Intervention to Promote Weight Loss in Latinas At-risk for Diabetes
Status: | Active, not recruiting |
---|---|
Conditions: | Diabetes |
Therapuetic Areas: | Endocrinology |
Healthy: | No |
Age Range: | 20 - 75 |
Updated: | 10/14/2017 |
Start Date: | September 2013 |
End Date: | February 2016 |
Promotora-led Intervention to Promote Weight Loss in Latinas At-risk for Diabetes
The overarching goal of this project is to develop and test a behavioral intervention
delivered by promotoras to help at-risk Latinas lose weight and prevent diabetes.
delivered by promotoras to help at-risk Latinas lose weight and prevent diabetes.
The goal of the proposed research is to compare two evidence-based strategies for preventing
type 2 diabetes - promotora-led lifestyle intervention and metformin - vs. usual care (UC)
among Latinas in a "real world" setting. The aims of this study are to 1) develop a
protocol-based, promotora-led lifestyle intervention (PLI) to promote weight loss in at-risk
Latinas, and assess its feasibility; 2) compare changes in weight and cardiometabolic
markers—hemoglobin A1C, fasting lipids, blood pressure—from baseline to 1 year between
at-risk Latinas randomly assigned to the PLI group versus metformin and usual care (UC)
groups; and 3) understand the social and cultural context surrounding weight-related
behaviors among Latinas at-risk for diabetes. The investigators hypothesize that Latinas
assigned to PLI and metformin will have greater weight loss (primary outcome) and greater
improvements in cardiometabolic markers from baseline to 1 year than those randomized to UC
type 2 diabetes - promotora-led lifestyle intervention and metformin - vs. usual care (UC)
among Latinas in a "real world" setting. The aims of this study are to 1) develop a
protocol-based, promotora-led lifestyle intervention (PLI) to promote weight loss in at-risk
Latinas, and assess its feasibility; 2) compare changes in weight and cardiometabolic
markers—hemoglobin A1C, fasting lipids, blood pressure—from baseline to 1 year between
at-risk Latinas randomly assigned to the PLI group versus metformin and usual care (UC)
groups; and 3) understand the social and cultural context surrounding weight-related
behaviors among Latinas at-risk for diabetes. The investigators hypothesize that Latinas
assigned to PLI and metformin will have greater weight loss (primary outcome) and greater
improvements in cardiometabolic markers from baseline to 1 year than those randomized to UC
Inclusion Criteria:
- Female gender
- Latino ethnicity
- Spanish fluency
- Age ≥20 years
- BMI ≥25 kg/m2
- And "increased risk of diabetes" (ADA Diabetes Risk Score ≥4 as determine by 7-item
questionnaire and hemoglobin A1C ≥ 5.6%)
Exclusion Criteria:
- Hemoglobin A1C ≥ 6.5%
- Current or planned pregnancy during the study period
- Chronic conditions that could affect potential participants' ability to participate
(osteoarthritis, heart disease, pulmonary disease requiring oxygen or daily
bronchodilator use, and severe psychiatric disease)
- Medical comorbidities that could influence weight loss or weight gain (thyroid
disease, cancer, and HIV)
- Medications that could affect weight or glucose metabolism (thiazide diuretics,
β-blockers, and systemic glucocorticoids).
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