Back to resultsA Feasibility Study of Mindfulness Training Transcranial Direct Current Stimulation (tDCS) in Adults With Overweight and Obesity (MINDED)
Primary Purpose
Adults With Overweight and Obesity
Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Mindfulness training + real tDCS
Mindfulness training + sham tDCS
Sponsored by
About this trial
This is an interventional basic science trial for Adults With Overweight and Obesity focused on measuring Mindfulness, Transcranial Direct Current Stimulation
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
No Intervention
Arm Label
[Mindfulness training + real tDCS]
[Mindfulness training + sham tDCS]
[Waiting list control group].
Arm Description
Outcomes
Primary Outcome Measures
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
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.
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
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.
Secondary Outcome Measures
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.
Change in food cravings
Food Cravings Questionnaire- Trait Version: it measures habitual experiences of food craving .
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).
Change in emotion regulation using Emotion Regulation Questionnaire
Emotion Regulation Questionnaire: A 10-item scale designed to measure respondents' tendency to regulate their emotions
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.
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.
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.
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
Change in high calorie food intake using the Short Food Frequency Questionnaire
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 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)
Change in Body composition
Body composition (primarily body fat percentage) will be assessed using a bioelectrical impedance machine (InBody S10).
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.
Change in inhibitory control using Antisaccade task
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
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.
Change in inhibitory control using Delayed Gratification Inventory
Delayed Gratification Inventory: this questionnaire assesses participants' ability/tendency to delay gratification.
Change in mindfulness outcomes
Mindful Awareness and Attention Scale: is a 15-item scale used to assess core characteristics of mindfulness
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05865912
Brief Title
A Feasibility Study of Mindfulness Training Transcranial Direct Current Stimulation (tDCS) in Adults With Overweight and Obesity
Acronym
MINDED
Official Title
A Feasibility Study of Mindfulness Training Transcranial Direct Current Stimulation (tDCS) in Adults With Overweight and Obesity.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 2023 (Anticipated)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King's College London
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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].
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adults With Overweight and Obesity
Keywords
Mindfulness, Transcranial Direct Current Stimulation
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
87 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
[Mindfulness training + real tDCS]
Arm Type
Experimental
Arm Title
[Mindfulness training + sham tDCS]
Arm Type
Placebo Comparator
Arm Title
[Waiting list control group].
Arm Type
No Intervention
Intervention Type
Combination Product
Intervention Name(s)
Mindfulness training + real tDCS
Intervention Description
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.
Intervention Type
Combination Product
Intervention Name(s)
Mindfulness training + sham tDCS
Intervention Description
Mindfulness training + sham tDCS
Primary Outcome Measure Information:
Title
The feasibility of combining an app-based Mindfulness training (MT) with at-home Administered transcranial direct current stimulation (tDCS) by assessing intervention adherence
Description
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)
Title
The feasibility of combining an app-based Mindfulness training (MT) with at-home Administered transcranial direct current stimulation (tDCS) by assessing intervention recruitment rate
Description
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)
Title
The feasibility of combining an app-based Mindfulness training (MT) with at-home Administered transcranial direct current stimulation (tDCS) by assessing intervention retention rates
Description
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)
Title
Participant views about treatment acceptability
Description
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)
Secondary Outcome Measure Information:
Title
Change in high calorie food intake in the lab
Description
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)
Title
Change in food cravings
Description
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)
Title
Change in weight loss using the bioelectrical impedance machine
Description
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)
Title
Change in emotion regulation using Emotion Regulation Questionnaire
Description
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)
Title
Change in mood using the The Depression, Anxiety and Stress-Scale
Description
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)
Title
Change in working memory
Description
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)
Title
Change in inhibitory control using the Go no Go Task
Description
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)
Title
Change mindful eating-related outcomes
Description
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)
Title
Change in high calorie food intake using the Short Food Frequency Questionnaire
Description
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.
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)
Title
Change in food cravings using the Power of Food Scale
Description
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)
Title
Change in Body composition
Description
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)
Title
Change in mood using Positive and Negative Affect Schedule
Description
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)
Title
Change in inhibitory control using Antisaccade task
Description
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
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)
Title
Change in inhibitory control using Barrett Impulsiveness Scale
Description
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)
Title
Change in inhibitory control using Delayed Gratification Inventory
Description
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)
Title
Change in mindfulness outcomes
Description
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)
Title
Eating Disorder Symptoms
Description
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)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
12. IPD Sharing Statement
Learn more about this trial
A Feasibility Study of Mindfulness Training Transcranial Direct Current Stimulation (tDCS) in Adults With Overweight and Obesity
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