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临床试验/NCT06636305
NCT06636305已完成不适用

Postpartum Behavioral Observation of Diet, Image, and Exercise Study (BODIES)

Nicolas D. Knuth2 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2017年10月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
42
试验地点
2
主要终点
Postpartum Weight Retention

研究概览

简要总结

The overall goal of this study is to investigate the impact of increased physical activity during the postpartum period on on weight loss, body composition, energy expenditure, and body image perceptions following pregnancy and childbirth. Specifically, this study utilizes a mixed methods approach including qualitative and quantitative analyses of the physiological and sociological determinants of postpartum women's health and wellness,

The primary objective of the proposed project is to assess the impact of a physical activity intervention on postpartum women's ability to return to pre-pregnancy body weight, the resumption of normal activity and bodily function, and the improvement of body image.

This objective will be achieved via the assessment of quantitative, physiological markers (i.e. physical activity level, body composition, energy expenditure, and hormone levels), as well as qualitative, sociological markers (i.e. self-report and interview data related to body image and bodily recovery) that serve as a measure of a postpartum body that has resumed relatively normal physical function and activity.

详细描述

Postpartum women will be recruited to participate and randomly assigned to a control group or an intervention group. Both groups will follow the data collection protocol described below; however, the intervention group will also be tasked with a self-administered physical activity intervention while the control group will be told to go about their normal routine and engage in whatever activity they would normally do. The intervention group will be asked to meet physical activity benchmarks of 10,000 steps per day and 150 minutes of moderate-to-vigorous physical activity (MVPA) per week (intervention protocol described in more detail below).

All participants will begin the study when they are between 6 weeks and 3 months postpartum and, overall, data will be collect at 4 separate visits, approximately 3 months apart, over the course of 9 months.

Testing to occur at each visit:

Body composition - Total fat mass, lean tissue mass and percentage of body fat will be assessed as participants lie in a supine position using dual-energy x-ray absorptiometry (DXA) (GE Lunar Prodigy, GE Medical Systems, Milwaukee WI).

Vascular Function Test - Indices of vascular function will be obtained in the non-dominant arm using a strain gauge plethsymograph or ultrasound. The testing entails wrapping a rubber band like device (i.e., strain gauge) around the forearm or placing an ultrasound on the skin while the subject is in a supine position. To induce a change in blood flow, a blood pressure cuff is wrapped around the upper portion of the limb (upper arm or thigh) and occluded for 5 minutes. After the 5 minute occlusion the blood pressure cuff is rapidly deflated. The change in the diameter of the strain gauge is used to quantify the change in blood flow and, in turn, the change in vascular function.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
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

  • between 6-12 weeks postpartum following a live singleton birth.

排除标准

  • inability to walk without assistance.
  • not cleared by their medical provider to resume physical activity by 12 weeks postpartum.

结局指标

主要结局

Postpartum Weight Retention

时间窗: From enrollment to the end of the study at the 12 month postpartum mark

Postpartum weight retention was calculated as the difference between the participant's postpartum weight at each visit and their self-reported pre-pregnancy weight.

次要结局

  • Postpartum Resting Energy Expenditure(REE was measured at enrollment (i.e., 6-12 weeks postpartum) and again at 6, 9, and 12 months postpartum.)
  • Postpartum Body Composition(Postpartum body composition was measured at enrollment (i.e., 6-12 weeks postpartum) and again at 6, 9, and 12 months postpartum.)
  • Postpartum Sleep Quality(Postpartum sleep quality was measured at enrollment (i.e., 6-12 weeks postpartum) and again at 6, 9, and 12 months postpartum.)

研究者

发起方
Nicolas D. Knuth
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Nicolas D. Knuth

Associate Professor

Towson University

研究点 (2)

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