Overview

This trial is active, not recruiting.

Conditions obesity, insulin resistance, diabetes
Treatment every little step counts intervention
Sponsor Arizona State University
Collaborator National Institutes of Health (NIH)
Start date April 2012
End date July 2016
Trial size 160 participants
Trial identifier NCT02039141, 1203007572, 5P20MD002316-07

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
Exercise classes (3/week) Lifestyle sessions (1/week)
every little step counts intervention ELSC Intervention
Youth participants randomized to participate in the experimental group will attend weekly healthy lifestyles education session with their parent(s)/guardian(s) and will also attend exercise sessions 3 times a week for 12 weeks. The education sessions will cover topics such as healthy eating choices, roles and responsibilities of both parents and youth in the realm of the family unit as well as in youth's own health, and self esteem among other topics. The exercise sessions will incorporate both aerobic and resistance training as well as other "free-play" physical activities i.e. basketball, volleyball etc.
(No Intervention)
Control group (delayed intervention group)

Primary Outcomes

Measure
Change in Insulin Sensitivity / Glucose Tolerance, Measured at Baseline, Change 3-months, 6-months, and 12-months
time frame: Baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline
Change in Quality of Life Measured at Baseline, 3-months, 6-months, and 12-months
time frame: Baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline

Secondary Outcomes

Measure
Change in Self efficacy for healthy eating and exercise
time frame: Baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline
Change in Social support from family and friends on healthy eating and exercise.
time frame: Baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline

Eligibility Criteria

Male or female participants from 14 years up to 16 years old.

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

Additional Information

Official title Community-Based Diabetes Prevention Program for Obese Latino Youth: Every Little Step Counts
Principal investigator Gabriel Q Shaibi, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Arizona State University.