Community-based Adolescent Diabetes Prevention Program

TEEN HEED: An Adolescent Peer Led Diabetes Prevention Intervention

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.

Study Overview

• Status: Completed
• Conditions: Pre-Diabetes
• Intervention / Treatment: Behavioral: TEEN HEED

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 Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 19 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria for pre-diabetes screening:

• Adolescents ages 13-19 years of age
• English speaking

• Residents of East Harlem or members of an East Harlem Institution. Membership in an East Harlem institution includes the following:

  1. attending a school in East Harlem
  2. attending an after school or recreational activity in East Harlem
  3. receiving health care in East Harlem Proof of address or membership in an East Harlem institution will not be asked.
• At risk for diabetes (overweight/obese based on measured BMI percentile and with either a parent or grandparent with type 2 diabetes)
• No plans to relocate from New York City in the next year

Note: additional inclusion criteria for participation in workshops include diagnosis of pre-diabetes based on oral glucose tolerance test

Exclusion Criteria for pre-diabetes screening:

• <13 or >19 years of age
• Previous diagnosis of diabetes
• BMI percentile <85th percentile for age and gender based on Centers for Disease Control and Prevention definition
• Currently pregnant
• Speaking a language other than English
• On medications that may raise or lower blood sugar
• Plans to relocate from New York City within one year of enrollment-

Note: additional exclusion criteria for participation in workshops include fingerstick glucoses outside the pre-diabetes range during oral glucose tolerance testing and any cognitive or physical impairment that would preclude comprehension of the group educational program

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: TEEN HEED; Peer-led workshops will cover behavioral skills including goal setting, self-monitoring, problem solving, contingency management, coping skills, and social support.
No Intervention: Wait List Control; Adolescent pre-diabetics in this group will not receive any intervention until collection of all follow up data and will then be offered the same intervention as the participants in the experimental arm.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in fasting blood glucose levels	Change in fasting blood glucose levels at post-intervention (approximately 3 months) as compared to baseline	Baseline and 3 months
Change in fasting blood glucose levels	Change in fasting blood glucose levels at 1 year as compared to baseline	Baseline and 1 year
Change in post prandial blood glucose level	Change in post prandial blood glucose level at post-intervention (approximately 3 months) as compared to baseline	Baseline and 3 months
Change in post prandial blood glucose level	Change in post prandial blood glucose level at 1 year as compared to baseline	Baseline and 1 year
Change in blood pressure	Change in blood pressure at post-intervention (approximately 3 months) as compared to baseline	Baseline and 3 months
Change in blood pressure	Change in blood pressure at 1 year as compared to baseline	Baseline and 1 year
Change in percent body fat	Change in percent body fat at post-intervention (approximately 3 months) as compared to baseline	Baseline and 3 months
Change in percent body fat	Change in percent body fat at 1 year as compared to baseline	Baseline and 1 year
Change in waist circumference	Change in waist circumference at post-intervention (approximately 3 months) as compared to baseline	Baseline and 3 months
Change in waist circumference	Change in waist circumference at 1 year as compared to baseline	Baseline and 1 year
Change in knowledge, attitudes, beliefs and behaviors related to diabetes and weight loss	Change in knowledge, attitudes, beliefs and behaviors (from the TEEN HEED survey) at post-intervention (approximately 3 months) as compared to baseline	Baseline and 3 months
Change in knowledge, attitudes, beliefs and behaviors related to diabetes and weight loss	Change in knowledge, attitudes, beliefs and behaviors (from the TEEN HEED survey) at 1 year as compared to baseline	Baseline and 1 year

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Nita Vangeepuram, MD, MPH, Icahn School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2016
• Primary Completion (Actual): August 24, 2019
• Study Completion (Actual): August 24, 2019

Study Registration Dates

• First Submitted: May 22, 2015
• First Submitted That Met QC Criteria: May 27, 2015
• First Posted (Estimate): May 29, 2015

Study Record Updates

• Last Update Posted (Actual): November 21, 2019
• Last Update Submitted That Met QC Criteria: November 20, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: adolescents; community-based participatory research
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Prediabetic State
• Other Study ID Numbers: GCO 13-0901; 5K23DK101692-02 (U.S. NIH Grant/Contract)