Diabetes Prevention for Mexican Americans

NCT03208010 | Completed DMC

• 1 other identifier: R01DK109920
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Prediabetic State; Overweight and Obesity

Keywords

health disparities; lifestyle behaviors; diabetes prevention; Hispanic health

Outcome Measures

Primary Outcomes (10)

• Change from baseline in glycosylated hemoglobin (A1C) at 3 months

  A1C, an indicator of long-term glucose control, is measured as the percentage of red blood cells that are glycosylated (have a glucose molecule connected) and is analyzed onsite using a point-of-care device (Siemens DCA Vantage Analyzer, Malvern, PA).

  Baseline and 3 months

• Change from baseline in glycosylated hemoglobin (A1C) at 6 months

  A1C, an indicator of long-term glucose control, is measured as the percentage of red blood cells that are glycosylated (have a glucose molecule connected) and is analyzed onsite using a point-of-care device (Siemens DCA Vantage Analyzer, Malvern, PA).

  Baseline and 6 months

• Change from baseline in glycosylated hemoglobin (A1C) at 12 months

  A1C, an indicator of long-term glucose control, is measured as the percentage of red blood cells that are glycosylated (have a glucose molecule connected) and is analyzed onsite using a point-of-care device (Siemens DCA Vantage Analyzer, Malvern, PA).

  Baseline and 12 months

• Change from baseline in glycosylated hemoglobin (A1C) at 24 months

  A1C, an indicator of long-term glucose control, is measured as the percentage of red blood cells that are glycosylated (have a glucose molecule connected) and is analyzed onsite using a point-of-care device (Siemens DCA Vantage Analyzer, Malvern, PA).

  Baseline and 24 months

• Change from baseline in glycosylated hemoglobin (A1C) at 36 months

  A1C, an indicator of long-term glucose control, is measured as the percentage of red blood cells that are glycosylated (have a glucose molecule connected) and is analyzed onsite using a point-of-care device (Siemens DCA Vantage Analyzer, Malvern, PA).

  Baseline and 36 months

• Change from baseline in body mass index (BMI) at 3 months

  Body weights are measured with a balance beam scale with individuals in street clothing and without shoes. Heights are obtained using a secured stadiometer. BMI is calculated (weight(kg)/height/meters\^2).

  Baseline and 3 months

• Change from baseline in body mass index (BMI) at 6 months

  Body weights are measured with a balance beam scale with individuals in street clothing and without shoes. Heights are obtained using a secured stadiometer. BMI is calculated (weight(kg)/height/meters\^2).

  Baseline and 6 months

• Change from baseline in body mass index (BMI) at 12 months

  Body weights are measured with a balance beam scale with individuals in street clothing and without shoes. Heights are obtained using a secured stadiometer. BMI is calculated (weight(kg)/height/meters\^2).

  Baseline and 12 months

• Change from baseline in body mass index (BMI) at 24 months

  Body weights are measured with a balance beam scale with individuals in street clothing and without shoes. Heights are obtained using a secured stadiometer. BMI is calculated (weight(kg)/height/meters\^2).

  Baseline and 24 months

• Change from baseline in body mass index (BMI) at 36 months

  Body weights are measured with a balance beam scale with individuals in street clothing and without shoes. Heights are obtained using a secured stadiometer. BMI is calculated (weight(kg)/height/meters\^2).

  Baseline and 36 months

Secondary Outcomes (50)

• Change from baseline to 3 months in quality of life as measured with 1 researcher-developed item

  Baseline and 3 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 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

• 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

Study Arms (2)

Diabetes Prevention Intervention

EXPERIMENTAL

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.

Behavioral: Diabetes Prevention Intervention

Enhanced Usual Care

ACTIVE COMPARATOR

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.

Other: Enhanced Usual Care

Interventions

Diabetes Prevention Intervention 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.

Also known as: Culturally Tailored Diabetes Prevention

Diabetes Prevention Intervention

Enhanced Usual Care OTHER

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

Enhanced Usual Care

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas at Austin: lead
• The University of Texas Health Science Center, Houston: collaborator

Study Sites (1)

Starr County Research Field Office

Rio Grande City, Texas, 78582, United States

Location

Related Publications (5)

• 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.

  PMID: 29644932 RESULT

• 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.

  PMID: 35356027 RESULT

• 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.

  PMID: 35331025 RESULT

• 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.

  PMID: 36683588 RESULT

• Brown SA, Winter MA, Becker HA, Garcia AA, Velasquez MM, Tanaka H, Perkison WB, Brown EL, Aguilar D, Hanis CL. Transitioning From an In-Person Intervention to Augmented Text Messaging During COVID-19 in Mexican Americans With Prediabetes: The Starr County Diabetes Prevention Randomized Clinical Trial. Sci Diabetes Self Manag Care. 2024 Apr;50(2):107-115. doi: 10.1177/26350106241233475. Epub 2024 Mar 7.

  PMID: 38454633 DERIVED

MeSH Terms

Conditions

Prediabetic State; Overweight; Obesity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sharon A. Brown, PhD

  University of Texas at Austin

  PRINCIPAL INVESTIGATOR

• Craig L. Hanis, PhD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Emeritus and Senior Research Scientist

Model Details: 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.

Study Record Dates

• First Submitted: June 22, 2017
• First Posted: July 5, 2017
• Study Start: April 1, 2017
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: October 17, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)