Clinical trial NCT03208010: Diabetes Prevention for Mexican Americans
Official title: Diabetes Prevention Culturally Tailored for Mexican Americans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prediabetic State
Overweight and Obesity
Keywords: health disparities
lifestyle behaviors
diabetes prevention
Hispanic health
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
Collaborators: name: The University of Texas Health Science Center, Houston
First posted: 2017-07-05
Enrollment: 300
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in glycosylated hemoglobin (A1C) at 3 months
timeFrame: Baseline and 3 months
measure: Change from baseline in glycosylated hemoglobin (A1C) at 6 months
timeFrame: Baseline and 6 months
measure: Change from baseline in glycosylated hemoglobin (A1C) at 12 months
timeFrame: Baseline and 12 months
measure: Change from baseline in glycosylated hemoglobin (A1C) at 24 months
timeFrame: Baseline and 24 months
measure: Change from baseline in glycosylated hemoglobin (A1C) at 36 months
timeFrame: Baseline and 36 months
measure: Change from baseline in body mass index (BMI) at 3 months
timeFrame: Baseline and 3 months
measure: Change from baseline in body mass index (BMI) at 6 months
timeFrame: Baseline and 6 months
measure: Change from baseline in body mass index (BMI) at 12 months
timeFrame: Baseline and 12 months
measure: Change from baseline in body mass index (BMI) at 24 months
timeFrame: Baseline and 24 months
measure: Change from baseline in body mass index (BMI) at 36 months
timeFrame: Baseline and 36 months
Secondary outcomes:
measure: Change from baseline to 3 months in quality of life as measured with 1 researcher-developed item
timeFrame: Baseline and 3 months
measure: Change from baseline to 12 months in quality of life as measured with 1 researcher-developed item
timeFrame: Baseline and 12 months
measure: Change from baseline to 24 months in quality of life as measured with 1 researcher-developed item
timeFrame: Baseline and 24 months
measure: Change from baseline to 36 months in quality of life as measured with 1 researcher-developed item
timeFrame: Baseline and 36 months
measure: 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).
timeFrame: Baseline and 12 months
measure: 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)
timeFrame: Baseline and 24 months
measure: 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)
timeFrame: Baseline and 36 months
measure: 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
timeFrame: Baseline and 3 months
measure: 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
timeFrame: Baseline and 6 months
measure: 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
timeFrame: Baseline and 12 months
measure: 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
timeFrame: Baseline and 24 months
measure: 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
timeFrame: Baseline and 36 months
measure: Change from baseline to 3 months in weekly average of daily steps walked using a Fitbit activity tracker
timeFrame: Baseline and 3 months
measure: Change from baseline to 6 months in weekly average of daily steps walked using a Fitbit activity tracker
timeFrame: Baseline and 6 months
measure: Change from baseline to 12 months in weekly average of daily steps walked using a Fitbit activity tracker
timeFrame: Baseline and 12 months
measure: Change from baseline to 24 months in weekly average of daily steps walked using a Fitbit activity tracker
timeFrame: Baseline and 24 months
measure: Change from baseline to 36 months in weekly average of daily steps walked using a Fitbit activity tracker
timeFrame: Baseline and 36 months
measure: 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
timeFrame: Baseline and 3 months
measure: 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
timeFrame: Baseline and 6 months
measure: 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
timeFrame: Baseline and 12 months
measure: 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
timeFrame: Baseline and 24 months
measure: 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
timeFrame: Baseline and 36 months
measure: Change from baseline in blood cholesterol levels at 12 months
timeFrame: Baseline and 12 months
measure: Change from baseline in blood cholesterol levels at 24 months
timeFrame: Baseline and 24 months
measure: Change from baseline in blood cholesterol levels at 36 months
timeFrame: Baseline and 36 months
measure: Change from baseline in blood triglyceride levels at 12 months
timeFrame: Baseline and 12 months
measure: Change from baseline in blood triglyceride levels at 24 months
timeFrame: Baseline and 24 months
measure: Change from baseline in blood triglyceride levels at 36 months
timeFrame: Baseline and 36 months
measure: Change from baseline in 2 hr.-Oral Glucose Tolerance Test (OGTT) at 12 months
timeFrame: Baseline and 12 months
measure: Change from baseline in 2 hr.-Oral Glucose Tolerance Test (OGTT) at 24 months
timeFrame: Baseline and 24 months
measure: Change from baseline in 2 hr.-Oral Glucose Tolerance Test (OGTT) at 36 months
timeFrame: Baseline and 36 months
measure: Change from baseline in blood pressure at 3 months
timeFrame: Baseline and 3 months
measure: Change from baseline in blood pressure at 6 months
timeFrame: Baseline and 6 months
measure: Change from baseline in blood pressure at 12 months
timeFrame: Baseline and 12 months
measure: Change from baseline in blood pressure at 24 months
timeFrame: Baseline and 24 months
measure: Change from baseline in blood pressure at 36 months
timeFrame: Baseline and 36 months
measure: Change from baseline in depression measured with the Patient Health Questionnaire (PHQ-9) at 3 months
timeFrame: Baseline and 3 months
measure: Change from baseline in depression measured with the Patient Health Questionnaire (PHQ-9) at 6 months
timeFrame: Baseline and 6 months
measure: Change from baseline in depression measured with the Patient Health Questionnaire (PHQ-9) at 12 months
timeFrame: Baseline and 12 months
measure: Change from baseline in depression measured with the Patient Health Questionnaire (PHQ-9) at 24 months
timeFrame: Baseline and 24 months
measure: Change from baseline in depression measured with the Patient Health Questionnaire (PHQ-9) at 36 months
timeFrame: Baseline and 36 months
measure: Change from baseline in confidence to improve dietary behaviors, using the Weight Efficacy Lifestyle Questionnaire Short Form (WEL-SF) at 3 months
timeFrame: Baseline and 3 months
measure: Change from baseline in confidence to improve dietary behaviors, using the Weight Efficacy Lifestyle Questionnaire Short Form (WEL-SF) at 6 months
timeFrame: Baseline and 6 months
measure: Change from baseline in confidence to improve dietary behaviors, using the Weight Efficacy Lifestyle Questionnaire Short Form (WEL-SF) at 12 months
timeFrame: Baseline and 12 months
measure: Change from baseline in confidence to improve dietary behaviors, using the Weight Efficacy Lifestyle Questionnaire Short Form (WEL-SF) at 24 months
timeFrame: Baseline and 24 months
measure: Change from baseline in confidence to improve dietary behaviors, using the Weight Efficacy Lifestyle Questionnaire Short Form (WEL-SF) at 36 months
timeFrame: Baseline and 36 months
measure: Change from baseline in perceived stress at 12 months
timeFrame: Change from baseline to 12 months
measure: Change from baseline in perceived stress at 24 months
timeFrame: Change from baseline to 24 months
measure: Change from baseline in perceived stress at 36 months
timeFrame: Change from baseline to 36 months
measure: Text Messages Intervention - Follow-up Phone Call Interview
timeFrame: 1 week after distribution of the videos
Other outcomes:
Locations:
city: Rio Grande City
country: United States
facility: Starr County Research Field Office
state: Texas
Study officials:
affiliation: University of Texas at Austin
name: Sharon A. Brown, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Texas Health Science Center, Houston
name: Craig L. Hanis, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brown SA, Perkison WB, Garcia AA, Cuevas HE, Velasquez MM, Winter MA, Hanis CL. The Starr County Border Health Initiative: Focus Groups on Diabetes Prevention in Mexican Americans. Diabetes Educ. 2018 Jun;44(3):293-306. doi: 10.1177/0145721718770143. Epub 2018 Apr 12.
citation: Essigmann HT, Aguilar DA, Perkison WB, Bay KG, Deaton MR, Brown SA, Hanis CL, Brown EL. Epidemiology of Antibiotic Use and Drivers of Cross-Border Procurement in a Mexican American Border Community. Front Public Health. 2022 Mar 10;10:832266. doi: 10.3389/fpubh.2022.832266. eCollection 2022.
citation: Brown SA, Becker HA, Garcia AA, Velasquez MM, Tanaka H, Winter MA, Perkison WB, Brown EL, Aguilar D, Hanis CL. The effects of gender and country of origin on acculturation, psychological factors, lifestyle factors, and diabetes-related physiological outcomes among Mexican Americans: The Starr County diabetes prevention initiative. Chronic Illn. 2023 Jun;19(2):444-457. doi: 10.1177/17423953221089315. Epub 2022 Mar 24.
citation: Brown SA, Becker HA, Garcia AA, Velasquez MM, Tanaka H, Winter MA, Perkison WB, Brown EL, Aguilar D, Hanis CL. Acculturation, Dietary Behaviors, and Macronutrient Intake Among Mexican Americans With Prediabetes: The Starr County Diabetes Prevention Initiative. Sci Diabetes Self Manag Care. 2023 Feb;49(1):65-76. doi: 10.1177/26350106221146473. Epub 2023 Jan 23.