Metabolic Disease, Obesity
Conditions
Keywords
Latinos, Obesity, Plant-based diet
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.
Interventions
BEHAVIORALBehavioral 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.
BEHAVIORALStandard care
Participants will meet with community health workers to receive general health information through individual check-ins.
Sponsors
Washington University School of Medicine
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sansum Diabetes Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body weight | Baseline and immediately after the intervention at 6 months | Percent change in body weight from baseline to post-intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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 |
| 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 |
| 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMiriam Jacome Sosa, PhD
Washington University School of Medicine
Outcome results
None listed