A Feasibility Study of Mindfulness Training Transcranial Direct Current Stimulation (tDCS) in Adults With Overweight and Obesity
- Conditions
- Adults With Overweight and Obesity
- Interventions
- Combination Product: Mindfulness training + sham tDCSCombination Product: Mindfulness training + real tDCS
- Registration Number
- NCT05865912
- Lead Sponsor
- King's College London
- 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 \[Waiting list control group\].
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 87
- 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).
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description [Mindfulness training + sham tDCS] Mindfulness training + sham tDCS - [Mindfulness training + real tDCS] Mindfulness training + real tDCS -
- Primary Outcome Measures
Name Time Method The feasibility of combining an app-based Mindfulness training (MT) with at-home Administered transcranial direct current stimulation (tDCS) by assessing intervention adherence 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 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 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 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.
- Secondary Outcome Measures
Name Time Method Change in inhibitory control using Delayed Gratification Inventory 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) Delayed Gratification Inventory: this questionnaire assesses participants' ability/tendency to delay gratification.
Change in mood using the The Depression, Anxiety and Stress-Scale 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) The Depression, Anxiety and Stress-Scale: is a 21-item self-report questionnaire which evaluates mood, anxiety and stress levels over the previous week.
Change in Body composition 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) Body composition (primarily body fat percentage) will be assessed using a bioelectrical impedance machine (InBody S10).
Change in mindfulness outcomes 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) Mindful Awareness and Attention Scale: is a 15-item scale used to assess core characteristics of mindfulness
Change in weight loss using the bioelectrical impedance machine 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) Body Mass Index will be calculated measuring body weight and height (kg/m2) using a bioelectrical impedance machine (InBody S10).
Change in high calorie food intake in the lab 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) 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.
Change in food cravings 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) Food Cravings Questionnaire- Trait Version: it measures habitual experiences of food craving .
Change in food cravings using the Power of Food Scale 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) 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)
Change in mood using Positive and Negative Affect Schedule 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) Positive and Negative Affect Schedule: this consists of two 10-item self-report scale which measures positive and negative affect.
Change in inhibitory control using Barrett Impulsiveness Scale 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) 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.
Change in emotion regulation using Emotion Regulation Questionnaire 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) Emotion Regulation Questionnaire: A 10-item scale designed to measure respondents' tendency to regulate their emotions
Change mindful eating-related outcomes 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) 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
Change in high calorie food intake using the Short Food Frequency Questionnaire 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) Short Food Frequency Questionnaire: this has 25 food items and focuses on fruit, vegetables, fibre-rich foods, high fat and high-sugar foods, meat, meat products and fish. It provides an important method for determining variations in diet quality.
Change in inhibitory control using Antisaccade task 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) Antisaccade task: this task measures participants' inhibitory attentional control performance under conditions that imposed a concurrent lower or heightened cognitive load. The task required participants to execute saccades towards (prosaccades), or saccades away from (antisaccades), a salient stimulus
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) 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.
Change in working memory 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) 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.
Change in inhibitory control using the Go no Go Task 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) 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.