Smart Walk: An Efficacy Trial of a Culturally Tailored Smartphone-Delivered Physical Activity Intervention for African American Women
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 210
- 试验地点
- 2
- 主要终点
- Change in accelerometer-measured moderate-to-vigorous intensity physical activity from baseline to 4- and 12-months
研究概览
简要总结
The purpose of this study is to test a culturally tailored, smartphone-delivered intervention designed to increase physical activity and reduce risk for heart disease and type 2 diabetes among African American women.
详细描述
This study addresses major public health concerns among African American women: physical inactivity and cardiometabolic disease risk.
African American women experience a high burden of cardiometabolic diseases, including heart disease, obesity, and type 2 diabetes. Regular aerobic physical activity is an established behavior to prevent and treat these conditions. Yet, the many African American women are insufficiently active, with only 27-40% meeting national aerobic physical activity guidelines.
This study will test the efficacy of Smart Walk, a culturally tailored, theory-based smartphone-delivered intervention designed to increase physical activity and improve cardiometabolic disease risk factors among African American women. In a 12-month trial, participants will be randomly assigned to either the Smart Walk intervention or a Fitbit-only comparison arm for an active 4-month intervention period, followed by an 8-month minimal contact follow-up period.
Specific Aims:
- Test the effects of Smart Walk to increase physical activity and promote adherence to national aerobic physical activity guidelines; compared to Fitbit-only comparison group.
- Test the effects of Smart Walk to improve cardiometabolic risk factors; compared to Fitbit-only comparison group.
- Compare cost and cost effectiveness of the two intervention groups from a societal perspective.
- Examine if protocol adherence predicts outcomes and potential mediation and moderation of intervention effects on physical activity and cardiometabolic outcomes.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 24 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Self-reported African American/Black female
- •Aged of 24-65 years
- •Insufficiently Active (< 60 minutes of moderate-to-vigorous physical activity per week as measured by Exercise Vital Sign Questionnaire)
- •BMI > 25 kg/m2
- •English speaking and reading
- •Ownership of a smartphone with the ability to download applications (i.e., apps)
- •Ownership of a smartphone with the ability to receive text messages
- •Willingness to receive a physical activity intervention delivered through their smartphone
- •Willingness to include their first name or create an alias to be used on their profile page on the Smart Walk app
排除标准
- •Plans to relocate out of Phoenix area in next 12 months
- •Endorsing an item on the Physical Activity Readiness Questionnaire (PAR-Q), unless a doctor's note for study participation in provided
- •Resting systolic blood pressure greater than 180 mmHG and/or a diastolic blood pressure greater than 120 mmHG , as assessed at baseline or at any other study assessment
- •Self-reported participation in another diet or weight loss study at screening
- •Pregnant or planning to become pregnant in the next 12 months
研究组 & 干预措施
Smart Walk
Participants will receive a culturally tailored smartphone-delivered physical activity intervention.
干预措施: Smart Walk (Behavioral)
Fitbit
Participants will receive a Fitbit Inspire 3 activity monitor.
干预措施: Fitbit (Behavioral)
结局指标
主要结局
Change in accelerometer-measured moderate-to-vigorous intensity physical activity from baseline to 4- and 12-months
时间窗: Assessed at baseline, 4-months, 12-months
Participants will wear wrist-worn ActiGraph GT9X Link Activity monitors the activity monitor on their non-dominant wrist during all waking hours for 7 consecutive days to provide an assessment of usual activity
Change in self-reported moderate-to-vigorous intensity physical activity from baseline to 4- and 12-months
时间窗: Assessed at baseline, 4-months, 12-months
Assessed by the 7-Day Physical Activity Recall
次要结局
- Change in cardiorespiratory fitness from baseline to 4- and 12-months(Assessed at baseline, 4-months, 12-months)
- Change in waste circumference from baseline to 4- and 12-months(Assessed at baseline, 4-months, 12-months)
- Change in tumor necrosis factor-alpha (TNF-α) from baseline to 4- and 12-months(Assessed at baseline, 4-months, 12-months)
- Change in interleukin 6 (IL-6) from baseline to 4- and 12-months(Assessed at baseline, 4-months, 12-months)
- Change in interleukin 10 (IL-10) from baseline to 4- and 12-months(Assessed at baseline, 4-months, 12-months)
- Change in serum insulin from baseline to 4- and 12-months(Assessed at baseline, 4-months, 12-months)
- Change in blood pressure (mmHG) from baseline to 4- and 12-months(Assessed at baseline, 4-months, 12-months)
- Change in self-regulation for physical activity from baseline to 4- and 12-months(Assessed at baseline, 4-months, 12-months)
- Change in aortic pulse wave velocity from baseline to 4- and 12-months(Assessed at baseline, 4-months, 12-months)
- Change in body weight from baseline to 4- and 12-months.(Assessed at baseline, 4-months, 12-months)
- Change in behavioral capability for physical activity from baseline to 4- and 12-months(Assessed at baseline, 4-months, 12-months)
- Change in body mass index from baseline to 4- and 12-months(Assessed at baseline, 4-months, 12-months)
- Change in serum lipids (mg/DL) from baseline to 4- and 12-months(Assessed at baseline, 4-months, 12-months)
- Change in exercise self-efficacy from baseline to 4- and 12-months(Assessed at baseline, 4-months, 12-months)
- Change in interleukin 15 (IL-15) from baseline to 4- and 12-months(Assessed at baseline, 4-months, 12-months)
- Change in fasting blood glucose glucose from baseline to 4- and 12-months(Assessed at baseline, 4-months, 12-months)
- Change in insulin sensitivity (µIU/mL) from baseline to 4- and 12-months(Assessed at baseline, 4-months, 12-months)
- Change in social support for physical activity from baseline to 4- and 12-months(Assessed at baseline, 4-months, 12-months)
- Change in outcome expectations for physical activity from baseline to 4- and 12-months(Assessed at baseline, 4-months, 12-months)