Preventing Diabetes in Latino Youth

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

117 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-13

Study Completion Date

2020-03-15

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.

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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.

Conditions

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Obesity Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Lifestyle Intervention

6 months of a bi-weekly Nutrition Education, Physical Activity, and Behavioral Modification program

Group Type EXPERIMENTAL

Intensive Lifestyle Intervention

Intervention Type BEHAVIORAL

6-months of lifestyle education

Usual Care Control

Medical screening and dietary counseling with a Endocrinologist and Registered Dietitian

Group Type PLACEBO_COMPARATOR

Usual Care Control

Intervention Type OTHER

Medical visit and dietary counseling

Interventions

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Intensive Lifestyle Intervention

6-months of lifestyle education

Intervention Type BEHAVIORAL

Usual Care Control

Medical visit and dietary counseling

Intervention Type OTHER

Other Intervention Names

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Control

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

Minimum Eligible Age

12 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No