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WITHDRAWN
NCT05444595
NA

Behavioral Plant-Based Dietary Intervention in Latinos

Sponsor: Washington University School of Medicine

View on ClinicalTrials.gov

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.

Official title: A Behavioral and Plant-Based Dietary Intervention to Improve Metabolic Health and Diabetes Risk Factors in an Underserved Latino Population

Key Details

Gender

All

Age Range

35 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

0

Start Date

2023-08-24

Completion Date

2025-01-31

Last Updated

2026-07-08

Healthy Volunteers

Yes

Interventions

BEHAVIORAL

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.

BEHAVIORAL

Standard care

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

Locations (1)

Sansum Diabetes Research Institute

Santa Barbara, California, United States