Clinical trial NCT02458131: Community-based Adolescent Diabetes Prevention Program
Official title: TEEN HEED: An Adolescent Peer Led Diabetes Prevention Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pre-Diabetes
Keywords: community-based participatory research
adolescents
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2015-05-29
Enrollment: 90
Sex: ALL
Minimum age (years): 13
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in body mass index (BMI)
timeFrame: Baseline and 3 months
measure: Change in BMI
timeFrame: Baseline and 1 year
Secondary outcomes:
measure: Change in fasting blood glucose levels
timeFrame: Baseline and 3 months
measure: Change in fasting blood glucose levels
timeFrame: Baseline and 1 year
measure: Change in post prandial blood glucose level
timeFrame: Baseline and 3 months
measure: Change in post prandial blood glucose level
timeFrame: Baseline and 1 year
measure: Change in blood pressure
timeFrame: Baseline and 3 months
measure: Change in blood pressure
timeFrame: Baseline and 1 year
measure: Change in percent body fat
timeFrame: Baseline and 3 months
measure: Change in percent body fat
timeFrame: Baseline and 1 year
measure: Change in waist circumference
timeFrame: Baseline and 3 months
measure: Change in waist circumference
timeFrame: Baseline and 1 year
measure: Change in knowledge, attitudes, beliefs and behaviors related to diabetes and weight loss
timeFrame: Baseline and 3 months
measure: Change in knowledge, attitudes, beliefs and behaviors related to diabetes and weight loss
timeFrame: Baseline and 1 year
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Nita Vangeepuram, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: