Time-Restricted Eating for Pregnancy with Obesity

(TRE-Preg Trial)

Overseen By Mary Dawn Koenig, PhD, RN

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: University of Illinois at Chicago

Disqualifiers: Diabetes, Autoimmune disorder, Anemia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 20 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether time-restricted eating (also known as time-restricted feeding or intermittent fasting) during the 2nd and 3rd trimesters of pregnancy can help manage weight and improve health outcomes for mothers and babies. The focus is on pregnant women with severe obesity, who face higher risks for complications like gestational diabetes and pre-eclampsia. Participants will either follow a specific eating schedule or continue with standard care. This trial suits pregnant women with a preconception BMI between 35 and 50, who have a single pregnancy and are within 20 weeks of gestation. As an unphased trial, it offers a unique opportunity to contribute to understanding how time-restricted eating might benefit pregnant women and their babies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study doctor and your obstetrician or midwife.

What prior data suggests that time-restricted eating is safe for pregnant women with obesity?

Research has shown that time-restricted eating (TRE) can safely manage weight and improve metabolism. TRE involves eating only during specific hours and fasting the rest of the time. This approach can help control blood sugar levels, which is crucial for pregnant women as it may reduce pregnancy-related risks.

In one study, participants practicing TRE lost weight and improved their health without major side effects. Another study found that healthy individuals could easily adhere to TRE for five weeks, suggesting it can be a manageable lifestyle change.

While these findings are encouraging, individual responses can vary. Participants in TRE studies did not report significant negative effects, indicating that TRE is generally safe for most people. However, pregnant women should consult their healthcare provider before making dietary changes to ensure it’s appropriate for them. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Time-restricted eating is unique because it focuses on limiting the hours during which food is consumed rather than restricting the types or quantities of food. This approach is different from traditional weight management strategies during pregnancy, which often emphasize calorie counting or specific diet plans. Researchers are excited about this method because it could offer a more flexible and potentially easier way for pregnant individuals with obesity to manage their weight and health without the stress of constant dietary monitoring. By encouraging a natural eating rhythm and allowing flexibility in food choices, time-restricted eating could improve adherence and overall outcomes.

What evidence suggests that time-restricted eating might be an effective treatment for obesity during pregnancy?

This trial will compare time-restricted eating (TRE) with standard care for pregnant individuals with obesity. Research suggests that TRE might help manage blood sugar levels during pregnancy. Studies have found that TRE can improve how the body processes sugar and may aid individuals with overweight or obesity in enhancing their body composition. Some research indicates that eating within a specific time frame, like 6 to 8 hours a day, could help reduce body fat. However, other studies show that TRE alone doesn't result in more weight loss than eating throughout the day. While TRE seems promising for managing blood sugar and body fat, more research is needed to understand its effects on weight loss and pregnancy outcomes. ^{2 3 4 6 7}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I was assigned female at birth.

Singleton pregnancy

Ability to provide informed consent

Exclusion Criteria

I have inflammatory bowel disease.

Deemed medically high risk

Previous spontaneous preterm birth

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in time-restricted eating with an 8-hour eating window in the 2nd trimester and a 10-hour eating window in the 3rd trimester, with weekly meetings with a nutritionist and monthly health check-ins.

20 weeks

Weekly meetings (virtual), monthly check-ins (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with data collected from labor and delivery records.

4 weeks

Data collection from electronic health records

What Are the Treatments Tested in This Trial?

Interventions

• Time Restricted Eating

Trial Overview

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.

How Is the Trial Designed?

Group I: Time-restricted eating Experimental Treatment 1 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 Care Active Control 1 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.

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

High gestational weight gain is the strongest predictor of maternal overweight or obesity after pregnancy, and both high and low weight gains during pregnancy are linked to an increased risk of childhood obesity.

Despite revised guidelines from the US Institute of Medicine in 2009, less than one third of pregnant women meet the recommended weight gain levels, highlighting the need for effective interventions to optimize weight gain during pregnancy to prevent obesity in mothers and their children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing weight gain in pregnancy to prevent obesity in women and children. Herring, SJ., Rose, MZ., Skouteris, H., et al.[2023]

In a study of 50 adults with overweight and obesity, participants successfully reduced their eating window from an average of 16 hours to about 12 hours over a 90-day time-restricted eating (TRE) intervention, leading to significant weight loss and reductions in waist circumference and blood pressure.

The TRE approach, which required no dietary counseling and was monitored through a smartphone app, showed a feasible and effective way to improve eating patterns and health outcomes in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Smartphone Intervention to Promote Time Restricted Eating Reduces Body Weight and Blood Pressure in Adults with Overweight and Obesity: A Pilot Study. Prasad, M., Fine, K., Gee, A., et al.[2021]

Maternal obesity is linked to serious risks for both the mother and baby, including fetal hyperinsulinaemia and increased birthweight, which can lead to long-term obesity in the child.

Implementing preconception and antenatal counseling on diet, lifestyle, and weight management can significantly improve pregnancy outcomes for obese women, highlighting the importance of monitoring weight gain and fetal growth during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Placental dysfunction in obese women and antenatal surveillance strategies. Jeve, YB., Konje, JC., Doshani, A.[2015]

The weight-gain restriction program for obese pregnant women resulted in significantly more total full days of sickness absence benefits (76.68 days) compared to the control group (53.09 days), indicating a potential impact on health-related work absence during pregnancy.

Despite the intervention, there were no significant differences in the total days of pregnancy benefits between the intervention group (39.66%) and the control group (41.41%), suggesting that addressing social factors and attitudes towards sickness absence may be crucial for improving outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a weight-gain restriction programme for obese pregnant women on sickness absence and pregnancy benefits. Sydsjö, G., Monfils, WG., de Keyser, N., et al.[2021]

Obesity is a growing global health crisis, particularly among pregnant women, leading to poor obstetrical and neonatal outcomes, as well as long-term health issues for both mothers and their infants.

Current guidelines for managing obesity in pregnancy are inconsistent and confusing, lacking standard recommendations for weight gain, nutritional needs, and preventive health services, highlighting the need for clearer protocols and broader healthcare coverage for obesity treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perspectives in obesity and pregnancy. Mariona, FG.[2023]

Antenatal lifestyle interventions for pregnant women with overweight or obesity significantly improved dietary patterns, with higher 'prudent' diet scores and lower 'Western' diet scores compared to standard care, indicating better nutritional choices during and after pregnancy.

The effectiveness of the intervention varied based on initial BMI and smoking status, suggesting that personalized approaches may enhance dietary improvements for different groups of women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of a lifestyle intervention on pregnancy and postpartum dietary patterns determined by factor analysis. Moran, LJ., Flynn, AC., Louise, J., et al.[2018]

Bariatric surgery has become increasingly common as a treatment for obesity, particularly in pregnant women, due to its potential benefits in reducing complications such as gestational diabetes and pre-eclampsia.

The review highlights the importance of considering maternal and fetal outcomes post-surgery, including nutrition and timing of pregnancy after surgery, to optimize health for both mother and baby.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Bariatric surgery and pregnancy: literature review]. Ferrand Miranda, P., Contreras Rivas, T., Leigh Pacciarini, S.[2018]

In a 12-week study involving 23 obese adults, time-restricted feeding (TRF) with an 8-hour eating window was found to be safe, as there were no significant changes in self-reported adverse events or disordered eating patterns.

The study suggests that TRF can effectively support weight loss in obese individuals without negatively impacting their health or body image perception.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of 8-h time restricted feeding in adults with obesity. Gabel, K., Hoddy, KK., Varady, KA.[2019]

A study involving 257 obese pregnant women showed that those on a monitored, balanced nutritional regimen did not experience adverse perinatal outcomes compared to those on conventional dietary management.

The monitored group had significant improvements in maternal weight management, with lower weight gain before delivery and at 6 weeks postpartum, suggesting that a structured nutritional approach can be safe and effective for obese pregnant women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perinatal outcomes in nutritionally monitored obese pregnant women: a randomized clinical trial. Thornton, YS., Smarkola, C., Kopacz, SM., et al.[2019]

In a study of 16,808 women with obesity, a gestational weight change of -1 to +4 kg was found to significantly reduce the risk of major neonatal morbidity compared to the current recommended weight gain guidelines.

Women with class II and III obesity may benefit from even lower weight gain during pregnancy, with optimal ranges of -2 to +2 kg and -2 to +3 kg respectively, indicating that tailored weight management strategies could improve maternal and neonatal outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimal Gestational Weight Gain for Women With Obesity. Bujold, L., Audibert, F., Chaillet, N.[2023]

Managing obesity in women of childbearing age is crucial, as it involves optimizing weight and medical conditions before and during pregnancy to ensure both maternal and fetal health.

Maternal obesity can lead to negative metabolic effects in offspring, contributing to a cycle of obesity that can affect future generations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Obesity in Pregnancy: Optimizing Outcomes for Mom and Baby. Dutton, H., Borengasser, SJ., Gaudet, LM., et al.[2023]

A survey of 213 families attending pediatric weight management programs found that 66% of parents were interested in trying time-limited eating (TLE) for 12 hours a day, indicating a strong acceptability of this dietary approach among families.

Interest in TLE decreased significantly when the eating window was limited to 10 hours (39%) or 8 hours (26%), suggesting that flexibility in the eating schedule may enhance adherence to dietary interventions for childhood obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptability of Time-Limited Eating in Pediatric Weight Management. Tucker, JM., Siegel, R., Murray, PJ., et al.[2023]

In a 12-week study involving 14 adults with obesity, time-restricted feeding (8-hour eating window) led to a significant weight loss of about 2 kg, indicating potential efficacy for weight management.

Despite the weight loss, the study found no significant changes in the diversity or composition of the gut microbiome, suggesting that time-restricted feeding may not impact gut health in terms of microbial diversity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of time restricted feeding on the gut microbiome in adults with obesity: A pilot study. Gabel, K., Marcell, J., Cares, K., et al.[2022]

Time-restricted eating (TRE) has shown promising therapeutic effects in rodent studies, particularly in relation to body weight and metabolic health, but results in humans are inconsistent due to varying study designs and populations.

This review highlights the need for more standardized research on TRE in humans to better understand its effects and interactions with circadian biology, as well as to identify gaps in current knowledge for future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complex physiology and clinical implications of time-restricted eating. Petersen, MC., Gallop, MR., Flores Ramos, S., et al.[2023]

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