Postpartum Weight Loss and Sleep Amongst Obese Women

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2016-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Obesity Sleep Disordered Breathing Weight Loss Postpartum Insomnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Go!®to sleep

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.

Group Type EXPERIMENTAL

Go!®to sleep

Intervention Type BEHAVIORAL

Routine prenatal care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Go!®to sleep

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No