Insulin Resistance Clinical Trial
Official title:
Culturally-adapted Diabetes Prevention Lifestyle Intervention for Latinos in Primary Care (E-LITE Latinos)
The purpose of the study is to develop a culturally adapted intervention (CAI) program to improve weight and physical activity in overweight or obese adult Latinos at high risk for developing type 2 diabetes and/or cardiovascular disease (CVD) and to rigorously evaluate the effectiveness and implementation potential of the CAI program.
This study has two phases: Phase 1: Formative research and Phase 2: Randomized Controlled
Trial (RCT). The purpose of the formative research phase is to develop a culturally adapted
intervention (CAI) program to improve weight and physical activity in overweight or obese
adult Latinos at high risk for developing type 2 diabetes and/or cardiovascular disease
(CVD). The purpose of the RCT is to rigorously evaluate the effectiveness and implementation
potential of the CAI program.
The proposed intervention will uniquely adapt the coach-led, technology-supported Group
Lifestyle Balance (GLB) program that the investigators proved effective in the investigators'
prior trial called E-LITE, to provide culturally and linguistically appropriate lifestyle
intervention for weight loss and increased physical activity among high-risk Latinos in
primary care. The CAI will be delivered in small groups as well as using existing, rapidly
expanding internet and mobile technologies (Website, email, and mobile text messaging). Once
developed the investigators will subject the CAI to rigorous evaluation in an RCT of 186
eligible and consenting Latinos. The investigators hypothesize that CAI participants will
achieve a greater mean reduction in body mass index (BMI) from baseline to 24 months (primary
outcome) than usual care controls. Secondary outcomes will include measures of
cardiometabolic risk factors (e.g., lower fasting glucose and lipid levels), psychosocial
well-being (e.g., improved mood), and behavior change (e.g., increased physical activity).
The overarching research goal is to determine the effectiveness and implementation potential
of the CAI based on the Reach, Effectiveness, Adoption, Implementation, and Maintenance
(RE-AIM) framework.
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