NCT03208010

Diabetes Prevention for Mexican Americans

Diabetes Prevention Culturally Tailored for Mexican Americans

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: University of Texas at Austin · Academic / Other
• Sex: All
• Age: 25 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study tests a culturally tailored lifestyle intervention designed to prevent, or delay onset of, T2DM in Mexican Americans with prediabetes. Half the participants take part in a lifestyle program that emphasizes preparing and eating healthy Mexican American foods and increasing physical activity; the other half take part in an "enhanced" usual care control group.

Detailed description

The main purpose of this study is to test a culturally tailored lifestyle intervention that incorporates motivational interviewing and is designed to prevent, or delay onset of, T2DM in Mexican Americans with prediabetes. Groups of participants are randomly assigned to: a) an experimental group that receives a lifestyle program (12 2-hour weekly educational group sessions) that emphasizes preparing and eating healthy Mexican American foods and increasing physical activity, followed by 14 biweekly support group sessions to problem solve remaining barriers to adopting recommended behaviors and 3 booster sessions to enhance maintenance of behavioral changes; OR b) an "enhanced" usual care control group that receives lab results with individualized guidance and referrals. A secondary goal of the study is to examine the influence of genetic variation at selected candidate genes for glucose regulation on response to the lifestyle intervention. The specific aims of the study are to: 1. Test a culturally tailored lifestyle intervention that incorporates motivational interviewing and is designed to prevent, or delay onset of, T2DM in Mexican Americans with prediabetes. Groups of participants are randomly assigned to: a) an experimental group that receives a lifestyle program (12 2-hour weekly educational group sessions) that emphasizes preparing and eating healthy Mexican American foods and increasing physical activity, followed by 14 biweekly support group sessions to problem solve remaining barriers to adopting recommended behaviors and 3 booster sessions to enhance maintenance of behavioral changes; OR b) an "enhanced" usual care control group that receives lab results with individualized guidance and referrals. H1: The experimental group, compared to the control group, will have better health outcomes at 3, 6, 12, 24, and 36 months post baseline: 2-hour OGTT, A1C, FBG, lipids, blood pressure, health behaviors (physical activity, dietary intake), health beliefs: barriers, and anthropometrics (BMI \[primary outcome\], waist circumference). Other baseline measures - demographics and acculturation - characterize the population and correct for any baseline imbalances between groups. 2. Prior to testing the intervention, we conduct focus groups in Starr County with participants of our previous DSMES studies, physicians from both sides of the border, local health officials, and key authority figures (Catholic priests, county officials) to fine tune intervention aspects in the context of diabetes prevention. 3. Exploratory Aim: Examine the influence of genetic variation at selected candidate genes for glucose regulation on response to the lifestyle intervention. The study addresses THE major public health problem of U.S.-Mexico border communities. Note: In response to the COVID-19 pandemic, a remote version of the intervention was designed to provide the program remotely instead of via the usual in-person group format. A series of augmented text messages were developed that included 5 to 10-minute videos of a project dietitian or nurse talking about previously-learned content and demonstrating a simple, healthier method of preparing favorite recipe(s). The URLs of other related Spanish-language videos from the Internet are included and the text messages with videos are supplemented with phone calls from community workers to provide follow-up coaching for motivation. This alternative strategy is designed to replace the biweekly support groups, which in the past focused on similar content, i.e., reviewing key educational content, demonstrations of healthy Mexican American recipes.

Conditions

• Prediabetic State
• Overweight and Obesity

Interventions

Type	Name	Description
BEHAVIORAL	Diabetes Prevention Intervention	* Educational sessions with emphasis on physical activity, healthy cultural diets, and strategies to promote positive behavioral changes. * Specific goals set for weight loss and physical activities * Fitbits provided for monitoring physical activity goals * Weekly review of and feedback on effects of physical activity (Fitbits) and dietary changes (checklists) * 15 biweekly support group sessions plus 3 booster sessions every 6 months thereafter Note: In response to the COVID-19 pandemic, a remote version of the intervention was designed to provide the program remotely instead of via the usual in-person group format. This alternative strategy is designed to replace the biweekly support groups, which in the past focused on similar content, i.e., reviewing key educational content, demonstrations of healthy Mexican American recipes.
OTHER	Enhanced Usual Care	* Monitoring by existing personal physicians * Feedback on lab results * Referrals to physicians or clinics, if needed * Diabetes prevention educational materials

Timeline

• Start date: 2017-04-01
• Primary completion: 2023-07-31
• Completion: 2023-07-31
• First posted: 2017-07-05
• Last updated: 2023-10-17

Locations

1 site across 1 country: United States