Eating Behavior Strategies for Childhood Obesity

Overseen By Hannah Kolpack, BS

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: State University of New York at Buffalo

Must not be taking: Appetite suppressants

Disqualifiers: Age, BMI, Food allergies, ED, others

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

Compensation: Varies

Number of Visits: 6

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different eating behaviors and food access affect childhood obesity. Researchers will examine how controlling or not controlling access to favorite foods influences children's weight and eating habits. Families will participate in two periods: one with limited access to certain foods (Restricted Access Period) and another with free access (Non-Restricted Access Period). Children aged 8-11 who are at risk for obesity or already have obesity and consume certain foods at least twice a week may be suitable for this study. As an unphased study, this trial offers families the chance to contribute to valuable research that could shape future strategies for managing childhood obesity.

Will I have to stop taking my current medications?

If your child is taking medications that affect appetite, such as Ritalin, Adderall, Concerta, Wellbutrin, or Prednisone, they will not be able to participate in the study.

What prior data suggests that these eating behavior strategies are safe for children?

Research shows that time-restricted feeding is generally safe for adults with obesity, with studies finding no major negative effects. Although this trial uses a slightly different method, involving periods when certain foods are restricted, similar approaches are often well-tolerated by children and teenagers.

While this specific trial lacks direct data, related studies in children have examined time-restricted eating and found no major safety issues. Participants in those studies typically experienced safe outcomes, including some weight loss and improvements in health measures like body fat and blood sugar levels.

Overall, related research generally considers the strategies used in this trial safe for children. Careful monitoring during the trial ensures safety and effectiveness. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Eating Behavior Strategies for Childhood Obesity trial because it explores a unique behavioral approach to managing childhood obesity. Unlike traditional treatments such as dietary changes, exercise programs, or medication, this trial focuses on altering food access through periods of restriction and structured intake. This method could offer a more natural and sustainable way to help children develop healthier eating habits by changing their food environment and preferences. By involving parents directly in managing food access, this trial aims to empower families to take proactive steps in addressing obesity, potentially leading to long-lasting behavioral changes.

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

Research has shown that time-restricted eating, which involves eating only during certain hours of the day, can aid in weight management. Studies have found that teenagers following this eating pattern lost weight and improved their blood sugar levels. One study reported a noticeable drop in body mass index (BMI) in young people after 12 weeks of intermittent fasting, which is similar to time-restricted eating. However, some research suggests that time-restricted eating might not be more effective for weight loss than eating throughout the day. Its success can depend on personal habits and adherence. In this trial, participants will undergo a Behavioral restriction arm, where their parents will restrict preferred foods for 2 weeks, to evaluate the impact on eating behaviors and weight management. ^{1 6 7 8 9}

Who Is on the Research Team?

Katherine Balantekin, PhD, RD

Principal Investigator

Clinical Associate Professor

Are You a Good Fit for This Trial?

This trial is for children aged 8-11 who are at risk for obesity or already obese, partly based on their own BMI or their parent's weight. They must enjoy at least half of the study foods and eat them twice a week. Kids with clinical eating disorders, allergies to study foods, not liking most study foods, or taking appetite-affecting meds can't join.

Inclusion Criteria

You need to like at least half of the study foods.

I am between 8 and 11 years old.

I am at risk for obesity or have obesity, based on my BMI or my parent's BMI.

Exclusion Criteria

I am taking medication that can change my appetite.

I have been diagnosed with an eating disorder.

I do not like most of the foods used in the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete consent, height/weight/body fat measurements, questionnaires, and tasks including delayed discounting and relative reinforcing value tasks.

4 visits

4 visits (in-person)

Randomized Cross-over Design

Participants undergo two weeks of restricted access and two weeks of non-restricted access, with a one-week washout period in between, including loss of control test meals.

5 weeks

Follow-up

Participants are monitored for changes in zBMI and body fat percentage, with follow-up visits at 6 and 12 months for measurements and tasks.

12 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Non-Restricted Access Period
• Restricted Access Period

Trial Overview The study examines how lack of control over eating and food restrictions affect kids' risk of becoming obese by monitoring them over a year. It includes periods where access to high-calorie foods is limited and times when it's not to see how this influences eating behavior.

How Is the Trial Designed?

Group I: Behavioral restriction Experimental Treatment 1 Intervention

In the restriction period participants will have their preferred (chosen after doing a preference task, including liking) food and similar alternatives restricted by their parent for 2 weeks. In the structured intake period period, participants and their parents will be given several portions of the preferred food (chosen after doing a preference task, including liking) and will consume it throughout the two-week period.

Who Is Running the Clinical Trial?

State University of New York at Buffalo

Lead Sponsor

Trials

279

Recruited

52,600+

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

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

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 of 71 children aged 3 to 5, maternal restriction of snack food access was found to predict higher snack food intake among girls, suggesting that restricting access may lead to increased desire for those foods.

Maternal restriction was influenced by children's adiposity and parents' own eating behaviors, indicating that parental eating habits and children's weight may play a role in how access to snacks is managed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Restricting access to foods and children's eating. Fisher, JO., Birch, LL.[2004]

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]

Time-restricted feeding (TRF) significantly reduced body weight and body mass index (BMI) in female college students with hidden obesity over an 8-week period, but it also led to increased blood lipid levels and decreased lean tissue mass.

Combining TRF with exercise did not provide additional benefits compared to TRF or exercise alone, indicating that TRF may not be the most effective strategy for fat reduction in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of time-restricted feeding and walking exercise on the physical health of female college students with hidden obesity: a randomized trial. Liu, H., Chen, S., Ji, H., et al.[2023]

Time-restricted eating (TRE) is a feasible and safe intervention for individuals with overweight, obesity, prediabetes, or type 2 diabetes, with high retention rates of 95% for studies under 12 weeks and 89% for those 12 weeks or longer.

Participants generally adhered to TRE well, with median adherence rates of 89% for shorter studies and 81% for longer ones, although individual experiences varied, highlighting the need for support and flexibility in the approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of time-restricted eating in individuals with overweight, obesity, prediabetes, or type 2 diabetes: A systematic scoping review. Termannsen, AD., Varming, A., van Elst, C., 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]

In a study of 80 individuals over 24 weeks, those on an energy-restricted diet lost more than twice the weight compared to those on a fat-restricted diet (11.5 kg vs. 5.2 kg).

Participants on the energy-restricted diet also reported better improvements in eating behaviors and feelings of wellness, suggesting that energy restriction may be a more effective and sustainable approach to weight loss than simply reducing dietary fat.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of dietary fat vs. total energy restriction for weight loss. Harvey-Berino, J.[2019]

Young adult females who experienced overt restrictive feeding practices (ORFP) during childhood reported that these practices led to internalized messages about weight and self-worth, suggesting a negative impact on their self-esteem.

The study indicates that parental ORFP may inadvertently reinforce weight stigma in children, providing evidence against the effectiveness of such practices for managing childhood weight.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overt restrictive feeding for weight management: a preliminary retrospective examination of childhood experiences. Brun, I., Russell-Mayhew, S., Klingle, K., et al.[2021]

The study aims to create a childhood obesity prevention program that focuses on helping children regulate their eating habits and develop healthy taste preferences, involving 320 participants from Head Start programs in Texas and Washington.

The program will be evaluated through a randomized controlled trial over 12 months, measuring various outcomes such as children's taste preferences and dietary intake, using advanced statistical methods to analyze the data effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strategies for Effective Eating Development-SEEDS: Design of an Obesity Prevention Program to Promote Healthy Food Preferences and Eating Self-Regulation in Children From Low-Income Families. Hughes, SO., Power, TG., Beck, A., 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]

Citations

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

Time-Limited Eating in Pediatric Patients with Obesity Effects of 8-hour time restricted feeding on body weight and metabolic disease risk factors in obese adults: A pilot study. Nutr Healthy Aging 4 (2018): 345 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9644044/

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.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714420301609

Time limited eating in adolescents with obesity (time LEAd) Time limited eating (TLE) has been shown to be effective for weight loss and improvement of glycemic control in adults with obesity and type 2 diabetes ...

4. nature.com nature.com/articles/s44324-024-00041-2

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 ...

5. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/2771095

Effects of Time-Restricted Eating on Weight Loss and Other ... Time-restricted eating, in the absence of other interventions, is not more effective in weight loss than eating throughout the day.

6. 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 ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8359671/

Time limited eating in adolescents with obesity (time LEAd) Outcomes will include change in total body fat (TBF) percentage measured on DEXA scan, BMI status and fasting blood glucose at 12 weeks compared to baseline.

8. researchgate.net researchgate.net/publication/364742358_A_time-restricted_feeding_intervention_in_children_and_adolescents_with_obesity_The_TRansForm_study_protocol

(PDF) 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.

9. withpower.com withpower.com/trial/phase-obesity-10-2021-b6beb

Eating Behavior Strategies for Childhood Obesity Research suggests that time-restricted feeding, where food is consumed within a specific time window, is generally safe for adults with obesity, as no adverse ...