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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00128570
Recruitment Status : Completed
First Posted : August 10, 2005
Last Update Posted : September 17, 2013
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
Unspecified Adult Solid Tumor, Protocol Specific Behavioral: behavioral dietary intervention Other: educational intervention Other: internet-based intervention Other: preventative dietary intervention Procedure: evaluation of cancer risk factors Not Applicable

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Primary Purpose: Prevention
Official Title: Cancer Prevention Mastery Model Internet Intervention
Study Start Date : April 2006
Actual Primary Completion Date : February 2010
Actual Study Completion Date : March 2011

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 63 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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)



  • 18 to 63

Performance status

  • Not specified

Life expectancy

  • Not specified


  • Not specified


  • No known liver disease


  • No known kidney disease


  • See Disease Characteristics
  • No known cardiovascular disease
  • Blood pressure ≤ 140/90 mm Hg


  • No known pulmonary disease


  • 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


Biologic therapy

  • Not specified


  • Not specified

Endocrine therapy

  • Not specified


  • Not specified


  • No prior organ transplantation


  • No concurrent beta-blockers

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00128570

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United States, Virginia
Virginia Polytechnic Institute and State University
Blacksburg, Virginia, United States, 24061
Sponsors and Collaborators
Virginia Polytechnic Institute and State University
National Cancer Institute (NCI)
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Principal Investigator: Richard A. Winett, PhD Virginia Polytechnic Institute and State University
Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00128570    
Other Study ID Numbers: CDR0000441158
First Posted: August 10, 2005    Key Record Dates
Last Update Posted: September 17, 2013
Last Verified: June 2009
Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific