Diabetes Prevention for Mexican Americans

The University of Texas System (UT)

Status: Completed

Conditions: Prediabetic State; Overweight and Obesity

Treatments: Other: Enhanced Usual Care; Behavioral: Diabetes Prevention Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03208010

R01DK109920

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 patients

Sex: All

Ages: 25 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• no prior diabetes diagnosis (except gestational)
• impaired fasting glucose (fasting glucose between 100 and 125 mg/dL) OR impaired glucose tolerance (between 140 and 199 mg/dL on a 2-hour post-load glucose tolerance test) OR A1C between 5.7% and 6.4%)
• have not previously participated in diabetes self-management education studies
• Mexican American

Exclusion criteria

• diagnosed with diabetes at baseline
• fasting glucose greater than or equal to 126 mg/dL
• ever used hypoglycemic medication (except during pregnancy)
• are currently pregnant or within 3 months postpartum
• are migrant farmworkers who migrate for more than 2 weeks
• take medications that could confound a diabetes diagnosis (e.g., steroids)
• have medical conditions for which changes in diet and/or physical activity would be contraindicated

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

300 participants in 2 patient groups

Diabetes Prevention Intervention

Experimental group

Description:

The intervention is 12 weeks of education on diet and physical activity, followed by 15 biweekly support groups for problem solving. Then, 3 booster sessions are scheduled, each one at 6-month intervals. Further, motivational interviewing is infused into all group sessions.

Treatment:

Behavioral: Diabetes Prevention Intervention

Enhanced Usual Care

Active Comparator group

Description:

The comparator is an "enhanced" usual care control group that receives health care from personal physicians plus has access to: a) data collection sessions; b) individualized exit interviews with program staff after each data collection session to receive immediate feedback on lab results and trends in personal health indicators (e.g., BMI, A1C) and to ask questions; c) referral to a local physician or clinic, if needed; and d) Spanish-language materials on diabetes prevention.

Treatment:

Other: Enhanced Usual Care