Behavioral Plant-Based Dietary Intervention in Latinos
Withdrawn before enrolling · Not applicable
Conditions studied: Obesity, Metabolic Disease
In brief
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.
Key facts
- Study ID
- NCT05444595
- Run by
- Washington University School of Medicine
- People needed
- 0
- Starts
- 2023-08-24
- Expected to finish
- 2025-01-31
- Last updated by the study team
- 2026-07-08
Who can join
Age: 35 and older, up to 65. Sex: any. Healthy volunteers: accepted.
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
Where it is running
- Sansum Diabetes Research Institute — Santa Barbara, California, United States
Full record on ClinicalTrials.gov
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