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Clinical Trials/NCT02039141
NCT02039141
Completed
Not Applicable

Community-Based Diabetes Prevention Program for Obese Latino Youth: Every Little Step Counts

Arizona State University1 site in 1 country160 target enrollmentApril 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity
Sponsor
Arizona State University
Enrollment
160
Locations
1
Primary Endpoint
Change in Insulin Sensitivity / Glucose Tolerance, Measured at Baseline, Change 3-months, 6-months, and 12-months
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2012
End Date
August 4, 2016
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Proximal indicator of diabetes risk

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

Generic and weight-specific quality of life

Secondary Outcomes

  • Change in Self efficacy for healthy eating and exercise(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.(Baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline)

Study Sites (1)

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