NCT01560676

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
384

participants targeted

Target at P75+ for phase_2 obesity

Timeline
Completed

Started Sep 2009

Typical duration for phase_2 obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 22, 2012

Completed
Last Updated

March 22, 2012

Status Verified

March 1, 2012

Enrollment Period

1.7 years

First QC Date

March 20, 2012

Last Update Submit

March 20, 2012

Conditions

ObesityType 2 Diabetes

Keywords

InternetSchool basedObesity Prevention ProgramAdolescents

Outcome Measures

Primary Outcomes (1)

  • BMI

    6 months

Secondary Outcomes (3)

  • Dietary behavior

    6 months

  • Sedentary behavior

    6 months

  • Physical activity

    6 months

Study Arms (2)

HEALTH[e]TEEN

ACTIVE COMPARATOR

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

HEALTH[e]TEEN + CST

ACTIVE COMPARATOR

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

Interventions

HEALTH[e]TEENBEHAVIORAL

8 lessons over 6-8 weeks

HEALTH[e]TEEN
HEALTH[e]TEEN + CSTBEHAVIORAL

12 lessons over 6-8 weeks

HEALTH[e]TEEN + CST

Eligibility Criteria

Age13 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale

New Haven, Connecticut, United States

Location

Related Publications (1)

  • Whittemore R, Jeon S, Grey M. An internet obesity prevention program for adolescents. J Adolesc Health. 2013 Apr;52(4):439-47. doi: 10.1016/j.jadohealth.2012.07.014. Epub 2012 Sep 27.

    PMID: 23299003DERIVED

MeSH Terms

Conditions

ObesityDiabetes Mellitus, Type 2

Interventions

galactosylceramide sulfotransferase

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Study Officials

  • Robin Whittemore, PhD

    Yale University

    PRINCIPAL INVESTIGATOR

  • Margaret Grey, DrPH

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 20, 2012

First Posted

March 22, 2012

Study Start

September 1, 2009

Primary Completion

June 1, 2011

Study Completion

August 1, 2011

Last Updated

March 22, 2012

Record last verified: 2012-03

Locations

US(1)