Back to resultsCommunity-based Adolescent Diabetes Prevention Program
Primary Purpose
Pre-Diabetes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TEEN HEED
Sponsored by
About this trial
This is an interventional prevention trial for Pre-Diabetes focused on measuring community-based participatory research, adolescents
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:
- attending a school in East Harlem
- attending an after school or recreational activity in East Harlem
- 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
Sites / Locations
- Icahn School of Medicine at Mount Sinai
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
TEEN HEED
Wait List Control
Arm Description
Adolescent pre-diabetics will receive 8-12 weekly peer-led diabetes prevention educational workshops in community sites. The in-person group workshops will be supplemented by support through mobile health technologies such as text messaging and social media.
Adolescent pre-diabetics in this group will not receive any intervention until collection of all follow up data and will then be offered the same intervention as the participants in the experimental arm.
Outcomes
Primary Outcome Measures
Change in body mass index (BMI)
Change in BMI at post-intervention (approximately 3 months) as compared to baseline
Change in BMI
Change in BMI at 1 year as compared to baseline
Secondary Outcome Measures
Change in fasting blood glucose levels
Change in fasting blood glucose levels at post-intervention (approximately 3 months) as compared to baseline
Change in fasting blood glucose levels
Change in fasting blood glucose levels at 1 year as compared to baseline
Change in post prandial blood glucose level
Change in post prandial blood glucose level at post-intervention (approximately 3 months) as compared to baseline
Change in post prandial blood glucose level
Change in post prandial blood glucose level at 1 year as compared to baseline
Change in blood pressure
Change in blood pressure at post-intervention (approximately 3 months) as compared to baseline
Change in blood pressure
Change in blood pressure at 1 year as compared to baseline
Change in percent body fat
Change in percent body fat at post-intervention (approximately 3 months) as compared to baseline
Change in percent body fat
Change in percent body fat at 1 year as compared to baseline
Change in waist circumference
Change in waist circumference at post-intervention (approximately 3 months) as compared to baseline
Change in waist circumference
Change in waist circumference at 1 year as compared to baseline
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
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
Full Information
NCT ID
NCT02458131
First Posted
May 22, 2015
Last Updated
November 20, 2019
Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT02458131
Brief Title
Community-based Adolescent Diabetes Prevention Program
Official Title
TEEN HEED: An Adolescent Peer Led Diabetes Prevention Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
November 11, 2016 (Actual)
Primary Completion Date
August 24, 2019 (Actual)
Study Completion Date
August 24, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-Diabetes
Keywords
community-based participatory research, adolescents
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TEEN HEED
Arm Type
Experimental
Arm Description
Adolescent pre-diabetics will receive 8-12 weekly peer-led diabetes prevention educational workshops in community sites. The in-person group workshops will be supplemented by support through mobile health technologies such as text messaging and social media.
Arm Title
Wait List Control
Arm Type
No Intervention
Arm Description
Adolescent pre-diabetics in this group will not receive any intervention until collection of all follow up data and will then be offered the same intervention as the participants in the experimental arm.
Intervention Type
Behavioral
Intervention Name(s)
TEEN HEED
Intervention Description
Peer-led workshops will cover behavioral skills including goal setting, self-monitoring, problem solving, contingency management, coping skills, and social support.
Primary Outcome Measure Information:
Title
Change in body mass index (BMI)
Description
Change in BMI at post-intervention (approximately 3 months) as compared to baseline
Time Frame
Baseline and 3 months
Title
Change in BMI
Description
Change in BMI at 1 year as compared to baseline
Time Frame
Baseline and 1 year
Secondary Outcome Measure Information:
Title
Change in fasting blood glucose levels
Description
Change in fasting blood glucose levels at post-intervention (approximately 3 months) as compared to baseline
Time Frame
Baseline and 3 months
Title
Change in fasting blood glucose levels
Description
Change in fasting blood glucose levels at 1 year as compared to baseline
Time Frame
Baseline and 1 year
Title
Change in post prandial blood glucose level
Description
Change in post prandial blood glucose level at post-intervention (approximately 3 months) as compared to baseline
Time Frame
Baseline and 3 months
Title
Change in post prandial blood glucose level
Description
Change in post prandial blood glucose level at 1 year as compared to baseline
Time Frame
Baseline and 1 year
Title
Change in blood pressure
Description
Change in blood pressure at post-intervention (approximately 3 months) as compared to baseline
Time Frame
Baseline and 3 months
Title
Change in blood pressure
Description
Change in blood pressure at 1 year as compared to baseline
Time Frame
Baseline and 1 year
Title
Change in percent body fat
Description
Change in percent body fat at post-intervention (approximately 3 months) as compared to baseline
Time Frame
Baseline and 3 months
Title
Change in percent body fat
Description
Change in percent body fat at 1 year as compared to baseline
Time Frame
Baseline and 1 year
Title
Change in waist circumference
Description
Change in waist circumference at post-intervention (approximately 3 months) as compared to baseline
Time Frame
Baseline and 3 months
Title
Change in waist circumference
Description
Change in waist circumference at 1 year as compared to baseline
Time Frame
Baseline and 1 year
Title
Change in knowledge, attitudes, beliefs and behaviors related to diabetes and weight loss
Description
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 3 months
Title
Change in knowledge, attitudes, beliefs and behaviors related to diabetes and weight loss
Description
Change in knowledge, attitudes, beliefs and behaviors (from the TEEN HEED survey) at 1 year as compared to baseline
Time Frame
Baseline and 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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:
attending a school in East Harlem
attending an after school or recreational activity in East Harlem
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nita Vangeepuram, MD, MPH
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Community-based Adolescent Diabetes Prevention Program
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