A Feasibility Study of Mindfulness Training Transcranial Direct Current Stimulation (tDCS) in Adults With Overweight and Obesity

NCT ID: NCT05865912

Last Updated: 2025-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-17
• Study Completion Date: 2025-02-19

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].

Conditions

Adults With Overweight and Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

[Mindfulness training + real tDCS]

Group Type: EXPERIMENTAL

Mindfulness training + real tDCS

Intervention Type: 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.

[Mindfulness training + sham tDCS]

Group Type: PLACEBO_COMPARATOR

Mindfulness training + sham tDCS

Intervention Type: COMBINATION_PRODUCT

Mindfulness training + sham tDCS

[Waiting list control group].

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Mindfulness training + real 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.

Intervention Type: COMBINATION_PRODUCT

Mindfulness training + sham tDCS

Mindfulness training + sham tDCS

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

Inclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

King's College London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CREW

London, Uk, United Kingdom

Countries

United Kingdom

Other Identifiers

3159550

Identifier Type: -

Identifier Source: org_study_id