NCT00128570

Brief Summary

RATIONALE: An internet-based health behavior program that provides information about physical activity, fitness, and nutrition may help participants become healthier and reduce the risk of developing cancer. PURPOSE: This randomized clinical trial is studying an individualized internet-based health behavior program to see how well it works compared to a standard internet-based health behavior program in preventing cancer and improving physical activity, fitness, and nutrition in participants who are physically inactive with a higher body mass index.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2006

Longer than P75 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 8, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 10, 2005

Completed
8 months until next milestone

Study Start

First participant enrolled

April 1, 2006

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

September 17, 2013

Status Verified

June 1, 2009

Enrollment Period

3.8 years

First QC Date

August 8, 2005

Last Update Submit

September 16, 2013

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Interventions

behavioral dietary interventionBEHAVIORAL
educational interventionOTHER
internet-based interventionOTHER
preventative dietary interventionOTHER
evaluation of cancer risk factorsPROCEDURE

Eligibility Criteria

Age18 Years - 63 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
DISEASE CHARACTERISTICS: * Sedentary participant * Not currently participating in a regular exercise program (i.e., \< 30 minutes/day of moderate physical activity, 5 days a week) * Body Mass Index 23-33.5 * Patiwnts that meet any of the following criteria are excluded: * High blood pressure (BP) (i.e., systolic BP ≥ 140 mm Hg OR diastolic BP ≥ 90 mm Hg) OR BP controlled with medications other than beta-blockers * Known high cholesterol (i.e., \> 200 mg/dL) * Known low high-density lipoprotein level (i.e., \< 40 mg/dL) * Use of antihyperlipidemic medications * Existing disease (i.e., heart disease, cancer, diabetes, and kidney or liver problems) PATIENT CHARACTERISTICS: Age * 18 to 63 Performance status * Not specified Life expectancy * Not specified Hematopoietic * Not specified Hepatic * No known liver disease Renal * No known kidney disease Cardiovascular * See Disease Characteristics * No known cardiovascular disease * Blood pressure ≤ 140/90 mm Hg Pulmonary * No known pulmonary disease Other * Not pregnant * No known diabetes * No known HIV positivity * No cancer within the past 5 years * No condition (e.g., orthopedic injuries or musculoskeletal disabilities) that would restrict physical activity or the ability to take a 1-mile walk test * No other known life-threatening illness or condition * Internet user PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * No prior organ transplantation Other * No concurrent beta-blockers

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Virginia Polytechnic Institute and State University

Blacksburg, Virginia, 24061, United States

Location

Related Publications (2)

  • Anderson-Bill ES, Winett RA, Wojcik JR. Social cognitive determinants of nutrition and physical activity among web-health users enrolling in an online intervention: the influence of social support, self-efficacy, outcome expectations, and self-regulation. J Med Internet Res. 2011 Mar 17;13(1):e28. doi: 10.2196/jmir.1551.

    PMID: 21441100RESULT

  • Anderson-Bill ES, Winett RA, Wojcik JR, Winett SG. Web-based guide to health: relationship of theoretical variables to change in physical activity, nutrition and weight at 16-months. J Med Internet Res. 2011 Mar 4;13(1):e27. doi: 10.2196/jmir.1614.

    PMID: 21447470DERIVED

MeSH Terms

Interventions

Early Intervention, Educational

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health Services

Study Officials

  • Richard A. Winett, PhD

    Virginia Polytechnic Institute and State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Purpose
PREVENTION
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 8, 2005

First Posted

August 10, 2005

Study Start

April 1, 2006

Primary Completion

February 1, 2010

Study Completion

March 1, 2011

Last Updated

September 17, 2013

Record last verified: 2009-06

Locations

US(1)