Community-based Adolescent Diabetes Prevention Program

Icahn School of Medicine at Mount Sinai90 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Pre-Diabetes

Interventions

TEEN HEEDBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 13 YearsMax age: 19 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Outcomes

Primary Outcomes

Change in body mass index (BMI)

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

Time frame: Baseline and 3 months

Change in BMI

Change in BMI at 1 year as compared to baseline

Time frame: Baseline and 1 year

Secondary Outcomes

Change in fasting blood glucose levels

Change in fasting blood glucose levels at post-intervention (approximately 3 months) as compared to baseline

Time frame: Baseline and 3 months

Change in fasting blood glucose levels

Change in fasting blood glucose levels at 1 year as compared to baseline

Time frame: 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

Time frame: 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

Time frame: Baseline and 1 year

Change in blood pressure

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

Time frame: Baseline and 3 months

Change in blood pressure

Change in blood pressure at 1 year as compared to baseline

Data from ClinicalTrials.gov

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