Clinical trial

Time-restricted Eating Among Pregnant Females With Severe Obesity

Recruiting now · Not applicable · 1 countries · Registry ID NCT06477120

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 44 Years

SexFemale

Healthy volunteersAccepted

ConditionObesity, Morbid, Time Restricted Eating, Pregnancy Weight Gain

Full registry criteria

Inclusion 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 Exclusion criteria: * 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

Treatments and study arms

Time Restricted Eating

Behavioral

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.

Primary outcomes

Recruitment FeasibilityFrom 6 months through 32 months (the funding period is 36 months)

≥ 30% of those approached enroll

Trial safety - Maternal Complete Blood CountBaseline (14-20 weeks gestational age) and monthly through labor and delivery, about 6 months

% and n with abnormal results by study arm

Trial safety - Non-stress Test for Fetal Safety29-31 weeks gestational age and 35-37 weeks gestational age

Measured with a fetal monitor to examine baby's heart rate over time (usually 20 to 30 minutes, but sometimes up to an hour) % and n with abnormal results by study arm

Intervention acceptability25-27 weeks gestational age and 35-37 weeks gestational age

Semi-structured interviews

Research visit feasibilityBaseline, 25-27 weeks gestational age and 35-37 weeks gestational age

Number of data collection visits completed with \>=80% completed at each timepoint and completeness of data

Intervention (TRE) session feasibilityWeekly from baseline through labor and delivery, about 6 months

Number and % of intervention sessions completed by TRE participants

TRE adherenceDaily from enrollment to labor and delivery (TRE arm only), about 6 months

Response rate to daily text message regarding eating start and stop time to determine adherence to the eating window goal is \>= 80% adherence on days reported

Trial safety - Maternal health checksWeekly from baseline to labor and delivery, about 6 months, % and n for health events reported by study arm

Weekly maternal health checks via videoconference in TRE and control group that is verified with electronic health record

Study locations

1 locations were listed when this page was built. The first 40 are shown.

University of Illinois at Chicago College of Applied Health Sciences🇺🇸 Chicago, Illinois, United States

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Lisa Tussing-Humphreys, PhD, MS, RDContact

Email · Call 312-355-5521