Preventing Diabetes in Latino Families

Arizona State University (ASU)

Status: Active, not recruiting

Conditions: Obesity; Pediatric Obesity; Type 2 Diabetes

Treatments: Behavioral: Lifestyle Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05228522

1R01DK107579-01

R01DK107579-06A1

Details and patient eligibility

About

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.

Full description

Background: T2D disproportionately impacts Latino children, families and communities. The Diabetes Prevention Program (DPP) established that T2D can be prevented in high-risk adults through intensive lifestyle intervention. Although the DPP has been translated to a variety of adult populations and settings, engagement and effectiveness is diminished in minority communities and there are no family-focused diabetes prevention trials for Latinos. The culturally-grounded approach is guided by an Ecodevelopmental model that considers community, family, peer, and individual-level factors that influence health behaviors and health outcomes over time. The study will test the efficacy of a 16-week family-focused lifestyle intervention for reducing T2D risk and increasing QoL among high-risk Latino families as compared to control families. The study will use Integrative Mixed Methods to understand how family structures and processes influence intervention outcomes.

Enrollment: 132 estimated patients

Sex: All

Ages: 10 to 99 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion/Exclusion Criteria - Children

Inclusion

• Latino: self-report
• Age: 10-16 years
• Obesity: BMI ≥ 95th percentile for age and sex

Exclusion

• Type 2 diabetes: (standard American Diabetes Association criteria)
• Taking medication(s) or diagnosed with a condition that influences carbohydrate metabolism, physical activity, and/or cognition
• Currently enrolled in (or within previous 12 months) a formal diabetes prevention or weight loss program
• Self-identify as American Indian
• Unstable depression or other mental health condition that may impact QoL

II. Inclusion/Exclusion Criteria - Parents

Inclusion

• Parent of a child who meets the above child inclusion/exclusion criteria

Exclusion

• Currently enrolled in (or within previous 12 months) a formal diabetes prevention or weight loss program
• Self-identify as American Indian

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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132 participants in 2 patient groups

Lifestyle Intervention

Experimental group

Description:

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

Treatment:

Behavioral: Lifestyle Intervention

Comparison control

No Intervention group

Description:

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.