Development of Novel Behavioral Intervention for Sustainable Weight Loss in Hispanic Adults With Obesity
- Conditions
- Obesity
- Interventions
- Behavioral: Healthy Weight for Living for Hispanics
- Registration Number
- NCT03978416
- Lead Sponsor
- Tufts University
- Brief 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. 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 23
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Pilot behavioral intervention Healthy Weight for Living for Hispanics 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.
- Primary Outcome Measures
Name Time Method Weight change 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 Pilot 1 and 2: 4 weeks. Pilot 3: 12 weeks Adherence will be measured as meeting attendance
- Secondary Outcome Measures
Name Time Method Change in blood pressure (systolic and diastolic) Depending on pilot phase the time frame will be 4 weeks or 12 weeks Change in systolic and diastolic blood pressure from baseline to the end of the intervention period
Change in waist circumference Depending on pilot phase the time frame will be 4 weeks or 12 weeks Change in waist circumference from baseline to the end of the intervention period
Change in hip circumference Depending on pilot phase the time frame will be 4 weeks or 12 weeks Change in hip circumference from baseline to the end of the intervention period
Themes generated from qualitative data Baseline, 4 weeks for pilot cycles 1 and 2, and 12 weeks for pilot cycle 3 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.Financial well-being Baseline 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.
Dietary intake Baseline 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/#scoringDietary behavior Baseline 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.Perceived stress Baseline Perceived Stress Scale 4 (PSS-4, 4 items) Score range: 0 to 16. Higher scores are correlated to more stress.
Eating behavior (hunger, satiety, cognitive restraint) Baseline 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.
Acculturation Baseline 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.
Trial Locations
- Locations (1)
Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University
🇺🇸Boston, Massachusetts, United States