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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Cancer Prevention Mastery Model Internet Intervention

Conditions
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Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
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* Behavioral: behavioral dietary intervention
* Other: educational intervention
* Other: internet-based intervention
* Other: preventative dietary intervention
* Procedure: evaluation of cancer risk factors


Participation Criteria
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Eligibility 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 63 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: behavioral dietary intervention|nan|
|Other: educational intervention|nan|
|Other: internet-based intervention|nan|
|Other: preventative dietary intervention|nan|
|Procedure: evaluation of cancer risk factors|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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unspecified adult solid tumor, protocol specific