Clinical trial NCT01968330: 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
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Sleep Disordered Breathing
Weight Loss
Postpartum
Insomnia
Lead sponsor: University of South Florida
Sponsor class: OTHER
First posted: 2013-10-24
Enrollment: 53
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Weight loss at 6 weeks postpartum.
timeFrame: six weeks postpartum
Secondary outcomes:
measure: Affects of improved sleep on insulin resistance and cholesterol levels
timeFrame: From the second trimester of pregnancy to six weeks postpartum
Other outcomes:
measure: Effect of improved sleep on mental health
timeFrame: Second trimester of pregnancy to six weeks postpartum.
measure: Effect of sleep on breast milk composition
timeFrame: Second trimester of pregnancy to six weeks postpartum
Locations:
city: Tampa
country: United States
facility: Tampa General Hospital Genesis Clinic
state: Florida
Study officials:
affiliation: University of South Florida Department of OBGYN
name: Mary A Cain, MD
role: STUDY_CHAIR
affiliation: University of South Florida Department of Obstetrics and Gynecology
name: Judette Louis, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of South Florida Department of Obstetrics and Gynecology
name: Linda Odibo
role: STUDY_DIRECTOR
References:
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.