Behavioral Plant-Based Dietary Intervention in Latinos

Not Applicable

Withdrawn

• Conditions: Obesity; Metabolic Disease

• Registration Number: NCT05444595
• Lead Sponsor: Washington University School of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-21
• Study First Submitted QC: 2022-07-01
• Study First Posted: 2022-07-06
• Study Start: 2023-08-24
• Primary Completion: 2025-01-31
• Study Completion: 2025-01-31
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-24
• Last Update Posted: 2025-04-27

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Body weight	Baseline and immediately after the intervention at 6 months	Percent change in body weight from baseline to post-intervention

Secondary Outcome Measures

Name	Time	Method
Fat mass and fat free mass	Baseline and immediately after the intervention at 6 months	Fat mass and fat free mass will be assessed using dual-energy x-ray absorptiometry (DXA)
Plasma Lipids	Baseline and immediately after the intervention at 6 months	Fasting plasma lipid profile will be assessed by routine blood tests
Blood pressure	Baseline and immediately after the intervention at 6 months	Systolic and diastolic blood pressure will be measured
β-cell function	Baseline and immediately after the intervention at 6 months	β-cell function will be assessed from a modified 3-hour oral glucose tolerance test
Insulin Clearance	Baseline and immediately after the intervention at 6 months	Insulin clearance will be assessed from a modified 3-hour oral glucose tolerance test
Program acceptability from community health workers and study participants	Immediately after the intervention at 6 months	Community health workers' and study participants' perceptions of program acceptability via questionnaire

Trial Locations

Locations (1)

Sansum Diabetes Research Institute; 🇺🇸 Santa Barbara, California, United States