Bringing Awareness Into Eating

Sponsor

Brown University (Other)

Overall Status

Completed

CT.gov ID

NCT04021745

Collaborator

(none)

Enrollment

Location

Arm

3.4

Actual Duration (Months)

18.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to test an app-based mindful eating intervention to decrease the reward value of unhealthy food.

Condition or Disease	Intervention/Treatment	Phase
Stress Eating Reward-based Eating Craving-related Eating	Behavioral: App-based mindful eating	N/A

Detailed Description

Eating healthily is highly beneficial. However, changing eating habits is notoriously difficult. Individuals often believe that they simply need to "restrain" their eating impulses in order to eat more healthily. However, such an approach has not only been shown to be quite ineffective over long time spans, it is also associated with aversive feelings: It simply does not feel good to struggle with one's own impulses.

Investigators are testing a new approach to overcoming unhealthy eating habits, which utilizes mindful eating to change the reward value of unhealthy food. The hypothesis is that if people pay attention to how unhealthy food (e.g. "junk" food) makes them feel in their bodies, their liking it and desire to eat it will decrease naturally. Participants might become aware, for example, that eating a whole bag of chips leads to nausea, while eating a salad makes them feel fresh and energetic.

Investigators will assess whether and how the anticipated and actual satisfaction associated with unhealthy food will decrease the more often participants use this intervention.

Study Design

Study Type:

Interventional

Actual Enrollment :

65 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Mindful Eating - Bringing Awareness Into Eating

Actual Study Start Date :

Jul 15, 2019

Actual Primary Completion Date :

Oct 28, 2019

Actual Study Completion Date :

Oct 28, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: App-based mindful eating The intervention will be delivered through a mindful eating smartphone application using the latest evidence-based mindful eating methods and behavior change theory.	Behavioral: App-based mindful eating This is a mindful eating smartphone application comprised of twenty-eight modules of 10-15 minutes each designed to teach mindfulness for binge eating. The feature that is being tested will ask individuals to do a mental exercise when they're craving and will measure their satisfaction related to the experience.

Arm

Intervention/Treatment

Experimental: App-based mindful eating

The intervention will be delivered through a mindful eating smartphone application using the latest evidence-based mindful eating methods and behavior change theory.

Behavioral: App-based mindful eating

This is a mindful eating smartphone application comprised of twenty-eight modules of 10-15 minutes each designed to teach mindfulness for binge eating. The feature that is being tested will ask individuals to do a mental exercise when they're craving and will measure their satisfaction related to the experience.

Outcome Measures

Primary Outcome Measures

Change in Reward Based Eating Drive (RED) Scale [2 months]
The Reward Based Eating Drive (RED) Scale will be used to assess three dimensions of reward-related eating (lack of satiety, preoccupation with food, and lack of control over eating), in order to comprehensively assess the spectrum of reward-related eating. The RED is a 13-item questionnaire that uses a 5-point Likert scale ranging from 0 ("Strongly Disagree") to 4 ("Strongly Agree"). Scores can range from 0 to 52 and higher scores correspond to higher levels of reward-related eating.

Secondary Outcome Measures

Change in Salzburg Stress Eating Scale (SSES) [2 months]
The Salzburg Stress Eating Scale (SSES) will be used to assess stress eating. The SSES is a 10-item questionnaire that uses a 5-point Likert scale where 1 is "I eat much less than usual" and 5 is "I eat much more than usual". Scores can range from 10 to 50 and higher scores correspond to higher levels of stress eating.
Change in Food Craving Questionnaire - Trait, Reduced (FCQ-T-r) [2 months]
Food Craving Questionnaire will be used to assess food cravings. The The FCQ-T-r is a 15-item questionnaire that uses a 5-point Likert scale where 1 is "Strongly Disagree" and 5 is "Strongly Agree". Scores can range from 15 to 75 and higher scores correspond to higher levels of food craving.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Craves & overeats a food at least 4 times/week (can be a specific food or food category - i.e. salty or sweet)
Desire to change eating habits
Owns a smartphone
Fluency in English

Exclusion Criteria:

Current eating disorder
Current strict diet (e.g. paleo, keto, vegan, calorie restriction)
Pregnancy
Current insulin use
Previous use of the EatRightNow application

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Brown University	Providence	Rhode Island	United States	02912

Sponsors and Collaborators

Brown University

Investigators

Principal Investigator: Judson Brewer, MD PhD, Brown University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Brown University

ClinicalTrials.gov Identifier:

NCT04021745

Other Study ID Numbers:

1904002405

First Posted:

Jul 16, 2019

Last Update Posted:

Jan 13, 2020

Last Verified:

Jan 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jan 13, 2020