Culturally-adapted Diabetes Prevention Lifestyle Intervention for Latinos (E-LITE Latinos)

Not Applicable

Completed

• Conditions: Metabolic Syndrome X; Insulin Resistance; Prediabetic State
• Interventions: Behavioral: Vida Sana; Other: Usual Care Only

• Registration Number: NCT02459691
• Lead Sponsor: Palo Alto Medical Foundation

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2015-05-29
• Study First Submitted QC: 2015-06-01
• Study First Posted: 2015-06-02
• Primary Completion: 2019-05
• Study Completion: 2019-05
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-06
• Last Update Posted: 2020-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 191

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vida Sana	Vida Sana	Patients assigned to this group will continue medical care as usual and in addition will receive the culturally adapted intervention.
Usual Care Only	Usual Care Only	Patients assigned to this group will continue medical care as usual.

Primary Outcome Measures

Name	Time	Method
Change in weight from baseline	12- and 24-months	Change in weight

Secondary Outcome Measures

Name	Time	Method
Change in Body Mass Index from Baseline	12- and 24-months	BMI
Clinically significant weight loss	12 and 24 months	5% or greater weight loss
Change in composite measure of cardiometabolic risk factors	Baseline, 12- and 24-months	Blood pressure, waist circumference, waist-to-height ratio