Community-based Adolescent Diabetes Prevention Program

Pre-Diabetes Clinical Trial

Official title:

TEEN HEED: An Adolescent Peer Led Diabetes Prevention Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02458131
• Other study ID #: GCO 13-0901
• Secondary ID: 5K23DK101692-02
• Status: Completed
• Phase: N/A
• Start date: November 11, 2016
• Est. completion date: August 24, 2019

Study information

• Verified date: November 2019
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: August 24, 2019
• Est. primary completion date: August 24, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Pre-Diabetes
• Prediabetic State

Intervention

Behavioral:
• TEEN HEED
Peer-led workshops will cover behavioral skills including goal setting, self-monitoring, problem solving, contingency management, coping skills, and social support.

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in body mass index (BMI)	Change in BMI at post-intervention (approximately 3 months) as compared to baseline	Baseline and 3 months
Primary	Change in BMI	Change in BMI at 1 year as compared to baseline	Baseline and 1 year
Secondary	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
Secondary	Change in fasting blood glucose levels	Change in fasting blood glucose levels at 1 year as compared to baseline	Baseline and 1 year
Secondary	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
Secondary	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
Secondary	Change in blood pressure	Change in blood pressure at post-intervention (approximately 3 months) as compared to baseline	Baseline and 3 months
Secondary	Change in blood pressure	Change in blood pressure at 1 year as compared to baseline	Baseline and 1 year
Secondary	Change in percent body fat	Change in percent body fat at post-intervention (approximately 3 months) as compared to baseline	Baseline and 3 months
Secondary	Change in percent body fat	Change in percent body fat at 1 year as compared to baseline	Baseline and 1 year
Secondary	Change in waist circumference	Change in waist circumference at post-intervention (approximately 3 months) as compared to baseline	Baseline and 3 months
Secondary	Change in waist circumference	Change in waist circumference at 1 year as compared to baseline	Baseline and 1 year
Secondary	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
Secondary	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