132 Participants Needed

Lifestyle Intervention for Preventing Type 2 Diabetes in Latinos

Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: Arizona State University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

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 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.12345

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.23567

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.12568

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.

Eligibility Criteria

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.
See 3 more

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.
See 4 more

Timeline

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Lifestyle InterventionExperimental Treatment1 Intervention
16-week family-focused intervention that includes nutrition education, behavioral change skills training, and physical activity.
Group II: Comparison controlActive Control1 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

Find a Clinic Near You

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+

Findings from Research

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

References

Diabetes Prevention in U.S. Hispanic Adults: A Systematic Review of Culturally Tailored Interventions. [2021]
Diabetes prevention in Hispanics: report from a randomized controlled trial. [2022]
Long-term outcomes from a multiple-risk-factor diabetes trial for Latinas: ¡Viva Bien! [2021]
A community-based pilot study of a diabetes pharmacist intervention in Latinos: impact on weight and hemoglobin A1c. [2022]
PREVENT-DM Comparative Effectiveness Trial of Lifestyle Intervention and Metformin. [2022]
Effective Translation of an Intensive Lifestyle Intervention for Hispanic Women With Prediabetes in a Community Health Center Setting. [2021]
Perspectives of health educators and interviewers in a randomized controlled trial of a postpartum diabetes prevention program for Latinas: a qualitative assessment. [2021]
Preventing diabetes in Latino families: A protocol for a randomized control trial. [2023]
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