Expired Study
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Blacksburg, Virginia 24061


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.


Study summary:

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.


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


NCT ID:

NCT00128570


Primary Contact:

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


Backup Contact:

N/A


Location Contact:

Blacksburg, Virginia 24061
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 10, 2017

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