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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00128570
First received: August 8, 2005
Last updated: September 16, 2013
Last verified: June 2009
  Purpose

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 Intervention
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

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Prevention
Official Title: Cancer Prevention Mastery Model Internet Intervention

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 300
Study Start Date: April 2006
Study Completion Date: March 2011
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 63 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00128570

Locations
United States, Virginia
Virginia Polytechnic Institute and State University
Blacksburg, Virginia, United States, 24061
Sponsors and Collaborators
Virginia Polytechnic Institute and State University
Investigators
Principal Investigator: Richard A. Winett, PhD Virginia Polytechnic Institute and State University
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00128570     History of Changes
Other Study ID Numbers: CDR0000441158, VPISU-04-644, VPISU-03-588
Study First Received: August 8, 2005
Last Updated: September 16, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific

ClinicalTrials.gov processed this record on April 17, 2014