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?

This trial aims to determine if a family-focused lifestyle program (Lifestyle Intervention) can reduce the risk of type 2 diabetes and improve life quality in Latino families at high risk. The program includes 16 weeks of nutrition education, habit formation, and increased physical activity. Another group will meet with a doctor and dietitian to discuss health results and lifestyle tips. The trial seeks Latino children aged 10-16 who are obese (very overweight for their age and sex) and their parents. As an unphased trial, this study provides a unique opportunity for families to contribute to important research that could enhance health outcomes in their community.

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.

What prior data suggests that this lifestyle intervention is safe for preventing type 2 diabetes in Latinos?

Research has shown that changes to diet, exercise, and daily habits are generally safe for most people. These lifestyle changes can significantly lower the risk of developing type 2 diabetes. One study found that such changes helped prevent diabetes in about one out of every seven people over three years. Another study found that lifestyle changes reduced the risk of diabetes by 58% compared to other treatments.

These programs aim to improve everyday habits, such as eating better and being more active, without involving medication or medical procedures, making them manageable for most people. No reports of serious side effects have emerged from these lifestyle changes, making them a safe choice for those seeking to reduce their diabetes risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this lifestyle intervention because it offers a family-focused approach to preventing type 2 diabetes, which is different from the typical individual-based treatments like medication and personal diet plans. This intervention emphasizes nutrition education, behavioral change skills, and physical activity, all tailored for the whole family, which can lead to more sustainable lifestyle changes. By involving the entire family, it aims to create a supportive environment that may enhance the effectiveness of diabetes prevention efforts, particularly in Latino communities where cultural and family dynamics play a crucial role in health behaviors.

What evidence suggests that this lifestyle intervention could be effective for preventing type 2 diabetes in Latinos?

Research has shown that lifestyle changes can greatly lower the risk of developing type 2 diabetes. In this trial, participants in the Lifestyle Intervention arm will engage in a 16-week family-focused program that includes nutrition education, behavioral change skills training, and physical activity. Studies have found that being active, eating healthy, and losing weight can cut the risk by 58%. Another study showed these changes reduced the chance of developing diabetes by 25%. These lifestyle changes also help control blood sugar and manage weight more effectively. Strong evidence supports that these changes can significantly help prevent type 2 diabetes. ^{1 2 6 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

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]

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]

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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6125024/

Lifestyle and the Prevention of Type 2 Diabetes: A Status ... Randomized controlled trials have shown that lifestyle interventions focused on physical activity, healthy diets, and weight loss can reduce diabetes risk by 58 ...

2. nejm.org nejm.org/doi/full/10.1056/NEJMoa012512

Reduction in the Incidence of Type 2 Diabetes with ... The incidence of diabetes was reduced by 58 percent with the lifestyle intervention and by 31 percent with metformin, as compared with placebo. These effects ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2589537022003807

Articles The effectiveness of lifestyle interventions on type 2 ... Lifestyle interventions decreased the incidence risk ratio of type 2 diabetes by 25% (0·75 [95% CI 0·61 to 0·91]), and reduced the levels of HbA1c by 0·15% [−0· ...

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2773398

Intensive Lifestyle Intervention in Type 2 Diabetes and ... Among linked participants, the intervention was associated with reduced weight, improved diabetes control, and reduced health care costs during ...

5. nature.com nature.com/articles/s41598-020-71119-2

Long-term effectiveness of a lifestyle intervention on the ... This study aims to assess the effects of a community-based lifestyle intervention program on the incidence of type 2 diabetes (T2D).

6. diabetesjournals.org diabetesjournals.org/care/article/25/12/2165/22085/The-Diabetes-Prevention-Program-DPP-Description-of

The Diabetes Prevention Program (DPP) Lifestyle intervention decreased the incidence of type 2 diabetes by 58% compared with 31% in the metformin-treated group, and information on ...

7. thecommunityguide.org thecommunityguide.org/findings/diabetes-intensive-lifestyle-interventions-patients-type-2-diabetes.html

Diabetes: Lifestyle Programs for Type 2 The CPSTF recommends intensive lifestyle interventions to control type 2 diabetes. Read effectiveness evidence from systematic review.

8. sciencedirect.com sciencedirect.com/science/article/pii/S0026049514003126

Effect of lifestyle intervention in patients with type 2 diabetes The meta-analysis found that lifestyle intervention showed significant benefit in risk factors that are known to be associated with development of ...