NCT00128570

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Virginia Polytechnic Institute and State University · Academic / Other
• Sex: All
• Age: 18 Years – 63 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BEHAVIORAL	behavioral dietary intervention
OTHER	educational intervention
OTHER	internet-based intervention
OTHER	preventative dietary intervention
PROCEDURE	evaluation of cancer risk factors

Timeline

• Start date: 2006-04-01
• Primary completion: 2010-02-01
• Completion: 2011-03-01
• First posted: 2005-08-10
• Last updated: 2013-09-17

Locations

1 site across 1 country: United States