Exergaming Intervention and Breast Cancer Biomarkers in Black Women
Condition: Breast Cancer; Obesity
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Overview: This is a 6 month, two-arm randomized clinical trial using comparing exergaming to
      a control group. The investigators will randomize Black sedentary overweight/obese women to
      Wii Fit exercise (n=50) or the control arm (n=50). Women in the Wii Fit exercise group will
      come to the Georgetown community-based exercise facility 3 days/wk. The control group will be
      asked to maintain their current daily activities and not to exercise for the duration of the
      study. Based on the investigators previous findings that women who engage in 75-150 mins/wk
      of brisk walking had an 18% decreased risk of breast cancer, the investigators will target
      this level of activity in the investigators intervention arm. Also, this 150 min/week of
      physical activity meets the current recommendations of the American College of Sports
      Medicine (ACSM) and the US Department of Health and Human Services for healthy individuals
      and is in line with recommendation of the American Cancer Society (ACS) for cancer
      prevention.
    

Detailed description: 
      1. * Purpose of project (one or two sentences): To examine the feasibility and
           acceptability of an exergaming intervention in a community-based setting, and to explore
           the effects of exergaming on cardiovascular fitness, body mass index and percent body
           fat in Black women who are sedentary and overweight or obese.

        2. * Study design (for example, hypothesis, research questions, standard and experimental
           procedures/drugs/devices or equipment, etc.):

      Overview: This is a 6 month, two-arm randomized clinical trial using comparing exergaming to
      a control group. The investigators will randomize Black sedentary overweight/obese women to
      Wii Fit exercise (n=50) or the control arm (n=50). Women in the Wii Fit exercise group will
      come to the Georgetown community-based exercise facility 3 days/wk. The control group will be
      asked to maintain their current daily activities and not to exercise for the duration of the
      study. Based on the investigators previous findings that women who engage in 75-150 mins/wk
      of brisk walking had an 18% decreased risk of breast cancer, the investigators will target
      this level of activity in the investigators intervention arm. Also, this 150 min/week of
      physical activity meets the current recommendations of the American College of Sports
      Medicine (ACSM) and the US Department of Health and Human Services for healthy individuals
      and is in line with recommendation of the American Cancer Society (ACS) for cancer
      prevention.

      Exercise Intervention: Participants in the Wii Fit exergaming group will have a goal of 150
      min/wk of moderate intensity exercise for the last 5 mo of the 6 mo intervention. Heart rate
      (HR) monitors will quantify exercise intensity. Participants will exercise at a HR equal to
      45-65% of their maximal oxygen consumption (VO2max). Given the expected VO2max values for
      this population, the investigators project that the Wii Fit videogames must elevate energy
      expenditure to 3-4 times resting metabolic rate to achieve the desired HR responses. As
      summarized above, previous studies have shown that such an elevation in energy expenditure
      can be expected from these activities. Wii Fit stations with a variety of active games will
      be available to participants at the Georgetown University Community Based Office.
      Participants will be instructed by the exercise physiologist on how to achieve the required
      HR. The training will consist of 3 days/wk of supervised Wii Fit physical activity. Exercise
      duration will increase gradually from 75 to 150 min/wk by wk 477. Thereafter, women will
      maintain >150 min/wk of moderate-intensity physical activity. Participants will complete
      daily exercise diaries recording the type and duration of physical activity, and HR.

      Control Group: After baseline testing the control group will be asked to maintain their
      current daily activities for the duration of the study. The control group will have the
      option to exercise at the Wii Fit stations following their completion of the study. They will
      receive the same measures as the exercise group.

      Diet: Participants in both groups will be instructed to maintain their diet constant
      throughout the study. Wii Fit intervention participants will be weighed at every session and
      those losing more weight than could be accounted for by their exercise will be counseled to
      return to their caloric intake at the start of the study.

      * Rationale and justification for study (i.e. historical background, investigator's personal
      experience, pertinent medical literature, etc.): Several risk factors have been identified
      that increase breast cancer risk, some of which are non-modifiable factors (e.g., age, family
      history, and race) and some of which are modifiable (e.g., physical activity, body weight,
      dietary habits, and alcohol intake). However, only within the last 10 years have cancer
      organizations started to recommend physical activity as a preventive measure for breast
      cancer. The American Cancer Society (ACS) and the International Agency for Research on Cancer
      of the World Health Organization now both recommend regular physical activity as a strategy
      for women to reduce their risk of developing breast cancer. Specific recommendations for
      breast cancer prevention, which initially focused on diet, are now focused on maintaining a
      healthy weight throughout life by balancing caloric intake while increasing caloric
      expenditure via increased physical activity levels, and losing weight if overweight or obese.
      Obesity itself is a significant public health problem and is associated with increased
      postmenopausal breast cancer incidence and mortality. This research proposal will assess a
      novel method to improve physical activity in African American women, who are generally less
      physically active and more overweight and obese than women of most other racial and ethnic
      groups.

        -  Treatment Plan:

      The participants in the Wii Fit exergaming group will be encouraged to meet and then maintain
      a goal of 150 min/wk of moderate intensity exercise for 6 months. Goals per individual will
      be based on their baseline data. Exercise duration will increase gradually from 75 min/wk at
      week 1 to 150 min/wk by week 4. Thereafter, women will maintain >150 min/wk of
      moderate-intensity physical activity. The training will consist of 3 days/wk of supervised
      physical activity using Nintendo Wii Fit active videogames.

      Participants will exercise at a HR equal to 45-65% of their VO2max. Given the expected VO2max
      values for this population, the investigators project that the Wii Fit videogames will
      elevate energy expenditure to 3-4 times resting metabolic rate to achieve the desired HR
      responses. As summarized above, previous studies have shown that such an elevation in energy
      expenditure can be expected from these activities. Participants will be instructed to monitor
      their physical activity in order to assist with their perceived behavioral control and
      increase self-efficacy towards meeting their goals.

      During aerobic exercise sessions, participants will wear Polar heart rate monitors to
      determine exercise intensity and will be given instruction by the exercise physiologist on
      how achieve the required HR. In addition, participants will complete daily exercise diaries
      to record the type and duration of physical activity, and exercise HR. Because many women may
      not have access to gym memberships or be able to afford expensive exercise equipment, the
      investigators address this environmental barrier by establishing Wii Fit stations with a
      variety of active games available to participants at the Community Based Office.

      Exergames selected for use during the exercise sessions will be chosen based on energy
      expenditure data. Those active videogames that have been shown to achieve energy expenditure
      levels above those necessary to achieve 60% HRmax in the investigators specific study
      population will be selected. For example, active videogames tested in published studies, such
      as Wii Fit boxing and Dance Dance Revolution, have been found to achieve physical activity
      levels of moderate intensity (3.0-6.0 METs), which meet American College of Sports Medicine
      guidelines for health and fitness. Graves et al. (2008), for example found physical activity
      levels to reach 68% of maximal heart rate (HRmax) using the Wii Fit which also meets ACSM
      aerobic fitness recommendations (60% HRmax).
    

Intervention name(s): Exergaming
Intervention type(s): Other
Intervention description(s): The participants in the Wii Fit exergaming group will be encouraged to meet and then maintain a goal of 150 min/wk of moderate intensity exercise for 6 months. Goals per individual will be based on their baseline data. Exercise duration will increase gradually from 75 min/wk at week 1 to 150 min/wk by week 4. Thereafter, women will maintain >150 min/wk of moderate-intensity physical activity. The training will consist of 3 days/wk of supervised physical activity using Nintendo Wii Fit active videogames.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: exergaming; breast cancer; African American women; obesity