RecruitingNot ApplicableNCT06477120

Time-restricted Eating Among Pregnant Females With Severe Obesity

A Pilot Study of Time-restricted Eating Among Pregnant Females With Severe Obesity


Sponsor

University of Illinois at Chicago

Enrollment

60 participants

Start Date

Sep 9, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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. Observational studies suggest weight maintenance and even modest body fat loss and altering the maternal metabolic milieu (availability of glucose and lipids) in the gestational period may be important to reducing perinatal health risks among pregnant females with severe obesity. The proposed research aims to assess time-restricted eating in the 2nd and 3rd trimesters of pregnancy to explore the effects on maternal weight, and perinatal health outcomes compared to standard clinical care.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 44 Years

Inclusion Criteria9

  • Female based on sex assigned at birth
  • Preconception body mass index (BMI) 35.0 - 60 kg/m2
  • Singleton pregnancy
  • Age 18-44 years old
  • \< = 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

Exclusion Criteria13

  • 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

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Interventions

BEHAVIORALTime Restricted Eating

The time-restricted eating arm will be instructed to eat ad libitum during an 8-hr window daily (10am - 6pm OR 11am - 7pm) in the 2nd trimester and 10-hr eating window from (9am - 7pm OR 10am - 8pm) in the 3rd trimester and abstain from caloric foods and beverages for the remaining 14-16 hours.


Locations(1)

University of Illinois at Chicago College of Applied Health Sciences

Chicago, Illinois, United States

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NCT06477120


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