Stress EatingNCT04021745
Bringing Awareness Into Eating
A study testing App-based mindful eating in people with Stress Eating and Reward-based Eating, run by Brown University at 1 site in United States.
Trial summary
The purpose of this study is to test an app-based mindful eating intervention to decrease the reward value of unhealthy food. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stress Eating, Reward-based Eating, Craving-related Eating
- What is being tested?
- App-based mindful eating
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2019to 28 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Current eating disorder
- Current strict diet (e.g. paleo, keto, vegan, calorie restriction)
- Pregnancy
- Current insulin use
- Previous use of the EatRightNow application
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Stress Eating, Reward-based Eating, Craving-related Eating
- Being tested
- App-based mindful eating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
App-based mindful eatingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| App-based mindful eating | Experimental | The intervention will be delivered through a mindful eating smartphone application using the latest evidence-based mindful eating methods and behavior change theory. Receives: Behavioral: App-based mindful eating |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 months
Secondary outcomes (2)
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.
Measured: 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.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2019
- Study start15 Jul 2019
- Primary completion28 Oct 2019
- Study completion28 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress EatingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Judson Brewer, MD PhD, Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04021745
- Sponsor's protocol ID
- 1904002405
- Status last verified
- Jan 2020
- First submitted
- 15 Jul 2019
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindful Eating - Bringing Awareness Into Eating
- ClinicalTrials.gov ID
- NCT04021745
- Acronym / sponsor ID
- 1904002405
- Conditions
- Stress Eating, Reward-based Eating, Craving-related Eating
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Study start
- 15 Jul 2019 (actual)
- Primary completion
- 28 Oct 2019 (actual)
- Study completion
- 28 Oct 2019 (actual)
- First posted
- 16 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test an app-based mindful eating intervention to decrease the reward value of unhealthy food.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| App-based mindful eating | Experimental | Behavioral: App-based mindful eatingThe intervention will be delivered through a mindful eating smartphone application using the latest evidence-based mindful eating methods and behavior change theory. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- Current eating disorder
- Current strict diet (e.g. paleo, keto, vegan, calorie restriction)
- Pregnancy
- Current insulin use
- Previous use of the EatRightNow application
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| App-based mindful eatingThis 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. | Behavioural | App-based mindful eating |
Primary outcome
Change in Reward Based Eating Drive (RED) Scale
Time frame: 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.
2 secondary outcomes
Change in Salzburg Stress Eating Scale (SSES)
Time frame: 2 months
Change in Food Craving Questionnaire - Trait, Reduced (FCQ-T-r)
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- Individual participant dataSharing planned: No
Related trials for Stress Eating
Active, not recruiting
The Effect of Lifestyle Program Women With PCOS
Polycystic Ovary Syndrome
RecruitingObservational study
Children s Growth and Behavior Study
Obesity, Eating Behaviors
Active, not recruiting
Effects of Basic Body Awareness Therapy on Pain, Work Stress, Quality of Life, and Eating Attitudes in Adults
Healthy Volunteers
Recruiting
Exercise Effects on the Neurobiology Underlying Stress-related Eating Behaviors in Veterans
Overweight/Obesity, Stress
Recruiting
Effects of Beef-Forward Ready-to-Eat Meals on Recovery Following Simulated Fire Suppression Activities
Physical Performance Parameters, Exercise Recovery
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Judson Brewer, MD PhD principal investigator
Brown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing App-based mindful eating in people with Stress Eating and Reward-based Eating, run by Brown University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Reward Based Eating Drive (RED) Scale (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2020.