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临床试验/NCT04605406
NCT04605406撤回不适用

Daily Step Count and Achieving Goal Gestational Weight Gain

Milton S. Hershey Medical Center1 个研究点 分布在 1 个国家开始时间: 2023年7月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Optimal average steps per day to achieve goal GWG

研究概览

简要总结

The purpose of this voluntary research study is to determine an optimal step count that aids in achieving the recommended weight gain during pregnancy and to use this count in future studies.

详细描述

The goal of this study is to contribute to the growing data that show a clear benefit in activity during pregnancy over sedentary behavior. Uniquely, this study looks to determine an optimal step count for achieving goal gestational weight gain. In doing so, this will enable clinicians to better counsel patients on a low cost, at home activity that can aid in improved maternal and fetal outcomes. This optimal step count would be used in future randomized clinical trials to determine whether this goal step count could be used to benefit other maternal and fetal outcomes such as gestational diabetes, preeclampsia, preterm labor, cesarean section rates, and birth weight.

Participation will begin at the patients 18-22 week clinic visit and will last until delivery. At the 18 - 22 week clinic visit a pedometer will be given to the patient. Patient will be instructed by a study team member to wear the pedometer on a hip for 7 days every 4 weeks and will submit daily step count for the day via a link to an online submission form which will arrive in the email once a day for 7 days in a row. An email reminder will be received every four weeks to prepare the patient for the reporting of daily step count, if no response is received electronically via the online submission form after 14 days a second reminder will be received. No change in normal activity will be required, instructions will be given to maintain normally activity during the week. The pedometer will be returned when patient arrives to labor and delivery to deliver.

The risks of this study are minimal as there will be no diversion from normal daily routine.

The results of this research may guide the future studies in walking in pregnancy in relation to maternal, fetal, and neonatal morbidity.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • 18 years and older
  • Pregnant women
  • A singleton pregnancy
  • Gestational age at inclusion 18-22 weeks
  • Ability to read and speak English
  • Access to a computer

排除标准

  • Multiple pregnancy
  • Pregestational diabetes
  • Diseases limiting level of physical activity
  • Previous bariatric surgery
  • Current alcohol use
  • Current drug abuse
  • Currently in a opioid treatment program
  • History of eating disorder
  • Non-English speaking

结局指标

主要结局

Optimal average steps per day to achieve goal GWG

时间窗: Steps per day will be measured for 7 consecutive days every 4 weeks after enrollment at the 18-22 week clinic visit until delivery at 37-41 weeks.

Assessing the optimal average steps per day a pregnant woman should take to meet her goal gestational weight gain (GWG) based on ACOG guidelines. Meeting the goal GWG is defined as a yes/no response.

次要结局

未报告次要终点

研究者

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

Serdar Ural

Associate Professor of Obstetrics and Gynecology

Milton S. Hershey Medical Center

研究点 (1)

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