Behavioral Plant-Based Dietary Intervention in Latinos

Study Overview
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Brief Summary
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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.

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

Conditions
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Obesity, Metabolic Disease

Intervention / Treatment
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* Behavioral: Behavioral plant-based dietary intervention
* Behavioral: Standard care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 | 
| Blood pressure | Systolic and diastolic blood pressure will be measured | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Latinos, Obesity, Plant-based diet