Time-Restricted Eating for Pregnancy with Obesity
(TRE-Preg Trial)
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Illinois at Chicago
Disqualifiers: Diabetes, Autoimmune disorder, Anemia, others
No Placebo Group
Trial Summary
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.
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.
12345Is 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.
678910How 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.
211121314Eligibility 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
+6 more
Exclusion Criteria
Deemed medically high risk
I have an autoimmune disorder like rheumatoid arthritis.
Night shift work
+9 more
Trial 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
Participant Groups
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.
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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Illinois at Chicago College of Applied Health SciencesChicago, IL
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Who Is Running the Clinical Trial?
University of Illinois at ChicagoLead Sponsor
References
Placental dysfunction in obese women and antenatal surveillance strategies. [2015]This review is aimed at discussing placental dysfunction in obesity and its clinical implication in pregnancy as well as an antenatal surveillance strategy for these women. Maternal obesity is associated with adverse perinatal outcome. Obesity is an independent risk factor for fetal hyperinsulinaemia, birthweight and newborn adiposity. Maternal obesity is associated with childhood obesity and obesity in adult life. Obesity induces a low-grade inflammatory response in placenta, which results in short- and long-term programming of obesity in fetal life. Preconception and antenatal counselling on obstetrics risk in pregnancy, on diet and lifestyle in pregnancy and on gestational weight gain is associated with a better outcome. Fetal growth velocity is closely associated with maternal weight and gestational weight gain. Careful monitoring of gestational weight gain and fetal growth, and screening and management of obstetrical complications such as gestational diabetes and pre-eclampsia, improves perinatal outcome. The use of metformin in non-diabetic obese women is under investigation; further evidence is required before recommending it.
Effects of a weight-gain restriction programme for obese pregnant women on sickness absence and pregnancy benefits. [2021]To evaluate the effect of a weight-gain restriction programme for obese pregnant women on sickness absence days and pregnancy benefit days during pregnancy and postpartum.
Perspectives in obesity and pregnancy. [2023]Obesity is currently recognized as a health epidemic worldwide. Its prevalence has doubled in the last three decades. Obesity is a complex clinical picture associated with physical, physiologic, hormonal, genetic, cultural, socioeconomic and environmental factors. The rate of obesity is also increasing in the pregnant women population. Maternal obesity is associated with less than optimal obstetrical, fetal and neonatal outcomes. It is also associated with significant adverse long-term effects on both obese parturients and the infants born from obese women. A number of guidelines have been published to educate health care workers and the general population in an attempt to develop effective interventions on a large scale to prevent obesity. These guidelines are multiple, confusing and inconsistent. There are no standard recommendations regarding gestational weight gaining goals, nutrients and additional elements necessary for certain obese women who have been treated with bariatric surgical procedures, screening for metabolic diseases such as diabetes, additional preventive health care services indicated for obese women in the pregnancy planning stages, during prenatal care, in the immediate post-partum period and as a long-term approach for health preservation. In 2013, the American Medical Association supported by several US national medical specialty organizations published Resolution 420 (A-13) recognizing obesity as a disease state with multiple pathophysiological aspects requiring a range of interventions to improve its prevention and treatment. The goal of this decision was to encourage a broader spectrum of health care benefits insurance coverage for the prevention and treatment of obesity. There are a number of myths and misconceptions associated with obesity. These perspectives present our views and clinical experience with a partial review of recent bibliography addressing the associations between obese reproductive age women and their risks during pregnancy.
Optimal Gestational Weight Gain for Women With Obesity. [2023]To determine the optimal gestational weight gain interval for women with obesity in order to minimize neonatal and maternal adverse events.
Optimizing weight gain in pregnancy to prevent obesity in women and children. [2023]Pregnancy is now considered to be an important risk factor for new or persistent obesity among women during the childbearing years. High gestational weight gain is the strongest predictor of maternal overweight or obesity following pregnancy. A growing body of evidence also suggests that both high and low gestational weight gains are independently associated with an increased risk of childhood obesity, suggesting that influences occurring very early in life are contributing to obesity onset. In response to these data, the US Institute of Medicine (IOM) revised gestational weight gain guidelines in 2009 for the first time in nearly two decades. However, less than one third of pregnant women achieve guideline-recommended gains, with the majority gaining above IOM recommended levels. To date, interventions to optimize pregnancy weight gains have had mixed success. In this paper, we summarize the evidence from human and animal studies linking over-nutrition and under-nutrition in pregnancy to maternal and child obesity. In addition, we discuss published trials and ongoing interventions to achieve appropriate gestational weight gain as a strategy for obesity prevention in women and their children.
Safety of 8-h time restricted feeding in adults with obesity. [2019]This study examines the safety of time restricted feeding (TRF; 8-h feeding window/16-h fasting window daily) in obese adults. Twenty-three subjects participated in an 8-h TRF intervention for 12 weeks. Self-reported adverse events, body image perception, complete blood count, and disordered eating patterns did not change from baseline to week 12. These findings suggest that consuming food within an 8-h window can safely facilitate weight loss in subjects with obesity.
Acceptability of Time-Limited Eating in Pediatric Weight Management. [2023]Adherence to dietary interventions is a significant barrier in the treatment of childhood obesity. Time-limited eating (TLE) is a simple dietary approach that limits food intake to a given number of consecutive hours per day, but parental and youth acceptability of TLE in youth with obesity is unknown. This study explored the feasibility of utilizing TLE among parents and youth attending pediatric weight management (PWM).
Effect of time restricted feeding on the gut microbiome in adults with obesity: A pilot study. [2022]Time restricted feeding is a form of intermittent fasting where participants shorten the daily window in which they eat.
A Smartphone Intervention to Promote Time Restricted Eating Reduces Body Weight and Blood Pressure in Adults with Overweight and Obesity: A Pilot Study. [2021]The goal of this study was to test the feasibility of time restricted eating (TRE) in adults with overweight and obesity. Participants (n = 50) logged all eating occasions (>0 kcal) for a 2-week run-in period using a smartphone application. Participants with eating duration ≥14 h enrolled in an open label, non-randomized, prospective 90-day TRE intervention, with a self-selected reduced eating window of 10 h. No dietary counseling was provided. Changes in anthropometrics, eating patterns and adherence after TRE were analyzed using t-tests or Wilcoxon Rank-Sum Test. The mean duration of the baseline eating window was 14 h 32 m ± 2 h 36 m (n = 50) with 56% of participants with duration ≥14 h. TRE participants (n = 16) successfully decreased their eating window from 16 h 04 m ± 1 h 24 m to 11 h 54 m ± 2 h 06 m (p < 0.001), and reduced the number of daily eating occasions by half (p < 0.001). Adherence to logging and to the reduced eating window was 64% ± 22% and 47% ± 19%, respectively. TRE resulted in decreases in body weight (-2.1 ± 3.0 kg, p = 0.017), waist circumference (-2.2 ± 4.6 cm, p = 0.002) and systolic blood pressure (-12 ± 11 mmHg, p = 0.002). This study demonstrates the feasibility and efficacy of TRE administered via a smartphone, in adults with overweight and obesity.
Complex physiology and clinical implications of time-restricted eating. [2023]Time-restricted eating (TRE) is a dietary intervention that limits food consumption to a specific time window each day. The effect of TRE on body weight and physiological functions has been extensively studied in rodent models, which have shown considerable therapeutic effects of TRE and important interactions among time of eating, circadian biology, and metabolic homeostasis. In contrast, it is difficult to make firm conclusions regarding the effect of TRE in people because of the heterogeneity in results, TRE regimens, and study populations. In this review, we 1) provide a background of the history of meal consumption in people and the normal physiology of eating and fasting; 2) discuss the interaction between circadian molecular metabolism and TRE; 3) integrate the results of preclinical and clinical studies that evaluated the effects of TRE on body weight and physiological functions; 4) summarize other time-related dietary interventions that have been studied in people; and 4) identify current gaps in knowledge and provide a framework for future research directions.
The effect of a lifestyle intervention on pregnancy and postpartum dietary patterns determined by factor analysis. [2018]Optimizing maternal diet during pregnancy improves maternal and infant health. This study assessed the effect of an antenatal lifestyle intervention for women with overweight or obesity on dietary patterns during pregnancy and post partum.
[Bariatric surgery and pregnancy: literature review]. [2018]Obesity has currently reached epidemic proportions, both in Chile and in the world. This condition is associated to a variety of maternal complications in all stages of the vital cycle and during pregnancy. Medical treatment has not proved successful thus resulting in an increase in bariatric surgery in recent years, even when it is not first line treatment. This literature review aims to report updated results of surgical treatment for obesity before and during pregnancy with respect to fertility, gestational diabetes, pre-eclampsia and pregnancy-induced hypertension. It also looks into the possible effects of surgery on fetal development, and its relation to premature delivery, fetal macrosomy, low birth weight and neural tube defects, as well as effects on maternal and fetal outcomes, mainly in nutrition. Lastly, we suggest some recommendations that arise from this review on the role of contraception, nutrition and time between surgery and pregnancy.
Perinatal outcomes in nutritionally monitored obese pregnant women: a randomized clinical trial. [2019]Although obesity in pregnancy continues to be associated with ongoing health problems, many clinicians have been reluctant to place nondiabetic, obese, pregnant women on a monitored, calorie-appropriate nutritional regimen for fear of fetal growth restriction, low birth weight, or starvation ketosis.
Obesity in Pregnancy: Optimizing Outcomes for Mom and Baby. [2023]Obesity is common in women of childbearing age, and management of this population around the time of pregnancy involves specific challenges. Weight and medical comorbidities should be optimized both before and during pregnancy. During pregnancy, gestational weight gain should be limited, comorbidities should be appropriately screened for and managed, and fetal health should be monitored. Consideration should be given to the optimal timing of delivery and to reducing surgical and anesthetic complications. In the postpartum period, breastfeeding and weight loss should be promoted. Maternal obesity is associated with adverse metabolic effects in offspring, promoting an intergenerational cycle of obesity.