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CompletedNCT00128570Updated Sep 17, 2013

An Individualized Internet-Based Health Behavior Program or a Standard Internet-Based Health Behavior Program in Preventing Cancer and Improving Physical Activity and Nutrition in Participants Who Are Physically Inactive With a Higher Body Mass Index

An interventional study of behavioral dietary intervention and educational intervention in Unspecified Adult Solid Tumor, Protocol Specific, sponsored by Virginia Polytechnic Institute and State University. Completed at 1 site in United States. Open to participants aged 18 Years to 63 Years. Per ClinicalTrials.gov, last updated 2013-09-17.

Sponsored by Virginia Polytechnic Institute and State University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
18 Years to 63 Years
Sex
All
01

Study 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.

Read the detailed description

OBJECTIVES:

  • Compare the efficacy of an internet-based mastery-model health behavior educational intervention vs internet-based standard care health behavior educational intervention in improving physical activity and nutrition in sedentary participants with a higher body mass index.
  • Compare the efficacy of these interventions in reducing cancer risk, in these participants.

OUTLINE: This is a randomized, controlled, multicenter study. Participants are stratified according to participating site, age (55 years and over vs under 55 years), gender, ethnic group, and aerobic capacity (≤ 6 metabolic equivalent tasks [METS] vs > 6 METS). Participants are randomized to 1 of 2 intervention arms.

  • Arm I (mastery model health behavior educational intervention): Participants log on to the Guide to Health Project (GTH) website weekly and are provided access over a 24-month period to healthy lifestyle coaching modules and a completely individualized fitness program organized according to a mastery-model health behavior educational intervention. The mastery-model intervention comprises a 6-month behavioral initiation phase that includes an orientation and refinement of goals and expectations for each content area; a 6-month behavioral establishment phase comprising healthy lifestyle coaching modules focusing on physical activity and nutrition at least once a week; and a 6-month behavioral maintenance phase comprising a taper in the frequency of coaching sessions to once a month.
  • Arm II (standard care health behavior educational intervention): Participants log on to the GTH website weekly and are provided access over a 24-month period to information regarding a healthy lifestyle focusing on physical activity and nutrition organized according to a standard care health behavior educational intervention.

In both arms, participants verify step-counts measured by a pedometer and complete the Block Food Frequency Questionnaire online at 10 and 18 months.

PROJECTED ACCRUAL: A total of 300 participants (150 per arm) will be accrued for this study within 1 year.

02

Conditions studied

  • Unspecified Adult Solid Tumor, Protocol Specific

Keywords

  • unspecified adult solid tumor, protocol specific
03

In context

Lead sponsor

Virginia Polytechnic Institute and State University is the lead sponsor of 124 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 63 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Enrollment
300 participants (estimated)

Interventions

  • Behavioralbehavioral dietary intervention
  • Othereducational intervention
  • Otherinternet-based intervention
  • Otherpreventative dietary intervention
  • Procedureevaluation of cancer risk factors
06

Study locations

1 site
  • Virginia Polytechnic Institute and State University
    Blacksburg, Virginia 24061, United States
07

References and documents

Publications

  • 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. PubMed 21441100 ↗
  • 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. PubMed 21447470 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 17, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00128570
Lead sponsor
Virginia Polytechnic Institute and State University
Collaborators
National Cancer Institute (NCI)
First posted
Aug 10, 2005
Start date
Apr 2006
Primary completion
Feb 2010
Completion
Mar 2011
Last update
Sep 17, 2013

Study contacts

Richard A. Winett, PhD
principal investigator · Virginia Polytechnic Institute and State University
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2009. You cannot join it, but the record below documents what was studied.

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