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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].
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [Mindfulness training + real tDCS] | Experimental |
| |
| [Mindfulness training + sham tDCS] | Placebo Comparator |
| |
| [Waiting list control group]. | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness training + real tDCS | Combination 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | 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 | 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. | post treatment assessment (assessed at week 3 post start of treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CREW | London | Uk | SE5 8AF | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41495839 | Derived | 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. |
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|
| Mindfulness training + sham tDCS | Combination Product | Mindfulness training + sham tDCS |
|
| Change in food cravings | Food Cravings Questionnaire- Trait Version: it measures habitual experiences of food craving . | 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). | 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 | 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. | 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. | 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. | 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 | 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) | 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). | 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. | 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. | 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. | 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 | 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. | 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) |
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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