Behavioral Plant-Based Dietary Intervention in Latinos — SB Pilot  

Obesity Clinical Trial

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

Status Not yet recruiting

Clinical Trial 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. The current status of the RCT is not yet ready to begin. The current activities are only preparatory to research, and/or activities that do not involve human subjects research (Aims 1 and 2). The investigators will submit a separate project before conducting the human subjects research that is described in this In-Concept project.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Metabolic Disease
• Metabolic Diseases
• Obesity

• NCT number: NCT05444595
• Study type: Interventional
• Source: Washington University School of Medicine
• Contact: Miriam Jacome Sosa, PhD
• Phone: (314) 362-4884
• Email: mjacome@wustl.edu
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Completion date: May 2025