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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A School-based Internet Obesity Prevention Program for Adolescents

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • BMI [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Dietary behavior [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Healthy eating

  • Sedentary behavior [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Computer, TV, video games

  • Physical activity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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
Genders Eligible for Study:   Both
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

No publications provided by Yale University

Additional 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
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on September 22, 2014