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临床试验/NCT05455008
NCT05455008已完成不适用

Feasibility, Acceptability, and Preliminary Efficacy of a Single-arm, Remotely-delivered Health Coaching Intervention to Increase Physical Activity and Reduce Sedentary Behavior During Pregnancy

University of Iowa2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2020年7月1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
36
试验地点
2
主要终点
Feasibility: retention

研究概览

简要总结

This pilot study will test the feasibility, acceptability, and efficacy of a remotely-delivered intervention for increasing daily physical activity levels and reducing sedentary behavior during pregnancy among women who are insufficiently active (i.e. reporting <150 minutes/week of moderate intensity activity and/or <7,000 steps/day). It is hypothesized that women will increase daily steps and decrease total sedentary time across the second trimester of pregnancy.

详细描述

Physical activity during pregnancy is safe for the mother and baby and has many health benefits; however, less than 25% of pregnant women meet the recommended physical activity guidelines. Data from the investigative team also indicates that high sedentary behavior across pregnancy trimesters is associated with an increased risk of hypertensive disorders of pregnancy and other adverse pregnancy outcomes, independent of physical activity level. There is a clear need to encourage physical activity participation while concurrently promoting a reduction in sedentary time during pregnancy.

This pilot study will test the feasibility, acceptability, and efficacy of a remotely-delivered intervention for increasing daily physical activity levels and reducing sedentary behavior during pregnancy among women who are insufficiently active (i.e. reporting <150 minutes/week of moderate intensity activity and/or <7,000 steps/day). We hypothesized that participants would increase daily steps and decrease total sedentary time over the course of the intensive intervention phase (second trimester, ~14 weeks). Further, we hypothesized that participants would maintain or have minimal changes in daily steps and total sedentary time from the end of the intensive intervention phase through the follow-up phase (third trimester, ~14 weeks).

Intervention Summary: Participants have 12 contacts with a health coach using a telehealth platform to provide ongoing support and discuss physical activity and sedentary behavior goals based on real-time data obtained from a Fitbit monitor. Intervention contacts will be weekly for the first month, bi-monthly in months 2-4, and monthly until delivery. Participants will also receive one text message between each intervention contact to reinforce content discussed in coaching sessions. Physical activity and sedentary time will be assessed objectively using an activPAL device for 7-days at baseline and at the end of the intensive intervention phase (second trimester, ~14 weeks).

Specific Aims:

Aim 1: To test the feasibility of a remotely-delivered intervention designed to increase physical activity levels and reduce sedentary behavior during pregnancy. Feasibility will be defined by: (1) recruitment and enrollment of at least 50% of eligible women who completed the screening form, (2) retention of 85% or more participants from baseline through delivery, (3) adherence if participants attended 75% or more of the health coaching sessions on average and wore and synced their Fitbit device on at least 75% of days from baseline through the end of the intervention.

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 44 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • less than 13 weeks pregnant
  • between 18-44 years of age
  • owned smart phone
  • able to speak, comprehend, read, and write in English
  • self-reported insufficient activity as determined by the PARmed-X for pregnancy (exercising less than 150 minutes per week) and less than 7,000 steps/day

排除标准

  • currently enrolled in another research study about exercise
  • physical limitations that prevented exercise
  • instructed by a physician to not exercise during pregnancy
  • hospitalized for a psychiatric disorder in the past six months
  • absolute or relative contraindication to exercise as determined by the PARmed-X for pregnancy
  • other serious medical conditions
  • averaged <9,000 steps/day as determined by the activPAL device worn prior to the first coaching session

结局指标

主要结局

Feasibility: retention

时间窗: Through study completion, an average of 28 weeks

Feasibility will be defined by retention of 85% or more participants from baseline through delivery

Feasibility: recruitment and enrollment

时间窗: Through study completion, an average of 28 weeks

Feasibility will be defined by recruitment and enrollment of at least 50% of eligible women who completed the screening form

Acceptability

时间窗: Through study completion, an average of 28 weeks

Acceptability will be defined as at least 75% of the participants indicating they were satisfied or very satisfied with the program overall.

Efficacy - changes in sedentary time (min/day)

时间窗: Across the second trimester (intensive intervention phase), an average of 14 weeks

Preliminary efficacy will be determined using paired t-tests to assess activPAL-measured changes in sedentary behavior (sedentary minutes/day).

Efficacy - changes in physical activity (steps/day)

时间窗: Across the second trimester (intensive intervention phase), an average of 14 weeks

Preliminary efficacy will be determined using paired t-tests to assess activPAL-measured changes in physical activity (steps/day).

Feasibility: adherence

时间窗: Through study completion, an average of 28 weeks

Feasibility will be defined by adherence if participants attended 75% or more of the health coaching sessions on average and wore and synced their Fitbit device on at least 75% of days from baseline through the end of the intervention.

次要结局

  • Efficacy - changes in physical activity (stepping min/day and standing min/day)(Across the second trimester (intensive intervention phase), an average of 14 weeks)
  • Efficacy - changes in sedentary time (sedentary min/day in bouts of 30 and 60 minutes)(Across the second trimester (intensive intervention phase), an average of 14 weeks)

研究者

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

Kara Whitaker

Assistant Professor

University of Iowa

研究点 (2)

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