Lifestyle Intervention for Preventing Type 2 Diabetes in Latinos

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Arizona State University

Must not be taking: Carbohydrate metabolism drugs

Disqualifiers: Type 2 diabetes, Unstable depression, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

132 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Purpose: This study will test the efficacy of a family-focused lifestyle intervention for reducing type 2 diabetes (T2D) risk factors and increasing Quality of Life (QoL) among high-risk Latino families.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes participants who are taking medications that affect carbohydrate metabolism, physical activity, or cognition.

Is the lifestyle intervention safe for preventing type 2 diabetes in Latinos?

Lifestyle interventions, including dietary changes and physical activity, have been shown to be safe for preventing type 2 diabetes in Latinos. These interventions have been used in various studies without significant safety concerns, focusing on improving health outcomes like weight loss and blood sugar control. ^{1 2 3 4 5}

How is the Lifestyle Intervention treatment for preventing type 2 diabetes in Latinos different from other treatments?

The Lifestyle Intervention treatment is unique because it focuses on culturally tailored lifestyle changes, such as diet and physical activity, specifically designed for Latino families, leveraging family engagement and empowerment to prevent type 2 diabetes, rather than relying on medication like metformin. ^{1 2 5 6 7}

What data supports the effectiveness of the treatment Lifestyle Intervention, Intensive Lifestyle Intervention, Behavioral Therapy, Dietary Counseling, Physical Activity Intervention for preventing Type 2 Diabetes in Latinos?

Research shows that lifestyle interventions, including dietary changes and physical activity, are effective in preventing diabetes and improving glucose regulation in Hispanics. Culturally adapted programs have been successful in reducing weight and improving health outcomes in this population. ^{1 3 5 7 8}

Are You a Good Fit for This Trial?

This trial is for Latino families with children aged 10-16 who are obese, meaning their BMI is at or above the 95th percentile. Parents and children must not be enrolled in any diabetes prevention or weight loss program recently and should not have type 2 diabetes or conditions affecting metabolism.

Inclusion Criteria

Parents of children who meet the above child inclusion/exclusion criteria

I am a Latino child aged between 10 and 16 years.

My child is considered obese based on their BMI.

Exclusion Criteria

My child has a mental health condition that affects their daily life.

Parents who identify themselves as American Indian.

My child is on medication or has a condition affecting their sugar levels, physical activity, or thinking.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Lifestyle Intervention

16-week family-focused intervention that includes nutrition education, behavioral change skills training, and physical activity

16 weeks

Control Group

Control families meet with the Study Physician and a Registered Dietitian to review laboratory results and receive lifestyle counseling

12 months

Monthly contact

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Lifestyle Intervention

Trial Overview The study tests a lifestyle intervention aimed at reducing risk factors for type 2 diabetes and improving quality of life among high-risk Latino families. It focuses on diet, exercise, and other daily habits to prevent diabetes.

How Is the Trial Designed?

Group I: Lifestyle Intervention Experimental Treatment 1 Intervention

16-week family-focused intervention that includes nutrition education, behavioral change skills training, and physical activity.

Group II: Comparison control Active Control 1 Intervention

Comparison control families meet with the Study Physician and a Registered Dietitian as a family to review laboratory results and receive lifestyle counseling. Control families will be contacted on a monthly basis for a total of 12 months.

Lifestyle Intervention is already approved in United States, European Union for the following indications:

Approved in United States as Lifestyle Intervention for:

• Obesity
• Weight Loss
• Type 2 Diabetes Prevention

Approved in European Union as Lifestyle Intervention for:

• Obesity
• Overweight
• Weight-Related Diseases

Who Is Running the Clinical Trial?

Arizona State University

Lead Sponsor

Trials

311

Recruited

109,000+

Phoenix Children's Hospital

Collaborator

Trials

78

Recruited

5,014,000+

St. Vincent de Paul Medical and Dental Clinic

Collaborator

Trials

3

Recruited

280+

University of Washington

Collaborator

Trials

1,858

Recruited

2,023,000+

Valley of the Sun YMCA, Arizona

Collaborator

Trials

2

Recruited

250+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

Culturally tailored diabetes prevention programs for Hispanic individuals in the U.S. have shown modest effectiveness, with nine out of twelve studies reporting significant weight reductions and two showing improvements in glucose regulation.

Interventions that included adaptations such as literacy modifications, use of Hispanic foods, and community involvement had the largest positive effects, highlighting the importance of cultural relevance in health programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diabetes Prevention in U.S. Hispanic Adults: A Systematic Review of Culturally Tailored Interventions. McCurley, JL., Gutierrez, AP., Gallo, LC.[2021]

A home-based educational intervention for Hispanic adults with elevated HbA1c levels led to a significant reduction in HbA1c scores by -0.64% compared to -0.44% in the delayed intervention group, indicating its efficacy in improving glucose regulation.

The intervention did not significantly change dietary habits or overall physical activity levels, but there was a trend towards increased moderate and vigorous physical activity in the immediate intervention group, suggesting potential benefits in lifestyle changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diabetes prevention in Hispanics: report from a randomized controlled trial. Duggan, C., Carosso, E., Mariscal, N., et al.[2022]

The ¡Viva Bien! program, a culturally adapted health intervention for Latinas with type 2 diabetes, led to significant long-term improvements in lifestyle factors such as fat intake, body mass index, and hemoglobin A1c over a 24-month period.

Participants in the ¡Viva Bien! program also experienced enhancements in psychosocial outcomes and social-environmental support, although these effects tended to decrease over time, highlighting the need for ongoing support to maintain lifestyle changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term outcomes from a multiple-risk-factor diabetes trial for Latinas: ¡Viva Bien! Toobert, DJ., Strycker, LA., King, DK., et al.[2021]

A culturally tailored pharmacist intervention for Latino diabetics led to a significant reduction in BMI and hemoglobin A1c levels after three months, indicating improved management of diabetes-related health markers.

The intervention included personalized counseling on medication, nutrition, and self-care, which was adapted to fit cultural beliefs and practices, demonstrating the importance of culturally sensitive approaches in healthcare.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A community-based pilot study of a diabetes pharmacist intervention in Latinos: impact on weight and hemoglobin A1c. Castejón, AM., Calderón, JL., Perez, A., et al.[2022]

In a study involving 92 Hispanic women with prediabetes, a 12-month intensive lifestyle intervention (ILI) led to significantly greater weight loss (-4.0 kg) compared to metformin (-0.9 kg) and standard care (+0.8 kg), indicating that lifestyle changes may be more effective for weight management in this population.

The ILI group also showed a greater reduction in waist circumference and a marginal improvement in hemoglobin A1c levels compared to the other groups, suggesting that community health worker-led interventions could be a superior strategy for diabetes prevention among high-risk individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PREVENT-DM Comparative Effectiveness Trial of Lifestyle Intervention and Metformin. O'Brien, MJ., Perez, A., Scanlan, AB., et al.[2022]

A 14-week intensive lifestyle intervention (ILI) program adapted from the Diabetes Prevention Program led to a significant weight loss of 3.8 kg (4.4%) in Hispanic women with prediabetes, while the usual care group gained weight.

The ILI group also showed improved metabolic measures, including a 15 mg/dL decrease in two-hour glucose levels and significant reductions in BMI, body fat percentage, waist circumference, and fasting insulin after one year.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effective Translation of an Intensive Lifestyle Intervention for Hispanic Women With Prediabetes in a Community Health Center Setting. Van Name, MA., Camp, AW., Magenheimer, EA., et al.[2021]

The study highlights both enabling factors and barriers faced by staff implementing a postpartum lifestyle intervention for Latinas at risk for type 2 diabetes, emphasizing the importance of cultural connection and flexible sessions in promoting participant engagement.

Barriers such as financial insecurity, low health literacy, and participant resistance to behavior change were significant challenges, suggesting that future interventions need to address these contextual issues to improve adherence and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perspectives of health educators and interviewers in a randomized controlled trial of a postpartum diabetes prevention program for Latinas: a qualitative assessment. Gubrium, A., Leckenby, D., Harvey, MW., et al.[2021]

The study aims to evaluate a culturally-grounded lifestyle intervention for Latino families, involving 132 participants, to improve glucose tolerance and quality of life over 12 months.

The intervention includes 16 weeks of nutrition and wellness classes led by bilingual professionals and supervised physical activities, which may enhance family engagement and empowerment in diabetes prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preventing diabetes in Latino families: A protocol for a randomized control trial. Braxton, ME., Nwabichie, E., Diaz, M., et al.[2023]

Citations

1. Netherlands pubmed.ncbi.nlm.nih.gov

Diabetes Prevention in U.S. Hispanic Adults: A Systematic Review of Culturally Tailored Interventions. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Diabetes prevention in Hispanics: report from a randomized controlled trial. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Long-term outcomes from a multiple-risk-factor diabetes trial for Latinas: ¡Viva Bien! [2021]

4. United States pubmed.ncbi.nlm.nih.gov

A community-based pilot study of a diabetes pharmacist intervention in Latinos: impact on weight and hemoglobin A1c. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

PREVENT-DM Comparative Effectiveness Trial of Lifestyle Intervention and Metformin. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Effective Translation of an Intensive Lifestyle Intervention for Hispanic Women With Prediabetes in a Community Health Center Setting. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Perspectives of health educators and interviewers in a randomized controlled trial of a postpartum diabetes prevention program for Latinas: a qualitative assessment. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Preventing diabetes in Latino families: A protocol for a randomized control trial. [2023]