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
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.
Unspecified Adult Solid Tumor, Protocol Specific
Behavioral: behavioral dietary intervention
Other: educational intervention
Other: internet-based intervention
Other: preventative dietary intervention
Procedure: evaluation of cancer risk factors
|Study Design:||Allocation: Randomized
Primary Purpose: Prevention
|Official Title:||Cancer Prevention Mastery Model Internet Intervention|
|Study Start Date:||April 2006|
|Study Completion Date:||March 2011|
|Primary Completion Date:||February 2010 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00128570
|United States, Virginia|
|Virginia Polytechnic Institute and State University|
|Blacksburg, Virginia, United States, 24061|
|Principal Investigator:||Richard A. Winett, PhD||Virginia Polytechnic Institute and State University|