Diabetes Prevention Program for Obese Latino Youth

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

Detailed Description
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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.

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

Conditions
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Obesity, Insulin Resistance, Diabetes

Intervention / Treatment
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* Other: Every Little Step Counts Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Every Little Step Counts Intervention<br>Exercise classes (3/week) Lifestyle sessions (1/week) | Other: Every Little Step Counts Intervention<br>* 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.<br>* Other names: ASU ELSC;|
| No Intervention: Delayed ELSC Intervention Group<br>Control group (delayed intervention group) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Insulin Sensitivity / Glucose Tolerance, Measured at Baseline, Change 3-months, 6-months, and 12-months | Proximal indicator of diabetes risk | 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 | Generic and weight-specific quality of life | Baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Self efficacy for healthy eating and exercise | 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. | 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. | 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. | Baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes prevention program, community based interventions, childhood obesity, insulin resistance, glucose tolerance, quality of life, Latino youth, physical activity, nutrition