Postpartum Weight Loss and Sleep Amongst Obese Women

Completed · Not applicable

Conditions studied: Obesity, Sleep Disordered Breathing, Weight Loss, Postpartum, Insomnia

In brief

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.

Key facts

Study ID: NCT01968330
Run by: University of South Florida
People needed: 53
Starts: 2014-05-01
Expected to finish: 2016-05-01
Last updated by the study team: 2016-05-20

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

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

Where it is running

Tampa General Hospital Genesis Clinic — Tampa, Florida, United States

Full record on ClinicalTrials.gov

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