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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Go!®to sleep | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| six weeks postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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
|
Inclusion Criteria:
• Pregnant female patients
Exclusion Criteria:
• Under 18 years of age
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| Name | Affiliation | Role |
|---|---|---|
| Mary A Cain, MD | University of South Florida Department of OBGYN | Study Chair |
| Judette Louis, MD, MPH | University of South Florida Department of Obstetrics and Gynecology | Principal Investigator |
| Linda Odibo | University of South Florida Department of Obstetrics and Gynecology | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tampa General Hospital Genesis Clinic | Tampa | Florida | 33610 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31130005 | Derived | 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. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D012891 | Sleep Apnea Syndromes |
| D015431 | Weight Loss |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| From the second trimester of pregnancy to six weeks postpartum |
| Second trimester of pregnancy to six weeks postpartum. |
| 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 |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001836 | Body Weight Changes |
| D001523 | Mental Disorders |