Mechanisms of Adherence to Light Intensity Physical Activity to Prevent Alzheimer's Disease and Related Dementias (ADRD)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Long-term adherence
研究概览
简要总结
The purpose of this study is to determine whether interaction with an adaptive Fitbit-based goal setting application can increase levels of everyday light intensity physical activity in middle-aged adults.
详细描述
The study is designed to examine the efficacy of a Fitbit-based, goal setting, mHealth intervention to increase light intensity physical activity. The study design is a 2-arm randomized controlled trial. Both groups will receive the underlying goal-setting intervention (adaptive daily step goals). The study involves 3 phases: a run-in ("calibration") phase, the intervention ("training") phase, and follow-up (1- and 12-months post-intervention).
To support goal maintenance our team has developed a Fitbit application designed to operate on the Fitbit Versa series watch as a 'clockface'. The application will first calibrate participants' average level of physical activity by recording daily step counts for a period of 14 days (calibration phase). After this period (and following a health education session) the application will begin delivering the underlying intervention to both treatment and control groups for a period of 1 month. The intervention is composed of daily step goals presented via the Fitbit clockface. Each day the application will suggest a daily step goal. The algorithm used to make these suggestions relies on the participant's own activity during the calibration period and is updated each day in study, ensuring all proposed step goals are within their existing repertoire. Follow-up assessments will be completed at 1- and 12-monts post-intervention.
Outcomes and moderators will be measured via activity monitors (the Fitbit application and activPals), surveys, and ecological momentary assessments (self-ratings and performance-based ambulatory cognitive assessments) conducted via the Mobile Monitoring of Cognitive Change ("M2C2") platform.
Some of the details of the intervention, algorithm, experimental manipulations, and outcomes have been omitted to preserve the scientific integrity of the study. These details will be added after the study is closed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Between 30 and 70 years of age
排除标准
- •Clinical diagnosis of ADRD or other neurodegenerative disease
- •Health condition contraindicated for increased physical activity
- •Medical conditions or medications that would prohibit participation in an exercise test (e.g., decompensated heart failure, severe aortic stenosis, uncontrolled arrhythmia, and acute coronary syndromes)
- •Limitations in use of a smart phone (e.g., issues with manual dexterity or visual impairment)
- •Inability to walk unassisted
- •BMI > 50
- •Plan to have surgery or other procedure over the next 12 months that could affect mobility or light intensity physical activity maintenance
- •Concurrent participation in a weight loss, physical activity, or cognitive training trial
- •Failure to comply with Run-in Period activity monitoring (<70% valid wear days for the Fitbit and activPal)
- •Anyone who will not discontinue the use of their own personal smartwatch during the training period.
- •Anyone who scores below 19 on the MoCA-B would not be randomized after the Run-in Calibration Period.
- •Note: The eligibility criteria are deliberately incomplete to preserve the scientific integrity of the study. These details will be added after study closure.
研究组 & 干预措施
Control
Participants receive the adaptive daily step goal mHealth intervention
干预措施: Adaptive Daily Goal Setting (Behavioral)
Treatment
Participants receive the adaptive daily step goal mHealth intervention plus interim goal setting prompts each day
干预措施: Adaptive Daily Goal Setting (Behavioral)
Treatment
Participants receive the adaptive daily step goal mHealth intervention plus interim goal setting prompts each day
干预措施: Interim Goal Prompt (Behavioral)
结局指标
主要结局
Long-term adherence
时间窗: 12-month follow-up
Average of 14-day step count totals collected via ActivPal monitors
Short-term adherence
时间窗: 1-month follow-up
Average of 14-day step count totals collected via ActivPal monitors
次要结局
- Change in Cognitive Health (Processing Speed)(Change in mean performance between the 2-week calibration phase and 12-month follow-up)
- Executive Control (Inhibitory Control)(Twice daily during the final 2 weeks of the training phase)
- Change in Self-Efficacy for light intensity physical activity(Change between pre-enrollment baseline survey and end of training phase (an average of 2 months))
- Self-Monitoring Behavior(Daily during intervention period)
- Change in Cognitive Health (Working Memory Binding)(Change in mean performance between the 2-week calibration phase and 12-month follow-up)
- Executive Control (Working Memory Capacity)(Twice daily during the final 2 weeks of the training phase)
研究者
Christopher Sciamanna, MD, MPH
Professor, Medicine
Milton S. Hershey Medical Center