Postpartum Weight Loss and Sleep Amongst Obese Women

May 19, 2016 updated by: Judette Louis, University of South Florida

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33610
        • Tampa General Hospital Genesis Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Behavioral: Go!®to sleep
NO_INTERVENTION: Routine prenatal care
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.
Time Frame: 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.
six weeks postpartum

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of improved sleep on mental health
Time Frame: Second trimester of pregnancy to six weeks postpartum.

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.
Second trimester of pregnancy to six weeks postpartum.
Effect of sleep on breast milk composition
Time Frame: Second trimester of pregnancy to six weeks postpartum
Breast milk will be collected from both arms at six weeks postpartum and evaluated for factors related to sleep including melatonin.
Second trimester of pregnancy to six weeks postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of South Florida

Investigators

  • Study Chair: Mary A Cain, MD, University of South Florida Department of OBGYN
  • Principal Investigator: Judette Louis, MD, MPH, University of South Florida Department of Obstetrics and Gynecology
  • Study Director: Linda Odibo, University of South Florida Department of Obstetrics and Gynecology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (ACTUAL)

May 1, 2016

Study Completion (ACTUAL)

May 1, 2016

Study Registration Dates

First Submitted

October 18, 2013

First Submitted That Met QC Criteria

October 18, 2013

First Posted (ESTIMATE)

October 24, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

May 20, 2016

Last Update Submitted That Met QC Criteria

May 19, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00014850

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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