Postpartum Weight Loss and Sleep Amongst Obese Women

NCT01968330 | Completed DMC

• 1 other identifier: Pro00014850
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Sleep Disordered Breathing; Weight Loss; Postpartum; Insomnia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Affects of improved sleep on insulin resistance and cholesterol levels

  From the second trimester of pregnancy to six weeks postpartum

Other Outcomes (2)

• Effect of improved sleep on mental health

  Second trimester of pregnancy to six weeks postpartum.

• Effect of sleep on breast milk composition

  Second trimester of pregnancy to six weeks postpartum

Study Arms (2)

Go!®to sleep

EXPERIMENTAL

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

Routine prenatal care

NO INTERVENTION

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

Interventions

Go!®to sleep BEHAVIORAL

Go!®to sleep

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of South Florida: lead

Study Sites (1)

Tampa General Hospital Genesis Clinic

Tampa, Florida, 33610, United States

Location

Related Publications (1)

• 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.

  PMID: 31130005 DERIVED

MeSH Terms

Conditions

Obesity; Sleep Apnea Syndromes; Weight Loss; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Body Weight Changes; Mental Disorders

Study Officials

• Mary A Cain, MD

  University of South Florida Department of OBGYN

  STUDY CHAIR

• Judette Louis, MD, MPH

  University of South Florida Department of Obstetrics and Gynecology

  PRINCIPAL INVESTIGATOR

• Linda Odibo

  University of South Florida Department of Obstetrics and Gynecology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor College of Medicine Obstetrics and Gynecology Assistant Professor College of Public Health Community and Family Health

Study Record Dates

• First Submitted: October 18, 2013
• First Posted: October 24, 2013
• Study Start: May 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: May 20, 2016

Record last verified: 2016-05

Locations

US (1)