Fit for Two: Feasibility and Acceptability of Incorporating Wearable Trackers Into Clinical Care for Pregnant Women With Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Retention
研究概览
简要总结
This study will investigate the feasibility of an intervention to increase physical activity in pregnant women with diabetes by incorporating a brief in-person counseling session and Fitbit activity trackers into routine clinical care
详细描述
This is a small, one-armed pilot study testing a physical activity intervention for pregnant patients with diabetes. The intervention will use both counseling and technology (a FitBit physical activity tracker and smartphone app) to create an individualized, interactive program for each patient. The primary aims of the study are to assess the feasibility of recruiting patients and implementing the program in the clinical setting, and the acceptability of the program for patients and clinicians. Participants will receive a counseling session based on the principles of motivational interviewing to help them set physical activity and step goals, then the interventionist will help them personalize the Fitbit app to their goals. Participants are instructed to continue adaptive goal setting and email their goals and activity weekly to their physicians. In addition to assessing feasibility and acceptability, we will also evaluate change in activity to explore potential efficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •diagnosed with type 2 diabetes or gestational diabetes
- •currently pregnant
- •in week 5-25 of gestation
- •under active (<100 minutes/week of physical activity)
- •access to a smartphone
排除标准
- •any medical condition that would make unsupervised activity unsafe or unfeasible, as determined by their physician
- •moving from the area within 3 months
研究组 & 干预措施
Physical activity intervention
Participants will receive an individual counseling session in the clinic to help them set physical activity and step goals. They will then receive a Fitbit wrist monitor and help personalizing the Fitbit app. They will send weekly emails to their physicians reporting their goals and current activity. They will return at 12 weeks to engage in a semi-structured interview to give their overall impressions of the intervention.
干预措施: physical activity counseling & Fitbit (Behavioral)
结局指标
主要结局
Retention
时间窗: 12 weeks
Determined by retention (%)
Feasibility of recruitment
时间窗: baseline
Determined by percent of those screened who enroll in the study
Acceptability
时间窗: 12 weeks
Determined by participant feedback (% indicating satisfaction with intervention)
次要结局
- Physical activity change(12 weeks)
研究者
Britta Larsen
Assistant Professor
University of California, San Diego