Development of Novel Behavioral Intervention for Sustainable Weight Loss in Hispanic Adults With Obesity

NCT03978416 | Terminated

• 1 other identifier: 13352
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

Obesity; Weight loss; Hispanic / Latino; Older adults; Eating habits

Outcome Measures

Primary Outcomes (2)

• Weight change

  Change in weight from baseline to the end of the intervention period

  Pilot 1 and 2: 4 weeks. Pilot 3: 12 weeks

• Attendance to weekly group meetings

  Adherence will be measured as meeting attendance

  Pilot 1 and 2: 4 weeks. Pilot 3: 12 weeks

Secondary Outcomes (10)

• Change in blood pressure (systolic and diastolic)

  Depending on pilot phase the time frame will be 4 weeks or 12 weeks

• Change in waist circumference

  Depending on pilot phase the time frame will be 4 weeks or 12 weeks

• Change in hip circumference

  Depending on pilot phase the time frame will be 4 weeks or 12 weeks

• Themes generated from qualitative data

  Baseline, 4 weeks for pilot cycles 1 and 2, and 12 weeks for pilot cycle 3

• Financial well-being

  Baseline

Study Arms (2)

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.

Behavioral: Healthy Weight for Living for Hispanics

Interventions

Healthy Weight for Living for Hispanics BEHAVIORAL

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.

Pilot behavioral intervention

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Tufts University: lead

Study Sites (1)

Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University

Boston, Massachusetts, 02111, United States

Location

Related Publications (1)

• 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.

  PMID: 37034568 DERIVED

MeSH Terms

Conditions

Obesity; Weight Loss; Feeding Behavior

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Behavior, Animal; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: The purpose of this project is to develop a lifestyle intervention for weight loss by conducting three pilot studies where small groups of participants undergo progressively developed versions of the intervention. There will not be masking as both subjects and investigators will be aware of the intervention.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientist

Model Details: 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.

Study Record Dates

• First Submitted: June 3, 2019
• First Posted: June 7, 2019
• Study Start: August 23, 2019
• Primary Completion: July 16, 2020
• Study Completion: July 16, 2020
• Last Updated: July 21, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)