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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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 group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Participants 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 |
| Control | No intervention | Participants 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.
Weight loss
Weight loss - reduction in weight (kg) or body mass index (BMI)
Measured: 3- months
Secondary outcomes (4)
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
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
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
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.
- First posted30 Jan 2019
- Study start2 Oct 2017
- Primary completion1 Nov 2018
- Study completion1 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Birmingham City University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindful Construal Diaries: Can the MCD Increase Mindfulness and Mindful Eating in Bariatric Surgery Patients
- ClinicalTrials.gov ID
- NCT03822481
- Acronym / sponsor ID
- Bahia #004.17 BLSS FAEC
- Conditions
- Obesity
- Keywords
- Post-Bariatric Surgery Weight-loss Diary
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Birmingham City UniversityUniversity, hospital or other
- Study start
- 2 Oct 2017 (actual)
- Primary completion
- 1 Nov 2018 (actual)
- Study completion
- 1 Nov 2018 (actual)
- First posted
- 30 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- One group given the MCD (experimental) other group not given the MCD (control).
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: Mindful Construal DiaryParticipants 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 |
| Control | No intervention | –Participants in this arm were required to eat as normal and were not given the MCD until the study was complete. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years old or above
- Bariatric surgery patients cared for at Heartlands Hospital
- English speakers (reading and writing)
- Post bariatric surgery
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindful Construal DiaryAlso: MCDA Mindful Eating Intervention | Behavioural | Experimental |
Primary outcome
Weight loss
Time frame: 3- months
Weight loss - reduction in weight (kg) or body mass index (BMI)
4 secondary outcomes
Mindfulness
Time frame: 3- months
Mindful eating
Time frame: 3- months
Grazing
Time frame: 3- months
Eating Behaviours
Time frame: 3- months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2019.
- Background: PubMed 24215123Mantzios 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.
- Individual participant dataSharing planned: No. Individual Participant Data will not be shared outside of BCU.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.