Behavioral Plant-Based Dietary Intervention in Latinos

Obesity Clinical Trial

— SB Pilot  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05444595
• Other study ID #: 202308026
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Est. completion date: May 2025

Study information

• Verified date: April 2024
• Source: Washington University School of Medicine
• Contact: Miriam Jacome Sosa, PhD
• Phone: (314) 362-4884
• Email: mjacome[@]wustl.edu
• Is FDA regulated: No
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: May 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Disease
• Metabolic Diseases
• Obesity

Intervention

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

Locations

Country	Name	City	State
United States	Sansum Diabetes Research Institute	Santa Barbara	California

Sponsors (3)

Lead Sponsor	Collaborator
Washington University School of Medicine	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Sansum Diabetes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight	Percent change in body weight from baseline to post-intervention	Baseline and immediately after the intervention at 6 months
Secondary	Fat mass and fat free mass	Fat mass and fat free mass will be assessed using dual-energy x-ray absorptiometry (DXA)	Baseline and immediately after the intervention at 6 months
Secondary	ß-cell function	ß-cell function will be assessed from a modified 3-hour oral glucose tolerance test	Baseline and immediately after the intervention at 6 months
Secondary	Insulin Clearance	Insulin clearance will be assessed from a modified 3-hour oral glucose tolerance test	Baseline and immediately after the intervention at 6 months
Secondary	Plasma Lipids	Fasting plasma lipid profile will be assessed by routine blood tests	Baseline and immediately after the intervention at 6 months
Secondary	Blood pressure	Systolic and diastolic blood pressure will be measured	Baseline and immediately after the intervention at 6 months
Secondary	Program acceptability from community health workers and study participants	Community health workers' and study participants' perceptions of program acceptability via questionnaire	Immediately after the intervention at 6 months