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Community-based Adolescent Diabetes Prevention Program

TEEN HEED: An Adolescent Peer Led Diabetes Prevention Intervention

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02458131
Enrollment
90
Registered
2015-05-29
Start date
2016-11-11
Completion date
2019-08-24
Last updated
2019-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pre-Diabetes

Keywords

community-based participatory research, adolescents

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.

Interventions

BEHAVIORALTEEN HEED

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

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
13 Years to 19 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in body mass index (BMI)Baseline and 3 monthsChange in BMI at post-intervention (approximately 3 months) as compared to baseline
Change in BMIBaseline and 1 yearChange in BMI at 1 year as compared to baseline

Secondary

MeasureTime frameDescription
Change in blood pressureBaseline and 3 monthsChange in blood pressure at post-intervention (approximately 3 months) as compared to baseline
Change in percent body fatBaseline and 3 monthsChange in percent body fat at post-intervention (approximately 3 months) as compared to baseline
Change in fasting blood glucose levelsBaseline and 3 monthsChange in fasting blood glucose levels at post-intervention (approximately 3 months) as compared to baseline
Change in knowledge, attitudes, beliefs and behaviors related to diabetes and weight lossBaseline and 3 monthsChange in knowledge, attitudes, beliefs and behaviors (from the TEEN HEED survey) at post-intervention (approximately 3 months) as compared to baseline
Change in waist circumferenceBaseline and 3 monthsChange in waist circumference at post-intervention (approximately 3 months) as compared to baseline
Change in post prandial blood glucose levelBaseline and 3 monthsChange in post prandial blood glucose level at post-intervention (approximately 3 months) as compared to baseline

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026