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

80 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Time-Restricted Eating for Pregnancy with Obesity?

The research highlights that managing weight gain during pregnancy is crucial for preventing obesity in both mothers and their children. Although specific data on time-restricted eating during pregnancy is not provided, interventions to optimize pregnancy weight gain have shown mixed success, suggesting that dietary strategies like time-restricted eating could potentially help manage weight gain effectively. ^{1 2 3 4 5}

Is time-restricted eating safe for people with obesity?

Research shows that time-restricted eating, where food is consumed within a specific time window each day, is generally safe for adults with obesity. Studies found no significant adverse effects, and participants did not report changes in body image perception or disordered eating patterns. ^{6 7 8 9 10}

How is time-restricted eating different from other treatments for obesity during pregnancy?

Time-restricted eating is unique because it focuses on limiting the hours during which food is consumed each day, aligning eating patterns with the body's natural circadian rhythms. This approach differs from other treatments that may focus on calorie restriction or specific dietary changes without considering the timing of food intake. ^{2 11 12 13 14}

What is the purpose of this trial?

In the United States, severe obesity (body mass index (BMI) ≥ 40.0 kg/m2) affects approximately 10% of females of reproductive age with Black females disproportionately burdened (16%). 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 - outcomes that also disproportionately affect Black females. 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 Criteria

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

Deemed medically high risk

I have an autoimmune disorder like rheumatoid arthritis.

Night shift work

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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 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]

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]

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]

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]

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Placental dysfunction in obese women and antenatal surveillance strategies. [2015]

2. United States pubmed.ncbi.nlm.nih.gov

Effects of a weight-gain restriction programme for obese pregnant women on sickness absence and pregnancy benefits. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Perspectives in obesity and pregnancy. [2023]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Optimal Gestational Weight Gain for Women With Obesity. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Optimizing weight gain in pregnancy to prevent obesity in women and children. [2023]

6. Canada pubmed.ncbi.nlm.nih.gov

Safety of 8-h time restricted feeding in adults with obesity. [2019]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Acceptability of Time-Limited Eating in Pediatric Weight Management. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Effect of time restricted feeding on the gut microbiome in adults with obesity: A pilot study. [2022]

9. Switzerland 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. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Complex physiology and clinical implications of time-restricted eating. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

The effect of a lifestyle intervention on pregnancy and postpartum dietary patterns determined by factor analysis. [2018]

12. Chile pubmed.ncbi.nlm.nih.gov

[Bariatric surgery and pregnancy: literature review]. [2018]

13. United States pubmed.ncbi.nlm.nih.gov

Perinatal outcomes in nutritionally monitored obese pregnant women: a randomized clinical trial. [2019]

14. United States pubmed.ncbi.nlm.nih.gov

Obesity in Pregnancy: Optimizing Outcomes for Mom and Baby. [2023]