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

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.

What data supports the effectiveness of the treatment Time-Restricted Eating for Childhood Obesity?

Intermittent fasting, a form of time-restricted eating, has shown health benefits in various patient groups and healthy individuals due to metabolic and hormonal changes. This suggests potential benefits for children with obesity, although direct evidence in this specific group is not provided. ^{1 2 3 4 5}

Is time-restricted eating safe for children with obesity?

Time-restricted eating (TRE) appears to be generally safe for humans, with studies showing it can lead to mild weight loss and improvements in blood pressure and insulin resistance. However, specific safety data for children is limited, and more research is needed to fully understand its effects on growth and eating behaviors in this age group. ^{6 7 8 9 10}

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

Time-restricted eating (TRE) is unique because it focuses on limiting the hours during which food is consumed each day, rather than restricting specific foods or counting calories. This approach can be more flexible and less stigmatizing for children, as it avoids prolonged calorie restriction that might interfere with growth and development. ^{6 7 10 11 12}

What is the purpose of this trial?

Determine the effectiveness of how limiting the time you eat within an early or late eating window and fasting for remainder of the day will impact weight loss and body mass index (BMI).

Research Team

Alaina P Vidmar, MD

Principal Investigator

Children's Hospital Los Angeles

Eligibility Criteria

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

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.

I have had weight loss surgery in the past.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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]

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) 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]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Continuous Versus Intermittent Nutrition in Pediatric Intensive Care Patients: Protocol for a Randomized Controlled Trial. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Early total enteral feeding in stable preterm infants: a systematic review and meta-analysis. [2022]

3. Bangladesh pubmed.ncbi.nlm.nih.gov

Early Versus Delayed Enteral Feeding for Achieving Full Feeding in Preterm Growth-Restricted Infants: A Randomized Clinical Trial. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Two-hourly versus 3-hourly feeding for very low birthweight infants: a randomised controlled trial. [2017]

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

Timing of enteral nutrition and parenteral nutrition in the PICU. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

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

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

Time-Limited Eating in Pediatric Patients with Obesity: A Case Series. [2022]

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

Randomized controlled trial for time-restricted eating in overweight and obese young adults. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Current research: effect of time restricted eating on weight and cardiometabolic health. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Time-Restricted Feeding during Puberty Ameliorates Adiposity and Prevents Hepatic Steatosis in a Mouse Model of Childhood Obesity. [2021]

11. England pubmed.ncbi.nlm.nih.gov

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

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

Time-Restricted Eating to Improve Cardiovascular Health. [2021]