Behavioral Plant-Based Dietary Intervention in Latinos
- Conditions
- ObesityMetabolic Disease
- Interventions
- Behavioral: Standard careBehavioral: Behavioral plant-based dietary intervention
- 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
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- 40
- Self-reported Hispanic and/or Latino heritage
- Body Mass Index (BMI) 30-42 kg/m²
- HbA1c ≤ 6.4%
- 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
- Arm && Interventions
Group Intervention Description Standard Care Standard care In this arm, participants will receive the standard care intervention from community health workers. Behavioral and Plant-based Dietary Intervention Behavioral plant-based dietary intervention In this arm, participants will receive the behavioral plant-based intervention from community health workers.
- 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