Culturally-adapted Diabetes Prevention Lifestyle Intervention for Latinos (E-LITE Latinos)
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|ClinicalTrials.gov Identifier: NCT02459691|
Recruitment Status : Completed
First Posted : June 2, 2015
Last Update Posted : March 10, 2020
|Condition or disease||Intervention/treatment||Phase|
|Prediabetic State Metabolic Syndrome X Insulin Resistance||Behavioral: Vida Sana Other: Usual Care Only||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||191 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Health Services Research|
|Official Title:||Culturally-adapted Diabetes Prevention Lifestyle Intervention for Latinos in Primary Care (E-LITE Latinos)|
|Actual Study Start Date :||September 2014|
|Actual Primary Completion Date :||May 2019|
|Actual Study Completion Date :||May 2019|
Active Comparator: Usual Care Only
Patients assigned to this group will continue medical care as usual.
Other: Usual Care Only
Patients assigned to this group will continue medical care as usual. That is, they will continue to see their primary care provider and any specialist he/she may recommend. They may also access additional health education resources available at the Palo Alto Medical Foundation. They will continue to receive general age and gender-appropriate reminders of health maintenance tests/exams and immunizations, per Palo Alto Medical Foundation standard practice.
Experimental: Vida Sana
Patients assigned to this group will continue medical care as usual and in addition will receive the culturally adapted intervention.
Behavioral: Vida Sana
Vida Sana is a Diabetes Prevention Program-based, culturally-adapted intervention that will have 2 distinct stages: The intensive treatment stage will implement a culturally adapted year-long Group Lifestyle Balance curriculum. The curriculum uses a goal-based approach to promote positive outcome expectancies and foster self-efficacy. The maintenance stage will be focused on (1) facilitating continued behavior change; (2) fostering participants' self-efficacy and independence; and (3) reinforcing problem-solving and behavior maintenance skills. These will be done via secure e-messaging.
- Change in weight from baseline [ Time Frame: 12- and 24-months ]Change in weight
- Change in composite measure of cardiometabolic risk factors [ Time Frame: Baseline, 12- and 24-months ]Blood pressure, waist circumference, waist-to-height ratio
- Change in Body Mass Index from Baseline [ Time Frame: 12- and 24-months ]BMI
- Clinically significant weight loss [ Time Frame: 12 and 24 months ]5% or greater weight loss
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02459691
|Principal Investigator:||Jun Ma, MD, PhD||UIC|