Preventing Diabetes in Latino Youth

Obesity Clinical Trial

Official title:

Preventing Diabetes in Latino Youth

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02615353
• Other study ID #: 1R01DK107579-01
• Secondary ID: 3R01DK107579-03S
• Status: Completed
• Phase: N/A
• Start date: May 13, 2016
• Est. completion date: March 15, 2020

Study information

• Verified date: October 2022
• Source: Arizona State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: March 15, 2020
• Est. primary completion date: March 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Obesity

Intervention

Behavioral:
• Intensive Lifestyle Intervention
6-months of lifestyle education

Other:
• Usual Care Control
Medical visit and dietary counseling

Locations

Country	Name	City	State
United States	Arizona State University	Phoenix	Arizona

Sponsors (6)

Lead Sponsor	Collaborator
Arizona State University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Phoenix Children's Hospital, St. Vincent de Paul Medical and Dental Clinic, University of Washington, Valley of the Sun YMCA, Arizona

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucose Tolerance	Change in 2 hour glucose concentration following a 75 gram Oral Glucose Tolerance Test	6-months, 12-months
Primary	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	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
Secondary	Body Composition	Change in fat mass and increase in lean tissue mass by DXA	6-months, 12-months