Exergaming Intervention and Breast Cancer Biomarkers in Black Women
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Biomarkers related to obesity and breast cancer risk
研究概览
简要总结
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.
详细描述
- * 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.
- * 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 59 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Black women
- •BMI ≥28 kg/m2 but ≤ 350 pounds of body weight
- •Aged 40-59 years
- •Sedentary (<60 min/wk exercise for past 6 months
- •Never been diagnosed with cancer
- •Ability to read and speak English and to provide meaningful consent
- •No physical limitations preventing them from exercising
- •Medical clearance by a health practitioner.
排除标准
- •History of cancer
- •Uncontrolled hypertension and medically treated diabetes
- •Current enrollment in another physical activity and/or dietary study or a diet/weight loss program
- •Pregnancy
- •Inability to consent to study participation and complete assessments
- •Telephone inaccessibility
- •Physical limitations to exercise inability to commit to the intervention schedule
结局指标
主要结局
Biomarkers related to obesity and breast cancer risk
时间窗: 6 months
Outcomes for plasma leptin, adiponectin, Insulin-like growth factor 1 (IGF-1), Insulin-like growth factor-binding protein 3 (IGFBP3), C-reactive protein (CRP), Interleukin 6 (IL-6), insulin, c-peptide, and Hb-A1c levels at baseline and 24 weeks.
次要结局
- Reported stress levels(6 months)
- Cardiovascular fitness (VO2 max)(6 months)
研究者
Lucile Adams-Campbell
Principal Investigator
Georgetown University
