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

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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.

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

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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