Postpartum Weight Loss and Sleep Amongst Obese Women

Obesity Clinical Trial

Official title:

Postpartum Weight Loss in Obese Women Using a Sleep Intervention in a Group Prenatal Care Setting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01968330
• Other study ID #: Pro00014850
• Status: Completed
• Phase: N/A
• First received: October 18, 2013
• Last updated: May 19, 2016
• Start date: May 2014
• Est. completion date: May 2016

Study information

• Verified date: May 2016
• Source: University of South Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Insomnia
• Obesity
• Postpartum
• Sleep Disordered Breathing
• Weight Loss

Intervention

Behavioral:
• Go!®to sleep

Locations

Country	Name	City	State
United States	Tampa General Hospital Genesis Clinic	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of South Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Effect of improved sleep on mental health	The tertiary objective will be to assess the affect of a sleep intervention on mental health This will be accomplished by; Perceived Stress Scale (PSS) at approximately 24 weeks, 38 weeks, and 6 weeks postpartum; Interpersonal Support Evaluation List (ISEL) at approximately 20 weeks gestation; Edinburgh Depression Scale at approximately 24 weeks and 6 weeks postpartum; COPE scale for ability to cope with stress at approximately 24 weeks, 38 weeks and 6 weeks postpartum; Obtaining qualitative feedback on the patient's mental health status throughout pregnancy.	Second trimester of pregnancy to six weeks postpartum.	No
Other	Effect of sleep on breast milk composition	Breast milk will be collected from both arms at six weeks postpartum and evaluated for factors related to sleep including melatonin.	Second trimester of pregnancy to six weeks postpartum	No
Primary	Weight loss at 6 weeks postpartum.	The Primary objective of this study is to determine if a sleep intervention delivered in a group prenatal care setting of obese women can improve weight loss at one year postpartum (i.e. patient's ability to loose weight gained in pregnancy). This will be accomplished by: Randomizing study subjects to groups with or without a sleep intervention component; Assessing weight, neck and abdominal circumference at each prenatal visit and at six weeks postpartum; Obtaining information regarding the patient's pre-pregnancy weight.; Assessing baseline sleep habits with at home polysomnography and actigraphy and repeating these measurements in the late third trimester as well as postpartum.; Assessing sleep habits through the Epworth Sleepiness scale and Pittsburgh Sleep Quality Index at baseline.; Obtaining qualitative feedback on the patient's experience with the sleep program and their sleep habits.	six weeks postpartum	No
Secondary	Affects of improved sleep on insulin resistance and cholesterol levels	The secondary objective will be to assess the affect of a sleep intervention on insulin resistance and cholesterol levels. This will be accomplished by: Assessing glucose, insulin, HOMA, AUCgluc, leptin, adiponectin, total cholesterol, HDL, LDL, triglyceride levels at four time points in pregnancy and postpartum.; Completing the PRIME screen, a diet assessment tool, at approximately 20 weeks, 34 weeks and 6 and weeks postpartum; Assessing the neonates body composition at birth.	From the second trimester of pregnancy to six weeks postpartum	No