Clinical trial NCT05228522: Preventing Diabetes in Latino Families
Official title: Preventing Diabetes in Latino Families
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 2 Diabetes
Obesity
Pediatric Obesity
Lead sponsor: Arizona State University
Sponsor class: OTHER
Collaborators: name: St. Vincent de Paul Medical and Dental Clinic
name: Valley of the Sun YMCA, Arizona
name: University of Washington
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2022-02-08
Enrollment: 132
Sex: ALL
Minimum age (years): 10
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Glucose Tolerance
timeFrame: 16 weeks
Secondary outcomes:
measure: Weight Specific Quality of Life (QoL)
timeFrame: 16 weeks
measure: Total body composition-muscle
timeFrame: 16 weeks
measure: Total body composition-fat
timeFrame: 16 weeks
measure: Total body composition-bone
timeFrame: 16 weeks
measure: Physical Activity
timeFrame: 16 weeks
measure: Dietary behaviors
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona State University
state: Arizona
Study officials:
References: