Community-based Adolescent Diabetes Prevention Program

Not Applicable

Completed

• Conditions: Pre-Diabetes
• Interventions: Behavioral: TEEN HEED

• Registration Number: NCT02458131
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

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.

Study Timeline

• Study First Submitted: 2015-05-22
• Study First Submitted QC: 2015-05-27
• Study First Posted: 2015-05-29
• Study Start: 2016-11-11
• Primary Completion: 2019-08-24
• Study Completion: 2019-08-24
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-20
• Last Update Posted: 2019-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TEEN HEED	TEEN HEED	Adolescent pre-diabetics will receive 8-12 weekly peer-led diabetes prevention educational workshops in community sites. The in-person group workshops will be supplemented by support through mobile health technologies such as text messaging and social media.

Primary Outcome Measures

Name	Time	Method
Change in body mass index (BMI)	Baseline and 3 months	Change in BMI at post-intervention (approximately 3 months) as compared to baseline
Change in BMI	Baseline and 1 year	Change in BMI at 1 year as compared to baseline

Secondary Outcome Measures

Name	Time	Method
Change in knowledge, attitudes, beliefs and behaviors related to diabetes and weight loss	Baseline and 1 year	Change in knowledge, attitudes, beliefs and behaviors (from the TEEN HEED survey) at 1 year as compared to baseline
Change in fasting blood glucose levels	Baseline and 1 year	Change in fasting blood glucose levels at 1 year as compared to baseline
Change in post prandial blood glucose level	Baseline and 1 year	Change in post prandial blood glucose level at 1 year as compared to baseline
Change in blood pressure	Baseline and 1 year	Change in blood pressure at 1 year as compared to baseline
Change in percent body fat	Baseline and 1 year	Change in percent body fat at 1 year as compared to baseline
Change in waist circumference	Baseline and 1 year	Change in waist circumference at 1 year as compared to baseline

Trial Locations

Locations (1)

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States