Self-monitoring Activity: a Randomized Trial of Game-oriented Applications (SMARTGOAL)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Change in Minutes Per Day of Physical Activity
研究概览
简要总结
The purpose of this study is to compare an enhanced intervention that includes narrative and game components to a standard intervention that only targets self-monitoring. These approaches will be tested among postmenopausal breast cancer survivors who are sedentary and overweight.
详细描述
Habitual physical activity decreases risk of multiple negative health outcomes, including breast cancer recurrence and mortality. It is also associated with better quality of life and reducing negative effects of cancer and cancer treatment. However, most breast cancer survivors do not engage in sufficient physical activity. Behavior change interventions produce short-term increases in activity but have difficulty motivating sustained active lifestyles over longer periods and are not equally effective in women of different races/ethnicities. The purpose of this study is to test a novel intervention that uses video games and storytelling to increase motivation. Video game mechanics increase enjoyment and feelings of autonomy (control), competence, and relatedness to others. All of these feelings are associated with motivation for activity and, in turn, sustained activity over time. Additionally, narrative storytelling is an effective method of persuading individuals to change their behavior. We propose that play of active video games that include compelling storylines will increase physical activity among a diverse sample of postmenopausal breast cancer survivors.
To test this hypothesis, we will conduct a clinical trial that compares the enhanced intervention (story-based video games) to a standard intervention in 90 sedentary, overweight postmenopausal breast cancer survivors. Participants in the enhanced group will receive a mobile device and accessories with two story-based video game applications installed. The games incorporate behavior change strategies such as self-monitoring and feedback while also using game mechanics and a lengthy storyline to motivate physical activity. Participants in the standard group will receive the same mobile device with an electronic activity monitor and its companion feedback application. Both groups will receive brief weekly telephone counseling. By comparing two groups that both receive typical behavior change intervention components (counseling) and a novel electronic intervention, we will be able to investigate the specific effects of game mechanics and storytelling on motivation and physical activity. We will measure changes in physical activity, fitness, function, and quality of life from the beginning of the study to 6 months. We will also investigate further changes during an additional 6 month follow-up period in which participants keep their intervention tools but do not receive any counseling, to measure maintenance of activity. This project will develop and test a promising, innovative intervention that has the potential to be used on a widespread basis in clinical and community settings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age between 45 and 75 years old
- •Report a breast cancer diagnosis no more than 10 years prior to enrollment
- •Cessation of menses for 12 months or more
- •Able to read and understand English
- •Able to read words in standard applications on a mobile device 3-4" large
- •Able to walk for exercise
- •Able to find transportation to the study location
- •Willing to use a mobile device provided by the study to participate (or to use one of their own)
- •Willing to be randomized to either group
排除标准
- •Currently pregnant or nursing
- •Surgery in the past six months
- •Chemotherapy or radiation treatment in the past six months
- •Evidence of disease recurrence
- •Participant is active (90 minutes of moderate-vigorous intensity activity per week or more)
- •BMI is under 25 kg/m2 or over 35 kg/m2
- •Report a heart condition, chest pain during periods of activity or rest, loss of consciousness, etc. on the Physical Activity Readiness Questionnaire (PAR-Q), unless cleared by their physician
- •Participant reports hospitalization within the past year due to psychiatric problem(s)
- •Report current symptoms of alcohol or substance dependence
- •Plans to move away from the Galveston-Houston area or to be out of town for more than 1 week during the study period
- •Stroke, hip fracture, hip or knee replacement, or spinal surgery in the past 6 months
- •Report a history of severe orthopedic complications that would prevent optimal participation in the physical activities prescribed (e.g., severe arthritis, leg amputations, etc.)
- •Clinical judgment concerning safety
- •Lost more than 5% body weight in the previous 6 months
- •Currently participating in a physical activity or weight loss program
- •Current smoker
- •Participant already uses an electronic activity monitor (we will ask them to stop)
- •Another member of the household is a participant or staff member on this trial
结局指标
主要结局
Change in Minutes Per Day of Physical Activity
时间窗: baseline and 6 months
Minutes of moderate-vigorous physical activity per day (averaged over a 7 day period) at baseline and 6 months.
次要结局
- Change in Intrinsic Motivation From Baseline to 6 Months, Measured by Intrinsic Motivation Specific to Physical Activity(baseline to 6 months)
- Change in Identified Regulation From Baseline to 6 Months, Measured by Identified Regulation Specific to Physical Activity(baseline to 6 Months)
- Change in Integrated Regulation From Baseline to 6 Months, Measured by Integrated Regulation Specific to Physical Activity(baseline to 6 Months)
- Change in Weight From Baseline to 6 Months(baseline to 6 months)
- Change in Physical Function From Baseline to 6 Months as Measured by the Senior Fitness Test's Arm Curl Measure(baseline to 6 Months)
- Change in Physical Fitness From Baseline to 6 Months, as Measured by 6 Minute Walk Test(baseline to 6 months)
- Change in Physical Function From Baseline to 6 Months as Measured by the Senior Fitness Test's Chair Stand Measure(baseline to 6 months)
- Change in Social/Family Quality of Life From Baseline to 6 Months as Measured by Functional Assessment of Cancer Therapy - Breast Measure's Social/Family Well-Being Subscale(baseline to 6 months)
- Change in Functional Quality of Life From Baseline to 6 Months as Measured by Functional Assessment of Cancer Therapy - Breast Measure's Functional Well-Being Subscale(baseline to 6 Months)
- Change in Physical Function From Baseline to 6 Months as Measured by the Senior Fitness Test's Back Scratch Measure(baseline to 6 Months)
- Change in Physical Function From Baseline to 6 Months as Measured by the Senior Fitness Test's 8 Foot Up and Go Test(baseline to 6 Months)
- Change in Emotional Quality of Life From Baseline to 6 Months as Measured by Functional Assessment of Cancer Therapy - Breast Measure's Emotional Well-Being Subscale(baseline to 6 Months)
- Change in Physical Function From Baseline to 6 Months as Measured by the Senior Fitness Test's Sit and Reach Measure(baseline to 6 Months)
- Change in Physical Quality of Life From Baseline to 6 Months as Measured by Functional Assessment of Cancer Therapy - Breast Measure(baseline to 6 months)
- Change in Breast Cancer-Specific Quality of Life From Baseline to 6 Months as Measured by Functional Assessment of Cancer Therapy - Breast Measure's Breast Cancer Subscale(baseline to 6 Months)