View Clinical Trial (Medical Research Study)
Cancer Prevention Mastery Model Internet Intervention
| City: |
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Blacksburg |
| State: |
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Virginia |
| Zip Code: |
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24061 |
| Conditions: |
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Unspecified Adult Solid Tumor, Protocol Specific |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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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
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| NCT ID: |
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NCT00128570 |
| Primary Contact: |
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Principal Investigator
Richard A. Winett, PhD
Virginia Polytechnic Institute and State University
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| Backup Contact: |
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N/A |
| Location Contact: |
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Blacksburg, Virginia 24061
United States
Clinical Trials Office - Virginia Polytechnic Institute and St
Phone: 540-231-6077
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 23, 2013 |
| Modifications to this listing: |
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