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Preventing Diabetes in Latino Youth

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ClinicalTrials.gov Identifier: NCT02615353
Recruitment Status : Recruiting
First Posted : November 26, 2015
Last Update Posted : August 28, 2019
Sponsor:
Collaborators:
Phoenix Children's Hospital
St. Vincent de Paul Medical and Dental Clinic
Valley of the Sun YMCA, Arizona
University of Washington
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Arizona State University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Obesity Diabetes Behavioral: Intensive Lifestyle Intervention Other: Usual Care Control Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Preventing Diabetes in Latino Youth
Actual Study Start Date : February 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Arm Intervention/treatment
Experimental: Lifestyle Intervention
6 months of a bi-weekly Nutrition Education, Physical Activity, and Behavioral Modification program
Behavioral: Intensive Lifestyle Intervention
6-months of lifestyle education

Placebo Comparator: Usual Care Control
Medical screening and dietary counseling with a Endocrinologist and Registered Dietitian
Other: Usual Care Control
Medical visit and dietary counseling
Other Name: Control




Primary Outcome Measures :
  1. Insulin Sensitivity [ Time Frame: 6-months ]
    Improvements 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).


Secondary Outcome Measures :
  1. Youth Quality of Life [ Time Frame: 6-months ]
    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.

  2. Body Composition [ Time Frame: 6-months ]
    Decrease in fat mass and increase in lean tissue mass by DXA



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Ages Eligible for Study:   12 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02615353


Locations
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United States, Arizona
Arizona State University Recruiting
Phoenix, Arizona, United States, 85004
Contact: Allison Williams, MSW    602-496-0147    Allison.nagle@asu.edu   
Principal Investigator: Gabriel Q Shaibi, PhD         
Sponsors and Collaborators
Arizona State University
Phoenix Children's Hospital
St. Vincent de Paul Medical and Dental Clinic
Valley of the Sun YMCA, Arizona
University of Washington
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Publications:
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Responsible Party: Arizona State University
ClinicalTrials.gov Identifier: NCT02615353     History of Changes
Other Study ID Numbers: 1R01DK107579-01 ( U.S. NIH Grant/Contract )
First Posted: November 26, 2015    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases