire, an 8-item instrument, measures how confident (or certain) one is that he/she will be able to resist overeating in a number of difficult situations, such as in social settings or watching TV. The scale is a Likert-type scale of 0 (not confident) to 10 (very confident). Total scores range from 0-80 and higher scores indicate higher self-efficacy.
Measured: Baseline and 12 months
Change from baseline in confidence to improve dietary behaviors, using the Weight Efficacy Lifestyle Questionnaire Short Form (WEL-SF) at 24 months
The Weight Efficacy Lifestyle Questionnaire, an 8-item instrument, measures how confident (or certain) one is that he/she will be able to resist overeating in a number of difficult situations, such as in social settings or watching TV. The scale is a Likert-type scale of 0 (not confident) to 10 (very confident). Total scores range from 0-80 and higher scores indicate higher self-efficacy.
Measured: Baseline and 24 months
Change from baseline in confidence to improve dietary behaviors, using the Weight Efficacy Lifestyle Questionnaire Short Form (WEL-SF) at 36 months
The Weight Efficacy Lifestyle Questionnaire, an 8-item instrument, measures how confident (or certain) one is that he/she will be able to resist overeating in a number of difficult situations, such as in social settings or watching TV. The scale is a Likert-type scale of 0 (not confident) to 10 (very confident). Total scores range from 0-80 and higher scores indicate higher self-efficacy.
Measured: Baseline and 36 months
Change from baseline in perceived stress at 12 months
To measure perceived stress, the NIH PROMIS questionnaire on perceived stress was added to the data collection plan. The instrument is a 10-item scale and each item is rated as 1 (never) to 5 (very often). Total scores range from 10 to 50, with higher scores indicating higher levels of perceived stress.
Measured: Change from baseline to 12 months
Change from baseline in perceived stress at 24 months
To measure perceived stress, the NIH PROMIS questionnaire on perceived stress was added to the data collection plan. The instrument is a 10-item scale and each item is rated as 1 (never) to 5 (very often). Total scores range from 10 to 50, with higher scores indicating higher levels of perceived stress.
Measured: Change from baseline to 24 months
Change from baseline in perceived stress at 36 months
To measure perceived stress, the NIH PROMIS questionnaire on perceived stress was added to the data collection plan. The instrument is a 10-item scale and each item is rated as 1 (never) to 5 (very often). Total scores range from 10 to 50, with higher scores indicating higher levels of perceived stress.
Measured: Change from baseline to 36 months
Text Messages Intervention - Follow-up Phone Call Interview
To measure participant satisfaction with the augmented text messaging revision to the intervention (in response to COVID-19 restrictions), the investigators developed a brief guide for follow-up phone interviews. Five questions are asked regarding changes in health, messages they remember from the video(s), questions they may have, preferences (text messages vs. in-person group sessions), and willingness to continue receiving future text messages.
Measured: 1 week after distribution of the videos
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2017
- Study start1 Apr 2017
- Primary completion31 Jul 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Prediabetic StateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study involves an examination of the effectiveness of a culturally-tailored diabetes prevention intervention using a randomized, repeated measures, pretest/post-test control group design. Groups are randomly assigned to: 1) the diabetes prevention intervention; or 2) an "enhanced" usual care control group. Outcome measurements are made at 3, 6, 12, 24, and 36 months post entry into the study to examine changes over time in key diabetes and health indicators.
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Collaborators
- The University of Texas Health Science Center, Houston
- Responsible party
- Principal investigator, Sharon A Brown, PhD, University of Texas at Austin
- Investigators
- Sharon A. Brown, PhD, Principal investigator, University of Texas at AustinCraig L. Hanis, PhD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03208010
- Sponsor's protocol ID
- R01DK109920
- Status last verified
- Oct 2023
- First submitted
- 22 Jun 2017
- Last updated
- 17 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brown SA, Perkison WB, Garcia AA, Cuevas HE, Velasquez MM, Winter MA, Hanis CL. The Starr County Border Health Initiative: Focus Groups on Diabetes Prevention in Mexican Americans. Diabetes Educ. 2018 Jun;44(3):293-306. doi: 10.1177/0145721718770143. Epub 2018 Apr 12.
PubMed 29644932Essigmann HT, Aguilar DA, Perkison WB, Bay KG, Deaton MR, Brown SA, Hanis CL, Brown EL. Epidemiology of Antibiotic Use and Drivers of Cross-Border Procurement in a Mexican American Border Community. Front Public Health. 2022 Mar 10;10:832266. doi: 10.3389/fpubh.2022.832266. eCollection 2022.
PubMed 35356027Brown SA, Becker HA, Garcia AA, Velasquez MM, Tanaka H, Winter MA, Perkison WB, Brown EL, Aguilar D, Hanis CL. The effects of gender and country of origin on acculturation, psychological factors, lifestyle factors, and diabetes-related physiological outcomes among Mexican Americans: The Starr County diabetes prevention initiative. Chronic Illn. 2023 Jun;19(2):444-457. doi: 10.1177/17423953221089315. Epub 2022 Mar 24.
PubMed 35331025Brown SA, Becker HA, Garcia AA, Velasquez MM, Tanaka H, Winter MA, Perkison WB, Brown EL, Aguilar D, Hanis CL. Acculturation, Dietary Behaviors, and Macronutrient Intake Among Mexican Americans With Prediabetes: The Starr County Diabetes Prevention Initiative. Sci Diabetes Self Manag Care. 2023 Feb;49(1):65-76. doi: 10.1177/26350106221146473. Epub 2023 Jan 23.
PubMed 36683588Brown SA, Winter MA, Becker HA, Garcia AA, Velasquez MM, Tanaka H, Perkison WB, Brown EL, Aguilar D, Hanis CL. Transitioning From an In-Person Intervention to Augmented Text Messaging During COVID-19 in Mexican Americans With Prediabetes: The Starr County Diabetes Prevention Randomized Clinical Trial. Sci Diabetes Self Manag Care. 2024 Apr;50(2):107-115. doi: 10.1177/26350106241233475. Epub 2024 Mar 7.
PubMed 38454633
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetes Prevention Culturally Tailored for Mexican Americans
- ClinicalTrials.gov ID
- NCT03208010
- Acronym / sponsor ID
- R01DK109920
- Conditions
- Prediabetic State, Overweight and Obesity
- Keywords
- health disparities, lifestyle behaviors, diabetes prevention, Hispanic health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Collaborators
- The University of Texas Health Science Center, Houston
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 5 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study tests a culturally tailored lifestyle intervention designed to prevent, or delay onset of, T2DM in Mexican Americans with prediabetes. Half the participants take part in a lifestyle program that emphasizes preparing and eating healthy Mexican American foods and increasing physical activity; the other half take part in an "enhanced" usual care control group.
Detailed description
The main purpose of this study is to test a culturally tailored lifestyle intervention that incorporates motivational interviewing and is designed to prevent, or delay onset of, T2DM in Mexican Americans with prediabetes. Groups of participants are randomly assigned to: a) an experimental group that receives a lifestyle program (12 2-hour weekly educational group sessions) that emphasizes preparing and eating healthy Mexican American foods and increasing physical activity, followed by 14 biweekly support group sessions to problem solve remaining barriers to adopting recommended behaviors and 3 booster sessions to enhance maintenance of behavioral changes; OR b) an "enhanced" usual care control group that receives lab results with individualized guidance and referrals. A secondary goal of the study is to examine the influence of genetic variation at selected candidate genes for glucose regulation on response to the lifestyle intervention.
The specific aims of the study are to:
- Test a culturally tailored lifestyle intervention that incorporates motivational interviewing and is designed to prevent, or delay onset of, T2DM in Mexican Americans with prediabetes. Groups of participants are randomly assigned to: a) an experimental group that receives a lifestyle program (12 2-hour weekly educational group sessions) that emphasizes preparing and eating healthy Mexican American foods and increasing physical activity, followed by 14 biweekly support group sessions to problem solve remaining barriers to adopting recommended behaviors and 3 booster sessions to enhance maintenance of behavioral changes; OR b) an "enhanced" usual care control group that receives lab results with individualized guidance and referrals. H1: The experimental group, compared to the control group, will have better health outcomes at 3, 6, 12, 24, and 36 months post baseline: 2-hour OGTT, A1C, FBG, lipids, blood pressure, health behaviors (physical activity, dietary intake), health beliefs: barriers, and anthropometrics (BMI [primary outcome], waist circumference). Other baseline measures - demographics and acculturation - characterize the population and correct for any baseline imbalances between groups.
- Prior to testing the intervention, we conduct focus groups in Starr County with participants of our previous DSMES studies, physicians from both sides of the border, local health officials, and key authority figures (Catholic priests, county officials) to fine tune intervention aspects in the context of diabetes prevention.
- Exploratory Aim: Examine the influence of genetic variation at selected candidate genes for glucose regulation on response to the lifestyle intervention.
The study addresses THE major public health problem of U.S.-Mexico border communities.
Note: In response to the COVID-19 pandemic, a remote version of the intervention was designed to provide the program remotely instead of via the usual in-person group format. A series of augmented text messages were developed that included 5 to 10-minute videos of a project dietitian or nurse talking about previously-learned content and demonstrating a simple, healthier method of preparing favorite recipe(s). The URLs of other related Spanish-language videos from the Internet are included and the text messages with videos are supplemented with phone calls from community workers to provide follow-up coaching for motivation. This alternative strategy is designed to replace the biweekly support groups, which in the past focused on similar content, i.e., reviewing key educational content, demonstrations of healthy Mexican American recipes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study involves an examination of the effectiveness of a culturally-tailored diabetes prevention intervention using a randomized, repeated measures, pretest/post-test control group design. Groups are randomly assigned to: 1) the diabetes prevention intervention; or 2) an "enhanced" usual care control group. Outcome measurements are made at 3, 6, 12, 24, and 36 months post entry into the study to examine changes over time in key diabetes and health indicators.
| Arm | Type | Receives |
|---|---|---|
| Diabetes Prevention Intervention | Experimental | Behavioral: Diabetes Prevention InterventionThe intervention is 12 weeks of education on diet and physical activity, followed by 15 biweekly support groups for problem solving. Then, 3 booster sessions are scheduled, each one at 6-month intervals. Further, motivational interviewing is infused into all group sessions. |
| Enhanced Usual Care | Active comparator | Other: Enhanced Usual CareThe comparator is an "enhanced" usual care control group that receives health care from personal physicians plus has access to: a) data collection sessions; b) individualized exit interviews with program staff after each data collection session to receive immediate feedback on lab results and trends in personal health indicators (e.g., BMI, A1C) and to ask questions; c) referral to a local physician or clinic, if needed; and d) Spanish-language materials on diabetes prevention. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- no prior diabetes diagnosis (except gestational)
- impaired fasting glucose (fasting glucose between 100 and 125 mg/dL) OR impaired glucose tolerance (between 140 and 199 mg/dL on a 2-hour post-load glucose tolerance test) OR A1C between 5.7% and 6.4%)
- have not previously participated in diabetes self-management education studies
- Mexican American
Key exclusion criteria (7 listed)
- diagnosed with diabetes at baseline
- fasting glucose greater than or equal to 126 mg/dL
- ever used hypoglycemic medication (except during pregnancy)
- are currently pregnant or within 3 months postpartum
- are migrant farmworkers who migrate for more than 2 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diabetes Prevention InterventionAlso: Culturally Tailored Diabetes Prevention* Educational sessions with emphasis on physical activity, healthy cultural diets, and strategies to promote positive behavioral changes. * Specific goals set for weight loss and physical activities * Fitbits provided for monitoring physical activity goals * Weekly review of and feedback on effects of physical activity (Fitbits) and dietary changes (checklists) * 15 biweekly support group sessions plus 3 booster sessions every 6 months thereafter Note: In response to the COVID-19 pandemic, a remote version of the intervention was designed to provide the program remotely instead of via the usual in-person group format. This alternative strategy is designed to replace the biweekly support groups, which in the past focused on similar content, i.e., reviewing key educational content, demonstrations of healthy Mexican American recipes. | Behavioural | Diabetes Prevention Intervention |
| Enhanced Usual Care* Monitoring by existing personal physicians * Feedback on lab results * Referrals to physicians or clinics, if needed * Diabetes prevention educational materials | Other | Enhanced Usual Care |
Primary outcome
Change from baseline in glycosylated hemoglobin (A1C) at 3 months
Time frame: Baseline and 3 months
A1C, an indicator of long-term glucose control, is measured as the percentage of red blood cells that are glycosylated (have a glucose molecule connected) and is analyzed onsite using a point-of-care device (Siemens DCA Vantage Analyzer, Malvern, PA).
Change from baseline in glycosylated hemoglobin (A1C) at 6 months
Time frame: Baseline and 6 months
A1C, an indicator of long-term glucose control, is measured as the percentage of red blood cells that are glycosylated (have a glucose molecule connected) and is analyzed onsite using a point-of-care device (Siemens DCA Vantage Analyzer, Malvern, PA).
Change from baseline in glycosylated hemoglobin (A1C) at 12 months
Time frame: Baseline and 12 months
A1C, an indicator of long-term glucose control, is measured as the percentage of red blood cells that are glycosylated (have a glucose molecule connected) and is analyzed onsite using a point-of-care device (Siemens DCA Vantage Analyzer, Malvern, PA).
Change from baseline in glycosylated hemoglobin (A1C) at 24 months
Time frame: Baseline and 24 months
A1C, an indicator of long-term glucose control, is measured as the percentage of red blood cells that are glycosylated (have a glucose molecule connected) and is analyzed onsite using a point-of-care device (Siemens DCA Vantage Analyzer, Malvern, PA).
Change from baseline in glycosylated hemoglobin (A1C) at 36 months
Time frame: Baseline and 36 months
A1C, an indicator of long-term glucose control, is measured as the percentage of red blood cells that are glycosylated (have a glucose molecule connected) and is analyzed onsite using a point-of-care device (Siemens DCA Vantage Analyzer, Malvern, PA).
Change from baseline in body mass index (BMI) at 3 months
Time frame: Baseline and 3 months
Body weights are measured with a balance beam scale with individuals in street clothing and without shoes. Heights are obtained using a secured stadiometer. BMI is calculated (weight(kg)/height/meters^2).
Change from baseline in body mass index (BMI) at 6 months
Time frame: Baseline and 6 months
Body weights are measured with a balance beam scale with individuals in street clothing and without shoes. Heights are obtained using a secured stadiometer. BMI is calculated (weight(kg)/height/meters^2).
Change from baseline in body mass index (BMI) at 12 months
Time frame: Baseline and 12 months
Body weights are measured with a balance beam scale with individuals in street clothing and without shoes. Heights are obtained using a secured stadiometer. BMI is calculated (weight(kg)/height/meters^2).
Change from baseline in body mass index (BMI) at 24 months
Time frame: Baseline and 24 months
Body weights are measured with a balance beam scale with individuals in street clothing and without shoes. Heights are obtained using a secured stadiometer. BMI is calculated (weight(kg)/height/meters^2).
Change from baseline in body mass index (BMI) at 36 months
Time frame: Baseline and 36 months
Body weights are measured with a balance beam scale with individuals in street clothing and without shoes. Heights are obtained using a secured stadiometer. BMI is calculated (weight(kg)/height/meters^2).
50 secondary outcomes
Change from baseline to 3 months in quality of life as measured with 1 researcher-developed item
Time frame: Baseline and 3 months
Change from baseline to 12 months in quality of life as measured with 1 researcher-developed item
Time frame: Baseline and 12 months
Change from baseline to 24 months in quality of life as measured with 1 researcher-developed item
Time frame: Baseline and 24 months
Change from baseline to 36 months in quality of life as measured with 1 researcher-developed item
Time frame: Baseline and 36 months
Changes from baseline to 12 months in number/amount of times foods were eaten during the previous month using the questionnaire entitled, Food Frequency Questionnaire for Starr County Health Studies (see McPherson et al., Ann Epidemiol, 1995).
Time frame: Baseline and 12 months
Changes from baseline to 24 months in number/amount of times foods were eaten during the previous month using the questionnaire entitled, Food Frequency Questionnaire for Starr County Health Studies (see McPherson et al., Ann Epidemiol, 1995)
Time frame: Baseline and 24 months
Changes from baseline to 36 months in number/amount of times foods were eaten during the previous month using the questionnaire entitled, Food Frequency Questionnaire for Starr County Health Studies (see McPherson et al., Ann Epidemiol, 1995)
Time frame: Baseline and 36 months
Changes from baseline to 3 months in the number of times high-fat foods were eaten during the previous month using the Saturated Fat/Cholesterol Avoidance Scale, a culturally-tailored instrument developed in Starr County
Time frame: Baseline and 3 months
Changes from baseline to 6 months in the number of times high-fat foods were eaten during the previous month using the Saturated Fat/Cholesterol Avoidance Scale, a culturally-tailored instrument developed in Starr County
Time frame: Baseline and 6 months
Changes from baseline to 12 months in the number of times high-fat foods were eaten during the previous month using the Saturated Fat/Cholesterol Avoidance Scale, a culturally-tailored instrument developed in Starr County
Time frame: Baseline and 12 months
Changes from baseline to 24 months in the number of times high-fat foods were eaten during the previous month using the Saturated Fat/Cholesterol Avoidance Scale, a culturally-tailored instrument developed in Starr County
Time frame: Baseline and 24 months
Changes from baseline to 36 months in the number of times high-fat foods were eaten during the previous month using the Saturated Fat/Cholesterol Avoidance Scale, a culturally-tailored instrument developed in Starr County
Time frame: Baseline and 36 months
Change from baseline to 3 months in weekly average of daily steps walked using a Fitbit activity tracker
Time frame: Baseline and 3 months
Change from baseline to 6 months in weekly average of daily steps walked using a Fitbit activity tracker
Time frame: Baseline and 6 months
Change from baseline to 12 months in weekly average of daily steps walked using a Fitbit activity tracker
Time frame: Baseline and 12 months
Change from baseline to 24 months in weekly average of daily steps walked using a Fitbit activity tracker
Time frame: Baseline and 24 months
Change from baseline to 36 months in weekly average of daily steps walked using a Fitbit activity tracker
Time frame: Baseline and 36 months
Change from baseline to 3 months in perceived barriers to improving dietary habits using the Givens & Givens health beliefs: barriers subscale adapted for Starr County studies
Time frame: Baseline and 3 months
Change from baseline to 6 months in perceived barriers to improving dietary habits using the Givens & Givens health beliefs: barriers subscale adapted for Starr County studies
Time frame: Baseline and 6 months
Change from baseline to 12 months in perceived barriers to improving dietary habits using the Givens & Givens health beliefs: barriers subscale adapted for Starr County studies
Time frame: Baseline and 12 months
Change from baseline to 24 months in perceived barriers to improving dietary habits using the Givens & Givens health beliefs: barriers subscale adapted for Starr County studies
Time frame: Baseline and 24 months
Change from baseline to 36 months in perceived barriers to improving dietary habits using the Givens & Givens health beliefs: barriers subscale adapted for Starr County studies
Time frame: Baseline and 36 months
Change from baseline in blood cholesterol levels at 12 months
Time frame: Baseline and 12 months
Change from baseline in blood cholesterol levels at 24 months
Time frame: Baseline and 24 months
Change from baseline in blood cholesterol levels at 36 months
Time frame: Baseline and 36 months
Change from baseline in blood triglyceride levels at 12 months
Time frame: Baseline and 12 months
Change from baseline in blood triglyceride levels at 24 months
Time frame: Baseline and 24 months
Change from baseline in blood triglyceride levels at 36 months
Time frame: Baseline and 36 months
Change from baseline in 2 hr.-Oral Glucose Tolerance Test (OGTT) at 12 months
Time frame: Baseline and 12 months
Change from baseline in 2 hr.-Oral Glucose Tolerance Test (OGTT) at 24 months
Time frame: Baseline and 24 months
Change from baseline in 2 hr.-Oral Glucose Tolerance Test (OGTT) at 36 months
Time frame: Baseline and 36 months
Change from baseline in blood pressure at 3 months
Time frame: Baseline and 3 months
Change from baseline in blood pressure at 6 months
Time frame: Baseline and 6 months
Change from baseline in blood pressure at 12 months
Time frame: Baseline and 12 months
Change from baseline in blood pressure at 24 months
Time frame: Baseline and 24 months
Change from baseline in blood pressure at 36 months
Time frame: Baseline and 36 months
Change from baseline in depression measured with the Patient Health Questionnaire (PHQ-9) at 3 months
Time frame: Baseline and 3 months
Change from baseline in depression measured with the Patient Health Questionnaire (PHQ-9) at 6 months
Time frame: Baseline and 6 months
Change from baseline in depression measured with the Patient Health Questionnaire (PHQ-9) at 12 months
Time frame: Baseline and 12 months
Change from baseline in depression measured with the Patient Health Questionnaire (PHQ-9) at 24 months
Time frame: Baseline and 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2023.
- Results publication: PubMed 29644932Brown SA, Perkison WB, Garcia AA, Cuevas HE, Velasquez MM, Winter MA, Hanis CL. The Starr County Border Health Initiative: Focus Groups on Diabetes Prevention in Mexican Americans. Diabetes Educ. 2018 Jun;44(3):293-306. doi: 10.1177/0145721718770143. Epub 2018 Apr 12.
- Results publication: PubMed 35356027Essigmann HT, Aguilar DA, Perkison WB, Bay KG, Deaton MR, Brown SA, Hanis CL, Brown EL. Epidemiology of Antibiotic Use and Drivers of Cross-Border Procurement in a Mexican American Border Community. Front Public Health. 2022 Mar 10;10:832266. doi: 10.3389/fpubh.2022.832266. eCollection 2022.
- Results publication: PubMed 35331025Brown SA, Becker HA, Garcia AA, Velasquez MM, Tanaka H, Winter MA, Perkison WB, Brown EL, Aguilar D, Hanis CL. The effects of gender and country of origin on acculturation, psychological factors, lifestyle factors, and diabetes-related physiological outcomes among Mexican Americans: The Starr County diabetes prevention initiative. Chronic Illn. 2023 Jun;19(2):444-457. doi: 10.1177/17423953221089315. Epub 2022 Mar 24.
- Results publication: PubMed 36683588Brown SA, Becker HA, Garcia AA, Velasquez MM, Tanaka H, Winter MA, Perkison WB, Brown EL, Aguilar D, Hanis CL. Acculturation, Dietary Behaviors, and Macronutrient Intake Among Mexican Americans With Prediabetes: The Starr County Diabetes Prevention Initiative. Sci Diabetes Self Manag Care. 2023 Feb;49(1):65-76. doi: 10.1177/26350106221146473. Epub 2023 Jan 23.
- Derived from this study: PubMed 38454633Brown SA, Winter MA, Becker HA, Garcia AA, Velasquez MM, Tanaka H, Perkison WB, Brown EL, Aguilar D, Hanis CL. Transitioning From an In-Person Intervention to Augmented Text Messaging During COVID-19 in Mexican Americans With Prediabetes: The Starr County Diabetes Prevention Randomized Clinical Trial. Sci Diabetes Self Manag Care. 2024 Apr;50(2):107-115. doi: 10.1177/26350106241233475. Epub 2024 Mar 7.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sharon A. Brown, PhD principal investigator
University of Texas at Austin
Craig L. Hanis, PhD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diabetes Prevention Intervention in people with Prediabetic State and Overweight and Obesity, run by University of Texas at Austin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in glycosylated hemoglobin (A1C) at 3 months (time frame: Baseline and 3 months). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03208010, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2023.