Craving Regulation Training for Diet Modification

(ROC Teens! Trial)

Overseen By Grace Shearrer, PhD

Age: < 65

Sex: Female

Trial Phase: Academic

Sponsor: University of Wyoming

Must not be taking: Insulin, Corticosteroids, Antipsychotics, others

Disqualifiers: Diabetes, Cancer, Thyroid disease, others

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

Compensation: Varies

Number of Visits: 2

Duration: 52 weeks

150 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to test if a regulation of craving training intervention in the form of a mobile phone app can increase fruit and vegetable intake in adolescent girls ages 14-18 years of age. The main questions it aims to answer are: 1. What is the effect of a mobile app version of the regulation of craving training intervention on healthy eating index scores over one year? 2. What is the effect of a mobile app version of the regulation of craving training intervention on body mass index, waist circumference, and blood glucose over one year? Researchers will compare the active regulation of craving training arm to a control fun food fact arm to see if the regulation of craving training improves HEI scores, BMI, and blood glucose over a year. Participants will be asked to play the regulation of craving training mobile app twice a week for a year.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are using medications related to metabolism or weight, you may not be eligible to participate.

What data supports the effectiveness of the treatment Regulation of craving training for diet modification?

Research shows that cognitive strategies to regulate craving, like those used in the Regulation of Craving (ROC) task, can help reduce food cravings and improve food choices. Additionally, imaginal retraining, a similar approach, has been shown to decrease cravings for high-calorie foods and aid in weight loss among overweight and obese women. ^{1 2 3 4 5}

Is Craving Regulation Training for Diet Modification safe for humans?

Research on craving regulation techniques, such as imaginal retraining and cue exposure therapy, suggests they are generally safe for humans. These methods have been used in studies with overweight and obese individuals without significant safety concerns reported. ^{2 3 6 7 8}

How does the craving regulation training treatment differ from other treatments for diet modification?

The craving regulation training is unique because it focuses on using cognitive strategies to manage cravings, which can influence food choices and reduce calorie intake. Unlike other treatments, it involves a computerized intervention that provides intensive practice in regulating cravings, potentially offering a novel approach to diet modification. ^{1 2 3 9 10}

Research Team

Grace Shearrer, PhD

Principal Investigator

University of Wyoming

Eligibility Criteria

This trial is for adolescent girls aged 14-18 living in rural areas who are interested in improving their diet. It's aimed at those who may be at risk of obesity, diabetes, or have poor dietary habits. Participants need to commit to using a mobile app twice weekly for one year.

Inclusion Criteria

I am biologically female.

I am female.

Exclusion Criteria

I identify as male.

I am biologically male.

My BMI is below the 5th percentile for my age and sex.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline in-person visit measures including oral glucose tolerance test, height, weight, and waist circumference measurements

1 day

1 visit (in-person)

Treatment

Participants use the mROC-T mobile app twice a week for a year to improve dietary intake

52 weeks

Bi-weekly app usage

Follow-up

1-year follow-up in-person visit to assess changes in HEI, BMI, waist circumference, and blood glucose

1 day

1 visit (in-person)

Treatment Details

Interventions

• Regulation of craving training

Trial Overview Researchers are testing if a mobile app that trains users to regulate cravings can lead to better eating habits and health outcomes like healthier body weight and blood sugar levels. The study compares the effects of this training with learning fun food facts over the course of a year.

Participant Groups

Group I: Positive regulation of craving training Experimental Treatment 1 Intervention

Participants randomized into the active mROC-T intervention (mROC-T+) will: 1. Read a brief essay about the social justice benefits of eating healthy foods 2. Participants complete six free-response questions to ensure that they understood the essays. 3. Participants are instructed to use the information from the essay. They are shown a cue matching the essay: "Think Positive" 4. They are shown an image of a healthy food (no added sugar and \< 2g/serving saturated fat) OR an image of an unhealthy food (contain added sugar and/or \>4.5g/serving saturated fat). 5. The participant is asked to rate how strong their craving is for the pictured food. The participant indicates their craving on a VAS from 1 (No craving at all) to 5 (Very high craving)

Group II: Critical regulation of craving training Experimental Treatment 1 Intervention

Participants randomized into the active mROC-T intervention (mROC-Tc) will: 1. Read a brief essay about the social justice consequences of eating unhealthy foods (CIRITCAL, mROCTc) 2. Participants complete six free-response questions to ensure that they understood the essays. 3. Participants are instructed to use the information from the essay. They are shown a cue matching the essay: "Think Critical" 4. They are shown an image of a healthy food (no added sugar and \< 2g/serving saturated fat) OR an image of an unhealthy food (contain added sugar and/or \>4.5g/serving saturated fat). 5. The participant is asked to rate how strong their craving is for the pictured food. The participant indicates their craving on a VAS from 1 (No craving at all) to 5 (Very high craving)

Group III: Control Placebo Group 1 Intervention

Participants randomized to the control (CRO) group will: 1. Read a brief essay about fun food trivia (unrelated to any aspects of perceived healthiness). The essays are matched on structure/word count to the mROC-T essays. 2. Participants complete six free-response questions to ensure that they understood the essays. 3. Participants are instructed to use the information from the essay. They are shown a cue matching the essay, either: "Think Relaxed" or "Think Serene". 4. They are shown an image of a healthy food (no added sugar and \< 2g/serving saturated fat) OR an image of an unhealthy food (contain added sugar and/or \>4.5g/serving saturated fat). 5. The participant is asked to rate how strong their craving is for the pictured food. The participant indicates their craving on a VAS from 1 (No craving at all) to 5 (Very high craving)

Who Is Running the Clinical Trial?

University of Wyoming

Lead Sponsor

Trials

20

Recruited

1,600+

American Diabetes Association

Collaborator

Trials

148

Recruited

102,000+

Findings from Research

Mindfulness-based therapy (MBT) showed significantly greater reductions in smoking compared to a control group over 16 weeks, indicating its potential long-term effectiveness in managing nicotine dependence.

Both MBT and cognitive behavioral therapy (CBT) effectively reduced cue-induced craving, but only MBT maintained its effectiveness without increasing smoking rates during follow-up, suggesting it may be a more durable intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized trial of mindfulness- and reappraisal-based regulation of craving training among daily cigarette smokers. Roos, CR., Harp, NR., Vafaie, N., 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]

References

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

Randomized trial of mindfulness- and reappraisal-based regulation of craving training among daily cigarette smokers. [2023]

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

Regulating food craving: From mechanisms to interventions. [2022]

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

Imaginal retraining decreases craving for high-calorie food in overweight and obese women: A randomized controlled trial. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Laboratory-based interventions targeting food craving: A systematic review and meta-analysis. [2021]

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

Transdisciplinary concepts and measures of craving: commentary and future directions. [2019]

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

From lab to clinic: Extinction of cued cravings to reduce overeating. [2022]

7. 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]

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

Reward-Induced Eating: Therapeutic Approaches to Addressing Food Cravings. [2018]

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

Imaginal retraining reduces craving for high-calorie food. [2023]

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

Pilot test of brief instructions to improve the self-management of general food cravings. [2019]