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| Name | Class |
|---|---|
| Agency for Healthcare Research and Quality (AHRQ) | FED |
| University of Illinois at Chicago | OTHER |
| University of Pittsburgh | OTHER |
| RTI International |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care Only | Active Comparator | Patients assigned to this group will continue medical care as usual. |
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| Vida Sana | Experimental | Patients assigned to this group will continue medical care as usual and in addition will receive the culturally adapted intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vida Sana | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in weight from baseline | Change in weight | 12- and 24-months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in composite measure of cardiometabolic risk factors | Blood pressure, waist circumference, waist-to-height ratio | Baseline, 12- and 24-months |
| Change in Body Mass Index from Baseline | BMI |
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Inclusion criteria:
Age(as of date of enrollment):
Race/ethnicity: Mexican Latino of any race
Gender: men and women
Body mass index: ≥24 kg/m2 (≥22 kg/m2 if of Asian descent)
Having pre-diabetes, metabolic syndrome, or both based on the following criteria:
Pre-diabetes according to any one of the following criteria:
Fasting plasma glucose of 100 to 125 mg/dL or HbA1c of 5.7 to 6.4 if detected by a recent (within the past year), documented, blood-based diagnostic test or by a fasting blood test during study screening
Plasma glucose measured 2 hours after a 75 gm glucose load of 140 to 199 mg/dl if detected by a recent (within the past year), documented, blood-based diagnostic test (Oral glucose tolerance test will not be performed for study screening considering participant burden)
Clinically diagnosed gestational diabetes mellitus during a previous pregnancy (may be self-reported)
Metabolic syndrome according to 3 or more of the following:
Primary Care Physician approval of patient contact for study screening
Able and willing to enroll and provide informed consent, i.e., to meet the time and data collection requirements of the study, be randomized to one of two study arms, participate in follow-up for 24 months, and authorize extraction of relevant information from the Electronic Health Record.
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jun Ma, MD, PhD | UIC | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33337491 | Derived | Rosas LG, Lv N, Xiao L, Lewis MA, Venditti EMJ, Zavella P, Azar K, Ma J. Effect of a Culturally Adapted Behavioral Intervention for Latino Adults on Weight Loss Over 2 Years: A Randomized Clinical Trial. JAMA Netw Open. 2020 Dec 1;3(12):e2027744. doi: 10.1001/jamanetworkopen.2020.27744. | |
| 26995280 | Derived | Rosas LG, Lv N, Xiao L, Lewis MA, Zavella P, Kramer MK, Luna V, Ma J. Evaluation of a culturally-adapted lifestyle intervention to treat elevated cardiometabolic risk of Latino adults in primary care (Vida Sana): A randomized controlled trial. Contemp Clin Trials. 2016 May;48:30-40. doi: 10.1016/j.cct.2016.03.003. Epub 2016 Mar 16. |
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| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| D024821 | Metabolic Syndrome |
| D007333 | Insulin Resistance |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| OTHER |
| University of California Santa Cruz | OTHER |
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| Usual Care Only | Other | 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. |
|
| 12- and 24-months |
| Clinically significant weight loss | 5% or greater weight loss | 12 and 24 months |
| D004700 | Endocrine System Diseases |
| D006946 | Hyperinsulinism |
| D001519 | Behavior |