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Completed

NCT Number: NCT01968330

Postpartum Weight Loss and Sleep Amongst Obese Women

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.

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Key information

Conditions

Obesity Apnea Body Weight Body Weight Changes Dyssomnias Insomnia Mental Disorders Nervous System Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Postpartum Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Sleep Apnea Syndromes Sleep Disordered Breathing Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Weight Loss

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Tampa General Hospital Genesis Clinic

Tampa, Florida, 33610, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Go!®to sleep

Behavioral

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

University of South Florida

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Oct 24, 2013
Registry last updated
May 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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