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

NCT ID: NCT00128570

Last Updated: 2013-09-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2011-03-31

Brief Summary

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

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.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: PREVENTION

Interventions

behavioral dietary intervention

Intervention Type: BEHAVIORAL

educational intervention

Intervention Type: OTHER

internet-based intervention

Intervention Type: OTHER

preventative dietary intervention

Intervention Type: OTHER

evaluation of cancer risk factors

Intervention Type: PROCEDURE

Eligibility Criteria

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 63 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Virginia Polytechnic Institute and State University

OTHER

Sponsor Role: lead

Principal Investigators

Richard A. Winett, PhD

Role: PRINCIPAL_INVESTIGATOR

Virginia Polytechnic Institute and State University

Locations

Virginia Polytechnic Institute and State University

Blacksburg, Virginia, United States

Countries

United States

References

Anderson-Bill ES, Winett RA, Wojcik JR. Social cognitive determinants of nutrition and physical activity among web-health users enrolling in an online intervention: the influence of social support, self-efficacy, outcome expectations, and self-regulation. J Med Internet Res. 2011 Mar 17;13(1):e28. doi: 10.2196/jmir.1551.

Reference Type: RESULT

PMID: 21441100 (View on PubMed)

Anderson-Bill ES, Winett RA, Wojcik JR, Winett SG. Web-based guide to health: relationship of theoretical variables to change in physical activity, nutrition and weight at 16-months. J Med Internet Res. 2011 Mar 4;13(1):e27. doi: 10.2196/jmir.1614.

Reference Type: DERIVED

PMID: 21447470 (View on PubMed)

Other Identifiers

VPISU-04-644

Identifier Type: -

Identifier Source: secondary_id

VPISU-03-588

Identifier Type: -

Identifier Source: secondary_id

CDR0000441158

Identifier Type: -

Identifier Source: org_study_id