Diabetes Prevention for Mexican Americans
Condition: Prediabetic State; Overweight and Obesity
MeSH terms: Overweight; Prediabetic State
Study type: Interventional

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.
    

Intervention name(s): Diabetes Prevention Intervention; Enhanced Usual Care
Intervention type(s): Behavioral; Other
Intervention description(s): 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.; Monitoring by existing personal physicians
Feedback on lab results
Referrals to physicians or clinics, if needed
Diabetes prevention educational materials
Other intervention name(s): Culturally Tailored Diabetes Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study involves an examination of the effectiveness of a culturally-tailored diabetes prevention intervention using a randomized, repeated measures, pretest/post-test control group design. Groups are randomly assigned to: 1) the diabetes prevention intervention; or 2) an "enhanced" usual care control group. Outcome measurements are made at 3, 6, 12, 24, and 36 months post entry into the study to examine changes over time in key diabetes and health indicators.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: health disparities; lifestyle behaviors; diabetes prevention; Hispanic health