Mindfulness App for Reducing Food Cravings

Emotional Eating Clinical Trial

Official title:

Mobile Mindfulness Intervention to Reduce Non-Homeostatic Food Cravings in Emotional Eaters: Research Pilot

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05347914
• Other study ID #: McGillU mindfulness app
• Status: Completed
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: August 28, 2023

Study information

• Verified date: October 2023
• Source: McGill University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

More than half of Canadian are overweight or obese and over fifty percent of individuals who are obese are emotional eaters. Emotional eating is defined as the tendency to eat in response to negative emotions and can be understood as reward-based eating behavior that is reinforced by modern obesogenic environments. Over time, food-related cues can interfere with reward-based learning processes such that an individual develops a conditioned response to eat for reasons that are not associated with physiological hunger. Mindfulness has the potential to act on the reward-base habit loop of emotional eating. One potential target is cravings or the urges to eat. This can be targeted using the mindfulness exercise called "RAIN" which calls for individuals to (1) Recognize and name their craving, to (2) Acknowledge its presence and to give it space to "be"; (3) then Investigate and bring an attitude of curiosity to their experience - Where did these feelings comes from? Have I felt this way before? then (4) Not-identify with your experience- that is, remind yourself that although your craving or urge to eat is very powerful, it only makes up a small part of who you are. The aim of the study is to therefore test a pilot intervention that implements a targeted mindfulness-based exercise (RAIN), using a mobile app, to attenuate the relationship between feeling a negative internal state (affect) and eating.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: August 28, 2023
• Est. primary completion date: August 28, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Adults (age > 18 years) who meet criteria for emotional eating

2. Demonstrate a lack of control over eating

3. High levels of preoccupation with food

Exclusion Criteria:

1. Having been pregnant in the past six months or planning on becoming pregnant in the next year

2. currently undergoing treatment for cancer

3. using medication that affects body weight or appetite

4. being diagnosed with Bulimia Nervosa, Binge Eating Disorder, currently active Major Depression, or other psychiatric illnesses that may affect appetite.

5. Participants must also be proficient in English

6. Own a smartphone

Related Conditions & MeSH terms

• Emotional Eating

Intervention

Behavioral:
• Mindfulness
Participants will be taught a mindfulness exercise and will be instructed to use this exercise (following a mobile app) whenever they experience a food craving to eat for non-homeostatic reasons.

Locations

Country	Name	City	State
Canada	McGill University	Montreal	Please Select...
Canada	McGill University	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
McGill University

Country where clinical trial is conducted

Canada, 

References & Publications (26)

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* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in food-related cravings	Food Craving Questionnaire Measures the frequency and intensity of food cravings in general. The 15-item scale assesses six dimensions of craving experiences: lack of control overeating, thoughts or preoccupation with food, intentions and plans to consume food, emotions before and during food cravings, as cues that may trigger food cravings. Items are rated on a scale of 1 (never) to 6 (always). Sample items include: "I feel like I have food on my mind all the time", "I crave foods when I feel bored, angry or sad" and "If I am craving something, thoughts of eating consume me". This measure has shown high internal consistency (Cronbach alphas between .80 and .91)	Baseline, week 6
Primary	Change in emotional eating	Dutch Eating Behaviour Questionnaire The DEBQ is a 33-item self-report measure that assesses three dimensions of eating behaviours: emotion eating, restrained eating, and external eating. Individual are asked to indicate the extent to which they agree with each statement from 1 (seldom) to 5 (very often). Sample items include "Do you have a desire to eat when you are anxious, worried or tense?" and "If you see other eating, do you also have a desire to eat?". This measure has shown high internal consistency (Cronbach's alpha = .95)	Baseline, week 6
Secondary	Change in feelings of control around eating	Brief Loss of Control Over-Eating Scale: The Brief Loss of Control Over-Eating Scale is a 7-item measure that assesses one's self-reported tendency to lose control over their eating behaviors. Items on the scale are rated from 1 (never) to 5 (always). Sample items include: "I felt like my cravings to eat overpowered me" and "I found myself eating despite negative consequences". The LOCES-B has shown high internal consistency (Cronbach alpha = .92)	Baseline, week 6
Secondary	Change in overidentification with food cravings	Cognitive Fusion Questionnaire- Food Cravings The Cognitive Fusion Questionnaire - Food Cravings is a (7-item) scale that assesses cognitive fusion with undesirable thoughts regards food craving and urges to eat. Sample items include: "It's very hard for me to let go of my food urges or cravings even when I know that letting go would be very helpful" and "I struggle to control my food urges or cravings." This measure has shown high internal consistency (Cronbach's alpha = .92).	Baseline, week 6
Secondary	Change in reactivity towards eating related experiences	UPPS-P Measure, Negative Urgency Scale: The UPPS-P Negative Urgency Scale is a 12-item measure that assess one's tendency to act rashly in response to negative mood states. Items on the scale are rated from 1 (I agree strongly) to 4 (I disagree strongly). Higher scores represent greater levels of impulsivity. Sample items include: "I have trouble controlling my impulses"). The UPPS-P Negative Urgency Scale has shown high internal consistency (Cronbach alpha = .88)	Baseline, week 6
Secondary	Change in judgment towards eating related experiences	Four Facet Mindful Eating Scale (FFaMES) The Four Facet Mindful Eating Scale is a 29-item self-report measure that assesses four dimensions of mindful eating: non-reactance, non-judgment, external awareness, and internal awareness. Individuals are asked to indicate the extent to which they agree with each statement from 1 (never) to 5 (very often). Sample items include: "I get carried away by my thoughts when I eat" and "I notice how the smell of food makes me want to eat." This measure has shown high internal consistency (non-reactance: Cronbach's alpha = .92, non-judgment: Cronbach's alpha = .91, external awareness: Cronbach's alpha = .82, internal awareness: Cronbach's alpha = .92).	Baseline, week 6
Secondary	Change in capacity to tolerate distress	Distress Tolerance Scale (DTS) The Distress Tolerance Scale is a 14-item scale that assesses an individual's ability to cope with various emotional states (e.g., happiness, anger, loneliness) that are in anticipating as well as in the present. Each item is rated on a scale of 1 (never) to 5 (all the time). Sample items include: "Felling distressed or upset is unbearable to me", "When I feel distressed or upset, all I can think about is how bad I feel" and "I can't handle feeling distressed or upset". The scale has shown high internal reliability (Cronbach's alpha = .91).	Baseline, week 6