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Administrative reasons
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
| Sansum Diabetes Research Institute | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Behavioral and Plant-based Dietary Intervention | Experimental | In this arm, participants will receive the behavioral plant-based intervention from community health workers. |
|
| Standard Care | Active Comparator | In this arm, participants will receive the standard care intervention from community health workers. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral plant-based dietary intervention | Behavioral | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Miriam Jacome Sosa, PhD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sansum Diabetes Research Institute | Santa Barbara | California | 93105 | United States |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D008659 | Metabolic Diseases |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Standard care | Behavioral | Participants will meet with community health workers to receive general health information through individual check-ins. |
|
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 |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |