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NCT05865912 | UNKNOWN | Adults With Overweight and Obesity

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

Condition or disease

Adults With Overweight and Obesity

Intervention/treatment

Mindfulness training + real tDCS

Mindfulness training + sham tDCS

Phase

PHASE4

Detailed Description:

A randomised controlled feasibility trial with three parallel arms: \[MT + real tDCS\] vs \[MT + sham tDCS\] vs \[Waiting list control group\].

Study Type : INTERVENTIONAL
Estimated Enrollment : 87 participants
Masking : DOUBLE
Primary Purpose : BASIC_SCIENCE
Official Title : A Feasibility Study of Mindfulness Training Transcranial Direct Current Stimulation (tDCS) in Adults With Overweight and Obesity.
Actual Study Start Date : 2023-07
Estimated Primary Completion Date : 2024-07
Estimated Study Completion Date : 2024-10

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 60 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: 1
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.
A Feasibility Study of Mindfulness Training Transcranial Direct Current Stimulation (tDCS) in Adults With Overweight and Obesity

Location Details

NCT05865912

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