- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01560676
Reducing Obesity and Type 2 Diabetes in High Risk Youth (HEALTH[e]TEEN)
March 20, 2012 updated by: Robin Whittemore, Yale University
A School-based Internet Obesity Prevention Program for Adolescents
Compare the effect of the HEALT[e]TEEN program and a HEALTH[e]TEEN plus coping skills training delivered to high school students on BMI, nutrition and physical activity behaviors, and self-efficacy over 6 months.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
384
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Connecticut
-
New Haven, Connecticut, United States
- Yale
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Student enrolled in Health, Biology, or Public Health course
Exclusion Criteria:
- Cognitive ability unable to read or respond to questions in program
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: HEALTH[e]TEEN
8 lessons over 6-8 weeks Education on healthy eating and physical activity Behavioral support for self-monitoring and goal setting
|
8 lessons over 6-8 weeks
|
|
Active Comparator: HEALTH[e]TEEN + CST
12 lessons over 6-8 weeks Education on healthy eating and coping skills training Behavioral support for self-monitoring and goal setting
|
12 lessons over 6-8 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
BMI
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dietary behavior
Time Frame: 6 months
|
Healthy eating
|
6 months
|
|
Sedentary behavior
Time Frame: 6 months
|
Computer, TV, video games
|
6 months
|
|
Physical activity
Time Frame: 6 months
|
Moderate to vigorous exercise
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Robin Whittemore, PhD, Yale University
- Principal Investigator: Margaret Grey, DrPH, Yale University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2009
Primary Completion (Actual)
June 1, 2011
Study Completion (Actual)
August 1, 2011
Study Registration Dates
First Submitted
March 20, 2012
First Submitted That Met QC Criteria
March 20, 2012
First Posted (Estimate)
March 22, 2012
Study Record Updates
Last Update Posted (Estimate)
March 22, 2012
Last Update Submitted That Met QC Criteria
March 20, 2012
Last Verified
March 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1008007228
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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