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Background <p>This study protocol describes the use of two brain-directed treatments, i.e. mindfulness training (MT) and transcranial direct current stimulation (tDCS), as interventions for obesity-related behaviours (e.g. food craving, over-eating). Individually, mindfulness and tDCS are promising interventions for addressing maladaptive eating behaviours. We hypothesise that clinical outcomes from MT and tDCS will be improved when the two interventions are combined.</p> Methods <p>This protocol is described in accordance with SPIRIT guidelines for clinical trials. The study is a feasibility double-blind randomised sham–controlled (RCT) trial of MT concurrent with or without self-administered tDCS in adults with obesity/overweight (BMI ≥ 25&#xa0;kg/m<sup>2</sup>) (the MINDED trial). Sixty-six adults will be randomly allocated to one of three groups: MT with active tDCS, MT with sham tDCS or waiting list control. Participants in both intervention arms will be asked to complete daily app-based MT for 8 weeks post-randomisation. They will also receive 10 sessions of active or sham tDCS over the first 3 weeks post-randomisation. On tDCS-days, MT will be delivered concurrently. Feasibility will be evaluated by recruitment, retention, and follow-up rates. Acceptability will be determined by monitoring side effects and by participant ratings. Clinical and cognitive outcomes (e.g. body fat percentage and working memory) will be assessed at baseline (T0), 3 weeks post-randomisation (T1) and 8 weeks post-randomisation (T2).</p> Discussion <p>The study will establish the feasibility of conducting a large-scale RCT of (MT + real tDCS) in adults with BMI ≥ 25&#xa0;kg/m<sup>2</sup> classified as overweight or obese. This will involve assessing recruitment, retention and follow-up rates together with measures of acceptability and credibility. It will provide preliminary evidence on the clinical efficacy of the concurrent administration of tDCS and MT for people with obesity/overweight and preliminary information on possible underlying mechanisms (e.g. change in neurocognitive outcomes).</p> Trial registration <p>ClinicalTrials.gov Identifier (NCT number): NCT05865912. Registered on 19 May 2023.</p>

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A feasibility study of the effects of concurrent transcranial direct current stimulation (tDCS) on mindfulness training in adults living with overweight or obesity: the MINDED trial protocol

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年1月6日

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  • Manar Ageeli,
  • Michaela Flynn,
  • Mariana Lopes,
  • Başak İnce,
  • Daniela Alves,
  • Samuel J. Westwood,
  • Iain C. Campbell,
  • Ulrike Schmidt

摘要

Background

This study protocol describes the use of two brain-directed treatments, i.e. mindfulness training (MT) and transcranial direct current stimulation (tDCS), as interventions for obesity-related behaviours (e.g. food craving, over-eating). Individually, mindfulness and tDCS are promising interventions for addressing maladaptive eating behaviours. We hypothesise that clinical outcomes from MT and tDCS will be improved when the two interventions are combined.

Methods

This protocol is described in accordance with SPIRIT guidelines for clinical trials. The study is a feasibility double-blind randomised sham–controlled (RCT) trial of MT concurrent with or without self-administered tDCS in adults with obesity/overweight (BMI ≥ 25 kg/m2) (the MINDED trial). Sixty-six adults will be randomly allocated to one of three groups: MT with active tDCS, MT with sham tDCS or waiting list control. Participants in both intervention arms will be asked to complete daily app-based MT for 8 weeks post-randomisation. They will also receive 10 sessions of active or sham tDCS over the first 3 weeks post-randomisation. On tDCS-days, MT will be delivered concurrently. Feasibility will be evaluated by recruitment, retention, and follow-up rates. Acceptability will be determined by monitoring side effects and by participant ratings. Clinical and cognitive outcomes (e.g. body fat percentage and working memory) will be assessed at baseline (T0), 3 weeks post-randomisation (T1) and 8 weeks post-randomisation (T2).

Discussion

The study will establish the feasibility of conducting a large-scale RCT of (MT + real tDCS) in adults with BMI ≥ 25 kg/m2 classified as overweight or obese. This will involve assessing recruitment, retention and follow-up rates together with measures of acceptability and credibility. It will provide preliminary evidence on the clinical efficacy of the concurrent administration of tDCS and MT for people with obesity/overweight and preliminary information on possible underlying mechanisms (e.g. change in neurocognitive outcomes).

Trial registration

ClinicalTrials.gov Identifier (NCT number): NCT05865912. Registered on 19 May 2023.