- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02615353
Preventing Diabetes in Latino Youth
October 12, 2022 updated by: Arizona State University
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.
Study Overview
Status
Completed
Intervention / Treatment
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
Interventional
Enrollment (Actual)
117
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arizona
-
Phoenix, Arizona, United States, 85004
- Arizona State University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 16 years (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Lifestyle Intervention
6 months of a bi-weekly Nutrition Education, Physical Activity, and Behavioral Modification program
|
6-months of lifestyle education
|
PLACEBO_COMPARATOR: Usual Care Control
Medical screening and dietary counseling with a Endocrinologist and Registered Dietitian
|
Medical visit and dietary counseling
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Glucose Tolerance
Time Frame: 6-months, 12-months
|
Change in 2 hour glucose concentration following a 75 gram Oral Glucose Tolerance Test
|
6-months, 12-months
|
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).
|
6-months, 12-months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
6-months, 12-months
|
Body Composition
Time Frame: 6-months, 12-months
|
Change in fat mass and increase in lean tissue mass by DXA
|
6-months, 12-months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Soltero EG, Konopken YP, Olson ML, Keller CS, Castro FG, Williams AN, Patrick DL, Ayers S, Hu HH, Sandoval M, Pimentel J, Knowler WC, Frick KD, Shaibi GQ. Preventing diabetes in obese Latino youth with prediabetes: a study protocol for a randomized controlled trial. BMC Public Health. 2017 Mar 16;17(1):261. doi: 10.1186/s12889-017-4174-2.
- Pena A, Olson ML, Hooker E, Ayers SL, Castro FG, Patrick DL, Corral L, Lish E, Knowler WC, Shaibi GQ. Effects of a Diabetes Prevention Program on Type 2 Diabetes Risk Factors and Quality of Life Among Latino Youths With Prediabetes: A Randomized Clinical Trial. JAMA Netw Open. 2022 Sep 1;5(9):e2231196. doi: 10.1001/jamanetworkopen.2022.31196. Erratum In: JAMA Netw Open. 2022 Oct 3;5(10):e2239217.
- Vander Wyst KB, Olson ML, Bailey SS, Valencia AM, Pena A, Miller J, Shub M, Seabrooke L, Pimentel J, Olsen K, Rosenberg RB, Shaibi GQ. Communicating incidental and reportable findings from research MRIs: considering factors beyond the findings in an underrepresented pediatric population. BMC Med Res Methodol. 2021 Dec 5;21(1):275. doi: 10.1186/s12874-021-01459-8.
- Vander Wyst KB, Olson ML, Hooker E, Soltero EG, Konopken YP, Keller CS, Castro FG, Williams AN, Fernandez ADR, Patrick DL, Ayers SL, Hu HH, Pena A, Pimentel J, Knowler WC, Shaibi GQ. Yields and costs of recruitment methods with participant phenotypic characteristics for a diabetes prevention research study in an underrepresented pediatric population. Trials. 2020 Aug 14;21(1):716. doi: 10.1186/s13063-020-04658-8.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
May 13, 2016
Primary Completion (ACTUAL)
March 15, 2020
Study Completion (ACTUAL)
March 15, 2020
Study Registration Dates
First Submitted
November 4, 2015
First Submitted That Met QC Criteria
November 25, 2015
First Posted (ESTIMATE)
November 26, 2015
Study Record Updates
Last Update Posted (ACTUAL)
October 14, 2022
Last Update Submitted That Met QC Criteria
October 12, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1R01DK107579-01 (U.S. NIH Grant/Contract)
- 3R01DK107579-03S1 (NIH)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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