Postpartum Weight Loss and Sleep Amongst Obese Women



Status:Completed
Conditions:Insomnia Sleep Studies, Obesity Weight Loss
Therapuetic Areas:Endocrinology, Psychiatry / Psychology
Healthy:No
Age Range:18 - Any
Updated:5/21/2016
Start Date:May 2014
End Date:May 2016

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Trial Summary
Trial Overview
Inclusion Criteria

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.


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
We found this trial at
1
site
Tampa General Hospital Genesis Clinic
Tampa, Florida 33610
?
mi
from
Tampa, FL
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