Postpartum Weight Loss and Sleep Amongst Obese Women

Not Applicable

Completed

• Conditions: Weight Loss; Postpartum; Insomnia; Obesity; Sleep Disordered Breathing
• Interventions: Behavioral: Go!®to sleep

• Registration Number: NCT01968330
• Lead Sponsor: University of South Florida

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-10-18
• Study First Submitted QC: 2013-10-18
• Study First Posted: 2013-10-24
• Study Start: 2014-05
• Status Verified: 2016-05
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Last Update Submitted: 2016-05-19
• Last Update Posted: 2016-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 53

Inclusion Criteria

• • 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

Exclusion Criteria

• • 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Go!®to sleep	Go!®to sleep	Patients in the sleep intervention arm will undergo a sleep wellness program entitled Go!®to sleep as part of their group prenatal visits. This intervention is a six-week online program developed by the Cleveland clinic for non-pregnant patients suffering from insomnia. In collaboration with the Cleveland clinic sleep disorders center researchers will modify the program to fit the specific needs of a pregnant population. Subjects will receive access to the program and instructed on its use at their initial group prenatal visit. In subsequent visits subjects will be able to discuss their experience with the program.

Primary Outcome Measures

Name	Time	Method
Weight loss at 6 weeks postpartum.	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.

Secondary Outcome Measures

Name	Time	Method
Affects of improved sleep on insulin resistance and cholesterol levels	From the second trimester of pregnancy to six weeks postpartum	The secondary objective will be to assess the affect of a sleep intervention on insulin resistance and cholesterol levels. This will be accomplished by: * Assessing glucose, insulin, HOMA, AUCgluc, leptin, adiponectin, total cholesterol, HDL, LDL, triglyceride levels at four time points in pregnancy and postpartum.; * Completing the PRIME screen, a diet assessment tool, at approximately 20 weeks, 34 weeks and 6 and weeks postpartum; * Assessing the neonates body composition at birth.

Trial Locations

Locations (1)

Tampa General Hospital Genesis Clinic; 🇺🇸 Tampa, Florida, United States