Behavioral Plant-Based Dietary Intervention in Latinos (SB Pilot)

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Obesity; Metabolic Disease
• Intervention / Treatment: Behavioral: Behavioral plant-based dietary intervention; Behavioral: Standard care

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Santa Barbara, California, United States, 93105
      • Sansum Diabetes Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Behavioral and Plant-based Dietary Intervention; In this arm, participants will receive the behavioral plant-based intervention from community health workers.	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.
Active Comparator: Standard Care; In this arm, participants will receive the standard care intervention from community health workers.	Behavioral: Standard care; Participants will meet with community health workers to receive general health information through individual check-ins.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body weight	Percent change in body weight from baseline to post-intervention	Baseline and immediately after the intervention at 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
β-cell function	β-cell function will be assessed from a modified 3-hour oral glucose tolerance test	Baseline and immediately after the intervention at 6 months
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
Plasma Lipids	Fasting plasma lipid profile will be assessed by routine blood tests	Baseline and immediately after the intervention at 6 months
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
Blood pressure	Systolic and diastolic blood pressure will be measured	Baseline and immediately after the intervention at 6 months

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Sansum Diabetes Research Institute
• Investigators: Principal Investigator: Miriam Jacome Sosa, PhD, Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): August 24, 2023
• Primary Completion (Actual): January 31, 2025
• Study Completion (Actual): January 31, 2025

Study Registration Dates

• First Submitted: June 21, 2022
• First Submitted That Met QC Criteria: July 1, 2022
• First Posted (Actual): July 6, 2022

Study Record Updates

• Last Update Posted (Actual): April 27, 2025
• Last Update Submitted That Met QC Criteria: April 24, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Obesity; Latinos; Plant-based diet
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Metabolic Diseases; Hypoglycemic Agents; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Incretins; Tirzepatide
• Other Study ID Numbers: 202308026; P30DK092950 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes