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Postpartum Weight Loss and Sleep Amongst Obese Women

Primary Purpose

Obesity, Sleep Disordered Breathing, Weight Loss

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Go!®to sleep
Sponsored by
University of South Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Tampa General Hospital Genesis Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Go!®to sleep

Routine prenatal care

Arm Description

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.

Patients in the routine prenatal care arm will complete prenatal care in a group setting and will not complete the sleep intervention.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
October 18, 2013
Last Updated
May 19, 2016
Sponsor
University of South Florida
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1. Study Identification

Unique Protocol Identification Number
NCT01968330
Brief Title
Postpartum Weight Loss and Sleep Amongst Obese Women
Official Title
Postpartum Weight Loss in Obese Women Using a Sleep Intervention in a Group Prenatal Care Setting
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of South Florida

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Sleep Disordered Breathing, Weight Loss, Postpartum, Insomnia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Go!®to sleep
Arm Type
Experimental
Arm Description
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.
Arm Title
Routine prenatal care
Arm Type
No Intervention
Arm Description
Patients in the routine prenatal care arm will complete prenatal care in a group setting and will not complete the sleep intervention.
Intervention Type
Behavioral
Intervention Name(s)
Go!®to sleep
Primary Outcome Measure Information:
Title
Weight loss at 6 weeks postpartum.
Description
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.
Time Frame
six weeks postpartum
Secondary Outcome Measure Information:
Title
Affects of improved sleep on insulin resistance and cholesterol levels
Description
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.
Time Frame
From the second trimester of pregnancy to six weeks postpartum
Other Pre-specified Outcome Measures:
Title
Effect of improved sleep on mental health
Description
The tertiary objective will be to assess the affect of a sleep intervention on mental health This will be accomplished by Perceived Stress Scale (PSS) at approximately 24 weeks, 38 weeks, and 6 weeks postpartum Interpersonal Support Evaluation List (ISEL) at approximately 20 weeks gestation Edinburgh Depression Scale at approximately 24 weeks and 6 weeks postpartum COPE scale for ability to cope with stress at approximately 24 weeks, 38 weeks and 6 weeks postpartum Obtaining qualitative feedback on the patient's mental health status throughout pregnancy.
Time Frame
Second trimester of pregnancy to six weeks postpartum.
Title
Effect of sleep on breast milk composition
Description
Breast milk will be collected from both arms at six weeks postpartum and evaluated for factors related to sleep including melatonin.
Time Frame
Second trimester of pregnancy to six weeks postpartum

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary A Cain, MD
Organizational Affiliation
University of South Florida Department of OBGYN
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Judette Louis, MD, MPH
Organizational Affiliation
University of South Florida Department of Obstetrics and Gynecology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Linda Odibo
Organizational Affiliation
University of South Florida Department of Obstetrics and Gynecology
Official's Role
Study Director
Facility Information:
Facility Name
Tampa General Hospital Genesis Clinic
City
Tampa
State/Province
Florida
ZIP/Postal Code
33610
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31130005
Citation
Cain MA, Brumley J, Louis-Jacques A, Drerup M, Stern M, Louis JM. A Pilot Study of a Sleep Intervention Delivered through Group Prenatal Care to Overweight and Obese Women. Behav Sleep Med. 2020 Jul-Aug;18(4):477-487. doi: 10.1080/15402002.2019.1613995. Epub 2019 May 25.
Results Reference
derived

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Postpartum Weight Loss and Sleep Amongst Obese Women

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