Postpartum Weight Loss and Sleep Amongst Obese Women

University of South Florida

Status: Completed

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

Treatments: Behavioral: Go!®to sleep

Study type: Interventional

Funder types: Other

Identifiers

NCT01968330

Pro00014850

Details and patient eligibility

About

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.

Enrollment: 53 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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53 participants in 2 patient groups

Go!®to sleep

Experimental group

Description:

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.

Treatment:

Behavioral: Go!®to sleep

Routine prenatal care

No Intervention group

Description:

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