ObesityNCT03978416
Development of Novel Behavioral Intervention for Sustainable Weight Loss in Hispanic Adults With Obesity
A study testing Healthy Weight for Living for Hispanics in people with Obesity, run by Tufts University at 1 site in United States.
Trial summary
There are great disparities in the prevalence of obesity and chronic disease in different sociodemographic groups. US Hispanic adults, in particular, have a higher prevalence of obesity and chronic diseases than non-Hispanic whites. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- Healthy Weight for Living for Hispanics
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Aug 2019to 16 Jul 2020
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Focus groups and Intervention:
- Adult men and women older than 50 years.
- Self-identifying as having Hispanic ethnicity, originating from Spanish-speaking Latin-American country.
- BMI ≥30.0 kg/m2.
- Intervention only:
- Willing to give informed consent.
- All individuals wishing to participate in the intervention part of this study will be required to agree to inform their physician prior to enrollment and to notify the Tufts team if their physician recommends against weight loss for any reason. A physician's clearance form will be provided by Tufts to all participants wishing to enroll in the intervention. Participants will be required to obtain their physicians' signature and their physician will send the completed form to us. We will enroll them only after we have obtained a signed physician clearance form.
- Willing to participate in a behavioral intervention for weight loss.
Who cannot join
- Intervention only:
- Self-reported weight loss >5 kg within past 6 months.
- Diagnosed gastrointestinal conditions, including celiac disease.
- Communicable or chronic diseases or medication use that would preclude safe and active study participation.
- Pregnancy or anticipated pregnancy within the study,
- Lactation, or giving birth within 6 months prior to enrollment.
Show all 10Show fewer
- Participation in other clinical trials.
- Illiteracy.
- Use of anti-obesity medications within the past year.
- Being on any special diets that would prevent following recommendations made through the program.
Trial locations and contacts
1 site in 1 country.
United States1 site
Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University
Boston, Massachusetts, 02111
About this study
There are great disparities in the prevalence of obesity and chronic disease in different sociodemographic groups. US Hispanic adults, in particular, have a higher prevalence of obesity and chronic diseases than non-Hispanic whites. Population aging is also a major contributing factor to the high prevalence of chronic disease, and Hispanics already make up approximately 10% of the older population. Therefore, preventive measures are needed to reduce the burden of chronic disease risks for Hispanics. Current lifestyle interventions for weight management have been particularly ineffective in this population.
The purpose of this pilot project is to develop a novel tailored lifestyle intervention for use by Hispanic older adults with obesity. The Healthy Weight for Living intervention has been validated among adults with mixed racial/ethnic backgrounds and has achieved clinically impactful weight-loss. Its design features make it particularly suitable for use in populations with low adherence to traditional interventions, including no requirement for daily food logging and no increase in physical activity.
The final product of this project will be a culturally adapted prototype intervention in Hispanic older adults that accounts for cultural heterogeneity. This work has direct relevance to reducing health disparities and the burden of obesity-associated chronic disease in a particularly at-risk population.
Read the detailed description
The scientific premise of this project is that appropriately tailored lifestyle interventions for weight loss can achieve clinically impactful weight loss in Hispanic adults with obesity. Older adults will be the focus, recognizing that requirements for tailoring may vary according to age group. Given that older adults have a higher risk of chronic diseases caused by obesity, there is a great need to focus on factors that disproportionately affect older Hispanic adults. The objective of this project is to tailor a validated lifestyle intervention developed and used by our team in ethnically mixed populations to older Hispanic adults with obesity. This novel intervention does not require food logging or a large increase in physical activity to achieve weight loss, making it more acceptable to population groups with low adherence to traditional interventions. The long-term goal of this work is to create an effective, culturally acceptable, sustainable, and scalable lifestyle weight management program for routine use in Hispanic adults with obesity. Findings from this work will be directly applicable to future community interventions and will be relevant for public health measures in this at-risk population.
The specific aims are:
Aim 1: To conduct focus groups in Hispanic older adults with obesity to identify factors that can be addressed in the tailored intervention. Information will be collected on practical and cultural barriers and promoters of successful weight management, including food access, dietary patterns, physical activity, time and financial constraints, and additional psychosocial and cultural factors.
Hypothesis 1: Malleable dietary and psychosocial targets for weight loss and weight loss maintenance can be identified, including factors such as food cravings, hunger and disinhibited eating that have been shown to be effective targets in other population groups.
Aim 2: To conduct a pilot behavioral intervention of an initially adapted program in Hispanic older adults with obesity. A prototype bilingual English-Spanish lifestyle intervention for weight reduction will be created. The prototype will then be iteratively refined during a series of short-term tests (two tests lasting 4 weeks, followed by a final test lasting 12 weeks) of intervention delivery. In these interventions, % weight loss, % drop-out, and safety benchmarks will be monitored. Participant-reported barriers to adherence identified during group meetings and exit interviews will be targets for improvement in successive iterations.
Hypothesis 2: Successive refinement of the program will result in progressive improvements in mean % weight loss and participant retention.
The final products of this project will be: a) a prototype adapted intervention in older US adults of Hispanic background, accounting for cultural heterogeneity in this population; and b) identification of additional barriers that can be addressed in subsequent iterations of the intervention.
- Conditions
- Obesity
- Being tested
- Healthy Weight for Living for Hispanics
- Keywords
- Obesity, Weight loss, Hispanic / Latino, Older adults, Eating habits
- Medical subject headings
- Obesity, Weight Loss, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Weight for Living for HispanicsBehavioural
The Healthy Weight for Living (HWL) intervention, previously developed at the Energy Metabolism Laboratory (HNRCA), is broadly informed by the same behavior change theories as other interventions. For example, it also recognizes individual and environmental factors as potential areas to support behavior change for weight regulation, and provides practical tools for facilitating new habits. However, the HWL places greater emphasis on the role of biology in influencing eating behavior, giving a central role to hunger and food cravings as modulators of eating behavior. Therefore, HWL does not emphasize self-monitoring food intake and does not require increasing physical activity for effectiveness. The new intervention also targets autonomous motivation and prioritizes ease of implementation.
Information from focus groups and sequential pilots will be used to develop a culturally tailored prototype version of Healthy Weight for Living that is acceptable for Hispanic older adults.
| Study group | Role | What they receive |
|---|---|---|
| Focus groups | No intervention | Information on practical and cultural barriers and promoters of successful weight management will be collected through focus groups. This will include include food access, dietary patterns, physical activity, time and financial constraints, and additional psychosocial and cultural factors. A total of 30 participants will be recruited for the focus groups. |
| Pilot behavioral intervention | Experimental | A prototype bilingual English-Spanish lifestyle intervention for weight reduction will be created. The prototype will then be iteratively refined during a series of short-term tests with 5 participants per test (two tests lasting 4 weeks, followed by a final test lasting 12 weeks) of intervention delivery. Receives: Behavioral: Healthy Weight for Living for Hispanics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight change
Change in weight from baseline to the end of the intervention period
Measured: Pilot 1 and 2: 4 weeks. Pilot 3: 12 weeks
Attendance to weekly group meetings
Adherence will be measured as meeting attendance
Measured: Pilot 1 and 2: 4 weeks. Pilot 3: 12 weeks
Secondary outcomes (10)
Change in blood pressure (systolic and diastolic)
Change in systolic and diastolic blood pressure from baseline to the end of the intervention period
Measured: Depending on pilot phase the time frame will be 4 weeks or 12 weeks
Change in waist circumference
Change in waist circumference from baseline to the end of the intervention period
Measured: Depending on pilot phase the time frame will be 4 weeks or 12 weeks
Change in hip circumference
Change in hip circumference from baseline to the end of the intervention period
Measured: Depending on pilot phase the time frame will be 4 weeks or 12 weeks
Themes generated from qualitative data
For the first phase of the study, focus groups will be analyzed and themes on eating behavior and barriers to successful weight management will be identified.
For the intervention phase of the study, exit interviews will be completed at the end of each pilot cycle.
Measured: Baseline, 4 weeks for pilot cycles 1 and 2, and 12 weeks for pilot cycle 3
Financial well-being
Financial well-being questionnaire (4 items). Financial satisfaction (1 item) Financial difficulty (1 item) Financial control (1 item) Scores are standardized and summed to capture financial well-being. Higher scores indicate more financial well-being.
Measured: Baseline
Dietary intake
NHANES Dietary Screener Questionnaire (DSQ, 26 items). The DSQ scoring algorithms developed at the National Cancer Institute will be used to calculate estimated intakes of food groups and certain nutrients: fruits and vegetables (cup equivalents), dairy (cup equivalents), added sugars (teaspoon equivalents), whole grains (ounce equivalents), and fiber (g).
Source: https://epi.grants.cancer.gov/nhanes/dietscreen/scoring/current/#scoring
Measured: Baseline
Dietary behavior
Latino Dietary Behaviors Questionnaire (LDBQ, 13 items)
Possible scores:
Health dietary changes score range: 0 to 19 Artificial sweeteners in drinks score range: 0 to 13 Number of meals per day score range: 0 to 6 Fat consumption score range: 0 to 9 Total LDBQ score range (sum of all items): 0 to 47 Lower scores indicate poorer dietary behaviors.
Measured: Baseline
Perceived stress
Perceived Stress Scale 4 (PSS-4, 4 items) Score range: 0 to 16. Higher scores are correlated to more stress.
Measured: Baseline
Eating behavior (hunger, satiety, cognitive restraint)
Three factor eating questionnaire (TFEQ, 51 items) Cognitive restraint score range: 0 to 21 Disinhibition score range: 0 to 16 Hunger score range: 0 to 14 Higher scores indicate higher degrees of the particular eating behavior.
Measured: Baseline
Acculturation
Short Acculturation Scale for Hispanics (SASH, 12 items) Each item response is based on a five-point bipolar scale. Scores are calculated by taking the average rating across all items. Higher scores indicate higher acculturation.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2019
- Study start23 Aug 2019
- Primary completion16 Jul 2020
- Study completion16 Jul 2020
Why it stopped: The study was terminated due to the SARS-CoV-2 pandemic. Aim 1 was completed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- A prototype bilingual English-Spanish lifestyle intervention for weight reduction will be created. The prototype will then be iteratively refined during a series of short-term tests (two tests lasting 4 weeks, followed by a final test lasting 12 weeks) of intervention delivery. In these interventions, % weight loss, % drop-out, and safety benchmarks will be monitored. Participant-reported barriers to adherence identified during group meetings and exit interviews will be targets for improvement in successive iterations.
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Carlota Dao, Tufts University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03978416
- Sponsor's protocol ID
- 13352
- Status last verified
- Jul 2020
- First submitted
- 3 Jun 2019
- Last updated
- 21 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dao MC, Yu Z, Maafs-Rodriguez A, Moser B, Cuevas AG, Economos CD, Roberts SB. Perceived intrinsic, social, and environmental barriers for weight management in older Hispanic/Latino adults with obesity. Obes Sci Pract. 2022 Aug 31;9(2):145-157. doi: 10.1002/osp4.631. eCollection 2023 Apr.
PubMed 37034568
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Novel Behavioral Intervention for Sustainable Weight Loss in Hispanic Adults With Obesity
- ClinicalTrials.gov ID
- NCT03978416
- Acronym / sponsor ID
- 13352
- Conditions
- Obesity
- Keywords
- Obesity, Weight loss, Hispanic / Latino, Older adults, Eating habits
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated due to the SARS-CoV-2 pandemic. Aim 1 was completed.
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Study start
- 23 Aug 2019 (actual)
- Primary completion
- 16 Jul 2020 (actual)
- Study completion
- 16 Jul 2020 (actual)
- First posted
- 7 Jun 2019 (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.
There are great disparities in the prevalence of obesity and chronic disease in different sociodemographic groups. US Hispanic adults, in particular, have a higher prevalence of obesity and chronic diseases than non-Hispanic whites. Population aging is also a major contributing factor to the high prevalence of chronic disease, and Hispanics already make up approximately 10% of the older population. Therefore, preventive measures are needed to reduce the burden of chronic disease risks for Hispanics. Current lifestyle interventions for weight management have been particularly ineffective in this population.
The purpose of this pilot project is to develop a novel tailored lifestyle intervention for use by Hispanic older adults with obesity. The Healthy Weight for Living intervention has been validated among adults with mixed racial/ethnic backgrounds and has achieved clinically impactful weight-loss. Its design features make it particularly suitable for use in populations with low adherence to traditional interventions, including no requirement for daily food logging and no increase in physical activity.
The final product of this project will be a culturally adapted prototype intervention in Hispanic older adults that accounts for cultural heterogeneity. This work has direct relevance to reducing health disparities and the burden of obesity-associated chronic disease in a particularly at-risk population.
Detailed description
The scientific premise of this project is that appropriately tailored lifestyle interventions for weight loss can achieve clinically impactful weight loss in Hispanic adults with obesity. Older adults will be the focus, recognizing that requirements for tailoring may vary according to age group. Given that older adults have a higher risk of chronic diseases caused by obesity, there is a great need to focus on factors that disproportionately affect older Hispanic adults. The objective of this project is to tailor a validated lifestyle intervention developed and used by our team in ethnically mixed populations to older Hispanic adults with obesity. This novel intervention does not require food logging or a large increase in physical activity to achieve weight loss, making it more acceptable to population groups with low adherence to traditional interventions. The long-term goal of this work is to create an effective, culturally acceptable, sustainable, and scalable lifestyle weight management program for routine use in Hispanic adults with obesity. Findings from this work will be directly applicable to future community interventions and will be relevant for public health measures in this at-risk population.
The specific aims are:
Aim 1: To conduct focus groups in Hispanic older adults with obesity to identify factors that can be addressed in the tailored intervention. Information will be collected on practical and cultural barriers and promoters of successful weight management, including food access, dietary patterns, physical activity, time and financial constraints, and additional psychosocial and cultural factors.
Hypothesis 1: Malleable dietary and psychosocial targets for weight loss and weight loss maintenance can be identified, including factors such as food cravings, hunger and disinhibited eating that have been shown to be effective targets in other population groups.
Aim 2: To conduct a pilot behavioral intervention of an initially adapted program in Hispanic older adults with obesity. A prototype bilingual English-Spanish lifestyle intervention for weight reduction will be created. The prototype will then be iteratively refined during a series of short-term tests (two tests lasting 4 weeks, followed by a final test lasting 12 weeks) of intervention delivery. In these interventions, % weight loss, % drop-out, and safety benchmarks will be monitored. Participant-reported barriers to adherence identified during group meetings and exit interviews will be targets for improvement in successive iterations.
Hypothesis 2: Successive refinement of the program will result in progressive improvements in mean % weight loss and participant retention.
The final products of this project will be: a) a prototype adapted intervention in older US adults of Hispanic background, accounting for cultural heterogeneity in this population; and b) identification of additional barriers that can be addressed in subsequent iterations of the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A prototype bilingual English-Spanish lifestyle intervention for weight reduction will be created. The prototype will then be iteratively refined during a series of short-term tests (two tests lasting 4 weeks, followed by a final test lasting 12 weeks) of intervention delivery. In these interventions, % weight loss, % drop-out, and safety benchmarks will be monitored. Participant-reported barriers to adherence identified during group meetings and exit interviews will be targets for improvement in successive iterations.
| Arm | Type | Receives |
|---|---|---|
| Focus groups | No intervention | –Information on practical and cultural barriers and promoters of successful weight management will be collected through focus groups. This will include include food access, dietary patterns, physical activity, time and financial constraints, and additional psychosocial and cultural factors. A total of 30 participants will be recruited for the focus groups. |
| Pilot behavioral intervention | Experimental | Behavioral: Healthy Weight for Living for HispanicsA prototype bilingual English-Spanish lifestyle intervention for weight reduction will be created. The prototype will then be iteratively refined during a series of short-term tests with 5 participants per test (two tests lasting 4 weeks, followed by a final test lasting 12 weeks) of intervention delivery. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adult men and women older than 50 years.
- Self-identifying as having Hispanic ethnicity, originating from Spanish-speaking Latin-American country.
- BMI ≥30.0 kg/m2.
- Willing to give informed consent.
- All individuals wishing to participate in the intervention part of this study will be required to agree to inform their physician prior to enrollment and to notify the Tufts team if their physician recommends against weight loss for any reason. A physician's clearance form will be provided by Tufts to all participants wishing to enroll in the intervention. Participants will be required to obtain their physicians' signature and their physician will send the completed form to us. We will enroll them only after we have obtained a signed physician clearance form.
Key exclusion criteria (10 listed)
- Self-reported weight loss >5 kg within past 6 months.
- Diagnosed gastrointestinal conditions, including celiac disease.
- Communicable or chronic diseases or medication use that would preclude safe and active study participation.
- Pregnancy or anticipated pregnancy within the study,
- Lactation, or giving birth within 6 months prior to enrollment.
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 |
|---|---|---|
| Healthy Weight for Living for HispanicsThe Healthy Weight for Living (HWL) intervention, previously developed at the Energy Metabolism Laboratory (HNRCA), is broadly informed by the same behavior change theories as other interventions. For example, it also recognizes individual and environmental factors as potential areas to support behavior change for weight regulation, and provides practical tools for facilitating new habits. However, the HWL places greater emphasis on the role of biology in influencing eating behavior, giving a central role to hunger and food cravings as modulators of eating behavior. Therefore, HWL does not emphasize self-monitoring food intake and does not require increasing physical activity for effectiveness. The new intervention also targets autonomous motivation and prioritizes ease of implementation. Information from focus groups and sequential pilots will be used to develop a culturally tailored prototype version of Healthy Weight for Living that is acceptable for Hispanic older adults. | Behavioural | Pilot behavioral intervention |
Primary outcome
Weight change
Time frame: Pilot 1 and 2: 4 weeks. Pilot 3: 12 weeks
Change in weight from baseline to the end of the intervention period
Attendance to weekly group meetings
Time frame: Pilot 1 and 2: 4 weeks. Pilot 3: 12 weeks
Adherence will be measured as meeting attendance
10 secondary outcomes
Change in blood pressure (systolic and diastolic)
Time frame: Depending on pilot phase the time frame will be 4 weeks or 12 weeks
Change in waist circumference
Time frame: Depending on pilot phase the time frame will be 4 weeks or 12 weeks
Change in hip circumference
Time frame: Depending on pilot phase the time frame will be 4 weeks or 12 weeks
Themes generated from qualitative data
Time frame: Baseline, 4 weeks for pilot cycles 1 and 2, and 12 weeks for pilot cycle 3
Financial well-being
Time frame: Baseline
Dietary intake
Time frame: Baseline
Dietary behavior
Time frame: Baseline
Perceived stress
Time frame: Baseline
Eating behavior (hunger, satiety, cognitive restraint)
Time frame: Baseline
Acculturation
Time frame: Baseline
Results and safety
The study was stopped early (reason given: The study was terminated due to the SARS-CoV-2 pandemic. Aim 1 was completed.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2020.
- Derived from this study: PubMed 37034568Dao MC, Yu Z, Maafs-Rodriguez A, Moser B, Cuevas AG, Economos CD, Roberts SB. Perceived intrinsic, social, and environmental barriers for weight management in older Hispanic/Latino adults with obesity. Obes Sci Pract. 2022 Aug 31;9(2):145-157. doi: 10.1002/osp4.631. eCollection 2023 Apr.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Weight for Living for Hispanics in people with Obesity, run by Tufts University 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 8 inclusion and 10 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: stopped early, as of the sponsor's last update on 21 Jul 2020. 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 was stopped early (reason given: The study was terminated due to the SARS-CoV-2 pandemic. Aim 1 was completed.). Results are not available in the source record.
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 change (time frame: Pilot 1 and 2: 4 weeks. Pilot 3: 12 weeks). 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 NCT03978416, 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 21 Jul 2020.