Brain Games for Obesity

Overseen By Madelyn Munoz, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: USDA Grand Forks Human Nutrition Research Center

Disqualifiers: Bariatric surgery, Eating disorder, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 9 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether specific brain games can alter thoughts about food, potentially leading to healthier eating choices. The focus is on enhancing executive function, which involves daily decision-making skills, including what and when to eat. Participants will play online games at least twice a week. Suitable candidates for this trial are U.S. citizens with a body mass index (BMI) between 23 and 38, who are not currently dieting or using tobacco products.

As an unphased trial, participants can contribute to innovative research that may improve daily decision-making and promote healthier lifestyles.

Do I have to stop taking my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators.

What prior data suggests that these brain games are safe for participants?

Research shows that programs designed to improve thinking skills have been studied for their impact on food choices and weight management, especially in children. These programs use exercises or games to aid decision-making. Previous studies have not identified major safety issues with this type of mental training. Since this trial involves a series of online games to boost thinking skills, joining is generally considered safe. Participants in similar studies did not experience significant negative effects, suggesting that the games are well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the "Train Your Brain - Executive Function" approach for obesity because it offers a fresh angle compared to traditional treatments like dietary changes, medications, or surgery. Unlike these standard methods, this approach focuses on enhancing executive function through online brain games, which may help improve decision-making related to food choices. This cognitive training method is non-invasive, easily accessible online, and could empower individuals to make healthier lifestyle choices, potentially leading to sustainable weight management.

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

Research has shown that training the brain to enhance skills like focus and decision-making can help people with obesity make healthier food choices and reduce body weight. In this trial, participants in the "EFfect-food choices" arm will engage in online games designed to enhance these skills. One study found that children with obesity who practiced these skills made better food choices and improved their thinking abilities. Another study suggested that online training can positively change how people feel about food. Overall, evidence indicates that playing games to boost these brain skills might help people think differently about food and support weight loss. ^{3 6 7 8 9}

Who Is on the Research Team?

Shanon Casperson, PhD

Principal Investigator

USDA Grand Forks Human Nutrition Research Center

Are You a Good Fit for This Trial?

This trial is for US citizens who are not pregnant, planning to become pregnant, or lactating. Participants should have a BMI between 23-38 kg/m2 and must not be currently dieting or have had significant weight changes in the past 3 months. They shouldn't use tobacco/e-cigarettes or have any major health issues that would affect their participation.

Inclusion Criteria

No tobacco or e-cigarette use

BMI 23-38 kg/m2

US citizenship

Exclusion Criteria

Not a US citizen

Currently dieting to lose weight

Tobacco or e-cigarette use

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants complete four online games at least biweekly to improve executive function and influence food choices

9 weeks

Biweekly online sessions

Follow-up

Participants are monitored for changes in attitudes and food choices after the training period

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Train Your Brain - Executive Function

Trial Overview

The study tests if playing online games designed to boost decision-making skills can influence food preferences. One group plays games with flower and songbird images, while another plays games featuring various food images.

How Is the Trial Designed?

Group I: EFfect-food choices Experimental Treatment 1 Intervention

Participants will complete four online games at least biweekly during the study.

Group II: Control Active Control 1 Intervention

Participants will complete four online games at least biweekly during the study.

Who Is Running the Clinical Trial?

USDA Grand Forks Human Nutrition Research Center

Lead Sponsor

Trials

60

Recruited

5,300+

Published Research Related to This Trial

A meta-analysis of 72 studies involving 4904 overweight and obese participants found that obesity is associated with significant impairments in various executive functions, including inhibition, cognitive flexibility, working memory, decision-making, verbal fluency, and planning.

Overweight individuals showed specific deficits primarily in inhibition and working memory, suggesting that the severity of obesity may correlate with the extent of executive function impairments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Executive function performance in obesity and overweight individuals: A meta-analysis and review. Yang, Y., Shields, GS., Guo, C., et al.[2022]

Children with obesity showed significantly reduced error-related negativity, indicating a diminished ability to monitor their mistakes compared to controls, which may affect their self-regulation skills.

The study suggests that impaired response monitoring in children with obesity could contribute to challenges in managing behaviors related to health and weight, highlighting the importance of cognitive control in self-regulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Response monitoring and cognitive control in childhood obesity. Skoranski, AM., Most, SB., Lutz-Stehl, M., et al.[2013]

Individuals with obesity showed poorer executive function and delay discounting compared to healthy weight controls, indicating that cognitive control may be linked to weight management.

In a multidisciplinary weight loss program, better working memory and self-reported inhibition were associated with greater weight loss, suggesting that enhancing executive function could improve obesity treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-regulation and obesity: the role of executive function and delay discounting in the prediction of weight loss. Dassen, FCM., Houben, K., Allom, V., et al.[2019]

A pilot study involving 50 participants (24 in the intervention group and 26 in the control group) found that a CBT-based weight management program improved executive functioning, as evidenced by better performance on cognitive tasks like the Flanker and Stroop tests over 4 months.

Participants in the intervention group also experienced significant weight loss (-7.1 pounds) compared to the control group (+1.0 pounds), suggesting that the CBT-based approach not only supports cognitive improvements but also effective weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Executive Function-Related Improvements on a Commercial CBT-Based Weight Management Intervention: Pilot Randomized Controlled Trial. Michaelides, A., Mitchell, ES., Behr, H., et al.[2022]

In a study of 320 adults undergoing a 6-month lifestyle modification program, higher baseline executive functioning was linked to greater weight loss and increased physical activity, suggesting that cognitive skills play a role in successful behavior change.

Participants without rule violations in executive functioning tasks lost an average of 11.0% of their weight, compared to 8.7% for those with violations, indicating that better executive functioning may facilitate healthier lifestyle choices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Executive Functioning as a Predictor of Weight Loss and Physical Activity Outcomes. Butryn, ML., Martinelli, MK., Remmert, JE., et al.[2020]

Obese individuals without eating disorders show significantly lower decision-making abilities, as measured by the Iowa Gambling Task (IGT), compared to healthy controls, indicating a potential barrier to effective weight loss.

While initial decision-making performance on the IGT was similar between obese and normal-weight individuals, the impairments became more pronounced in the later trials, suggesting that risky decision-making is particularly affected in obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decision-making in obesity without eating disorders: a systematic review and meta-analysis of Iowa gambling task performances. Rotge, JY., Poitou, C., Fossati, P., et al.[2018]

Children with obesity initially showed poorer performance on inhibitory control tasks compared to their normal-weight peers, taking longer to react and complete tasks that required more cognitive effort.

After engaging in exergaming, children with obesity demonstrated significant improvements in their inhibitory control, completing tasks faster and making fewer errors, suggesting that exergaming can enhance cognitive function in this group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Inhibitory Control After Acute Bouts of Exergaming Between Children with Obesity and Their Normal-Weight Peers. Hwang, J., Hillman, CH., Lee, IM., et al.[2022]

This study will assess whether targeted executive function training can improve food choices and cognitive abilities in 30 children with obesity over a 12-month period, using a randomized controlled trial design.

The intervention includes gamified training on iPads, dietary counseling, and activity tracking, with outcomes measured through cognitive tests, emotional assessments, and neuroimaging to evaluate changes in brain connectivity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Executive Function Training in Childhood Obesity: Food Choice, Quality of Life, and Brain Connectivity (TOuCH): A Randomized Control Trial Protocol. Sanchez-Castañeda, C., Luis-Ruiz, S., Ramon-Krauel, M., et al.[2021]

The study involves 176 obese participants who will be randomly assigned to either a behavioral weight loss (BWL) program or a combined Cognitive Remediation Therapy for Obesity (CRT-O) plus BWL, aiming to assess the effectiveness of these interventions on weight loss and executive function.

By measuring inflammatory markers and cognitive outcomes, the study seeks to determine if the CRT-O + BWL approach leads to greater long-term weight loss and improved cognitive function compared to BWL alone, potentially addressing the cognitive deficits associated with obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive remediation therapy plus behavioural weight loss compared to behavioural weight loss alone for obesity: study protocol for a randomised controlled trial. Smith, E., Whittingham, C.[2018]

A randomized controlled trial involving 171 overweight children aged 7-11 years showed that aerobic exercise significantly improves executive function, with greater benefits observed in children participating in higher intensity exercise programs.

Both exercise groups (high dose and low dose) demonstrated better executive function scores compared to a control group, indicating that regular aerobic activity can enhance cognitive abilities in children, although no significant differences were found in mathematics achievement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aerobic exercise enhances executive function and academic achievement in sedentary, overweight children aged 7-11 years. O'Malley, G.[2012]

Citations

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Objective: The primary objective is to determine the efficacy of a web-based EF training program designed to concurrently improve attitudes ...

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We summarize evidence relating EF to obesity and reduced weight loss following BWL, as well as the past success of cognitive training on EF.

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The current study aimed to explore the association between specific executive functions (attentional capacities, sequencing, and flexibility) with self- ...

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NCT05938894 | Train Your Brain - Executive Function

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Train Your Brain - Executive Function

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This study evaluates the impact of EF training on body mass index (BMI), food choice, and cognition in children with obesity.

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Executive function in individuals with clinically significant ...

Executive function (EF) is associated with obesity development and self‐management. Individuals who demonstrate or self‐report poorer EF performance tend to ...