Behavioral Plant-Based Dietary Intervention in Latinos

NCT05444595 | Withdrawn DMC

• 1 other identifier: 202308026
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Metabolic Disease

Keywords

Latinos; Obesity; Plant-based diet

Outcome Measures

Primary Outcomes (1)

• Body weight

  Percent change in body weight from baseline to post-intervention

  Baseline and immediately after the intervention at 6 months

Secondary Outcomes (6)

• Fat mass and fat free mass

  Baseline and immediately after the intervention at 6 months

• β-cell function

  Baseline and immediately after the intervention at 6 months

• Insulin Clearance

  Baseline and immediately after the intervention at 6 months

• Plasma Lipids

  Baseline and immediately after the intervention at 6 months

• Blood pressure

  Baseline and immediately after the intervention at 6 months

Study Arms (2)

Behavioral and Plant-based Dietary Intervention

EXPERIMENTAL

In this arm, participants will receive the behavioral plant-based intervention from community health workers.

Behavioral: Behavioral plant-based dietary intervention

Standard Care

ACTIVE COMPARATOR

In this arm, participants will receive the standard care intervention from community health workers.

Behavioral: Standard care

Interventions

Behavioral plant-based dietary intervention BEHAVIORAL

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 and Plant-based Dietary Intervention

Standard care BEHAVIORAL

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

Standard Care

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Self-reported Hispanic and/or Latino heritage
• Body Mass Index (BMI) 30-42 kg/m²
• HbA1c ≤ 6.4%

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Sansum Diabetes Research Institute: collaborator

Study Sites (1)

Sansum Diabetes Research Institute

Santa Barbara, California, 93105, United States

Location

MeSH Terms

Conditions

Obesity; Metabolic Diseases

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Miriam Jacome Sosa, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2022
• First Posted: July 6, 2022
• Study Start: August 24, 2023
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: April 27, 2025

Record last verified: 2025-04

Locations

US (1)