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Internet-Based Individualized Health Behavior Program or Internet-Based Standard 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 - Article


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Exercise and Physical Fitness; Physical Fitness 




Clinical Trial: Internet-Based Individualized Health Behavior Program or Internet-Based Standard 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

This study is not yet open for patient recruitment.
Verified by National Cancer Institute (NCI) August 2005

Sponsors and Collaborators: Virginia Polytechnic Institute and State University
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00128570

Purpose

RATIONALE: An internet-based health behavior program that provides information about physical activity, fitness, and nutrition may help participants become more active and reduce the risk of developing cancer.

PURPOSE: This randomized clinical trial is studying an internet-based individualized health behavior program to see how well it works compared to an internet-based standard 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
 Procedure: cancer prevention intervention
 Procedure: dietary intervention
 Procedure: educational intervention
 Procedure: evaluation of cancer risk factors

MedlinePlus related topics:  Cancer;   Cancer Alternative Therapies

Study Type: Interventional
Study Design: Prevention

Official Title: Randomized Study of an Internet-Based Mastery-Model Health Behavior Educational Intervention Versus Internet-Based Standard Care Health Behavior Educational Intervention in Preventing Cancer and Improving Physical Activity, Fitness, and Nutrition in Sedentary Participants With a Higher Body Mass Index

Further Study Details: 

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, fitness, and nutrition in sedentary participants with a higher body mass index.
  • Compare the efficacy of these interventions in preventing disease, including 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, fitness, 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, fitness, and nutrition organized according to a standard care health behavior educational intervention.

In both arms, participants complete a 1-mile walk test, verify step-counts measured by a pedometer, and complete the Block Food Frequency Questionnaire online at 6, 15, and 24 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   -   65 Years,  Genders Eligible for Study:  Both
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 23-35
  • Permission from attending physician required for participants meeting any of the following criteria:
  • Male participant 45 years of age and over
  • Female participant 55 years of age and over
  • Very low fitness level (e.g., < 5 metabolic equivalent tasks [METS]) by self report OR by 1-mile walk test
  • Has ≥ 2 of the following coronary risk factors:
  • Inactivity, inconsistent activity, or only low intensity, low duration, or inconsistent moderate activity for the past 3 months
  • 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
  • Family history of early heart disease (i.e., heart attack, heart surgery, or stroke in male first-degree relative < 55 years of age OR female first-degree relative < 65 years of age)
  • Current cigarette smoker OR quit smoking within the past 6 months

PATIENT CHARACTERISTICS:

Age

  • 18 to 65

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

Renal

Cardiovascular

  • See Disease Characteristics
  • No known cardiovascular disease
  • Blood pressure ≤ 170/105 mm Hg

Pulmonary

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

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00128570


Study chairs or principal investigators

Richard A. Winett, PhD,  Principal Investigator,  Virginia Polytechnic Institute and State University   

More Information

Clinical trial summary from the National Cancer Institute''''s PDQ® database

Study ID Numbers:  CDR0000441158; VPISU-04-644; VPISU-03-588
Last Updated:  August 9, 2005
Record first received:  August 8, 2005
ClinicalTrials.gov Identifier:  NCT00128570
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-08-23

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Page Updated: September 6, 2005
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