Food Rating for Childhood Obesity

(BRAKE Trial)

Overseen By Alaina L Pearce, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Penn State University

Must not be taking: Cold medications, Allergy medications

Disqualifiers: Diabetes, ADHD, Autism, others

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

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how different ways of learning about food cues might impact childhood obesity. It examines how children rate foods based on health, desire, and taste to determine how these ratings relate to their eating habits and body fat. The goal is to identify factors that help some children avoid obesity despite living in environments that might encourage it. Children aged 8-10, who are healthy and do not have learning disabilities or food allergies, may be suitable for this study. As an unphased study, this trial offers a unique opportunity to contribute to important research that could help prevent childhood obesity.

Do I need to stop my current medications to join the trial?

Yes, you must stop taking any medications that influence body weight, taste, food intake, behavior, or blood flow. This includes cold or allergy medications and others affecting cognitive function, taste, appetite, or blood flow.

What prior data suggests that this method is safe for children?

A previous study examined how access to healthy food affects childhood obesity. Researchers found that children in areas with limited access to healthy foods tend to have higher body mass index (BMI), suggesting that a child's living environment can influence their weight.

In the Food Rating study, children engage in activities like rating foods based on healthiness, desirability, and taste. These non-invasive activities involve no physical procedures or medications, ensuring no major safety concerns for participants. The methods, including computer tasks and brain imaging, are generally easy for children to handle and aim to understand behavior rather than test new drugs or treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the "Food Rating" trial for childhood obesity because it explores how children’s perceptions of food can influence healthier eating habits. Unlike traditional treatments that might focus on diet plans or exercise regimens, this approach taps into the psychology of food choices by having kids rate foods based on health, taste, and desire to eat. This innovative method aims to empower children to make better eating decisions by understanding their own preferences and perceptions, potentially leading to sustainable lifestyle changes. By focusing on the decision-making process, this trial could provide fresh insights into battling childhood obesity.

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

In this trial, children will rate foods based on health, taste, and their desire to eat. Previous studies have shown that differences in children's responses to food link to obesity. Research indicates that "goal-trackers" might better avoid obesity by focusing on true hunger rather than food's appearance or smell. They also control impulsive eating more effectively. In contrast, "sign-trackers" are more drawn to food's appearance and smell, which can lead to overeating. Understanding these behaviors can help develop effective obesity prevention strategies. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for healthy 8-9-year-old children who speak English, without neurodevelopmental disorders like ADHD or learning disabilities such as dyslexia. They should not have food allergies relevant to the study, nor be on medications affecting weight, taste, intake, behavior, or blood flow. A knowledgeable parent must accompany them.

Inclusion Criteria

Child must have no allergies to the foods or ingredients used in the study

Child must be of good health based on parental self-report

My child is not on any medication that affects weight, taste, eating habits, behavior, or blood flow.

Exclusion Criteria

My child is not between 8 and 9 years old.

My child is currently on medication that could affect their thinking, taste, appetite, or blood flow.

Child is allergic to foods or ingredients 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

Initial assessments including reinforcement learning tasks, body composition, and neural food cue reactivity

1-2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for changes in adiposity and other measures over 1 year

1 year

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Food Rating

Trial Overview The study investigates how different reinforcement learning styles (goal-tracking and sign-tracking) relate to obesity in children from rural areas. It involves computer tasks assessing these learning styles and measures body fat using dual x-ray absorptiometry along with brain responses to food cues.

How Is the Trial Designed?

Group I: Wanting Experimental Treatment 1 Intervention

Children will rate foods on desire to eat

Group II: Taste Experimental Treatment 1 Intervention

Children will rate foods on taste

Group III: Health Experimental Treatment 1 Intervention

Children will rate foods on health

Who Is Running the Clinical Trial?

Penn State University

Lead Sponsor

Trials

380

Recruited

131,000+

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials

394

Recruited

404,000+

Published Research Related to This Trial

In a study of 240 mother-child pairs, children whose mothers received SNAP benefits were found to be over twice as likely to be overweight, indicating a potential link between food security and childhood obesity.

Consumption of desserts was also a significant factor, with children who ate desserts being nearly three times more likely to be overweight, highlighting the impact of dietary choices on child weight status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Food security, maternal feeding practices and child weight-for-length. Barroso, CS., Roncancio, A., Moramarco, MW., et al.[2018]

Food labeling has a positive impact on the consumption of food products, suggesting that clear labeling can help prevent obesity and overweight.

Sensory attributes of food (like taste and smell) were found to be more influential on consumer choices than health recommendations provided on labels, indicating that appealing food qualities may drive consumption more than nutritional information.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Food labeling and the prevention of overweight and obesity: a systematic review]. Sebastián-Ponce, MI., Sanz-Valero, J., Wanden-Berghe, C.[2019]

The Healthy Meal Index (HMI) was developed and validated as a tool to score the healthfulness of meals served to children, based on the presence of healthy 'Adequacy foods' and the absence of less healthy 'Moderation foods'.

In a study involving 233 children aged 4-8 years, it was found that parents with higher education levels served meals with better health scores, indicating that sociodemographic factors can influence meal quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Healthy Meal Index: A tool for measuring the healthfulness of meals served to children. Kasper, N., Mandell, C., Ball, S., et al.[2019]

The Kids Choice Program effectively increased fruit and vegetable consumption among both overweight and average-weight children during the month-long initiative.

The program not only boosted consumption but also maintained children's preference for these healthy foods, suggesting it can positively influence nutrition and weight management behaviors in a school setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overweight and average-weight children equally responsive to "Kids Choice Program" to increase fruit and vegetable consumption. Hendy, HM., Williams, KE., Camise, TS., et al.[2019]

The Best Food for Families, Infants, and Toddlers (Best Food FITS) initiative successfully partnered with 17 local restaurants in San Marcos, Texas, to improve children's access to healthier menu options by removing sugary drinks and increasing fruits and vegetables.

This community-based intervention demonstrates that modifying restaurant menus can effectively influence children's eating habits and can be replicated in other communities with minimal funding for promotional support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving children's menus in community restaurants: best food for families, infants, and toddlers (Best Food FITS) intervention, South Central Texas, 2010-2014. Crixell, SH., Friedman, B., Fisher, DT., et al.[2022]

A study involving 304 children aged 7-9 years showed that a targeted dietary intervention significantly increased the consumption of certain fruits, such as grapes and peaches, indicating that specific fruits can be effectively changed in children's diets.

The intervention did not yield significant changes in vegetable consumption, suggesting that the methods used may be more effective for fruits than vegetables, highlighting the need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating changeability to improve fruit and vegetable intake among school aged children. Nanney, MS., Haire-Joshu, D., Elliott, M., et al.[2018]

A study of 548 new food products targeted at children revealed that 74% had a high dietary energy density (ED), which is linked to childhood obesity and poor diet quality.

The Australian Health Star Rating (HSR) system did not effectively differentiate between high and low ED foods, as both high and low HSR products still had high median ED values, indicating a need for better alignment between HSR and ED to promote healthier food choices for children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Energy Density of New Food Products Targeted to Children. Azzopardi, DJ., Lacy, KE., Woods, JL.[2023]

The review of 60 studies involving children under 10 years old found that higher consumption of sugar-sweetened beverages and unhealthy foods is associated with increased body mass index (BMI) and higher odds of overweight or obesity, although the evidence quality is low.

Consumption of artificially sweetened beverages and 100% fruit juice showed little to no impact on BMI or obesity outcomes, indicating that not all sugary drinks have the same effect on children's weight.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unhealthy Food and Beverage Consumption in Children and Risk of Overweight and Obesity: A Systematic Review and Meta-Analysis. Rousham, EK., Goudet, S., Markey, O., et al.[2023]

Obesity in children has become a major public health issue, with one in four children in the U.S. being overweight and a significant risk of remaining overweight into adulthood, highlighting the need for effective prevention strategies.

Changes in children's eating patterns, such as increased restaurant meals and larger portion sizes, contribute to rising obesity rates, suggesting that promoting healthier lifestyles is crucial for preventing obesity and its associated health risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Eating patterns, dietary quality and obesity. Nicklas, TA., Baranowski, T., Cullen, KW., et al.[2022]

Higher consumption of sugar-sweetened beverages and fast food significantly increases the odds of overweight and obesity in children and adolescents, with odds ratios of 1.20 and 1.17 respectively, based on a meta-analysis of 60 studies.

Interestingly, higher intake of whole grains was associated with a decreased risk of overweight/obesity (OR 0.86), suggesting that not all food categories contribute negatively to weight status, and highlighting the importance of dietary choices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association between Food, Beverages and Overweight/Obesity in Children and Adolescents-A Systematic Review and Meta-Analysis of Observational Studies. Jakobsen, DD., Brader, L., Bruun, JM.[2023]

A study using data from the Avon Longitudinal Study of Parents and Children found that certain foods, like butter, fried potatoes, and sugar-sweetened beverages, are strongly linked to excess weight gain in children aged 7-13 over three years.

Conversely, the consumption of whole grains and high-fiber cereals was associated with weight loss, suggesting that promoting these healthier options could help combat childhood obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Consumption Of Specific Foods And Beverages And Excess Weight Gain Among Children And Adolescents. Dong, D., Bilger, M., van Dam, RM., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9857183/

The Effects of Food Environment on Obesity in Children This review aims to highlight the relationship between residing in a food desert or a similar environment on body mass index (BMI) in school-aged children.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8107859/

Effectiveness of dietary interventions on weight outcomes ... Dietary interventions showed greater reduction in BMI and BMI z-score in children, but results are limited by study heterogeneity and quality.

3. sciencedirect.com sciencedirect.com/science/article/pii/S2211335525000920

The effectiveness of school-based obesity prevention ... The aim of this study is to synthesise the effects of child obesity prevention programs on diet, physical activity, tobacco smoking and alcohol intake.

4. odphp.health.gov odphp.health.gov/sites/default/files/2019-09/Appendix-E-2.31.pdf

Dietary Patterns and Obesity The studies included in the reviews examined a variety of school-based approaches assessing the effectiveness of childhood obesity prevention interventions.

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/obr.13736

Childhood obesity prevention trials: A systematic review ... A systematic review and meta-analysis were conducted to report on the design of child obesity prevention randomized controlled trials and effectiveness ...

6. cdc.gov cdc.gov/obesity/childhood-obesity-facts/childhood-obesity-facts.html

Childhood Obesity Facts The prevalence of obesity among US children and adolescents was 19.7%1. This means that approximately 14.7 million US youths aged 2–19 years have obesity.

7. nutrition.bmj.com nutrition.bmj.com/content/early/2024/04/21/bmjnph-2023-000663

Food environment and obesity: a systematic review ... Food outlets which sell mostly unhealthy and ultra-processed foods were associated with higher levels of obesity.

8. nih.gov nih.gov/news-events/nih-research-matters/childhood-obesity-linked-limited-food-options

Childhood obesity linked to limited food options BMI z scores were elevated at ages 5, 10, and 15 among those with limited food access early in life. The association was strongest among those ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S2161831323000339

Unhealthy Food and Beverage Consumption in Children ... Evidence indicated that consumption of sugar-sweetened beverages (SSBs) and unhealthy foods in childhood may increase BMI/BMI z-score, percentage body fat, or ...