Diabetes Prevention Program for Obese Latino Youth

Not Applicable

Completed

• Conditions: Obesity; Insulin Resistance; Diabetes
• Interventions: Other: Every Little Step Counts Intervention

• Registration Number: NCT02039141
• Lead Sponsor: Arizona State University

Brief Summary

The purpose of this study is to examine the effects of 12 week lifestyle intervention on diabetes risk in obese Latino adolescents.

Detailed Description

Obesity in the United States has reached epidemic proportions and Latinos youth are disproportionally impacted. Pediatric obesity is associated with several chronic health conditions including insulin resistance and type 2 diabetes. However, very few interventions specifically targeting diabetes prevention for obese Latino adolescents have been developed.

Therefore, the purpose of this study is to examine the effects a culturally-grounded, community-based lifestyle intervention on psychosocial and health outcomes among obese Latino adolescents. Eligible participants of this study will be randomly selected to the intervention group or the delayed-intervention group (control group) after an initial health screening for eligibility.

Participants selected to the intervention group will attend weekly healthy lifestyle education sessions with their parent(s)/guardian(s) and three physical activity sessions / week with other youth. After which, participants will attend monthly booster group meetings for three months.

All participants will be assessed at baseline, 3 months, 6 months, and 12 months for insulin sensitivity, glucose tolerance, quality of life, fitness, and nutrition and physical activity behaviors.

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2013-07-31
• Study First Submitted QC: 2014-01-16
• Study First Posted: 2014-01-17
• Primary Completion: 2016-07
• Study Completion: 2016-08-04
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-03
• Last Update Posted: 2020-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• Latino: self-report by parents
• Age: 14-16
• Obese: BMI percentile >= 95th percentile for age and gender or BMI >= 30 kg/m^2

Exclusion Criteria

• Taking medication(s) or diagnosed with a condition that could influence carbohydrate metabolism, physical activity, and/or cognition
• Type 2 diabetes: Fasting plasma glucose >= 126 mg/dL or 2-hour plasma glucose >= 200 mg/dL (youth found to be diabetic through study's procedures will be referred for follow up care and excluded)
• Recent hospitalizations (previous 2 months)
• Currently enrolled in (or with in previous 6 months) a formal weight loss program
• Diagnosed depression or other condition that may impact QoL

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Every Little Step Counts Intervention	Every Little Step Counts Intervention	Exercise classes (3/week) Lifestyle sessions (1/week)

Primary Outcome Measures

Name	Time	Method
Change in Insulin Sensitivity / Glucose Tolerance, Measured at Baseline, Change 3-months, 6-months, and 12-months	Baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline	Proximal indicator of diabetes risk
Change in Quality of Life Measured at Baseline, 3-months, 6-months, and 12-months	Baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline	Generic and weight-specific quality of life

Secondary Outcome Measures

Name	Time	Method
Change in Self efficacy for healthy eating and exercise	Baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline	These secondary outcomes measures aim to explore the mechanisms of the intervention by assessing the "mediated effect" on the outcomes of insulin sensitivity and weight-specific QoL through the following putative mediators targeted in the program: self-efficacy for healthy eating and exercise.
Change in Social support from family and friends on healthy eating and exercise.	Baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline	These secondary outcomes measures aim to explore the mechanisms of the intervention by assessing the "mediated effect" on the outcomes of insulin sensitivity and weight-specific QoL through the following putative mediators targeted in the program: Social support from family and friends on healthy eating and exercise.

Trial Locations

Locations (1)

Arizona State University; 🇺🇸 Phoenix, Arizona, United States