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Clinical Trials/NCT02458131
NCT02458131
Completed
N/A

TEEN HEED: An Adolescent Peer Led Diabetes Prevention Intervention

Icahn School of Medicine at Mount Sinai1 site in 1 country90 target enrollmentNovember 11, 2016
ConditionsPre-Diabetes

Overview

Phase
N/A
Intervention
Not specified
Conditions
Pre-Diabetes
Sponsor
Icahn School of Medicine at Mount Sinai
Enrollment
90
Locations
1
Primary Endpoint
Change in body mass index (BMI)
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

The number of youth with type 2 diabetes is predicted to quadruple by 2050, with a disproportionate increase among minority youth. The research proposed in this Career Development Award will use community-based participatory research methodology as well as novel strategies (peer education and mobile health technologies) to design, implement and evaluate a diabetes prevention intervention for at-risk ethnic minority youth in an urban community with high disease burden.

Detailed Description

Approach: The proposed research addresses diabetes risk and prevention among racial/ethnic minority adolescents in East Harlem (EH), NY. Aim 1 will use qualitative methods to explore the best strategies for using peer education for diabetes risk reduction in youth and the potential role of mobile health technologies in improving adherence to behavioral modification plans. Aim 2 will utilize findings from preliminary studies and Aim 1 to design and evaluate a pilot community-based intervention to 1) maintain/reduce BMI (primary outcome), 2) improve adolescent dietary, physical activity and weight control behaviors, and 3) improve other measures of diabetes risk. Data will be collected at baseline, immediately after the intervention (3 months) and at one year in the intervention and wait list control groups. Aim 3 involves refining the pilot intervention based on an examination of intervention feasibility, acceptability, and sustainability and planning for a future R01.

Registry
clinicaltrials.gov
Start Date
November 11, 2016
End Date
August 24, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Change in body mass index (BMI)

Time Frame: Baseline and 3 months

Change in BMI at post-intervention (approximately 3 months) as compared to baseline

Change in BMI

Time Frame: Baseline and 1 year

Change in BMI at 1 year as compared to baseline

Secondary Outcomes

  • Change in knowledge, attitudes, beliefs and behaviors related to diabetes and weight loss(Baseline and 1 year)
  • Change in fasting blood glucose levels(Baseline and 1 year)
  • Change in post prandial blood glucose level(Baseline and 1 year)
  • Change in blood pressure(Baseline and 1 year)
  • Change in percent body fat(Baseline and 1 year)
  • Change in waist circumference(Baseline and 1 year)

Study Sites (1)

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