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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
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.
Participants will meet with community health workers to receive general health information through individual check-ins.
Sansum Diabetes Research Institute
Santa Barbara, California, United States
Body weight
Percent change in body weight from baseline to post-intervention
Time frame: Baseline and immediately after the intervention at 6 months
Fat mass and fat free mass
Fat mass and fat free mass will be assessed using dual-energy x-ray absorptiometry (DXA)
Time frame: 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
Time frame: 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
Time frame: Baseline and immediately after the intervention at 6 months
Plasma Lipids
Fasting plasma lipid profile will be assessed by routine blood tests
Time frame: Baseline and immediately after the intervention at 6 months
Blood pressure
Systolic and diastolic blood pressure will be measured
Time frame: 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
Time frame: Immediately after the intervention at 6 months
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