Preventing Diabetes in Latino Youth

Study Overview
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Brief Summary
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Obesity and type 2 diabetes are critical public health issues in youth. This study will test the effects and estimate the cost-effectiveness of a culturally-grounded community-based lifestyle intervention on type 2 diabetes risk among obese Latino adolescents with prediabetes.

Detailed Description
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Obesity and related health disparities represent some of the most significant public health challenges facing society. In particular, obese Latino adolescents are disproportionately impacted by insulin resistance and type 2 diabetes. Prediabetes is an intermediate stage in the pathogenesis of type 2 diabetes and represents a critical opportunity for intervention. The Diabetes Prevention Program established that lifestyle intervention can prevent or delay type 2 diabetes in adults with prediabetes. To date, no diabetes prevention studies have been conducted in obese Latino youth with prediabetes, a highly vulnerable and underserved group. Therefore, investigators propose a randomized-controlled trial to test the short-term (6-month) and long-term (12-month) efficacy of a culturally-grounded, lifestyle intervention, as compared to usual care, for improving glucose tolerance and reducing diabetes risk in 120 obese Latino adolescents with prediabetes. Investigators will further test intervention effects on changes in quality of life, explore the potential mediating effects of changes in total, regional, and organ fat on improving glucose tolerance and increasing insulin sensitivity, and estimate the initial incremental cost-effectiveness of the intervention as compared with usual care for improving glucose tolerance. The overall approach is framed within a multilevel Ecodevelopmental model that leverages community, family, peer, and individual factors during the critical transition period of adolescence when changes in health behaviors and health outcomes are linked to future health trajectories. The intervention is guided by Social Cognitive Theory and employs key behavioral modification strategies to enhance self-efficacy and foster social support for making and sustaining healthy behavior changes. The proposal builds upon extant collaborations of a transdisciplinary team of investigators working in concert with local community agencies to address critical gaps in how diabetes prevention interventions for obese Latino youth are developed, implemented and evaluated. This innovative approach is an essential step in the development of scalable, cost-effective, solution-oriented programs to prevent type 2 diabetes in this and other populations of high-risk youth.

Official Title
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Preventing Diabetes in Latino Youth

Conditions
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Obesity, Diabetes

Intervention / Treatment
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* Behavioral: Intensive Lifestyle Intervention
* Other: Usual Care Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Latino: self-report Age: 12-16 Obese: BMI percentile ≥95th percentile for age and gender or BMI ≥30 kg/m22 Prediabetic: fasting glucose ≥100, or 2-hour post-OGTT glucose ≥120 mg/dl, or HbA1c ≥5.7 Exclusion Criteria: Taking medication(s) or diagnosed with a condition that influences carbohydrate metabolism, PA, and/or cognition Type 2 diabetes: Fasting glucose ≥126 mg/dl or 2-hour glucose ≥200 mg/dl, or HbA1c ≥6.5 Recent Hospitalization (previous 2 months) Currently enrolled in (or within 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: 12 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: Lifestyle Intervention<br>6 months of a bi-weekly Nutrition Education, Physical Activity, and Behavioral Modification program | Behavioral: Intensive Lifestyle Intervention<br>* 6-months of lifestyle education<br>|
| Placebo Comparator: Usual Care Control<br>Medical screening and dietary counseling with a Endocrinologist and Registered Dietitian | Other: Usual Care Control<br>* Medical visit and dietary counseling<br>* Other names: Control;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose Tolerance | Change in 2 hour glucose concentration following a 75 gram Oral Glucose Tolerance Test | 6-months, 12-months | 
| Insulin Sensitivity | Change in Insulin Sensitivity following a 75 gram Oral Glucose Tolerance Test. Insulin sensitivity will be estimated by the Whole-body insulin sensitivity index (Matsuda Index). | 6-months, 12-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Youth Quality of Life | YQOL has domains of self (feelings about one's self), social relationships (friends and family), environment (social and cultural milieu) are assessed and an overall QoL score is computed. The instrument shows strong psychometric properties including internal consistency (Chronbach's alpha >0.80), test-retest reliability (ICC >0.74), and construct validity with other pediatric QoL measures (r = 0.73, P<0.05 with KINDL). Weight specific QoL will be assessed by the YQOL-W which, measures three domains of weight-related QoL (Self, Social, and Environmental). It is specific to obese adolescents (11-18 years) for use in evaluating weight management interventions in clinical and community research. The instrument shows good reliability (ICC =0.77) and construct validity with the children's depression inventory (r=0.57, P<0.01) in adolescents and is more sensitive then generic measures for detecting changes in QoL among obese youth participating in lifestyle interventions. | 6-months, 12-months | 
| Body Composition | Change in fat mass and increase in lean tissue mass by DXA | 6-months, 12-months |