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Behavioural Intervention

Time-Restricted Eating for Pregnancy with Obesity (TRE-Preg Trial)

N/A

Recruiting

Research Sponsored by University of Illinois at Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Female based on sex assigned at birth

Age 18-44 years old

Must not have

Autoimmune disorder (e.g., rheumatoid arthritis)

Iron deficiency anemia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up monthly 16-32 weeks gestational age and twice monthly 33 weeks gestational age up through delivery

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to study the effects of time-restricted eating on pregnant women with severe obesity in their 2nd and 3rd trimesters. Severe obesity can lead to various complications during pregnancy

Who is the study for?

This trial is for pregnant women with severe obesity, specifically those with a BMI of 40.0 kg/m2 or higher. It's particularly focused on Black females who are more affected by these conditions. The study aims to include individuals in their 2nd and 3rd trimesters but the specific inclusion and exclusion criteria details are not provided.

What is being tested?

The study is testing time-restricted eating during the second and third trimesters of pregnancy. Participants will follow this diet plan to see if it affects maternal weight and improves perinatal health outcomes, compared to standard clinical care received by others.

What are the potential side effects?

Potential side effects aren't detailed here, but time-restricted eating may lead to hunger outside of designated eating times, potential nutritional deficiencies if not properly managed, and could affect energy levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I was assigned female at birth.

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I am between 18 and 44 years old.

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I am less than or equal to 17 weeks pregnant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have an autoimmune disorder like rheumatoid arthritis.

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I have anemia caused by a lack of iron.

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I have inflammatory bowel disease.

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I have had weight loss surgery in the past.

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I have type 1 or type 2 diabetes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ monthly 16-32 weeks gestational age and twice monthly 33 weeks gestational age up through delivery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~monthly 16-32 weeks gestational age and twice monthly 33 weeks gestational age up through delivery

This trial's timeline: 3 weeks for screening, Varies for treatment, and monthly 16-32 weeks gestational age and twice monthly 33 weeks gestational age up through delivery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Fetal Heart Tones

Intervention Acceptability

Maternal Complete Blood Count

+3 more

Secondary study objectives

Body weight

C-reactive protein

Diastolic Blood Pressure

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Time-restricted eatingExperimental Treatment1 Intervention

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.

Group II: Standard CareActive Control1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Time Restricted Eating

2018

N/A

~50

0 / 8Eligibility criteria met