Food Rating for Childhood Obesity
(BRAKE Trial)
Trial Summary
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 data supports the idea that Food Rating for Childhood Obesity is an effective treatment?
The available research shows that food labeling, which is part of the Food Rating approach, has a positive effect on food consumption choices, helping to prevent obesity. This suggests that Food Rating can be effective in guiding healthier eating habits. Additionally, the Healthy Meal Index, a tool for assessing meal healthfulness, indicates that meals scored higher in healthfulness when parents had more education, which could be linked to better food choices and reduced obesity risk. While the Kids Choice Program is another treatment that increases fruit and vegetable consumption among children, Food Rating's focus on labeling and meal quality offers a different strategy for managing childhood obesity.12345
What safety data exists for the Food Rating treatment for childhood obesity?
The provided research does not contain specific safety data for the Food Rating treatment or any treatment evaluated under different names. The studies focus on food labeling, energy density of food products, and associations between food consumption and obesity, but do not address safety data for a specific treatment like Food Rating.16789
Is the treatment in the trial 'Food Rating for Childhood Obesity' a promising treatment?
What is the purpose of this trial?
Children from rural communities are at greater risk for obesity than children from more urban communities. However, some children are resilient to obesity despite greater exposure to obesogenic influences in rural communities (e.g., fewer community-level physical activity or healthy eating resources). Identifying factors that promote this resiliency could inform obesity prevention. Eating habits are learned through reinforcement (e.g., hedonic, familial environment), the process through which environmental food cues become valued and influence behavior. Therefore, understanding individual differences in reinforcement learning is essential to uncovering the causes of obesity. Preclinical models have identified two reinforcement learning phenotypes that may have translational importance for understanding excess consumption in humans: 1) goal-tracking-environmental cues have predictive value; and 2) sign-tracking-environmental cues have predictive and hedonic value (i.e., incentive salience). Sign-tracking is associated with poorer attentional control, greater impulsivity, and lower prefrontal cortex (PFC) engagement in response to reward cues. This parallels neurocognitive deficits observed in pediatric obesity (i.e., worse impulsivity, lower PFC food cue reactivity). The proposed research aims to determine if reinforcement learning phenotype (i.e., sign- and goal-tracking) is 1) associated with adiposity due to its influence on neural food cue reactivity, 2) associated with reward-driven overconsumption and meal intake due to its influence on eating behaviors; and 3) associated with changes in adiposity over 1 year. The investigators hypothesize that goal-tracking will promote resiliency to obesity due to: 1) reduced attribution of incentive salience and greater PFC engagement to food cues; and 2) reduced reward-driven overconsumption. Finally, the investigators hypothesize reinforcement learning phenotype will be associated due to its influence on eating behaviors associated with overconsumption (e.g., larger bites, faster bite rat and eating sped). To test this hypothesis, the investigators will enroll 76, 8-10-year-old children, half with healthy weight and half with obesity based on Centers for Disease Control definitions. Methods will include computer tasks to assess reinforcement learning, dual x-ray absorptiometry to assess adiposity, and neural food cue reactivity from functional near-infrared spectroscopy (fNIRS).
Eligibility Criteria
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Initial assessments including reinforcement learning tasks, body composition, and neural food cue reactivity
Follow-up
Participants are monitored for changes in adiposity and other measures over 1 year
Treatment Details
Interventions
- Food Rating
Find a Clinic Near You
Who Is Running the Clinical Trial?
Penn State University
Lead Sponsor
National Center for Advancing Translational Sciences (NCATS)
Collaborator