Icahn School of Medicine at Mount Sinai
New York, 10029, United States
NCT Number: NCT02458131
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.
Looking for future studies?
Notify Me13 year–19 year
All sexes
Interventional
Not applicable
New York, 10029, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for pre-diabetes screening:
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:
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
Peer-led workshops will cover behavioral skills including goal setting, self-monitoring, problem solving, contingency management, coping skills, and social support.
Time frame: Baseline and 3 months
Change in BMI at post-intervention (approximately 3 months) as compared to baseline
Time frame: Baseline and 1 year
Change in BMI at 1 year as compared to baseline
Time frame: Baseline and 3 months
Change in fasting blood glucose levels at post-intervention (approximately 3 months) as compared to baseline
Time frame: Baseline and 1 year
Change in fasting blood glucose levels at 1 year as compared to baseline
Time frame: Baseline and 3 months
Change in post prandial blood glucose level at post-intervention (approximately 3 months) as compared to baseline
Time frame: Baseline and 1 year
Change in post prandial blood glucose level at 1 year as compared to baseline
Time frame: Baseline and 3 months
Change in blood pressure at post-intervention (approximately 3 months) as compared to baseline
Time frame: Baseline and 1 year
Change in blood pressure at 1 year as compared to baseline
Time frame: Baseline and 3 months
Change in percent body fat at post-intervention (approximately 3 months) as compared to baseline
Time frame: Baseline and 1 year
Change in percent body fat at 1 year as compared to baseline
Time frame: Baseline and 3 months
Change in waist circumference at post-intervention (approximately 3 months) as compared to baseline
Time frame: Baseline and 1 year
Change in waist circumference at 1 year as compared to baseline
Time frame: Baseline and 3 months
Change in knowledge, attitudes, beliefs and behaviors (from the TEEN HEED survey) at post-intervention (approximately 3 months) as compared to baseline
Time frame: Baseline and 1 year
Change in knowledge, attitudes, beliefs and behaviors (from the TEEN HEED survey) at 1 year as compared to baseline
Icahn School of Medicine at Mount Sinai
Other
TEEN HEED: An Adolescent Peer Led Diabetes Prevention Intervention
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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