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Preventing Diabetes in Latino Youth

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02615353
Recruitment Status : Completed
First Posted : November 26, 2015
Last Update Posted : October 14, 2022
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

Tracking Information
First Submitted Date  ICMJE November 4, 2015
First Posted Date  ICMJE November 26, 2015
Last Update Posted Date October 14, 2022
Actual Study Start Date  ICMJE May 13, 2016
Actual Primary Completion Date March 15, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 12, 2022)
  • Glucose Tolerance [ Time Frame: 6-months, 12-months ]
    Change in 2 hour glucose concentration following a 75 gram Oral Glucose Tolerance Test
  • Insulin Sensitivity [ Time Frame: 6-months, 12-months ]
    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).
Original Primary Outcome Measures  ICMJE
 (submitted: November 25, 2015)
Improvements in Glucose Tolerance [ Time Frame: 12-months ]
Reductions in 2-hour glucose following an oral glucose tolerance test
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 12, 2022)
  • Youth Quality of Life [ Time Frame: 6-months, 12-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.
  • Body Composition [ Time Frame: 6-months, 12-months ]
    Change in fat mass and increase in lean tissue mass by DXA
Original Secondary Outcome Measures  ICMJE
 (submitted: November 25, 2015)
  • Quality of Life [ Time Frame: 12-months ]
  • Body Composition [ Time Frame: 12-months ]
    Decrease in fat mass and increase in lean tissue mass by DXA
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Preventing Diabetes in Latino Youth
Official Title  ICMJE Preventing Diabetes in Latino Youth
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Obesity
  • Diabetes
Intervention  ICMJE
  • Behavioral: Intensive Lifestyle Intervention
    6-months of lifestyle education
  • Other: Usual Care Control
    Medical visit and dietary counseling
    Other Name: Control
Study Arms  ICMJE
  • Experimental: Lifestyle Intervention
    6 months of a bi-weekly Nutrition Education, Physical Activity, and Behavioral Modification program
    Intervention: Behavioral: Intensive Lifestyle Intervention
  • Placebo Comparator: Usual Care Control
    Medical screening and dietary counseling with a Endocrinologist and Registered Dietitian
    Intervention: Other: Usual Care Control
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 15, 2019)
117
Original Estimated Enrollment  ICMJE
 (submitted: November 25, 2015)
120
Actual Study Completion Date  ICMJE March 15, 2020
Actual Primary Completion Date March 15, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 16 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02615353
Other Study ID Numbers  ICMJE 1R01DK107579-01( U.S. NIH Grant/Contract )
3R01DK107579-03S1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Current Responsible Party Arizona State University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Arizona State University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • 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)
Investigators  ICMJE Not Provided
PRS Account Arizona State University
Verification Date October 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP