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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Robin Whittemore, Yale University
ClinicalTrials.gov Identifier:
NCT01560676
First received: March 20, 2012
Last updated: NA
Last verified: March 2012
History: No changes posted
  Purpose
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 Intervention Phase
Obesity Type 2 Diabetes Behavioral: HEALTH[e]TEEN Behavioral: HEALTH[e]TEEN + CST Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A School-based Internet Obesity Prevention Program for Adolescents

Further study details as provided by Robin Whittemore, Yale University:

Primary Outcome Measures:
  • BMI [ Time Frame: 6 months ]

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

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

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


Enrollment: 384
Study Start Date: September 2009
Study Completion Date: August 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

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
Study First Received: March 20, 2012
Last Updated: March 20, 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

ClinicalTrials.gov processed this record on September 21, 2017