An interventional study of Mindfulness training + real tDCS and Mindfulness training + sham tDCS in Adults With Overweight and Obesity, sponsored by King's College London. Completed at 1 site in United Kingdom. Open to female participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-28.
Sponsored by King's College London · Not applicable, Interventional, and Basic science
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.
A randomised controlled feasibility trial with three parallel arms: [MT + real tDCS] vs [MT + sham tDCS] vs [Waiting list control group].
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's enrollment of 52 is below the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →King's College London is the lead sponsor of 506 studies on the registry; 125 are open to participants now.
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Exclusion Criteria:
Combination Product: Mindfulness training + real tDCS
Combination Product: Mindfulness training + sham tDCS
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 tDCS
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
Time frame: 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.
Time frame: 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
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)
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.
Time frame: post treatment assessment (assessed at week 3 post start of treatment)
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.
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
Food Cravings Questionnaire- Trait Version: it measures habitual experiences of food craving .
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
Body Mass Index will be calculated measuring body weight and height (kg/m2) using a bioelectrical impedance machine (InBody S10).
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
Emotion Regulation Questionnaire: A 10-item scale designed to measure respondents' tendency to regulate their emotions
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
The Depression, Anxiety and Stress-Scale: is a 21-item self-report questionnaire which evaluates mood, anxiety and stress levels over the previous week.
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
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.
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
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.
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
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
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
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)
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
Body composition (primarily body fat percentage) will be assessed using a bioelectrical impedance machine (InBody S10).
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
Positive and Negative Affect Schedule: this consists of two 10-item self-report scale which measures positive and negative affect.
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
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.
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
Delayed Gratification Inventory: this questionnaire assesses participants' ability/tendency to delay gratification.
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
Mindful Awareness and Attention Scale: is a 15-item scale used to assess core characteristics of mindfulness
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
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.
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)
Plan to share: No
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King's College London