Postpartum Weight Loss in Obese Women Using a Sleep Intervention in a Group Prenatal Care Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- Weight loss at 6 weeks postpartum.
研究概览
简要总结
This study will be a randomized controlled trial involving obese women obtaining prenatal care at an obstetric care clinic. Study subjects will undergo prenatal care in a group setting or prenatal care with a behavioral intervention to improve sleep. Anthropometric measurements, blood draws, questionnaires and at home sleep studies will be completed at three specified times (two antepartum and one postpartum). Primary outcome will be a comparison of postpartum weight loss amongst the intervention and control groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 否
入选标准
- •• Pregnant female patients
- •Currently receiving obstetrical care at the TGH Health Park Genesis Clinic
- •Between in the second trimester at entry into the study
- •Overweight or obese defined as a pre-pregnancy body mass index greater than or equal to 25.0 kg/msquared
- •Over 18 years of age
- •Able to speak and understand as well as give informed consent in English
- •Have access to internet services
- •Have reported nightly sleep duration of <6.5 hours
排除标准
- •• Under 18 years of age
- •Pre-existing type 1 or 2 diabetes mellitus
- •Pre-existing obstructive sleep apnea
- •Current use of sleep medication
- •Serious physical or mental illness or condition that would substantially interfere with participation in, or completion of, the entire intervention
结局指标
主要结局
Weight loss at 6 weeks postpartum.
时间窗: six weeks postpartum
The Primary objective of this study is to determine if a sleep intervention delivered in a group prenatal care setting of obese women can improve weight loss at one year postpartum (i.e. patient's ability to loose weight gained in pregnancy). This will be accomplished by: * Randomizing study subjects to groups with or without a sleep intervention component * Assessing weight, neck and abdominal circumference at each prenatal visit and at six weeks postpartum * Obtaining information regarding the patient's pre-pregnancy weight. * Assessing baseline sleep habits with at home polysomnography and actigraphy and repeating these measurements in the late third trimester as well as postpartum. * Assessing sleep habits through the Epworth Sleepiness scale and Pittsburgh Sleep Quality Index at baseline. * Obtaining qualitative feedback on the patient's experience with the sleep program and their sleep habits.
次要结局
- Affects of improved sleep on insulin resistance and cholesterol levels(From the second trimester of pregnancy to six weeks postpartum)
研究者
Judette Louis
Assistant Professor College of Medicine Obstetrics and Gynecology Assistant Professor College of Public Health Community and Family Health
University of South Florida