The influence of mindfulness training on stress-eating behavior on both the behavioral and neuronal levels

ISRCTN ISRCTN12901054
DOI https://doi.org/10.1186/ISRCTN12901054
Submission date
17/05/2023
Registration date
19/05/2023
Last edited
28/04/2025
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
Frequently engaging in stress-related overeating behavior can lead to weight gain and a heightened BMI, which can, in turn, increase the risk of metabolic and cardiovascular diseases. Mindfulness training could serve as an intervention strategy for stress-eating behaviors through its ability to regulate emotions, decrease sensitivity to stress, and increase body awareness. Mindfulness training could thereby effectively help individuals develop a healthier relationship with food.

Who can participate?
Meditation-naïve, healthy, right-handed participants between the ages of 18 and 45 who have the tendency to over eat when stressed.

What does the study involve?
To investigate whether mindfulness can serve as an intervention strategy for stress-eating behaviors, a longitudinal experiment was conducted. Participants were either placed into a food-related mindfulness condition or an active control condition for 31 days. Behavioral and neuroimaging data were acquired prior-to and upon completing the mindfulness training.

What are the possible benefits and risks of participating?
Participants in both conditions will be exposed to similar benefits as well as risks. For example, whether participants receive information pertaining to mindfulness meditation (including daily guided meditation sessions) in the experimental condition or receive information pertaining to overall health in the control condition, both groups will be provided with the opportunity to prove their health. Our aim in the study was therefore to observe how mindfulness training differentiates itself from the active control group by means of its ability to reduce stress-eating tendencies and improve overall perceived mindfulness.
While both groups will primarily be exposed to benefiting from participating in this study, neuroimaging studies comes with inherent risks. While extensive measures are taken to ensure minimal risk for every participant, the MRI machine is a large piece of medical, technological, equipment and if necessary, precautionary, measures are not taken, participants can experience the heating of the skin or injury due to undisclosed metal (i.e., paramagnetic material) in the body or in metal brought into the MRI room.
Additionally, while mindfulness meditation has been demonstrated to be effective in reducing stress and anxiety levels, initial exposure to mindfulness (given its ability to increase awareness of bodily sensations) could highlight or draw attention existing stress or anxiety symptoms causing the participant to experience initial, increased, discomfort.

Where is the study run from?
Technical University of Munich (Germany)

When is the study starting and how long is it expected to run for?
January 2018 to June 2021

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Alyssa Torske, alyssa.torske@tum.de
Prof Kathrin Koch, kathrin.koch@tum.de

Contact information

Ms Alyssa Torske
Scientific

Ismaninger Str. 22
Munich
81675
Germany

ORCiD logoORCID ID 0000-0003-2016-3862
Phone +49 8941407971
Email alyssa.torske@tum.de
Prof Kathrin Koch
Principal Investigator

Ismaninger Str. 22
Munich
81675
Germany

Phone +49 8941407972
Email kathrin.koch@tum.de

Study information

Study designLongitudinal single-blinded randomized controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Home, Hospital, Internet/virtual
Study typeOther
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet.
Scientific titleStress as a mediator of overeating and the effectiveness of mindfulness training as an intervention strategy
Study objectivesMindfulness training, through its ability to reduce stress and increase body awareness, could serve as an intervention strategy for stress-related overeating behavior. This study, therefore, sought to observe the effects of mindfulness training on eating behavior on the behavioral and neuronal levels. We hypothesized that mindfulness training will not only reduce stress-eating and emotional eating tendencies, but that these behavioral changes would also be reflected on the neuronal level through changes in brain function and structure in and between areas associated with reward, emotion, processing, and brains areas fundamental to regulating eating behavior (including the hypothalamus and insula).
Ethics approval(s)Approved 30/04/2019, Ethics committee of Technische Universität München (Ismaninger Straße 22, 81675 München, Germany; +49 89 4140-7737; ethikkommission@mri.tum.de), ref: 71/19 S-SR
Health condition(s) or problem(s) studiedEffects of mindfulness meditation on stress-eating behavior, brain structure, and brain function in healthy adults who have the tendency to overeat when stressed.
InterventionParticipants were pseudo-randomly assigned to either a mindfulness meditation training program or an active control training program that provided participants with information pertaining to overall health. Both training programs were web-based and delivered over the span of 31 days.

Participants were pseudo-randomly allocated to conditions using an online tool. Given single-blinded nature of the study, the experimenter was aware of the condition and was therefore able to allocate the participant into the appropriate training group.
Intervention typeBehavioural
Primary outcome measure1. Stress and emotional eating measured using standardized, behavioral questionnaires (SEES and SSES) at pre-/post- intervention
2. Perceived mindfulness measured using the standardized behavioral questionnaire (MAAS) at pre-/post-intervention
3. Brain structure and function measured through the acquisition of neuroimaging data (BOLD, resting-state, fMRI, DTI, MPGRAGE) at pre-/post-intervention
Secondary outcome measuresFood cravings and restraint measured using the standardized behavioral questionnaires (FCT-S, FCT-T, and the Restraint Scale) at pre-/post- intervention
Overall study start date01/01/2018
Completion date01/06/2021

Eligibility

Participant type(s)Healthy volunteer
Age groupAdult
Lower age limit18 Years
Upper age limit45 Years
SexBoth
Target number of participants60
Total final enrolment80
Key inclusion criteriaMeditation-naïve, healthy, right-handed participants between the ages of 18 and 45 years who have the tendency to over eat when stressed
Key exclusion criteria1. BMI exceeds the range: 18 - 30 kg/m²
2. Dietary restrictions (including veganism and vegetarianism)
3. Smokers
4. Use of oral contraceptives
5. Untreated thyroid dysfunction
6. Respiratory disease
7. Metal implants
8. Claustrophobia
9. Left-handedness
10. Reduced olfaction
Date of first enrolment01/05/2019
Date of final enrolment01/03/2021

Locations

Countries of recruitment

  • Germany

Study participating centre

Klinikum Rechts der Isar, Technical University of Munich
Ismaninger Str. 22
Munich
81675
Germany

Sponsor information

Technical University of Munich
University/education

Ismaninger Str. 22
Munich
81675
Germany

Phone +49 89 28901
Email info@tum.de
Website https://www.tum.de/en/
ROR logo "ROR" https://ror.org/02kkvpp62

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date01/08/2023
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryStored in publicly available repository
Publication and dissemination planPlanned publication in a high-impact peer-reviewed journal
IPD sharing planData will be made publicly available on OSF. Activation clusters in the form of .nii images will be uploaded into the repository.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 27/03/2024 28/03/2024 Yes No
Results article 25/04/2025 28/04/2025 Yes No

Editorial Notes

28/04/2025: Publication reference added.
28/03/2024: Publication reference added.
19/05/2023: Trial's existence confirmed by Ethics committee of Technische Universität München.