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New treatment option for Obesity, Morbid
Official title Time-restricted Eating Among Pregnant Females With Severe Obesity
ClinicalTrials.gov ID: NCT06477120
What this study is testing
- What it's testing
- In the United States, a body mass index (BMI) of at least 35.0 kg/m2 affects about 15% of women of reproductive age. Severe obesity is a significant predictor of adverse perinatal outcomes including gestational diabetes mellitus, pre-eclampsia, premature birth, and at its most severe, fetal death, birth defects and a three-fold greater risk of maternal mortality.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 44, women only. Healthy volunteers may be eligible.
You may be able to join if
- Female based on sex assigned at birth
- Preconception body mass index (BMI) 35.0 - 60 kg/m2
- Singleton pregnancy
- Age 18-44 years old
- 14 - \< = 20 weeks gestational age
You likely can't join if
- Deemed medically high risk
- Multiple pregnancy (e.g., twins)
- Type 1 or 2 diabetes mellitus
- Early gestational diabetes (diagnosed at \< = to17 weeks gestational age through an oral glucose tolerance test)
- Currently eating ≤ 12 hours daily
- Autoimmune disorder (e.g., rheumatoid arthritis)
See the full eligibility criteria
- Female based on sex assigned at birth
- Preconception body mass index (BMI) 35.0 - 60 kg/m2
- Singleton pregnancy
- Age 18-44 years old
- 14 - \< = 20 weeks gestational age
- Fluency in English to provide consent and complete study procedures
- Ability to provide informed consent
- Cleared by study doctor and the obstetrician/mid-wife provider to participate
- Access to a smartphone to complete intervention procedures
- Deemed medically high risk
- Multiple pregnancy (e.g., twins)
- Type 1 or 2 diabetes mellitus
- Early gestational diabetes (diagnosed at \< = to17 weeks gestational age through an oral glucose tolerance test)
- Currently eating ≤ 12 hours daily
- Autoimmune disorder (e.g., rheumatoid arthritis)
- iron deficiency anemia
- Inflammatory bowel disease
- Previous spontaneous preterm birth
- History of bariatric surgery
- Night shift work
- Currently incarcerated
- Eating disorder
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 44 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.