Clinical trial NCT05865912: A Feasibility Study of Mindfulness Training Transcranial Direct Current Stimulation (tDCS) in Adults With Overweight and Obesity
Official title: A Feasibility Study of Mindfulness Training Transcranial Direct Current Stimulation (tDCS) in Adults With Overweight and Obesity.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Adults With Overweight and Obesity
Keywords: Mindfulness, Transcranial Direct Current Stimulation
Lead sponsor: King's College London
Sponsor class: OTHER
First posted: 2023-05-19
Enrollment: 87
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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. 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 \[Waiting list control group\].

Eligibility criteria: Inclusion Criteria:

* Right-handed 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).

Exclusion Criteria:

* 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
* 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.

Primary outcomes:
measure: The feasibility of combining an app-based Mindfulness training (MT) with at-home Administered transcranial direct current stimulation (tDCS) by assessing intervention adherence
timeFrame: post treatment assessment (assessed at week 3 post start of treatment)
measure: The feasibility of combining an app-based Mindfulness training (MT) with at-home Administered transcranial direct current stimulation (tDCS) by assessing intervention recruitment rate
timeFrame: post treatment assessment (assessed at week 3 post start of treatment)
measure: The feasibility of combining an app-based Mindfulness training (MT) with at-home Administered transcranial direct current stimulation (tDCS) by assessing intervention retention rates
timeFrame: post treatment assessment (assessed at week 3 post start of treatment) and at follow up (assessed at week 8 post start of treatment)
measure: Participant views about treatment acceptability
timeFrame: post treatment assessment (assessed at week 3 post start of treatment)
Secondary outcomes:
measure: Change in high calorie food intake in the lab
timeFrame: 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)
measure: Change in food cravings
timeFrame: 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)
measure: Change in weight loss using the bioelectrical impedance machine
timeFrame: 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)
measure: Change in emotion regulation using Emotion Regulation Questionnaire
timeFrame: 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)
measure: Change in mood using the The Depression, Anxiety and Stress-Scale
timeFrame: 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)
measure: Change in working memory
timeFrame: 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)
measure: Change in inhibitory control using the Go no Go Task
timeFrame: 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)
measure: Change mindful eating-related outcomes
timeFrame: 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)
measure: Change in high calorie food intake using the Short Food Frequency Questionnaire
timeFrame: 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)
measure: Change in food cravings using the Power of Food Scale
timeFrame: 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)
measure: Change in Body composition
timeFrame: 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)
measure: Change in mood using Positive and Negative Affect Schedule
timeFrame: 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)
measure: Change in inhibitory control using Antisaccade task
timeFrame: 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)
measure: Change in inhibitory control using Barrett Impulsiveness Scale
timeFrame: 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)
measure: Change in inhibitory control using Delayed Gratification Inventory
timeFrame: 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)
measure: Change in mindfulness outcomes
timeFrame: 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)
measure: Eating Disorder Symptoms
timeFrame: 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)
Other outcomes:
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