Insomnia, Obesity, Postpartum, Sleep Disordered Breathing, Weight Loss
Conditions
Brief 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.
Interventions
BEHAVIORALGo!®to sleep
Sponsors
University of South Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight loss at 6 weeks postpartum. | six 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Affects of improved sleep on insulin resistance and cholesterol levels | From the second trimester of pregnancy to six weeks postpartum | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Effect of improved sleep on mental health | Second trimester of pregnancy to six weeks postpartum. | 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. |
| Effect of sleep on breast milk composition | Second trimester of pregnancy to six weeks postpartum | Breast milk will be collected from both arms at six weeks postpartum and evaluated for factors related to sleep including melatonin. |
Countries
United States
Outcome results
None listed