Adults With Overweight and ObesityMINDEDNCT05865912
A Feasibility Study of Mindfulness Training Transcranial Direct Current Stimulation (tDCS) in Adults With Overweight and Obesity
A study testing Mindfulness training + real tDCS in people with Adults With Overweight and Obesity, run by King's College London at 1 site in United Kingdom.
Trial summary
This study will investigate the feasibility of combining an app-based Mindfulness training (MT) with at-home administered transcranial direct current stimulation (tDCS) in adults with overweight or obesity and assess whether MT with tDCS may improve weight-related behaviours in this population. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Adults With Overweight and Obesity
- What is being tested?
- Mindfulness training + real tDCS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 Oct 2023to 19 Feb 2025
- 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 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults aged 18 to 60 w
- Overweight or obese (BMI ≥25 kg/ m2) according to World Health Organisation (WHO) criteria.
- Use and understand English as a language for everyday conversation.
- Have access to a laptop or desktop computer with webcam and to able to attend baseline, post intervention and follow up assessments in the Institute of Psychiatry, Psychology and Neuroscience (KCL).
Who cannot join
- Insufficient written and spoken English
- All known contraindications to tDCS (Brunoni et al., 2012)
- Pregnancy; history of neurological disease and/or seizure
- Having any metallic implants in the head or body
- History of head or eye injury
- Significant health problems in the previous six months
Show all 13Show fewer
- A lifetime diagnosis of substance dependence, psychosis, bipolar disorder, borderline personality disorder; any other primary psychiatric disorder requiring treatment in its own right
- Taking psychotropic medication
- Taking medication for weight loss Regular, current or past, mindfulness meditation or yoga practice (defined as > 20 minutes, twice or more per week during the past 2 months)
- Consuming more than 14 units of alcohol per week who are unwilling to reduce their alcohol intake for the duration of the treatment
- Current illicit drug use
- Learning difficulties that would preclude safe tDCS self-administration and/or completion of questionnaire measures and neurocognitive tasks (e.g.; working memory and inhibitory control)
- Current atypical anorexia nervosa or purging once a week or more.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Feasibility Study of Mindfulness Training Transcranial Direct Current Stimulation (tDCS) in Adults With Overweight and Obesity.
This study will investigate the feasibility of combining an app-based Mindfulness training (MT) with at-home administered transcranial direct current stimulation (tDCS) in adults with overweight or obesity and assess whether MT with tDCS may improve weight-related behaviours in this population. Specifically, the study will assess whether MT+ active tDCS, as opposed to MT+ sham tDCS or waiting list control, reduces high calorie food craving and consumption. Findings will inform the development of a future large-scale randomised controlled trial. The trial will be conducted in the UK.
Read the detailed description
A randomised controlled feasibility trial with three parallel arms: [MT + real tDCS] vs [MT + sham tDCS] vs [Waiting list control group].
- Conditions
- Adults With Overweight and Obesity
- Being tested
- Mindfulness training + real tDCS, Mindfulness training + sham tDCS
- Keywords
- Mindfulness, Transcranial Direct Current Stimulation
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness training + real tDCSCombination product
The MT is an established app-based programme delivered by Headspace®. During MT, participants complete guided meditation sessions which focus on mindful eating and on coping with cravings. Each MT session lasts 15 min. Participants in the MT+ real tDCS and MT+ sham tDCS groups will be given instructions to practice daily mindfulness for 3 weeks. During 10 of these sessions, MT and real/sham tDCS will be delivered concurrently.
TDCS: During tDCS, a constant weak direct current is applied via electrodes (anode and cathode) placed on the scalp. In this study, the anode will be placed over the right dorsolateral prefrontal cortex (dlPFC) and the cathode will be placed over the left dlPFC. In the real tDCS condition, stimulation will be delivered at a constant current of 2 mA with a 10 second fade in/fade out for 20 minutes. In sham tDCS, the stimulator will deliver 60 seconds of active stimulation at the start ("ramping up") and end ("ramping down") of the 20 minute period.
Mindfulness training + sham tDCSCombination product
Mindfulness training + sham tDCS
| Study group | Role | What they receive |
|---|---|---|
| [Mindfulness training + real tDCS] | Experimental | Not described Receives: Combination Product: Mindfulness training + real tDCS |
| [Mindfulness training + sham tDCS] | Placebo comparator | Not described Receives: Combination Product: Mindfulness training + sham tDCS |
| [Waiting list control group]. | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The feasibility of combining an app-based Mindfulness training (MT) with at-home Administered transcranial direct current stimulation (tDCS) by assessing intervention adherence
By assessing the tDCS session completed and the number of the MT sessions completed will be tracked through the app across the full 8 weeks
Measured: post treatment assessment (assessed at week 3 post start of treatment)
The feasibility of combining an app-based Mindfulness training (MT) with at-home Administered transcranial direct current stimulation (tDCS) by assessing intervention recruitment rate
Recruitment rate/month over months will be assessed to demonstrate that recruitment targets for the main trial can be met within an adequate time-frame.
Measured: post treatment assessment (assessed at week 3 post start of treatment)
The feasibility of combining an app-based Mindfulness training (MT) with at-home Administered transcranial direct current stimulation (tDCS) by assessing intervention retention rates
determine retention rates from randomization through intervention completion
Measured: post treatment assessment (assessed at week 3 post start of treatment) and at follow up (assessed at week 8 post start of treatment)
Participant views about treatment acceptability
Treatment Acceptability Questionnaire: asking participants to indicate if MT with self-administered tDCS is an acceptable approach to treatment and whether they would recommend MT + tDCS to a friend if they were struggling with their weight.
Measured: post treatment assessment (assessed at week 3 post start of treatment)
Secondary outcomes (15)
Change in high calorie food intake in the lab
Taste Test: actual food consumption will be measured by means of a bogus "taste test". Consumption will be determined by weighing the food before and after the "taste test" and the difference in weight from pre- to post-assessment will be converted into calories and used as a measure of food intake.
Measured: Baseline assessment, post treatment assessment (assessed at week 3 post start of treatment) and at follow up up (assessed at week 8 post start of treatment)
Change in food cravings
Food Cravings Questionnaire- Trait Version: it measures habitual experiences of food craving .
Measured: Baseline assessment, post treatment assessment (assessed at week 3 post start of treatment) and at follow up up (assessed at week 8 post start of treatment)
Change in weight loss using the bioelectrical impedance machine
Body Mass Index will be calculated measuring body weight and height (kg/m2) using a bioelectrical impedance machine (InBody S10).
Measured: Baseline assessment, post treatment assessment (assessed at week 3 post start of treatment) and at follow up up (assessed at week 8 post start of treatment)
Change in emotion regulation using Emotion Regulation Questionnaire
Emotion Regulation Questionnaire: A 10-item scale designed to measure respondents' tendency to regulate their emotions
Measured: Baseline assessment, post treatment assessment (assessed at week 3 post start of treatment) and at follow up up (assessed at week 8 post start of treatment)
Change in mood using the The Depression, Anxiety and Stress-Scale
The Depression, Anxiety and Stress-Scale: is a 21-item self-report questionnaire which evaluates mood, anxiety and stress levels over the previous week.
Measured: Baseline assessment, post treatment assessment (assessed at week 3 post start of treatment) and at follow up up (assessed at week 8 post start of treatment)
Change in working memory
Digital Span: the digit-span test for working memory is used to assess short-term memory. It has two subtests, the forward and backward tests.
Measured: Baseline assessment, post treatment assessment (assessed at week 3 post start of treatment) and at follow up up (assessed at week 8 post start of treatment)
Change in inhibitory control using the Go no Go Task
Go no Go Task: this task measures response inhibition. In the go/no-go task, participants respond to certain stimuli ("go" stimuli) and make no response for others ("no-go" stimuli). The main dependent measure in go/no-go tasks is the commission error rate (making a "go" response on "no-go" trials); fewer errors signify better response inhibition.
Measured: Baseline assessment, post treatment assessment (assessed at week 3 post start of treatment) and at follow up up (assessed at week 8 post start of treatment)
Change mindful eating-related outcomes
The Mindful Eating Questionnaire: is a 28-item questionnaire which will be used to assess awareness, distraction, disinhibition of eating and emotional and external eating. The
Measured: Baseline assessment, post treatment assessment (assessed at week 3 post start of treatment) and at follow up up (assessed at week 8 post start of treatment)
Change in food cravings using the Power of Food Scale
Power of Food Scale: this assesses the psychological influence of the presence or Availability of food. It measures appetite for, rather than consumption of, palatable foods at three levels of food proximity (food available, food present, and food tasted)
Measured: Baseline assessment, post treatment assessment (assessed at week 3 post start of treatment) and at follow up up (assessed at week 8 post start of treatment)
Change in Body composition
Body composition (primarily body fat percentage) will be assessed using a bioelectrical impedance machine (InBody S10).
Measured: Baseline assessment, post treatment assessment (assessed at week 3 post start of treatment) and at follow up up (assessed at week 8 post start of treatment)
Change in mood using Positive and Negative Affect Schedule
Positive and Negative Affect Schedule: this consists of two 10-item self-report scale which measures positive and negative affect.
Measured: Baseline assessment, post treatment assessment (assessed at week 3 post start of treatment) and at follow up up (assessed at week 8 post start of treatment)
Change in inhibitory control using Barrett Impulsiveness Scale
Barrett Impulsiveness Scale: this 30-item questionnaire during which participants are asked to reflect on a series of statements and indicate how frequently they apply to them.
Measured: Baseline assessment, post treatment assessment (assessed at week 3 post start of treatment) and at follow up up (assessed at week 8 post start of treatment)
Change in inhibitory control using Delayed Gratification Inventory
Delayed Gratification Inventory: this questionnaire assesses participants' ability/tendency to delay gratification.
Measured: Baseline assessment, post treatment assessment (assessed at week 3 post start of treatment) and at follow up up (assessed at week 8 post start of treatment)
Change in mindfulness outcomes
Mindful Awareness and Attention Scale: is a 15-item scale used to assess core characteristics of mindfulness
Measured: Baseline assessment, post treatment assessment (assessed at week 3 post start of treatment) and at follow up up (assessed at week 8 post start of treatment)
Eating Disorder Symptoms
The Eating Disorder Examination Questionnaire (EDE-Q) will be used to assess eating disorders symptoms. The EDE-Q is a 36-item self-report quesitonnaire, and a higher global score indicates more severe eating disorder symptoms.
Measured: Baseline assessment, post treatment assessment (assessed at week 3 post start of treatment) and at follow up up (assessed at week 8 post start of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study start17 Oct 2023
- Primary completion19 Feb 2025
- Study completion19 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adults With Overweight and ObesityStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05865912
- Sponsor's protocol ID
- 3159550
- Acronym
- MINDED
- Status last verified
- Apr 2023
- First submitted
- 11 Apr 2023
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ageeli M, Flynn M, Lopes M, Ince B, Alves D, Westwood SJ, Campbell IC, Schmidt U. A feasibility study of the effects of concurrent transcranial direct current stimulation (tDCS) on mindfulness training in adults living with overweight or obesity: the MINDED trial protocol. Pilot Feasibility Stud. 2026 Jan 6;12(1):19. doi: 10.1186/s40814-025-01748-9.
PubMed 41495839
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of Mindfulness Training Transcranial Direct Current Stimulation (tDCS) in Adults With Overweight and Obesity.
- ClinicalTrials.gov ID
- NCT05865912
- Acronym / sponsor ID
- MINDED / 3159550
- Conditions
- Adults With Overweight and Obesity
- Keywords
- Mindfulness, Transcranial Direct Current Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- 17 Oct 2023 (actual)
- Primary completion
- 19 Feb 2025 (actual)
- Study completion
- 19 Feb 2025 (actual)
- First posted
- 19 May 2023 (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.
This study will investigate the feasibility of combining an app-based Mindfulness training (MT) with at-home administered transcranial direct current stimulation (tDCS) in adults with overweight or obesity and assess whether MT with tDCS may improve weight-related behaviours in this population. Specifically, the study will assess whether MT+ active tDCS, as opposed to MT+ sham tDCS or waiting list control, reduces high calorie food craving and consumption. Findings will inform the development of a future large-scale randomised controlled trial. The trial will be conducted in the UK.
Detailed description
A randomised controlled feasibility trial with three parallel arms: [MT + real tDCS] vs [MT + sham tDCS] vs [Waiting list control group].
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| [Mindfulness training + real tDCS] | Experimental | Combination Product: Mindfulness training + real tDCS |
| [Mindfulness training + sham tDCS] | Placebo comparator | Combination Product: Mindfulness training + sham tDCS |
| [Waiting list control group]. | No intervention | – |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Adults aged 18 to 60 w
- Overweight or obese (BMI ≥25 kg/ m2) according to World Health Organisation (WHO) criteria.
- Use and understand English as a language for everyday conversation.
- Have access to a laptop or desktop computer with webcam and to able to attend baseline, post intervention and follow up assessments in the Institute of Psychiatry, Psychology and Neuroscience (KCL).
Key exclusion criteria (13 listed)
- Insufficient written and spoken English
- All known contraindications to tDCS (Brunoni et al., 2012)
- Pregnancy; history of neurological disease and/or seizure
- Having any metallic implants in the head or body
- History of head or eye injury
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 |
|---|---|---|
| Mindfulness training + real tDCSThe MT is an established app-based programme delivered by Headspace®. During MT, participants complete guided meditation sessions which focus on mindful eating and on coping with cravings. Each MT session lasts 15 min. Participants in the MT+ real tDCS and MT+ sham tDCS groups will be given instructions to practice daily mindfulness for 3 weeks. During 10 of these sessions, MT and real/sham tDCS will be delivered concurrently. TDCS: During tDCS, a constant weak direct current is applied via electrodes (anode and cathode) placed on the scalp. In this study, the anode will be placed over the right dorsolateral prefrontal cortex (dlPFC) and the cathode will be placed over the left dlPFC. In the real tDCS condition, stimulation will be delivered at a constant current of 2 mA with a 10 second fade in/fade out for 20 minutes. In sham tDCS, the stimulator will deliver 60 seconds of active stimulation at the start ("ramping up") and end ("ramping down") of the 20 minute period. | Combination product | [Mindfulness training + real tDCS] |
| Mindfulness training + sham tDCSMindfulness training + sham tDCS | Combination product | [Mindfulness training + sham tDCS] |
Primary outcome
The feasibility of combining an app-based Mindfulness training (MT) with at-home Administered transcranial direct current stimulation (tDCS) by assessing intervention adherence
Time frame: post treatment assessment (assessed at week 3 post start of treatment)
By assessing the tDCS session completed and the number of the MT sessions completed will be tracked through the app across the full 8 weeks
The feasibility of combining an app-based Mindfulness training (MT) with at-home Administered transcranial direct current stimulation (tDCS) by assessing intervention recruitment rate
Time frame: post treatment assessment (assessed at week 3 post start of treatment)
Recruitment rate/month over months will be assessed to demonstrate that recruitment targets for the main trial can be met within an adequate time-frame.
The feasibility of combining an app-based Mindfulness training (MT) with at-home Administered transcranial direct current stimulation (tDCS) by assessing intervention retention rates
Time frame: post treatment assessment (assessed at week 3 post start of treatment) and at follow up (assessed at week 8 post start of treatment)
determine retention rates from randomization through intervention completion
Participant views about treatment acceptability
Time frame: post treatment assessment (assessed at week 3 post start of treatment)
Treatment Acceptability Questionnaire: asking participants to indicate if MT with self-administered tDCS is an acceptable approach to treatment and whether they would recommend MT + tDCS to a friend if they were struggling with their weight.
15 secondary outcomes
Change in high calorie food intake in the lab
Time frame: Baseline assessment, post treatment assessment (assessed at week 3 post start of treatment) and at follow up up (assessed at week 8 post start of treatment)
Change in food cravings
Time frame: Baseline assessment, post treatment assessment (assessed at week 3 post start of treatment) and at follow up up (assessed at week 8 post start of treatment)
Change in weight loss using the bioelectrical impedance machine
Time frame: Baseline assessment, post treatment assessment (assessed at week 3 post start of treatment) and at follow up up (assessed at week 8 post start of treatment)
Change in emotion regulation using Emotion Regulation Questionnaire
Time frame: Baseline assessment, post treatment assessment (assessed at week 3 post start of treatment) and at follow up up (assessed at week 8 post start of treatment)
Change in mood using the The Depression, Anxiety and Stress-Scale
Time frame: Baseline assessment, post treatment assessment (assessed at week 3 post start of treatment) and at follow up up (assessed at week 8 post start of treatment)
Change in working memory
Time frame: Baseline assessment, post treatment assessment (assessed at week 3 post start of treatment) and at follow up up (assessed at week 8 post start of treatment)
Change in inhibitory control using the Go no Go Task
Time frame: Baseline assessment, post treatment assessment (assessed at week 3 post start of treatment) and at follow up up (assessed at week 8 post start of treatment)
Change mindful eating-related outcomes
Time frame: Baseline assessment, post treatment assessment (assessed at week 3 post start of treatment) and at follow up up (assessed at week 8 post start of treatment)
Change in food cravings using the Power of Food Scale
Time frame: Baseline assessment, post treatment assessment (assessed at week 3 post start of treatment) and at follow up up (assessed at week 8 post start of treatment)
Change in Body composition
Time frame: Baseline assessment, post treatment assessment (assessed at week 3 post start of treatment) and at follow up up (assessed at week 8 post start of treatment)
Change in mood using Positive and Negative Affect Schedule
Time frame: Baseline assessment, post treatment assessment (assessed at week 3 post start of treatment) and at follow up up (assessed at week 8 post start of treatment)
Change in inhibitory control using Barrett Impulsiveness Scale
Time frame: Baseline assessment, post treatment assessment (assessed at week 3 post start of treatment) and at follow up up (assessed at week 8 post start of treatment)
Change in inhibitory control using Delayed Gratification Inventory
Time frame: Baseline assessment, post treatment assessment (assessed at week 3 post start of treatment) and at follow up up (assessed at week 8 post start of treatment)
Change in mindfulness outcomes
Time frame: Baseline assessment, post treatment assessment (assessed at week 3 post start of treatment) and at follow up up (assessed at week 8 post start of treatment)
Eating Disorder Symptoms
Time frame: Baseline assessment, post treatment assessment (assessed at week 3 post start of treatment) and at follow up up (assessed at week 8 post start of treatment)
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 28 Jul 2025.
- Derived from this study: PubMed 41495839Ageeli M, Flynn M, Lopes M, Ince B, Alves D, Westwood SJ, Campbell IC, Schmidt U. A feasibility study of the effects of concurrent transcranial direct current stimulation (tDCS) on mindfulness training in adults living with overweight or obesity: the MINDED trial protocol. Pilot Feasibility Stud. 2026 Jan 6;12(1):19. doi: 10.1186/s40814-025-01748-9.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness training + real tDCS in people with Adults With Overweight and Obesity, run by King's College London at 1 site in United Kingdom.
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 13 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 28 Jul 2025. 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 Kingdom. 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. Some participants in this study may receive a placebo. 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?
The feasibility of combining an app-based Mindfulness training (MT) with at-home Administered transcranial direct current stimulation (tDCS) by assessing intervention adherence (time frame: post treatment assessment (assessed at week 3 post start of treatment)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05865912, which also lists 1 linked publication.
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 28 Jul 2025.