DiabetesNCT03113916
De Por Vida: A Diabetes Risk Reduction Intervention for Hispanic Women
A study testing Behavioural Lifestyle Intervention in people with Diabetes and Weight Loss, run by Kaiser Permanente.
Trial summary
This pragmatic randomized clinical trial will assess the efficacy, cost, and sustainability of a culturally tailored weight-loss program targeting obese Hispanic women with pre-diabetes or T2D. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Weight Loss, PreDiabetes
- What is being tested?
- Behavioural Lifestyle Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 195 participants
- Where
- No sites listed yet
- Study dates
- 23 Jun 2014to 5 Mar 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All participants will be patients who receive their primary medical care at the Virginia Garcia Memorial Health Center (VGMHC)
- Self-identified as Spanish-speaking Latina or Hispanic
- Female
- Age 18 and older
- BMI greater than or equal to 27kg/m2
- Classified as diabetic or prediabetic in the electronic medical record by at least one of the following:
Show all 15Show fewer
- Fasting plasma glucose ≥ 100
- 2-h post glucose level on the 75-g oral glucose tolerance test ≥ 140-199 mg/dL (7.8-11.0 mmol/L)
- Hemoglobin HBA1c ≥ 5.7
- Diagnosis of diabetes in patient's medical chart
- Diagnosis of prediabetes in patient's medical chart
- Residing in the Portland metropolitan area, and having no plans to leave the area in the next 18 months.
- Willing and able to attend the 26-weekly group meetings and 6 monthly group meetings.
- Willing to accept random assignment to the active intervention or enhanced usual care control.
- Clearance by the patient's VGMHC primary care physician to participate in the intervention.
Who cannot join
- Treatment for cancer in the past two years (excluding non-melanoma skin cancers).
- Having conditions that require limitation of physical activity or that would be contraindicated for the DASH (Dietary Approaches to Stop Hypertension) diet patterns.
- Taking weight-loss medication currently or within the past 6 months.
- Current or recent (< 12 months) pregnancy, breastfeeding, or planning pregnancy in the next 18 months.
About this study
Official title: Culturally Competent Behavioral Intervention for Diabetes Risk Reduction
This pragmatic randomized clinical trial will assess the efficacy, cost, and sustainability of a culturally tailored weight-loss program targeting obese Hispanic women with pre-diabetes or T2D. The intervention will be integrated into patient care at a Federally Qualified Health Center serving over 30,000 low-income patients, and will be delivered by trained clinic staff, with minimal support from research staff. After the effectiveness clinical trial, two cohorts of clinic patients will receive the intervention in a sustainability test.
Read the detailed description
Hispanic women have the highest estimated lifetime risk of developing diabetes of all ethnic/gender groups in the US, and their prevalence rates of overweight and obesity are among the highest in the US. Currently, nearly 90% of Hispanic women aged 40-59 are overweight or obese. If diagnosed with Type 2 diabetes (T2D) at age 40, Hispanic women are projected to lose 12.4 life-years, and 21.5 quality-adjusted life-years.
Several clinical trials have produced compelling evidence demonstrating the benefits of weight-loss interventions for both diabetic and pre-diabetic individuals, but most of the successful interventions tested in large clinical trials have been too costly for implementation in community settings, and they have not been assessed under real life conditions, targeting vulnerable populations.
This study builds on the investigators' success with a culturally-tailored weight-loss intervention designed for Hispanic women. Elements of cultural adaptation will include: women-only groups, skill-building tasks around food measurement, focus on traditional dietary habits and cultural norms regulating food preparation and consumption, interactive learning formats with a minimum of written materials, culturally congruent physical activity, and addressing acculturative concerns.
Follow-up data, including change in weight, waist circumference, and diabetes outcomes, will be collected at 6-, 12-, and 18-months post randomization. Additional analyses will include the cost of delivering the intervention and assessing the intervention's sustainability. The results of this study will inform the development of interventions to prevent diabetes onset or manage T2D in this population.
Description of Measures Used
Southwest Food Frequency Questionnaire (SWFFQ).
The Southwestern Food Frequency Questionnaire (SWFFQ) consists of 158 food items and was adapted from the Arizona Food Frequency Questionnaire. It provides a culturally appropriate means of collecting dietary information for the Southwestern U.S. Hispanic populations predominantly of Mexican descent. It is the only Spanish bicultural and bilingual questionnaire in widespread use in the country. Examples of food items that are included in the questionnaire are nopalitos (cactus leaves), corn and flour tortillas, refried beans, machaca, and chorizo. The SWFFQ has been tested for validity and reliability (Taren et al, 2000). The output provides 87 nutrients in addition to 25 derived variables such as percent of calories from fat. VALIDATION PAPER Taren D, Tobar M, Ritenbaugh C, Graver E, Whitacre R, Aickin M. Evaluation of the Southwest Food Frequency Questionnaire. Ecology of Food and Nutrition 38:515-547, 2000.
General Practice Physical Activity Questionnaire (GPPAQ)
The GPPAQ is a validated screening tool for use in primary care that is used to assess adult (16 - 74 years) physical activity levels. It provides a simple, 4-level Physical Activity Index (PAI) categorizing patients as: Active, Moderately Active, Moderately Inactive, and Inactive. SOURCE: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/192453/GPPAQ_-_guidance.pdf
Client Satisfaction Questionnaire (CSQ-8).
The CSQ-8 is a well-validated, 8-item Likert-type questionnaire that has been widely used in studies of physical and mental health among Spanish-speaking and Hispanic individuals. SOURCE http://www.csqscales.com/csq-8.htm
Barriers to Healthy Eating Questionnaire (BHEQ)
The BHE is a 22-item questionnaire asking individuals to rate various feelings or situations related to following the calorie and fat-restricted diet, eg, feelings of deprivation or cost of the recommended eating plan. It has 3 subscales: Emotions (11 items), Daily Mechanics of Following a Healthy Eating Plan (8 items), and Social Support (3 items). VALIDATION PAPER Impact of Perceived Barriers to Healthy Eating on Diet and Weight in a 24-Month Behavioral Weight Loss Trial. Wang, Jing et al. Journal of Nutrition Education and Behavior , Volume 47 , Issue 5 , 432 - 436.e1
Subjective Numeracy Scale
The Subjective Numeracy Scale (SNS) is a self-report measure of perceived ability to perform various mathematical tasks and preferences for the use of numerical versus prose information. The SNS has been validated against objective numeracy measures and found to predict comprehension of risk communications and ability to complete utility elicitations.
The De Por Vida study asked questions 3 and 4 of the SNS ability subscale which asked respondents to assess their numerical ability in different contexts. The scale contains no mathematics questions and has no correct or incorrect answers. VALIDATION PAPER Fagerlin, A., Zikmund-Fisher, B.J., Ubel, P.A., Jankovic, A., Derry, H.A., \& Smith, D.M. Measuring numeracy without a math test: Development of the Subjective Numeracy Scale (SNS). Medical Decision Making, 2007: 27: 672-680.
Screening Questions for Limited Health Literacy
We asked 3 screening questions to assess limited health literacy validated by Chew et al. VALIDATION PAPER Chew LD, Griffin JM, Partin MR, et al. Validation of Screening Questions for Limited Health Literacy in a Large VA Outpatient Population. Journal of General Internal Medicine. 2008;23(5):561-566. doi:10.1007/s11606-008-0520-5.
Language-Based Acculturation Scale
A simple scale for quantifying English use among Mexican Americans was constructed from four brief questions which proved to have excellent scaling characteristics by Guttman Scalogram Analysis in two independent data sets. Construct validity was established by significant associations of the scale with ethnicity, place of birth, generation within the United States, and type of neighborhood. Highly significant associations were found between scale scores and use of oral contraceptives, parity, "fatalism" regarding health, and attitudes toward folk healers. These associations remained significant (though weak) after controlling for education and family income. The language scale thus appears to be reliable and valid, to be capable of distinguishing meaningful subsets among the Mexican American population, and to be applicable to health care investigation. VALIDATION PAPER A Simple Language-based Acculturation Scale for Mexican Americans: Validation and Application to Health Care Research. Deyo, Richard A.; And Others. American Journal of Public Health, v75 n1 p51-55 Jan 1985
- Conditions
- Diabetes, Weight Loss, PreDiabetes, Obesity
- Being tested
- Behavioural Lifestyle Intervention
- Keywords
- Culturally-tailored, Weight Loss, Diabetes, Women, Hispanic, Obesity
- Medical subject headings
- Diabetes Mellitus, Weight Loss, Prediabetic State, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioural Lifestyle InterventionBehavioural
A culturally tailored behavioral intervention.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral | Experimental | 26 weekly behavioral intervention sessions 6 monthly behavioral intervention sessions Sessions focused on diet, physical activity, behavior change Receives: Behavioral: Behavioural Lifestyle Intervention |
| Enhanced usual care | No intervention | Printed materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight in Kilograms
Comparison of body weight trajectories in kilograms between the intervention and usual-care control groups.
Measured: Baseline, 6, 12, and 18 months
Waist Circumference in Centimeters
Comparison of waist circumference trajectories in centimeters between the intervention and usual-care control groups.
Measured: Baseline, 6, 12, and 18 months
Secondary outcomes (9)
Hemoglobin HbA1c % (Transformed Using the Inverse Cube, or 1/HbAlc%^3)
Comparison of hemoglobin HbA1c trajectories between the intervention and usual-care control groups.
Because of the severe kurtosis and skewness present in this outcome, a transformation (using the inverse cube, or 1/HbAlc%^3) was undertaken to better meet the assumptions of the analysis. Thus, the trajectory differences between arms were formally tested using the inverse cube of HbA1c, and back transforming the least square mean estimates from this model will not result in the least square means in the original metric. We performed a sensitivity analysis using the untransformed HbA1c, and that model exhibited poorer model fit. We can present the crude, observed means, or the least square means from the model using the untransformed HbA1c if it is of greater priority to have more direct interpretability of the HbA1c values than using the model that better meets the statistical assumptions.
Measured: Baseline, 6, 12 and 18 months from enrollment
Fasting Blood Glucose (Fbg; Transformed Using the Inverse Square, or 1/Fbg in mg/dl^2 )
Comparison of fasting blood glucose trajectories between the intervention and usual-care control groups.
Because of the severe kurtosis and skewness present in this outcome, a transformation (using the inverse square, or 1/fasting blood glucose in mg/dl^2) was undertaken to better meet the assumptions of the analysis. Thus, the trajectory differences between arms were formally tested using the inverse square of fasting blood glucose, and back transforming the least square mean estimates from this model will not result in the least square means in the original metric. We performed a sensitivity analysis using the untransformed fasting blood glucose, and that model exhibited poorer model fit. We can present the crude, observed means, or the least square means from the model using the untransformed fasting blood glucose if it is of greater priority to have more direct interpretability of the fasting blood glucose values than using the model that better meets the statistical assumptions.
Measured: Baseline, 6, 12, and 18 months
Total Cholesterol
Comparison of total cholesterol trajectories between the intervention and usual-care control groups.
Measured: Baseline, 6, 12, and 18 months
Number of Fruit Servings Per Day (Transformed Using the Natural Log)
Comparison of number fruit servings per day trajectories between the intervention and usual-care control groups.
Because of the severe kurtosis and skewness present in this outcome, a transformation (using the natural log) was undertaken to better meet the assumptions of the analysis. Thus, the trajectory differences between arms were formally tested using the log of the number of fruit servings per day, and back transforming the least square mean estimates from this model will not result in the least square means in the original metric. We performed a sensitivity analysis using the untransformed number of fruit servings per day, and that model exhibited poorer model fit. We can present the crude, observed means, or the least square means from the model using the untransformed number of fruit servings per day if it is of greater priority to have more direct interpretability of the # of fruit servings per day values than using the model that better meets the statistical assumptions.
Measured: Baseline, 6, 12, and 18 months
Number of Kilocalories
Comparison of the number of kilocalories trajectories between the intervention and usual-care control groups.
Measured: Baseline, 6, 12, and 18 months
Sugar Intake in Grams
Comparison of the sugar intake in grams trajectories between the intervention and usual-care control groups.
Measured: Baseline, 6, 12, and 18 months
Dietary Fiber Intake in Grams (Transformed Using the Natural Log)
Comparison of the dietary fiber intake in grams trajectories between the intervention and usual-care control groups.
Because of the severe kurtosis and skewness present in this outcome, a transformation (using the natural log) was undertaken to better meet the assumptions of the analysis. Thus, the trajectory differences between arms were formally tested using the log of the dietary fiber intake in grams and back transforming the least square mean estimates from this model will not result in the least square means in the original metric. We performed a sensitivity analysis using the untransformed dietary fiber intake in grams, and that model exhibited poorer model fit. We can present the crude, observed means, or the least square means from the model using the untransformed dietary fiber intake in grams if it is of greater priority to have more direct interpretability of the dietary fiber intake in grams values than using the model that better meets the statistical assumptions.
Measured: Baseline, 6, 12, and 18 months
Saturated Fat Intake as Percentage of Total Energy Intake
Comparison of the saturated fat intake as percentage of total energy intake trajectories between the intervention and usual-care control groups.
Measured: Baseline, 6, 12, and 18 months
Number of Vegetable Servings Per Day (Transformed Using the Natural Log)
Comparison of the dietary intake of the number of vegetable servings per day trajectories between the intervention and usual-care control groups.
Because of the severe kurtosis and skewness present in this outcome, a transformation (using the natural log) was undertaken to better meet the assumptions of the analysis. Thus, the trajectory differences between arms were formally tested using the log of the number of vegetable servings per day, and back transforming the least square mean estimates from this model will not result in the least square means in the original metric. We performed a sensitivity analysis using the untransformed outcome, and that model exhibited poorer model fit. We can present the crude, observed means, or the least square means from the model using the untransformed number of vegetable servings per day if it is of greater priority to have more direct interpretability of the outcome values than using the model that better meets the statistical assumptions.
Measured: Baseline, 6, 12, and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study start23 Jun 2014
- Primary completion5 Mar 2018
- Study completion5 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe sponsor's other registered studies.
- 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
- Trial participants are randomly assigned to one of two conditions: 1) Enhanced usual care control, or 2) a culturally tailored behavioral intervention.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- Arizona State University
- Responsible party
- Sponsor
- Investigators
- Nangel Lindberg, PhD, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03113916
- Sponsor's protocol ID
- 5R01DK099277-04
- Status last verified
- Sep 2020
- First submitted
- 5 Apr 2017
- Last updated
- 23 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lindberg NM, Vega-Lopez S, LeBlanc ES, Leo MC, Stevens VJ, Gille S, Arias-Gastelum M, Meenan R. Lessons Learned From a Program to Reduce Diabetes Risk Among Low-Income Hispanic Women in a Community Health Clinic. Front Endocrinol (Lausanne). 2021 Jan 8;11:489882. doi: 10.3389/fendo.2020.489882. eCollection 2020.
PubMed 33488511
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Culturally Competent Behavioral Intervention for Diabetes Risk Reduction
- ClinicalTrials.gov ID
- NCT03113916
- Acronym / sponsor ID
- 5R01DK099277-04
- Conditions
- Diabetes, Weight Loss, PreDiabetes, Obesity
- Keywords
- Culturally-tailored, Weight Loss, Diabetes, Women, Hispanic, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- Arizona State University
- Study start
- 23 Jun 2014 (actual)
- Primary completion
- 5 Mar 2018 (actual)
- Study completion
- 5 Mar 2018 (actual)
- First posted
- 14 Apr 2017 (actual)
- Results
- Posted 23 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pragmatic randomized clinical trial will assess the efficacy, cost, and sustainability of a culturally tailored weight-loss program targeting obese Hispanic women with pre-diabetes or T2D. The intervention will be integrated into patient care at a Federally Qualified Health Center serving over 30,000 low-income patients, and will be delivered by trained clinic staff, with minimal support from research staff. After the effectiveness clinical trial, two cohorts of clinic patients will receive the intervention in a sustainability test.
Detailed description
Hispanic women have the highest estimated lifetime risk of developing diabetes of all ethnic/gender groups in the US, and their prevalence rates of overweight and obesity are among the highest in the US. Currently, nearly 90% of Hispanic women aged 40-59 are overweight or obese. If diagnosed with Type 2 diabetes (T2D) at age 40, Hispanic women are projected to lose 12.4 life-years, and 21.5 quality-adjusted life-years.
Several clinical trials have produced compelling evidence demonstrating the benefits of weight-loss interventions for both diabetic and pre-diabetic individuals, but most of the successful interventions tested in large clinical trials have been too costly for implementation in community settings, and they have not been assessed under real life conditions, targeting vulnerable populations.
This study builds on the investigators' success with a culturally-tailored weight-loss intervention designed for Hispanic women. Elements of cultural adaptation will include: women-only groups, skill-building tasks around food measurement, focus on traditional dietary habits and cultural norms regulating food preparation and consumption, interactive learning formats with a minimum of written materials, culturally congruent physical activity, and addressing acculturative concerns.
Follow-up data, including change in weight, waist circumference, and diabetes outcomes, will be collected at 6-, 12-, and 18-months post randomization. Additional analyses will include the cost of delivering the intervention and assessing the intervention's sustainability. The results of this study will inform the development of interventions to prevent diabetes onset or manage T2D in this population.
Description of Measures Used
Southwest Food Frequency Questionnaire (SWFFQ).
The Southwestern Food Frequency Questionnaire (SWFFQ) consists of 158 food items and was adapted from the Arizona Food Frequency Questionnaire. It provides a culturally appropriate means of collecting dietary information for the Southwestern U.S. Hispanic populations predominantly of Mexican descent. It is the only Spanish bicultural and bilingual questionnaire in widespread use in the country. Examples of food items that are included in the questionnaire are nopalitos (cactus leaves), corn and flour tortillas, refried beans, machaca, and chorizo. The SWFFQ has been tested for validity and reliability (Taren et al, 2000). The output provides 87 nutrients in addition to 25 derived variables such as percent of calories from fat. VALIDATION PAPER Taren D, Tobar M, Ritenbaugh C, Graver E, Whitacre R, Aickin M. Evaluation of the Southwest Food Frequency Questionnaire. Ecology of Food and Nutrition 38:515-547, 2000.
General Practice Physical Activity Questionnaire (GPPAQ)
The GPPAQ is a validated screening tool for use in primary care that is used to assess adult (16 - 74 years) physical activity levels. It provides a simple, 4-level Physical Activity Index (PAI) categorizing patients as: Active, Moderately Active, Moderately Inactive, and Inactive. SOURCE: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/192453/GPPAQ_-_guidance.pdf
Client Satisfaction Questionnaire (CSQ-8).
The CSQ-8 is a well-validated, 8-item Likert-type questionnaire that has been widely used in studies of physical and mental health among Spanish-speaking and Hispanic individuals. SOURCE http://www.csqscales.com/csq-8.htm
Barriers to Healthy Eating Questionnaire (BHEQ)
The BHE is a 22-item questionnaire asking individuals to rate various feelings or situations related to following the calorie and fat-restricted diet, eg, feelings of deprivation or cost of the recommended eating plan. It has 3 subscales: Emotions (11 items), Daily Mechanics of Following a Healthy Eating Plan (8 items), and Social Support (3 items). VALIDATION PAPER Impact of Perceived Barriers to Healthy Eating on Diet and Weight in a 24-Month Behavioral Weight Loss Trial. Wang, Jing et al. Journal of Nutrition Education and Behavior , Volume 47 , Issue 5 , 432 - 436.e1
Subjective Numeracy Scale
The Subjective Numeracy Scale (SNS) is a self-report measure of perceived ability to perform various mathematical tasks and preferences for the use of numerical versus prose information. The SNS has been validated against objective numeracy measures and found to predict comprehension of risk communications and ability to complete utility elicitations.
The De Por Vida study asked questions 3 and 4 of the SNS ability subscale which asked respondents to assess their numerical ability in different contexts. The scale contains no mathematics questions and has no correct or incorrect answers. VALIDATION PAPER Fagerlin, A., Zikmund-Fisher, B.J., Ubel, P.A., Jankovic, A., Derry, H.A., \& Smith, D.M. Measuring numeracy without a math test: Development of the Subjective Numeracy Scale (SNS). Medical Decision Making, 2007: 27: 672-680.
Screening Questions for Limited Health Literacy
We asked 3 screening questions to assess limited health literacy validated by Chew et al. VALIDATION PAPER Chew LD, Griffin JM, Partin MR, et al. Validation of Screening Questions for Limited Health Literacy in a Large VA Outpatient Population. Journal of General Internal Medicine. 2008;23(5):561-566. doi:10.1007/s11606-008-0520-5.
Language-Based Acculturation Scale
A simple scale for quantifying English use among Mexican Americans was constructed from four brief questions which proved to have excellent scaling characteristics by Guttman Scalogram Analysis in two independent data sets. Construct validity was established by significant associations of the scale with ethnicity, place of birth, generation within the United States, and type of neighborhood. Highly significant associations were found between scale scores and use of oral contraceptives, parity, "fatalism" regarding health, and attitudes toward folk healers. These associations remained significant (though weak) after controlling for education and family income. The language scale thus appears to be reliable and valid, to be capable of distinguishing meaningful subsets among the Mexican American population, and to be applicable to health care investigation. VALIDATION PAPER A Simple Language-based Acculturation Scale for Mexican Americans: Validation and Application to Health Care Research. Deyo, Richard A.; And Others. American Journal of Public Health, v75 n1 p51-55 Jan 1985
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Trial participants are randomly assigned to one of two conditions: 1) Enhanced usual care control, or 2) a culturally tailored behavioral intervention.
| Arm | Type | Receives |
|---|---|---|
| Behavioral | Experimental | Behavioral: Behavioural Lifestyle Intervention26 weekly behavioral intervention sessions 6 monthly behavioral intervention sessions Sessions focused on diet, physical activity, behavior change |
| Enhanced usual care | No intervention | –Printed materials |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- All participants will be patients who receive their primary medical care at the Virginia Garcia Memorial Health Center (VGMHC)
- Self-identified as Spanish-speaking Latina or Hispanic
- Female
- Age 18 and older
- BMI greater than or equal to 27kg/m2
Key exclusion criteria (4 listed)
- Treatment for cancer in the past two years (excluding non-melanoma skin cancers).
- Having conditions that require limitation of physical activity or that would be contraindicated for the DASH (Dietary Approaches to Stop Hypertension) diet patterns.
- Taking weight-loss medication currently or within the past 6 months.
- Current or recent (< 12 months) pregnancy, breastfeeding, or planning pregnancy in the next 18 months.
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 |
|---|---|---|
| Behavioural Lifestyle InterventionA culturally tailored behavioral intervention. | Behavioural | Behavioral |
Primary outcome
Weight in Kilograms
Time frame: Baseline, 6, 12, and 18 months
Comparison of body weight trajectories in kilograms between the intervention and usual-care control groups.
Waist Circumference in Centimeters
Time frame: Baseline, 6, 12, and 18 months
Comparison of waist circumference trajectories in centimeters between the intervention and usual-care control groups.
9 secondary outcomes
Hemoglobin HbA1c % (Transformed Using the Inverse Cube, or 1/HbAlc%^3)
Time frame: Baseline, 6, 12 and 18 months from enrollment
Fasting Blood Glucose (Fbg; Transformed Using the Inverse Square, or 1/Fbg in mg/dl^2 )
Time frame: Baseline, 6, 12, and 18 months
Total Cholesterol
Time frame: Baseline, 6, 12, and 18 months
Number of Fruit Servings Per Day (Transformed Using the Natural Log)
Time frame: Baseline, 6, 12, and 18 months
Number of Kilocalories
Time frame: Baseline, 6, 12, and 18 months
Sugar Intake in Grams
Time frame: Baseline, 6, 12, and 18 months
Dietary Fiber Intake in Grams (Transformed Using the Natural Log)
Time frame: Baseline, 6, 12, and 18 months
Saturated Fat Intake as Percentage of Total Energy Intake
Time frame: Baseline, 6, 12, and 18 months
Number of Vegetable Servings Per Day (Transformed Using the Natural Log)
Time frame: Baseline, 6, 12, and 18 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33488511Lindberg NM, Vega-Lopez S, LeBlanc ES, Leo MC, Stevens VJ, Gille S, Arias-Gastelum M, Meenan R. Lessons Learned From a Program to Reduce Diabetes Risk Among Low-Income Hispanic Women in a Community Health Clinic. Front Endocrinol (Lausanne). 2021 Jan 8;11:489882. doi: 10.3389/fendo.2020.489882. eCollection 2020.
- 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.
Nangel Lindberg, PhD principal investigator
Kaiser Permanente
Questions about this trial
What is this clinical trial studying?
A study testing Behavioural Lifestyle Intervention in people with Diabetes and Weight Loss, run by Kaiser Permanente.
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 15 inclusion and 4 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 23 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 23 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Weight in Kilograms (time frame: Baseline, 6, 12, and 18 months). The study lists 2 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 NCT03113916, which also lists 1 linked publication.
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 23 Sep 2020.