Time-restricted Eating Among Pregnant Females With Severe Obesity

NCT06477120 | Recruiting

• 2 other identifiers: 2024-01385R01DK136085-02
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity, Morbid; Time Restricted Eating; Pregnancy Weight Gain

Outcome Measures

Primary Outcomes (11)

• Recruitment Feasibility

  ≥ 30% of those approached enroll

  From 6 months through 32 months (the funding period is 36 months)

• Trial safety - Maternal Complete Blood Count

  % and n with abnormal results by study arm

  Baseline (14-20 weeks gestational age) and monthly through labor and delivery, about 6 months

• Trial safety - Non-stress Test for Fetal Safety

  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

  29-31 weeks gestational age and 35-37 weeks gestational age

• Intervention acceptability

  Semi-structured interviews

  25-27 weeks gestational age and 35-37 weeks gestational age

• Research visit feasibility

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

  Baseline, 25-27 weeks gestational age and 35-37 weeks gestational age

• Intervention (TRE) session feasibility

  Number and % of intervention sessions completed by TRE participants

  Weekly from baseline through labor and delivery, about 6 months

• TRE adherence

  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

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

• Trial safety - Maternal health checks

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

  Weekly from baseline to labor and delivery, about 6 months, % and n for health events reported by study arm

• Trial safety - Maternal outcomes

  Data obtained from the participant's electronic health record (gestational age at delivery, gestational diabetes, gestational hypertension, preeclampsia, c-section, spontaneous pre-term birth, iron deficiency anemia) % and n with abnormal results by study arm

  Labor and delivery

• Trial safety - Neonatal outcomes

  Data obtained from the participant's electronic health record (small or large for gestational age, neonatal intensive care admission, jaundice, APGAR score) % and n with abnormal results by study arm

  Labor and delivery

• Trial Retention

  n and % of women retained through the final in-person data collection with \>= 80% retained

  35-37 week gestational age

Secondary Outcomes (8)

• Maternal Body Weight

  Baseline (14-20 weeks), 25-27 weeks gestational age, 35-37 weeks gestational age

• Maternal Fasting Blood Glucose

  Baseline (14-20 weeks gestational age), 25-27 weeks gestational age, 35-37 weeks gestational age

• Maternal Fasting Insulin

  Baseline (14-20 weeks gestational age), 25-27 weeks gestational age, 35-37 weeks gestational age

• Maternal Fasting Blood Lipids

  Baseline (14-20 weeks gestational age), 25-27 weeks gestational age, 35-37 weeks gestational age

• Maternal C-reactive protein

  Baseline (14-20 weeks gestational age), 25-27 weeks gestational age, 35-37 weeks gestational age

Study Arms (2)

Time-restricted eating

EXPERIMENTAL

Participants randomized to the time-restricted eating arm will be instructed to eat ad libitum during an 8-hr window daily 11am - 7pm in the 2nd trimester and 10-hr eating window from 10am - 8pm in the 3rd trimester and abstain from caloric foods and beverages for the remaining 14-16 hours. During the eating window there will be no restrictions on types or quantities of foods consumed. Moreover, participants will not be required to monitor calorie intake during the ad libitum eating period. During the fasting period, participants will be encouraged to drink plenty of water and will be allowed to consume calorie-free beverages.

Behavioral: Time Restricted Eating

Enhanced Standard Care

NO INTERVENTION

The standard care arm will not receive diet-related counseling. Participants will meet with study staff weekly to record health changes and to transmit weight through the text messaging platform. The remote videoconferencing visits will occur at the same day and time each week. Standard care participants will attend the in-person research data collection visits. Participants will be asked to maintain current (baseline) level of physical activity throughout the intervention.

Interventions

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.

Time-restricted eating

Eligibility Criteria

• Age: 18 Years - 44 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify 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
• \< = 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

You may not qualify 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)
• iron deficiency anemia
• Inflammatory bowel disease
• Previous spontaneous preterm birth
• History of bariatric surgery
• Night shift work
• Currently incarcerated
• Eating disorder

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Illinois at Chicago College of Applied Health Sciences

Chicago, Illinois, 60612, United States

RECRUITING

MeSH Terms

Conditions

Obesity, Morbid; Intermittent Fasting; Gestational Weight Gain

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Fasting; Feeding Behavior; Behavior; Weight Gain; Body Weight Changes

Central Study Contacts

Lisa Tussing-Humphreys, PhD, RD

CONTACT

312-355-5521; tussing@uic.edu

Mary Dawn Koenig, PhD, RN

CONTACT

(312) 996-7942; marydh@uic.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Kinesiology and Nutrition, PhD, MS, RD

Model Details: 1:1 allocation ratio. Randomization will be stratified by participant age (18-30 and 31-44 years old).

Study Record Dates

• First Submitted: May 30, 2024
• First Posted: June 27, 2024
• Study Start: September 9, 2024
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): November 29, 2026
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)