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Completed

NCT Number: NCT04021745

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.

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Key information

Conditions

Stress Eating Craving-related Eating Reward-based Eating

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Brown University

Providence, Rhode Island, 02912, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

App-based mindful eating

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change in Salzburg Stress Eating Scale (SSES)

    Time frame: 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.

  2. Change in Food Craving Questionnaire - Trait, Reduced (FCQ-T-r)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Brown University

Other

Registry information

Official study title

Mindful Eating - Bringing Awareness Into Eating

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jul 16, 2019
Registry last updated
Jan 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.