NCT05444595

Behavioral Plant-Based Dietary Intervention in Latinos

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 35 Years – 65 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-08-24
• Primary completion: 2025-01-31
• Completion: 2025-01-31
• First posted: 2022-07-06
• Last updated: 2025-04-27

Locations

1 site across 1 country: United States