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
Condition: Unspecified Adult Solid Tumor, Protocol Specific
Study type: Interventional

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.
    

Intervention name(s): behavioral dietary intervention; educational intervention; internet-based intervention; preventative dietary intervention; evaluation of cancer risk factors
Intervention type(s): Behavioral; Other; Other; Other; Procedure
Allocation: Randomized
Primary purpose: Prevention
Keywords: unspecified adult solid tumor, protocol specific