Postpartum Weight Loss and Sleep Amongst Obese Women

Study Overview
=================
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.

Official Title
-----------------
Postpartum Weight Loss in Obese Women Using a Sleep Intervention in a Group Prenatal Care Setting

Conditions
-----------------
Obesity, Sleep Disordered Breathing, Weight Loss, Postpartum, Insomnia

Intervention / Treatment
-----------------
* Behavioral: Go!®to sleep


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Go!®to sleep<br>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. | Behavioral: Go!®to sleep<br> <br> |
| No Intervention: Routine prenatal care<br>Patients in the routine prenatal care arm will complete prenatal care in a group setting and will not complete the sleep intervention. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight loss at 6 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. | six weeks postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Affects of improved sleep on insulin resistance and cholesterol levels | 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. | From the second trimester of pregnancy to six weeks postpartum |