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

Cancer Prevention Mastery Model Internet Intervention

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.

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.

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