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临床试验/NCT03302377
NCT03302377已完成不适用

Fit for Two: Feasibility and Acceptability of Incorporating Wearable Trackers Into Clinical Care for Pregnant Women With Diabetes

University of California, San Diego2 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2017年10月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
19
试验地点
2
主要终点
Feasibility of recruitment

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

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

结局指标

主要结局

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)

Retention

时间窗: 12 weeks

Determined by retention (%)

次要结局

  • Physical activity change(12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Britta Larsen

Assistant Professor

University of California, San Diego

研究点 (2)

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