Time-Restricted Eating for Childhood Obesity

Overseen By Harvey Peralta

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital Los Angeles

Disqualifiers: Prader-Willi, Brain tumor, Diabetes, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how changing eating times can aid weight loss in young people with obesity. Participants will follow one of two eating schedules: Early Time Restricted Eating (eTRE), which involves eating early in the day, or Late Time Restricted Eating (LTRE), which involves eating later in the day and fasting the rest of the time. Researchers aim to determine which schedule is more effective for weight loss and reducing body mass index (BMI). The trial seeks young individuals, ages 12 to 21, who have a BMI above the 95th percentile and typically eat over a period longer than 12 hours daily. As an unphased trial, this study offers a unique opportunity to contribute to understanding effective weight loss strategies for young people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

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

Research shows that time-restricted eating (TRE) is generally safe and easy to follow. Studies have found that both early and late TRE can aid weight loss and improve health without major side effects.

For early TRE, one study found it helps young adults lose weight and improve blood sugar levels. Another study showed it supports weight loss over 2 to 12 months.

Late TRE has also been researched. One study found it can improve insulin use by 12% to 29%. Importantly, research shows that TRE, whether early or late, does not negatively affect sleep, mood, or quality of life.

Overall, these studies suggest that time-restricted eating is a safe way to manage weight and health for people with obesity, including teenagers. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Time-Restricted Eating (TRE) protocols for childhood obesity because they offer a novel approach to weight management by focusing on when kids eat rather than just what they eat. Unlike traditional methods that often emphasize calorie counting or specific food restrictions, TRE employs different eating windows to potentially align with natural body rhythms. Early Time Restricted Eating (7:00 to 15:00) and Late Time Restricted Eating (12:00 to 20:00) are being explored to see how meal timing can influence metabolism and weight loss. This innovative perspective could provide a more sustainable and less restrictive way for children to manage their weight and improve their overall health.

What evidence suggests that this trial's time-restricted eating treatments could be effective for childhood obesity?

Research shows that time-restricted eating (TRE) can help people with obesity lose weight. Studies have found that TRE can lead to a 3%–5% reduction in body weight over 2 to 12 months. This trial will compare two methods of TRE: Early Time-Restricted Eating (eTRE) and Late Time-Restricted Eating (LTRE). Eating earlier in the day, known as early time-restricted eating, reduces body fat and improves overall health. Eating later in the day, or late time-restricted eating, also effectively lowers body mass index (BMI) in some studies. Both TRE methods can lead to weight loss and better health, making them promising options for addressing obesity. ^{1 2 3 4 6}

Who Is on the Research Team?

Alaina P Vidmar, MD

Principal Investigator

Children's Hospital Los Angeles

Are You a Good Fit for This Trial?

This trial is for adolescents aged 12-21 with obesity, defined as having a BMI above the 95th percentile. They must be able to follow the study's schedule and eating/fasting times, which requires not currently being in other weight loss studies, no history of bariatric surgery or certain medical conditions like Prader-Willi Syndrome, brain tumors, diabetes, serious intellectual disability or eating disorders.

Inclusion Criteria

Participant must be willing and able to adhere to the assessments, visit schedules, and eating/fasting periods

Baseline eating window greater than 12 hours.

I am between 12 and 21 years old and have obesity.

Exclusion Criteria

Current participation in other interventional weight loss studies.

I have had or almost had an eating disorder like anorexia, bulimia, or binge-eating.

My guardian believes I can't participate in the study assessments due to physical or mental reasons.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are assigned to either early or late time-restricted eating for 24 weeks to assess effects on glycemic profiles, weight loss, and body composition

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Early Time Restricted Eating
• Late Time Restricted Eating

Trial Overview The study tests two different time-restricted eating strategies for managing obesity in adolescents at risk for diabetes. One group will eat during an early window and fast afterwards; another will have a later eating window. The focus is on when they eat rather than what or how much.

How Is the Trial Designed?

Group I: Late Time Restricted Eating Experimental Treatment 1 Intervention

late TRE (12:00 to 20:00 h)

Group II: Early Time Restricted Eating Experimental Treatment 1 Intervention

early-day TRE (7:00 to 15:00 h)

Who Is Running the Clinical Trial?

Children's Hospital Los Angeles

Lead Sponsor

Trials

257

Recruited

5,075,000+

Published Research Related to This Trial

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]

A Time Limited Eating (TLE) approach, involving a 16-hour fast followed by an 8-hour eating window for 3-5 days a week, led to an average decrease in BMI z-score of -0.24 SD in four children aged 5-15 over a 4-month period.

Families reported high satisfaction with the TLE method, finding it feasible and flexible, suggesting it could be a promising strategy for managing obesity in children, though further research is needed to assess its long-term effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time-Limited Eating in Pediatric Patients with Obesity: A Case Series. Vidmar, AP., Goran, MI., Raymond, JK.[2022]

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 involving overweight and obese young adults, both early time-restricted eating (eTRE) and late time-restricted eating (lTRE) resulted in similar weight loss after 8 weeks compared to a control group.

eTRE was more effective than lTRE in improving several metabolic health markers, including reducing systolic blood pressure, glucose levels, fasting insulin, insulin resistance, and thyroid axis activity, while lTRE only reduced leptin levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled trial for time-restricted eating in overweight and obese young adults. Zhang, LM., Liu, Z., Wang, JQ., et al.[2022]

In a randomized clinical trial involving 50 growth-restricted preterm infants, those who received early enteral feeding reached full feeding significantly faster and regained birth weight more quickly compared to those who were fed later.

Early feeding was associated with a lower incidence of neonatal sepsis, reduced feeding intolerance, shorter hospital stays, and better weight gain by day 16, indicating that it is a safe and beneficial practice for these vulnerable infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Versus Delayed Enteral Feeding for Achieving Full Feeding in Preterm Growth-Restricted Infants: A Randomized Clinical Trial. Ahmed, F., Dey, SK., Shahidullah, M., et al.[2020]

In a study of 150 very low birthweight preterm infants, feeding every 2 hours did not significantly reduce the time to achieve full enteral feeding compared to feeding every 3 hours, with times of 10.2 days and 11.3 days respectively.

However, infants fed every 3 hours regained their birth weight faster than those fed every 2 hours, taking an average of 12.9 days compared to 14.8 days, indicating that 3-hourly feeding may be more beneficial for weight recovery without increasing adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two-hourly versus 3-hourly feeding for very low birthweight infants: a randomised controlled trial. Ibrahim, NR., Kheng, TH., Nasir, A., et al.[2017]

Initiating early enteral nutrition within 24-48 hours in critically ill infants and children is associated with improved survival rates, especially when energy and protein goals are met within the first week of intensive care.

Current guidelines recommend avoiding early parenteral nutrition due to potential increased morbidity and mortality, but the evidence supporting these guidelines is limited and calls for further research to optimize nutrition support practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Timing of enteral nutrition and parenteral nutrition in the PICU. Fell, DM., Bitetto, EA., Skillman, HE.[2023]

The study aims to evaluate the safety and feasibility of intermittent fasting in critically ill children in the PICU by comparing an overnight feeding interruption to continuous 24-hour nutrition, involving 140 participants over a 14-day period.

The primary outcome will assess differences in ketosis between the two feeding strategies, while secondary outcomes will include feeding intolerance and severe hypoglycemic events, providing insights into the potential clinical benefits of intermittent nutrition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous Versus Intermittent Nutrition in Pediatric Intensive Care Patients: Protocol for a Randomized Controlled Trial. Veldscholte, K., Cramer, ABG., de Jonge, RCJ., et al.[2022]

Time-restricted feeding (TRF) can effectively improve metabolic health in a mouse model of childhood obesity, particularly by normalizing liver fat content, which is a significant concern in obesity-related health issues.

Among two different TRF approaches tested, one (TRF2) led to reduced caloric intake and body weight, suggesting that the timing of food access can play a crucial role in managing obesity in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time-Restricted Feeding during Puberty Ameliorates Adiposity and Prevents Hepatic Steatosis in a Mouse Model of Childhood Obesity. Ribas-Aulinas, F., Parra-Vargas, M., Ramon-Krauel, M., et al.[2021]

Time-restricted eating (TRE) can lead to a weight loss of 1-4% over 1-16 weeks in individuals with obesity, primarily due to unintentional reductions in daily calorie intake of about 350-500 kcal.

TRE is effective in improving cardiovascular health by lowering fat mass, blood pressure, triglyceride levels, and markers of oxidative stress, and it is considered safe with few adverse events reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time-Restricted Eating to Improve Cardiovascular Health. Gabel, K., Cienfuegos, S., Kalam, F., et al.[2021]

Early total enteral feeding (ETEF) in stable very low birth weight (VLBW) infants is safe and feasible, showing no significant increase in the risk of necrotizing enterocolitis (NEC) or feeding intolerance compared to slower feeding advancements.

ETEF is associated with a lower risk of late-onset sepsis and a reduced length of hospital stay by about 1.31 days, suggesting potential benefits for the health and recovery of these infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early total enteral feeding in stable preterm infants: a systematic review and meta-analysis. Alshaikh, B., Dharel, D., Yusuf, K., et al.[2022]

Time-restricted eating (TRE) can lead to a spontaneous reduction in energy intake by 20-30%, resulting in a small but significant weight loss of 1-4% in human subjects.

TRE may also improve cardiometabolic health by significantly lowering both systolic and diastolic blood pressure, as well as enhancing fasting insulin levels and reducing insulin resistance, independent of weight loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current research: effect of time restricted eating on weight and cardiometabolic health. Gabel, K., Varady, KA.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11685102/

Intermittent fasting as a treatment for obesity in young people Hegedus et al. reported a significant decrease in body mass index at the 95th percentile at week 12, with a 46% reduction observed in the late ...

2. jamanetwork.com jamanetwork.com/journals/jamapediatrics/fullarticle/2822791

Intermittent Energy Restriction for Adolescents With Obesity In this randomized clinical trial of 141 adolescents with obesity, no differences were found in improvements in body composition or cardiometabolic health.

3. sciencedirect.com sciencedirect.com/science/article/pii/S1550413123004540

Time-restricted eating: Watching the clock to treat obesity In participants with obesity, time-restricted eating results in 3%–5% weight loss over 2–12 months, versus controls. Reductions in body weight ...

4. frontiersin.org frontiersin.org/journals/nutrition/articles/10.3389/fnut.2022.1026694/full

A time-restricted feeding intervention in children and ... This study aims to determine both short- and long-term effects of a TRF intervention in children and adolescents with obesity.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7243444/

Time-Limited Eating in Pediatric Patients with Obesity Time limited eating (TLE) is a dietary intervention that has been reported to result in weight loss, decreased body fat and improvement in β-cell function [9, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12479299/

Effects of time-restricted eating on body composition and ... Our findings indicate that TRE significantly improves insulin levels in overweight and obese women, whereas no significant alterations were ...