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

110 Participants Needed

Trial Summary

What is the purpose of this trial?

This study aims to determine the relationships among loss of control eating, restriction, relative reinforcing value of high energy-dense food, and obesity risk. In order to achieve this aim, the investigators will follow children over the course of a year, obtaining behavioral and observational measurements, in addition to a two-week restricted access and two week non-restricted access period.

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 data supports the effectiveness of the treatment Eating Behavior Strategies for Childhood Obesity?

Research suggests that time-limited eating (TLE), a component of the treatment, may be effective for managing obesity in children. TLE is seen as feasible and potentially more effective than other methods because it simplifies eating patterns by focusing on eating within a specific time frame, which can help reduce weight without affecting growth. ^{1 2 3 4 5}

Is time-restricted feeding safe for humans, including children, with 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 events were reported in a study. However, there is limited safety data specifically for children, though it is considered potentially more feasible and less stigmatizing than other dietary approaches. ^{1 2 3 6 7}

How does the treatment in the Eating Behavior Strategies for Childhood Obesity trial differ from other treatments for childhood obesity?

This treatment uses Time-Limited Eating (TLE), which is unique because it focuses on eating within a specific time window rather than counting calories or restricting certain foods. This approach is potentially more flexible and less stigmatizing for children, making it easier for them to follow compared to traditional methods that require constant monitoring of food intake. ^{1 2 8 9 10}

Research Team

Katherine Balantekin, PhD, RD

Principal Investigator

Clinical Associate Professor

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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]

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

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

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

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

3. Canada pubmed.ncbi.nlm.nih.gov

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

4. Switzerland 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. [2023]

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

The efficacy of dietary fat vs. total energy restriction for weight loss. [2019]

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

Feasibility of time-restricted eating in individuals with overweight, obesity, prediabetes, or type 2 diabetes: A systematic scoping review. [2023]

7. 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]

8. Germany pubmed.ncbi.nlm.nih.gov

Overt restrictive feeding for weight management: a preliminary retrospective examination of childhood experiences. [2021]

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

Restricting access to foods and children's eating. [2004]

10. United States 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. [2022]