Clinical trial NCT03978416: Development of Novel Behavioral Intervention for Sustainable Weight Loss in Hispanic Adults With Obesity
Official title: Development of Novel Behavioral Intervention for Sustainable Weight Loss in Hispanic Adults With Obesity
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Obesity
Keywords: Obesity
Weight loss
Hispanic / Latino
Older adults
Eating habits
Lead sponsor: Tufts University
Sponsor class: OTHER
First posted: 2019-06-07
Enrollment: 23
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: INCLUSION CRITERIA:

Focus groups and Intervention:

1. Adult men and women older than 50 years.
2. Self-identifying as having Hispanic ethnicity, originating from Spanish-speaking Latin-American country.
3. BMI ≥30.0 kg/m2.

   Intervention only:
4. Willing to give informed consent.
5. 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.
6. Willing to participate in a behavioral intervention for weight loss.

EXCLUSION CRITERIA:

Intervention only:

1. Self-reported weight loss \>5 kg within past 6 months.
2. Diagnosed gastrointestinal conditions, including celiac disease.
3. Communicable or chronic diseases or medication use that would preclude safe and active study participation.
4. Pregnancy or anticipated pregnancy within the study,
5. Lactation, or giving birth within 6 months prior to enrollment.
6. Participation in other clinical trials.
7. Illiteracy.
8. Use of anti-obesity medications within the past year.
9. Being on any special diets that would prevent following recommendations made through the program.

Primary outcomes:
measure: Weight change
timeFrame: Pilot 1 and 2: 4 weeks. Pilot 3: 12 weeks
measure: Attendance to weekly group meetings
timeFrame: Pilot 1 and 2: 4 weeks. Pilot 3: 12 weeks
Secondary outcomes:
measure: Change in blood pressure (systolic and diastolic)
timeFrame: Depending on pilot phase the time frame will be 4 weeks or 12 weeks
measure: Change in waist circumference
timeFrame: Depending on pilot phase the time frame will be 4 weeks or 12 weeks
measure: Change in hip circumference
timeFrame: Depending on pilot phase the time frame will be 4 weeks or 12 weeks
measure: Themes generated from qualitative data
timeFrame: Baseline, 4 weeks for pilot cycles 1 and 2, and 12 weeks for pilot cycle 3
measure: Financial well-being
timeFrame: Baseline
measure: Dietary intake
timeFrame: Baseline
measure: Dietary behavior
timeFrame: Baseline
measure: Perceived stress
timeFrame: Baseline
measure: Eating behavior (hunger, satiety, cognitive restraint)
timeFrame: Baseline
measure: Acculturation
timeFrame: Baseline
Other outcomes:
Locations:
city: Boston
country: United States
facility: Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University
state: Massachusetts
Study officials:
References: