Diabetes Prevention Culturally Tailored for Mexican Americans

Brief Summary

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.

Primary Outcomes

Secondary Outcomes

• Change from baseline to 24 months in quality of life as measured with 1 researcher-developed item(Baseline and 24 months)
• Change from baseline to 36 months in quality of life as measured with 1 researcher-developed item(Baseline and 36 months)
• Change from baseline to 12 months in quality of life as measured with 1 researcher-developed item(Baseline and 12 months)
• Change from baseline to 3 months in quality of life as measured with 1 researcher-developed item(Baseline and 3 months)
• Changes from baseline to 3 months in the number of times high-fat foods were eaten during the previous month using the Saturated Fat/Cholesterol Avoidance Scale, a culturally-tailored instrument developed in Starr County(Baseline and 3 months)
• Changes from baseline to 12 months in the number of times high-fat foods were eaten during the previous month using the Saturated Fat/Cholesterol Avoidance Scale, a culturally-tailored instrument developed in Starr County(Baseline and 12 months)
• Change from baseline to 12 months in weekly average of daily steps walked using a Fitbit activity tracker(Baseline and 12 months)
• Change from baseline to 24 months in weekly average of daily steps walked using a Fitbit activity tracker(Baseline and 24 months)
• Change from baseline in blood cholesterol levels at 12 months(Baseline and 12 months)
• Change from baseline in depression measured with the Patient Health Questionnaire (PHQ-9) at 6 months(Baseline and 6 months)
• Change from baseline in confidence to improve dietary behaviors, using the Weight Efficacy Lifestyle Questionnaire Short Form (WEL-SF) at 36 months(Baseline and 36 months)
• Changes from baseline to 12 months in number/amount of times foods were eaten during the previous month using the questionnaire entitled, Food Frequency Questionnaire for Starr County Health Studies (see McPherson et al., Ann Epidemiol, 1995).(Baseline and 12 months)
• Changes from baseline to 6 months in the number of times high-fat foods were eaten during the previous month using the Saturated Fat/Cholesterol Avoidance Scale, a culturally-tailored instrument developed in Starr County(Baseline and 6 months)
• Changes from baseline to 24 months in the number of times high-fat foods were eaten during the previous month using the Saturated Fat/Cholesterol Avoidance Scale, a culturally-tailored instrument developed in Starr County(Baseline and 24 months)
• Change from baseline to 6 months in perceived barriers to improving dietary habits using the Givens & Givens health beliefs: barriers subscale adapted for Starr County studies(Baseline and 6 months)
• Change from baseline in blood cholesterol levels at 36 months(Baseline and 36 months)
• Change from baseline in blood triglyceride levels at 12 months(Baseline and 12 months)
• Change from baseline in blood triglyceride levels at 24 months(Baseline and 24 months)
• Change from baseline in 2 hr.-Oral Glucose Tolerance Test (OGTT) at 12 months(Baseline and 12 months)
• Change from baseline in blood pressure at 12 months(Baseline and 12 months)
• Changes from baseline to 24 months in number/amount of times foods were eaten during the previous month using the questionnaire entitled, Food Frequency Questionnaire for Starr County Health Studies (see McPherson et al., Ann Epidemiol, 1995)(Baseline and 24 months)
• Change from baseline to 3 months in weekly average of daily steps walked using a Fitbit activity tracker(Baseline and 3 months)
• Change from baseline to 24 months in perceived barriers to improving dietary habits using the Givens & Givens health beliefs: barriers subscale adapted for Starr County studies(Baseline and 24 months)
• Change from baseline in blood triglyceride levels at 36 months(Baseline and 36 months)
• Change from baseline in blood pressure at 24 months(Baseline and 24 months)
• Changes from baseline to 36 months in number/amount of times foods were eaten during the previous month using the questionnaire entitled, Food Frequency Questionnaire for Starr County Health Studies (see McPherson et al., Ann Epidemiol, 1995)(Baseline and 36 months)
• Changes from baseline to 36 months in the number of times high-fat foods were eaten during the previous month using the Saturated Fat/Cholesterol Avoidance Scale, a culturally-tailored instrument developed in Starr County(Baseline and 36 months)
• Change from baseline to 6 months in weekly average of daily steps walked using a Fitbit activity tracker(Baseline and 6 months)
• Change from baseline to 3 months in perceived barriers to improving dietary habits using the Givens & Givens health beliefs: barriers subscale adapted for Starr County studies(Baseline and 3 months)
• Change from baseline to 36 months in perceived barriers to improving dietary habits using the Givens & Givens health beliefs: barriers subscale adapted for Starr County studies(Baseline and 36 months)
• Change from baseline in 2 hr.-Oral Glucose Tolerance Test (OGTT) at 36 months(Baseline and 36 months)
• Change from baseline in blood pressure at 3 months(Baseline and 3 months)
• Change from baseline in depression measured with the Patient Health Questionnaire (PHQ-9) at 12 months(Baseline and 12 months)
• Change from baseline to 36 months in weekly average of daily steps walked using a Fitbit activity tracker(Baseline and 36 months)
• Change from baseline to 12 months in perceived barriers to improving dietary habits using the Givens & Givens health beliefs: barriers subscale adapted for Starr County studies(Baseline and 12 months)
• Change from baseline in blood cholesterol levels at 24 months(Baseline and 24 months)
• Change from baseline in 2 hr.-Oral Glucose Tolerance Test (OGTT) at 24 months(Baseline and 24 months)
• Change from baseline in blood pressure at 6 months(Baseline and 6 months)
• Change from baseline in depression measured with the Patient Health Questionnaire (PHQ-9) at 3 months(Baseline and 3 months)
• Change from baseline in confidence to improve dietary behaviors, using the Weight Efficacy Lifestyle Questionnaire Short Form (WEL-SF) at 6 months(Baseline and 6 months)
• Change from baseline in blood pressure at 36 months(Baseline and 36 months)
• Change from baseline in confidence to improve dietary behaviors, using the Weight Efficacy Lifestyle Questionnaire Short Form (WEL-SF) at 12 months(Baseline and 12 months)
• Change from baseline in perceived stress at 12 months(Change from baseline to 12 months)
• Change from baseline in perceived stress at 36 months(Change from baseline to 36 months)
• Change from baseline in depression measured with the Patient Health Questionnaire (PHQ-9) at 24 months(Baseline and 24 months)
• Change from baseline in depression measured with the Patient Health Questionnaire (PHQ-9) at 36 months(Baseline and 36 months)
• Change from baseline in confidence to improve dietary behaviors, using the Weight Efficacy Lifestyle Questionnaire Short Form (WEL-SF) at 3 months(Baseline and 3 months)
• Change from baseline in confidence to improve dietary behaviors, using the Weight Efficacy Lifestyle Questionnaire Short Form (WEL-SF) at 24 months(Baseline and 24 months)
• Change from baseline in perceived stress at 24 months(Change from baseline to 24 months)
• Text Messages Intervention - Follow-up Phone Call Interview(1 week after distribution of the videos)