Culturally Adapted DPP Intervention for Mexican Americans in Primary Care: A Randomized Control Trial (Vida Sana)
- Principal Investigator
- Ma, Jun
- Start Date
- End Date
Latinos are the largest and fastest growing minority group (16% of the US population) and provide a potent example of existing health disparities among U.S. racial/ethnic groups. in particular, Mexican Americans-the largest U.S. Latino subpopulation -- have a notably higher prevalence of overweight and obesity (80%) than non-Hispanic whites (NHWs, 68%), and they are disproportionately affected by obesity-related risk factors (e.g., metabolic syndrome, pre-diabetes) and diseases (e.g., diabetes). Until efficacious lifestyle interventions for weight management are translated into practice, obesity and its comorbidities will continue to exact enormous and disproportionate burdens. Population-specific interventions are needed because undifferentiated interventions (often developed in white-dominant populations) may be inefficient-or even unintentionally increase health disparities.
The Diabetes Prevention Program (DPP) trial demonstrated that an intensive lifestyle intervention reduced type 2 diabetes incidence by 58% among high-risk adults and that weight loss was the dominant predictor. Numerous DPP translation studies have been undertaken, including a pragmatic randomized trial our team recently completed ("E-LITE") with 241 participants (78% NHW) that showed success in integrating group counseling with health information technology (HIT) to operationalize the DPP intervention in primary care. To date, very few DPP translation studies have targeted Latinos.
We are culturally adapting the HIT-enhanced group DPP intervention from E-LITE and testing it among Spanish-speaking or bilingual Mexican Americans who are overweight or obese and have metabolic syndrome, pre-diabetes, or both.
Participants (n=186) from six primary care practices in Santa Cruz, California (35% Latino residents; 91% of Mexican origin), will be randomly assigned to receive the culturally adapted intervention or usual care.
The primary aim is to determine the effectiveness of the intervention ("E" in the RE-AIM model). We hypothesize that the culturally adapted intervention will lead to a greater mean reduction in body mass index at 24 months (primary outcome) vs. usual care. Secondary outcomes will include cost-effectiveness, clinical (e.g., fasting glucose), psychosocial (e.g., quality of life), behavior change (e.g., diet, physical activity) measures.
The secondary aim is to conduct process evaluation with mixed methods for the other RE-AIM attributes: Reach (e.g., participation rate of the target population), Adoption (e.g., participating clinic & provide characteristics), Implementation (e.g., intervention fidelity), and Maintenance (e.g., sustainabiliy in the practice setting).
This health services research project falls within the AHRQ Research Portfolio areas of comparative effectiveness, HIT, and prevention and care management; it also targets a priority population. The findings will be of value to clinicians, patients, and other decision makers considering effective obesity and diabetes prevention programs for the millions of MAs who carry a disproportionate burden of these, with high potential for real-world applicability and impact on MA minority health and policies aimed to eliminate health disparities.
This pragmatic randomized controlled trial evaluate the effectiveness and potential generalizability of a culturally adapted intervention directed at weigh management in primary care for overweight or obese Mexican Americans at high risk for diabetes and cardiovascular disease. The findings will be of value to clinicians, patients, and other decision makers considering effective obesity and diabetes prevention programs for the millions of Mexican Americans who carry a strikingly disproportionate burden of these, with high potential for a sustained public health and policy impact and real-world applicability.
About this grant
This grant was administered by the Palo Alto Medical Foundation Research Institute until November 2017, when it was transferred to the University of Illinois at Chicago.
Agency for Healthcare Research and Quality (Grant No. R01 HS022702)
Rosas LG, Lv N, Lewis MA, et al. A Latino Patient-Centered, Evidence-Based Approach to Diabetes Prevention. J Am Board Fam Med. 2018;31(3):364–374. doi:10.3122/jabfm.2018.03.170280
Lv N, Azar KMJ, Rosas LG, Wulfovich S, Xiao L, Ma J. Behavioral lifestyle interventions for moderate and severe obesity: A systematic review. Prev Med. 2017 Jul;100:180-193.
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.
Ma J, Rosas LG, Lv N. Precision lifestyle medicine: a new frontier in the science of behavior change and population health. Am J Prev Med. 2016 Mar;50(3):395-397.