An Interactive Web-Based Program to Improve Food and Acti... | NCT00983567

Studies
An Interactive Web-Based Program to Improve Food and Activity Choices of Teens

NCT00983567

Sponsor

Baylor College of Medicine

Status

Completed

Last Update Posted

Mar 20, 2015Estimated

Enrollment

400Actual

Phase

Not Applicable

Conditions

Diet
Physical Activity

Interventions

teen web

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
USDA 2007-55215-17998

Status Module

Record Verification Date

Mar 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2009

Primary Completion Date

Dec 2012Actual

Completion Date

Dec 2012Actual

First Submitted Date

Jul 30, 2009

First Submission Date that Met QC Criteria

Sep 23, 2009

First Posted Date

Sep 24, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 18, 2015

Last Update Posted Date

Mar 20, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study will test a website for teens designed to help them improve both diet and physical activity. The website will have several components: educational messages, role model stories, goal setting, self-monitoring forms, problem solving, a monitored discussion forum, and diet and physical activity (PA) assessment questionnaires.

Detailed Description

Increasing numbers of youth are at risk for becoming overweight because of poor diets and low physical activity levels. Prevention is key to reducing the obesity problem. Intervention programs must be easily accessible, and include intervention materials in a format that draws attention and interest. This study evaluates an 8-week web-based intervention for teens to promote healthy food and physical activity choices. The web program includes role model stories, nutrition and activity information pieces, goal setting and problem solving, and self-monitoring. Students will complete assessments at baseline, 8-weeks post, and then 6 and 12-months post intervention.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

400Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Teen web	Experimental	Main web - with all components	Other: teen web
Minimal teen web	Active Comparator	Teen web minus behavioral components	Other: teen web

Interventions

Name	Type	Description	Arm Group Labels	Other Names
teen web	Other	Min web	Minimal teen web Teen web

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
diet (fruit, vegetables, sweetened beverages, fat)		baseline, post, 6-and 12-months

Secondary Outcomes

Measure	Description	Time Frame
BMI		baseline, post, 6- and 12-months
Physical activity:self-report		baseline, post, 6-and 12-months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ability to speak English
12-17 years old

Exclusion Criteria:

no special diets

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

17 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Karen W Cullen, DrPH	Baylor College of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Children's Nutrition Research Center		Houston	Texas	77030	United States