Diabetes Prevention for Mexican Americans

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-01

Study Completion Date

2023-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Preventing Diabetes in Latino Families

NCT05228522

Type 2 Diabetes Obesity Pediatric Obesity

ACTIVE_NOT_RECRUITING NA

Diabetes Prevention Program for Obese Latino Youth

NCT02039141

Obesity Insulin Resistance Diabetes

COMPLETED NA

Intensive Life-Style Intervention in Type 2 Diabetes Patients

NCT01813708

Type 2 Diabetes

COMPLETED NA

Community Based DPP Program for Hispanic/Latino Females

NCT04052815

Pre Diabetes Obesity

UNKNOWN NA

Prevention and Choice for Type 2

NCT06377020

PreDiabetes

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Prediabetic State Overweight and Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

NONE

Given the nature of behavioral programs, we are not able to mask participant involvement. Some primary care providers may not know the details of their patients' participation in the study.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Diabetes Prevention Intervention

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.

Group Type EXPERIMENTAL

Diabetes Prevention Intervention

Intervention Type BEHAVIORAL

* 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.

Enhanced Usual Care

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.

Group Type ACTIVE_COMPARATOR

Enhanced Usual Care

Intervention Type OTHER

* Monitoring by existing personal physicians
* Feedback on lab results
* Referrals to physicians or clinics, if needed
* Diabetes prevention educational materials

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Enhanced Usual Care

* Monitoring by existing personal physicians
* Feedback on lab results
* Referrals to physicians or clinics, if needed
* Diabetes prevention educational materials

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Culturally Tailored Diabetes Prevention

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No