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NCT05865912 | Not yet recruiting | 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

Phase 4

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 : July 2023
Estimated Primary Completion Date : July 2024
Estimated Study Completion Date : October 2024
Arm Intervention/treatment

Experimental: [Mindfulness training + real tDCS]

Placebo Comparator: [Mindfulness training + sham tDCS]

No Intervention: [Waiting list control group].

Ages Eligible for Study: 18 Years to 60 Years
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: Accepts Healthy Volunteers
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

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

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