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临床试验/NCT05093842
NCT05093842已完成不适用

Sedentary Behavior Reduction in Pregnancy Intervention Study

University of Pittsburgh1 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2021年10月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
51
试验地点
1
主要终点
Steps Per Day

研究概览

简要总结

This pilot and feasibility study will enroll newly pregnant women at risk for high sedentary behavior (SED) and elevated APO risk (n=53) and will randomize them to either a SED reduction intervention or control. Research aims include to: 1) demonstrate our ability to decrease SED and increase standing and light activity in pregnant women; 2) evaluate feasibility; and 3) gather preliminary effects on clinical outcomes including APOs, cardiometabolic risk factors, well-being, and fetal outcomes.

详细描述

Cardiovascular disease (CVD) accounts for 1 in 4 deaths among women of reproductive age. Decreasing adverse pregnancy outcomes (APO), e.g. hypertensive disorders of pregnancy, gestational diabetes, and preterm birth, could reduce this burden. APOs have serious immediate health consequences and are recognized by the AHA as major risk factors for future CVD. Yet, APOs are hard to prevent and treat, with a 20% prevalence that is increasing in the U.S. Moderate-vigorous intensity physical activity (MVPA) reduces APOs, but less than 1 in 4 pregnant women achieve guidelines and pregnant women report unique barriers such as fatigue, pain, medical restriction, and concern for the baby.

Sitting, or 'sedentary behavior' (SED) is a novel risk factor for CVD. Yet, sparse research and no U.S. guidelines exist for SED in pregnancy. Our recent AHA-funded cohort study in pregnant women (n=120) objectively measured SED and MVPA during each trimester. While MVPA was not related to outcomes, pregnant women with high vs. low SED across pregnancy had greater odds of APO and gave birth to babies at a reduced gestational age. Considering that decreasing SED may be more feasible given the barriers to MVPA, the investigators hypothesize that a SED reduction intervention may be especially promising for reducing APOs and improving cardiovascular health for women and their children.

Given the dearth of SED research, trials, or guidelines for pregnant women, the investigators propose to use our preliminary data on behavioral targets, correlates, and determinants of SED during pregnancy to adapt our previously successful SED reduction interventions. This pilot and feasibility study will enroll newly pregnant women with high SED and elevated APO risk (n=53) and randomize them to either a SED reduction intervention or control (2:1 ratio). Research aims include to: 1) demonstrate our ability to decrease SED and increase standing and light activity in pregnant women; 2) evaluate feasibility; and 3) gather preliminary effects on clinical outcomes including APOs, cardiometabolic risk factors, well-being, and fetal outcomes.

Participants will complete three assessment visits, one in each trimester, including 1-week monitoring of SED and activity patterns with a thigh-worn activPAL and blood pressure measurement using a standard protocol. Other outcomes will be assessed by self-report and medical record review after the participant gives birth. Participants randomized to the intervention arm will be provided with a fitbit, a sit-stand desk attachment, and will complete virtual health coaching visits every two weeks throughout pregnancy to facilitate reduced SED, increase standing, and increased stepping throughout the day.

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)

盲法说明

Research personnel conducting outcome assessments will be blinded to participant group assignment. As the participant will be receiving a behavioral intervention, both the participant and interventionist will be aware of group assignment.

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •<13 w 0 d pregnant
  • •at risk for high levels of sedentary behavior: i) work at a desk job ≥ 30 hrs per week; ii) work at a desk job <30 hrs per week and report sitting on non-work days 1/2 the time or more; iii) do not work but report sitting 3/4 of the time or more; iv) self-reports <6000 steps per day
  • •≥1 risk factor for APO: nulliparity, history of APO, prepregnancy BMI ≥ 30 kg/m2, or age ≥35 yr
  • •plan to deliver at UPMC facility or willing to provide medical record release for prenatal care and birth records

排除标准

  • •chronic hypertension (resting blood pressure ≥140/90 mmHg or antihypertensive medication use)
  • •pre-gestational diabetes
  • •self-report of inability to walk 2 blocks or climb a flight of stairs
  • •other serious medical condition in pregnancy for which exercise is contraindicated (e.g., underlying cardiac disease, severe anemia, chronic bronchitis, or poorly controlled hyperthyroidism or seizure disorder)
  • •unable to provide physician's consent to participate
  • •participating in another health-related intervention study that could affect study outcomes

研究组 & 干预措施

Sedentary Behavior Reduction Intervention

Experimental

Biweekly virtual health coaching, height-adjustable work station, and fitbit - targetting decreasing sedentary behavior, increasing standing, and increasing steps per day. Printable information on physical activity recommendations also provided.

干预措施: Sedentary Behavior Reduction (Behavioral)

Sedentary Behavior Reduction Intervention

Experimental

Biweekly virtual health coaching, height-adjustable work station, and fitbit - targetting decreasing sedentary behavior, increasing standing, and increasing steps per day. Printable information on physical activity recommendations also provided.

干预措施: Information on Physical Activity Recommendations during Pregnancy (Behavioral)

Usual Care Control

Active Comparator

Printable information on physical activity recommendations only

干预措施: Information on Physical Activity Recommendations during Pregnancy (Behavioral)

结局指标

主要结局

Steps Per Day

时间窗: Randomization to study completion, about 6 months

Objectively measured using activPAL3 micro

Sedentary Time

时间窗: Randomization to study completion, about 6 months

objectively measured using activPAL3 micro

Standing

时间窗: Randomization to study completion, about 6 months

Objectively measured using activPAL3 micro

次要结局

  • Recruitment(Active recruitment phase, about 1 year)
  • Retention(Beginning of randomization to 2nd trimester and 3rd trimester)
  • Intervention Adherence to Behavioral Coaching Contacts(Randomization to study completion, about 6 months)
  • Outcome Assessment Rates(Second and third trimester visit. Two participants were removed from this analysis due to miscarriage after randomization.)

研究者

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

Bethany Barone Gibbs

Associate Professor

University of Pittsburgh

研究点 (1)

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