ObesityNCT01968330
Postpartum Weight Loss and Sleep Amongst Obese Women
A study testing Go!®to sleep in people with Obesity and Sleep Disordered Breathing, run by University of South Florida at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Obesity, Sleep Disordered Breathing, Weight Loss
- What is being tested?
- Go!®to sleep
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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
Who cannot join
- • 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 locations and contacts
1 site in 1 country.
United States1 site
Tampa General Hospital Genesis Clinic
Tampa, Florida, 33610
About this study
Official title: 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.
- Conditions
- Obesity, Sleep Disordered Breathing, Weight Loss, Postpartum, Insomnia
- Being tested
- Go!®to sleep
- Medical subject headings
- Obesity, Sleep Apnea Syndromes, Weight Loss, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Go!®to sleepBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Go!®to sleep | Experimental | 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. Receives: Behavioral: Go!®to sleep |
| Routine prenatal care | No intervention | Patients in the routine prenatal care arm will complete prenatal care in a group setting and will not complete the sleep intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: six weeks postpartum
Secondary outcomes (1)
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.
Measured: From the second trimester of pregnancy to six weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2013 (estimated)
- Study startMay 2014
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of South FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Judette Louis, University of South Florida
- Investigators
- Mary A Cain, MD, Study chair, University of South Florida Department of OBGYNJudette Louis, MD, MPH, Principal investigator, University of South Florida Department of Obstetrics and GynecologyLinda Odibo, Study director, University of South Florida Department of Obstetrics and Gynecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01968330
- Sponsor's protocol ID
- Pro00014850
- Status last verified
- May 2016
- First submitted
- 18 Oct 2013
- Last updated
- 20 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cain MA, Brumley J, Louis-Jacques A, Drerup M, Stern M, Louis JM. A Pilot Study of a Sleep Intervention Delivered through Group Prenatal Care to Overweight and Obese Women. Behav Sleep Med. 2020 Jul-Aug;18(4):477-487. doi: 10.1080/15402002.2019.1613995. Epub 2019 May 25.
PubMed 31130005
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postpartum Weight Loss in Obese Women Using a Sleep Intervention in a Group Prenatal Care Setting
- ClinicalTrials.gov ID
- NCT01968330
- Acronym / sponsor ID
- Pro00014850
- Conditions
- Obesity, Sleep Disordered Breathing, Weight Loss, Postpartum, Insomnia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 24 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Go!®to sleep | Experimental | Behavioral: Go!®to sleepPatients 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. |
| Routine prenatal care | No intervention | –Patients in the routine prenatal care arm will complete prenatal care in a group setting and will not complete the sleep intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- • Pregnant female patients
Key exclusion criteria (5 listed)
- • Under 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Go!®to sleep | Behavioural | Go!®to sleep |
Primary outcome
Weight loss at 6 weeks postpartum.
Time frame: 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.
1 secondary outcome
Affects of improved sleep on insulin resistance and cholesterol levels
Time frame: From the second trimester of pregnancy to six weeks postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2016.
- Derived from this study: PubMed 31130005Cain MA, Brumley J, Louis-Jacques A, Drerup M, Stern M, Louis JM. A Pilot Study of a Sleep Intervention Delivered through Group Prenatal Care to Overweight and Obese Women. Behav Sleep Med. 2020 Jul-Aug;18(4):477-487. doi: 10.1080/15402002.2019.1613995. Epub 2019 May 25.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary A Cain, MD study chair
University of South Florida Department of OBGYN
Judette Louis, MD, MPH principal investigator
University of South Florida Department of Obstetrics and Gynecology
Linda Odibo study director
University of South Florida Department of Obstetrics and Gynecology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Go!®to sleep in people with Obesity and Sleep Disordered Breathing, run by University of South Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight loss at 6 weeks postpartum. (time frame: six weeks postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01968330, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2016; AzTrials last refreshed its copy on 8 Nov 2026.