Bringing Awareness Into Eating

Mindful Eating - Bringing Awareness Into Eating

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

Study Overview

• Status: Completed
• Conditions: Stress Eating; Reward-based Eating; Craving-related Eating
• Intervention / Treatment: Behavioral: App-based mindful eating

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 Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02912
      • Brown University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Reward Based Eating Drive (RED) Scale	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.	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Salzburg Stress Eating Scale (SSES)	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.	2 months
Change in Food Craving Questionnaire - Trait, Reduced (FCQ-T-r)	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.	2 months

Collaborators and Investigators

• Sponsor: Brown University
• Investigators: Principal Investigator: Judson Brewer, MD PhD, Brown University

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 15, 2019
• Primary Completion (ACTUAL): October 28, 2019
• Study Completion (ACTUAL): October 28, 2019

Study Registration Dates

• First Submitted: July 15, 2019
• First Submitted That Met QC Criteria: July 15, 2019
• First Posted (ACTUAL): July 16, 2019

Study Record Updates

• Last Update Posted (ACTUAL): January 13, 2020
• Last Update Submitted That Met QC Criteria: January 9, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 1904002405

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No