Fitness |
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
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
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
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
- No known liver disease
Renal
- No known kidney disease
Cardiovascular
- See Disease Characteristics
- No known cardiovascular disease
- Blood pressure ≤ 170/105 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
Location and Contact Information
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
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
Resources
- 10 Tips to Healthy Eating and Physical Activity for You (President's Council on Physical Fitness and Sports)
- Active at Any Size (National Institute of Diabetes and Digestive and Kidney Diseases)

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