Behavioral Plant-Based Dietary Intervention in Latinos

NCT ID: NCT05444595

Last Updated: 2025-04-27

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-24
• Study Completion Date: 2025-01-31

Brief Summary

The Aims of this study are 1) to develop a traditional plant-based diet that is palatable and acceptable to the Latino population and which contains the appropriate calorie and macronutrient composition needed to lose weight and improve metabolic function and; 2) to develop a culturally sensitive [based on previous literature and stakeholder input] lifestyle intervention program, that will be delivered by community health workers [CHWs], that focuses on consuming a traditional plant-based diet and overcoming the barriers to incorporating this dietary therapy as part of the family lifestyle but with a focus on the adult participant with obesity. Ultimately, in Aim 3 the investigators will conduct a 16-week randomized controlled trial (RCT) in 40 Latino adults with obesity [20 control, 20 treatment] to evaluate the intervention's: i) clinical efficacy; ii) fidelity of the implementation by CHWs; and iii) acceptance by CHWs and study participants.

Conditions

Obesity; Metabolic Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Behavioral and Plant-based Dietary Intervention

In this arm, participants will receive the behavioral plant-based intervention from community health workers.

Group Type: EXPERIMENTAL

Behavioral plant-based dietary intervention

Intervention Type: BEHAVIORAL

Participants will meet with community health workers to receive information focused on healthy eating and consuming a traditional plant-based diet in a group format for the first few months followed by individual check-ins.

Standard Care

In this arm, participants will receive the standard care intervention from community health workers.

Group Type: ACTIVE_COMPARATOR

Standard care

Intervention Type: BEHAVIORAL

Participants will meet with community health workers to receive general health information through individual check-ins.

Interventions

Behavioral plant-based dietary intervention

Participants will meet with community health workers to receive information focused on healthy eating and consuming a traditional plant-based diet in a group format for the first few months followed by individual check-ins.

Intervention Type: BEHAVIORAL

Standard care

Participants will meet with community health workers to receive general health information through individual check-ins.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Self-reported Hispanic and/or Latino heritage
• Body Mass Index (BMI) 30-42 kg/m²
• HbA1c ≤ 6.4%

Exclusion Criteria

• Previous diagnosis of diabetes
• Unstable weight (≥4% during the last 2 months prior to study enrollment)
• Severe cardiovascular disease within the 6 months prior to study enrollment
• Severe organ system dysfunction
• active substance abuse with alcohol or drugs
• Severe anemia
• Pregnant or breastfeeding
• Use of medications that are known to affect the study outcome measures
• Persons who are not able to grant voluntary informed consent

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Sansum Diabetes Research Institute

OTHER

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Miriam Jacome Sosa, PhD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Sansum Diabetes Research Institute

Santa Barbara, California, United States

Countries

United States

Other Identifiers

202308026

Identifier Type: -

Identifier Source: org_study_id