Food Response Training for Obesity

Recruiting at 1 trial location

Overseen By Melanie Jay, MD, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Must not be taking: Immunosuppressants, Steroids, Weight loss, others

Disqualifiers: Pregnancy, Bariatric surgery, Institutionalized, others

Stay on Your Current Meds You can continue your current medications while participating

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

Compensation: Varies

Number of Visits: 3

35 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

If you are taking medications that affect your diet or weight, like immunosuppressants, steroids, weight loss drugs, or certain psychiatric medications, you may not be eligible for the trial. The protocol does not specify if you need to stop other medications.

What data supports the effectiveness of the treatment Food Response Training (FRT) for obesity?

Research suggests that food response training, which involves training the brain to respond differently to food cues, may help reduce overeating by decreasing the brain's reward response to high-calorie foods and increasing inhibitory control. However, results have been mixed, with some studies showing changes in food preferences but not significant weight loss. ^{1 2 3 4 5}

Is Food Response Training (FRT) safe for humans?

The research articles do not provide specific safety data for Food Response Training (FRT) or similar interventions, but they focus on modifying eating behaviors and food choices without mentioning any adverse effects, suggesting that these interventions are generally considered safe. ^{1 3 6 7 8}

How does the Food Response Training (FRT) treatment for obesity differ from other treatments?

Food Response Training (FRT) is unique because it focuses on training individuals to inhibit their automatic responses to high-calorie foods, which can help reduce cravings and energy intake. Unlike traditional weight-loss methods that may focus on diet and exercise, FRT targets the brain's response to food cues, aiming to change eating behaviors by reducing the attention and reward responses to tempting foods. ^{1 3 4 9 10}

What is the purpose of this trial?

The aim of this mixed methods, single-group, single-center study will be to examine the feasibility of a food response training (FRT). This study will be conducted in patients with obesity recruited from NYU Langone Health. Measurements will occur at screening, baseline, and 3 months, for a subgroup of participants for we will collect saliva samples for genetic analysis at baseline assessment (ancillary study).

Research Team

Melanie Jay, MD, MS

Principal Investigator

NYU Langone Health

Sandra Wittleder, PhD

Principal Investigator

NYU Langone Health

Eligibility Criteria

This study is for adults aged 18-80 with obesity (BMI ≥30.0 kg/m2) who have access to a computer or iPhone/iPad, including those willing to use a loaner smartphone from the study. It's not for individuals who've had bariatric surgery in the last 2 years, are on certain medications, pregnant or planning pregnancy soon, enrolled in other dietary interventions, had significant weight changes recently, can't engage with English software due to impairments or language barriers.

Inclusion Criteria

You have a body mass index (BMI) of 30 or higher.

Access to a computer or an iPhone/iPad or be willing to use a study loaner smart phone

You are willing to use a study loaner smart phone or a computer.

Exclusion Criteria

You have had weight loss surgery in the last 2 years.

You are taking medications that can affect your appetite, weight, or mental health, except for medications for anxiety or depression.

Pregnant or breastfeeding or plan to become pregnant in the next 6 months, or who become pregnant during the study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Assessment

Baseline measurements and saliva sample collection for genetic analysis for a subgroup

1 day

1 visit (in-person)

Food Response Training (FRT)

Participants undergo food response training to reduce unhealthy dietary intake and promote weight loss

12 weeks

Regular sessions (frequency not specified)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

Treatment Details

Interventions

• Food Response Training (FRT)

Trial Overview The trial tests Food Response Training (FRT) as a method to promote healthy eating habits among obese patients at NYU Langone Health. Participants will be monitored over three months and some will provide saliva samples for genetic analysis related to eating behaviors.

Participant Groups

Group I: Patients with Obesity Experimental Treatment 1 Intervention

NYU Langone Health patients ≥18 to 80 years of age with a BMI ≥30.0 kg/m2

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

American Heart Association

Collaborator

Trials

352

Recruited

6,196,000+

Findings from Research

A smartphone-based response inhibition training intervention led to significant reductions in both explicit liking and implicit wanting for energy-dense foods among 84 adults over a two-week period, indicating a decrease in reward-related appetite.

However, the response inhibition training did not provide additional benefits compared to a control game, suggesting that while the training may reduce cravings and hedonic eating drive, it may not be more effective than other activities in modifying eating behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can smartphone-based response inhibition training elicit sustained changes in appetite, preference, and cravings for energy-dense foods? A free-living randomized controlled trial. Moore, H., White, MJ., Finlayson, G., et al.[2023]

In a study involving 84 families with children aged 8-12 years who are obese, adding appetite awareness training (AAT) to standard family-based behavioral treatment (FBT) resulted in significantly lower weights for children in the FBT-AAT group at both one and two years post-treatment.

While both treatment groups showed no significant differences immediately after treatment, the FBT-AAT group continued to improve in weight management over the second year, suggesting that AAT may help maintain treatment effects longer than standard FBT alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incorporating Appetite Awareness Training Within Family-Based Behavioral Treatment of Pediatric Obesity: A Randomized Controlled Pilot Study. Njardvik, U., Gunnarsdottir, T., Olafsdottir, AS., et al.[2019]

The iROC (Intervention for Regulation of Cues) program aims to reduce overeating in overweight children by using learning theory to modify their responses to food cues, addressing a significant issue as traditional weight-loss treatments only work long-term for about one-third of children.

The study will rigorously test the effectiveness of extinction processes by exposing children to their favorite foods to help them learn to control their cravings, potentially leading to more sustainable weight loss or prevention of weight gain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design and implementation of a study evaluating extinction processes to food cues in obese children: the Intervention for Regulations of Cues Trial (iROC). Boutelle, KN., Liang, J., Knatz, S., et al.[2018]

Brain imaging studies indicate that certain neural vulnerability factors can predict excessive weight gain, highlighting the importance of understanding brain responses to food cues in obesity.

Cognitive training interventions that reduce brain responses to high-calorie food cues and enhance inhibitory control may lead to effective weight loss, suggesting a need for further research on intensive training methods to improve existing weight loss strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Training motor responses to food: A novel treatment for obesity targeting implicit processes. Stice, E., Lawrence, NS., Kemps, E., et al.[2019]

A randomized controlled trial with 179 adults showed that a training protocol aimed at reducing responses to high-calorie foods increased the appeal of low-calorie foods, but did not lead to body fat loss or reduced responses to high-calorie foods.

The study suggests that the lack of expected outcomes may be due to weaker learning effects compared to previous trials, possibly because of the use of a more diverse range of food images in the training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a food response and attention training treatment for obesity: A randomized placebo controlled trial. Stice, E., Yokum, S., Gau, J., et al.[2023]

A randomized controlled trial involving 45 overweight adult females tested an 8-session food cue exposure therapy aimed at reducing appetitive responses to food cues, showing promise for treating overeating and obesity.

The study focused on key outcomes such as weight loss and changes in eating behavior, indicating that this innovative approach could provide effective clinical recommendations for managing obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing inhibitory learning to reduce overeating: Design and rationale of a cue exposure therapy trial in overweight and obese women. van den Akker, K., Schyns, G., Jansen, A.[2019]

The study involved 59 overweight children and adolescents aged 8-16 years, and it demonstrated that approach-avoidance training (AAT) significantly improved children's tendencies to reject unhealthy snack items and approach healthier vegetable options, indicating a potential method for modifying eating behaviors.

While both implicit and explicit training approaches were tested, the results showed no significant differences between them, suggesting that AAT can effectively influence automatic food-related behaviors in children regardless of the training method used.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Battle of plates: a pilot study of an approach-avoidance training for overweight children and adolescents. Warschburger, P., Gmeiner, M., Morawietz, M., et al.[2023]

Participants in the hunger training (HT) program reported successfully learning to align their eating habits with their glucose levels, indicating the intervention's potential effectiveness for weight management.

Barriers to adherence included social pressures and rigid meal schedules, while having a routine and social support were key factors that helped participants stick to the program, highlighting areas for improvement in future implementations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

'Am I really hungry?' A qualitative exploration of patients' experience, adherence and behaviour change during hunger training: a pilot study. de Bruin, WE., Ward, AL., Taylor, RW., et al.[2020]

In a study of 83 predominantly overweight or obese adults, online response inhibition training targeting high-energy density foods led to significant weight loss and reduced daily energy intake compared to a control group.

Participants who underwent the active training not only lost weight but also reported a decreased liking for high-energy foods, indicating that this intervention could be an effective strategy for reducing food consumption and improving public health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Training response inhibition to food is associated with weight loss and reduced energy intake. Lawrence, NS., O'Sullivan, J., Parslow, D., et al.[2022]

Cognitive training that balances response inhibition between food and non-food stimuli can lead to reduced snack consumption and lower food-related anxiety among female restrained eaters, as shown in a study with 64 participants.

The training that included both food and non-food stimuli improved positive implicit attitudes toward food, suggesting that this approach helps manage eating behaviors without negatively impacting how participants feel about food.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Influence of Response Inhibition Training on Food Consumption and Implicit Attitudes toward Food among Female Restrained Eaters. Weinbach, N., Keha, E., Leib, H., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Can smartphone-based response inhibition training elicit sustained changes in appetite, preference, and cravings for energy-dense foods? A free-living randomized controlled trial. [2023]

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

Incorporating Appetite Awareness Training Within Family-Based Behavioral Treatment of Pediatric Obesity: A Randomized Controlled Pilot Study. [2019]

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

Design and implementation of a study evaluating extinction processes to food cues in obese children: the Intervention for Regulations of Cues Trial (iROC). [2018]

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

Training motor responses to food: A novel treatment for obesity targeting implicit processes. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Efficacy of a food response and attention training treatment for obesity: A randomized placebo controlled trial. [2023]

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

Enhancing inhibitory learning to reduce overeating: Design and rationale of a cue exposure therapy trial in overweight and obese women. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Battle of plates: a pilot study of an approach-avoidance training for overweight children and adolescents. [2023]

8. England pubmed.ncbi.nlm.nih.gov

'Am I really hungry?' A qualitative exploration of patients' experience, adherence and behaviour change during hunger training: a pilot study. [2020]

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

Training response inhibition to food is associated with weight loss and reduced energy intake. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

The Influence of Response Inhibition Training on Food Consumption and Implicit Attitudes toward Food among Female Restrained Eaters. [2021]