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ObesityNCT03822481

Mindful Construal Diaries: Can the MCD Increase Mindfulness and Mindful Eating in Bariatric Surgery Patients

A study testing Mindful Construal Diary in people with Obesity, run by Birmingham City University at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study aims to test the Mindful Construal Diary (MCD- a mindful eating intervention) initially developed by Mantzios and Wilson. The diary aims to facilitate weight-loss, while also promoting a present centred awareness to current food consumption. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Obesity
What is being tested?
Mindful Construal Diary
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
1 siteUnited Kingdom
Study dates
2 Oct 2017to 1 Nov 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 18 years old or above
  • Bariatric surgery patients cared for at Heartlands Hospital
  • English speakers (reading and writing)
  • Post bariatric surgery

Who cannot join

  • Under the age of 18 years old
  • A lack of capacity
  • Not cared for at Heartlands Hospital
  • Non-english speakers (reading and writing inc)
  • Special communication needs
  • Severe mental health illness

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • Heartlands Hospital

    Birmingham, West Midlands, B9 5SS

Other trials in United Kingdom

About this study

The study aims to test the Mindful Construal Diary (MCD- a mindful eating intervention) initially developed by Mantzios and Wilson. The diary aims to facilitate weight-loss, while also promoting a present centred awareness to current food consumption. There has yet to be any research testing the MCD in clinical populations.

Read the detailed description

(BSP = Bariatric surgery patients) The MCD is an intervention that consists of 10 questions an individual must consider prior to eating, and revisit while eating. Mindfulness refers to being consciously aware in the present moment and being accepting to emotions, and in practice, ME can be defined as an awareness to thoughts, feelings and emotions related to current food consumption (e.g., portion size, feelings of hunger/satiety, and healthfulness of food). Being underpinned by both concepts, the MCD intervention prompts individuals to consider aspects of their meal by generating a more focused perspective to the experience of eating. Current applications of mindfulness in health-related settings are promising, benefits include long-term weight-loss, and decreases in symptoms associated with physical and psychiatric disorders. Although the MCD is similarly associated with weight-loss, existing literature on its utility within the bariatric surgery population is scant. Furthermore, as weight regain is often observed post-surgery, it is important to explore how the MCD can help BSP overcome this obstacles. Furthermore, as the MCD is yet to be applied to BSP, this research will also establish whether the MCD is effective in promoting mindfulness, ME and subsequent weight-loss in this population. The potential benefits of this research are broad, as it can help establish a novel approach to effective weight-loss in BSP, and equip health care practitioners with a cost-effective weight-loss intervention. This research will employ a mixed-method design, where participants will be asked to maintain use of the MCD when eating for a three month period, and at their usual care visit complete questionnaires and an interview. Participants will be recruited from Heartland Hospital's Bariatric Clinic.

Conditions
Obesity
Being tested
Mindful Construal Diary
Keywords
Post-Bariatric Surgery Weight-loss Diary
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mindful Construal DiaryBehavioural

    Also called MCD

    A Mindful Eating Intervention

Study groups in NCT03822481
Study groupRoleWhat they receive
ExperimentalExperimentalParticipants in this arm were given the MCD. The MCD is a mindful eating intervention aimed at facilitating weight loss and cultivating a present centred awareness. The MCD consists of ten questions that an individual must consider while eating. Participants were required to consider the questions while eating (no writing required). Participants were asked to use the MCD at their three main meals (breakfast, lunch, dinner). The
Receives: Behavioral: Mindful Construal Diary
ControlNo interventionParticipants in this arm were required to eat as normal and were not given the MCD until the study was complete.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Weight loss

    Weight loss - reduction in weight (kg) or body mass index (BMI)

    Measured: 3- months

Secondary outcomes (4)
  1. Mindfulness

    Questionnaire - Five Facet Mindfulness Questionnaire - Short Form (FFMQ-SF; Bohlmeijer, Klooster, Fledderus, Veehof \& Baer, 2011) is a 24-item measure which assesses five different but related aspects of mindfulness on a Likert scale, with a response scale of 1 (never or very rarely true) and 5 (very often or always true). Higher scores indicate higher levels of mindfulness (scores range from 24-120) total FFMQ scores are calculated by summing all items. The scale yields five subscales: observe, describe, acting with awareness, non-judgement and non-reactivity. Each subscales is calculated by summing each item that represents each subscale and subtracting six. Sample items include 'I tell myself that I shouldn't be feeling the way I'm feeling' and 'It seems I am running on automatic without much awareness of what I'm doing'. Higher scores are usually perceived positively as this represents engagement in positive practices which are associated with a range of health benefits.

    Measured: 3- months

  2. Mindful eating

    Questionnaire - Mindful Eating Scale (Hulbert-Williams, Joy \& Hulbert-Williams 2013) is a 28-item measure which assesses mindful eating on a Likert scale, with a response scale of 1 (never) and 4 (usually). Higher scores indicate higher levels of mindful eating (scores range from 28-121), total Mindful Eating Scales scores are calculated by summing all items. The scale yields five subscales which assess different components of mindful eating: acceptance, awareness, non-reactivity, routine, distractibility and unstructured eating. Each subscales is calculated by summing each item that represents each subscale. Sample items include 'I criticise myself for the way I eat' and 'I notice how my food looks'. Higher scores are usually perceived positively as this represents engagement in positive eating practices.

    Measured: 3- months

  3. Grazing

    Questionnaire- The Grazing Scale (Lane \& Szabo, 2013) is an 8-item measure which assesses an individual's tendency to eat small amounts of food, throughout the duration of the day, in a way which can be defined as unplanned, repetitious and uncontrolled. Responses are scored on a Likert scales 1 (rarely) and 4 (all of the time). Scores range from 8-32 and higher scores indicate higher levels of grazing, total scores are calculated by summing all items. Higher grazing scores are usually perceived as negative as this represents engagement in a maladaptive eating behaviour.

    Measured: 3- months

  4. Eating Behaviours

    Questionnaire - Dutch Eating Behaviour Questionnaire(DEBQ; Van Strien, 2002) is a 33-item scale which assesses eating behaviour styles. Responses are scored on a 5-point Likert scale (never-very often). Total scores range from 33-165, and higher scores relate to more engagement in maladaptive eating behaviours, total DEBQ scores are calculated by summing all items. The scale contains subscales which identify three different types of eating behaviours, these are: restrained, emotional, and external eating. Each subscales is calculated by summing each item that represents each subscale. Sample items include 'do you have the desire to eat when you are irritated?' and 'do you have the desire to eat when you are emotionally upset'.

    Measured: 3- months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2019
  2. Study start2 Oct 2017
  3. Primary completion1 Nov 2018
  4. Study completion1 Nov 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
One group given the MCD (experimental) other group not given the MCD (control).
Masking
None (open label)
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03822481
Sponsor's protocol ID
Bahia #004.17 BLSS FAEC
Other IDs
226930
Status last verified
Jan 2019
First submitted
29 Jan 2019
Last updated
4 Feb 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual Participant Data will not be shared outside of BCU.

Publications

  • Mantzios M, Wilson JC. Making concrete construals mindful: a novel approach for developing mindfulness and self-compassion to assist weight loss. Psychol Health. 2014;29(4):422-41. doi: 10.1080/08870446.2013.863883. Epub 2013 Dec 4.

    PubMed 24215123

Questions about this trial

What is this clinical trial studying?

A study testing Mindful Construal Diary in people with Obesity, run by Birmingham City University at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Weight loss (time frame: 3- months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03822481, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2019.

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