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Reducing Obesity and Type 2 Diabetes in High Risk Youth (HEALTH[e]TEEN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01560676
Recruitment Status : Completed
First Posted : March 22, 2012
Last Update Posted : March 22, 2012
Sponsor:
Information provided by (Responsible Party):
Robin Whittemore, Yale University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Obesity Type 2 Diabetes Behavioral: HEALTH[e]TEEN Behavioral: HEALTH[e]TEEN + CST Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 384 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A School-based Internet Obesity Prevention Program for Adolescents
Study Start Date : September 2009
Primary Completion Date : June 2011
Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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
Behavioral: HEALTH[e]TEEN
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
Behavioral: HEALTH[e]TEEN + CST
12 lessons over 6-8 weeks



Primary Outcome Measures :
  1. BMI [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Dietary behavior [ Time Frame: 6 months ]
    Healthy eating

  2. Sedentary behavior [ Time Frame: 6 months ]
    Computer, TV, video games

  3. Physical activity [ Time Frame: 6 months ]
    Moderate to vigorous exercise



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Student enrolled in Health, Biology, or Public Health course

Exclusion Criteria:

  • Cognitive ability unable to read or respond to questions in program

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01560676


Locations
United States, Connecticut
Yale
New Haven, Connecticut, United States
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Robin Whittemore, PhD Yale University
Principal Investigator: Margaret Grey, DrPH Yale University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Robin Whittemore, Associate Professor, Yale University
ClinicalTrials.gov Identifier: NCT01560676     History of Changes
Other Study ID Numbers: 1008007228
First Posted: March 22, 2012    Key Record Dates
Last Update Posted: March 22, 2012
Last Verified: March 2012

Keywords provided by Robin Whittemore, Yale University:
Internet
School based
Obesity Prevention Program
Adolescents

Additional relevant MeSH terms:
Obesity
Diabetes Mellitus, Type 2
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases