<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03822481</url>
  </required_header>
  <id_info>
    <org_study_id>Bahia #004.17 BLSS FAEC</org_study_id>
    <secondary_id>226930</secondary_id>
    <nct_id>NCT03822481</nct_id>
  </id_info>
  <brief_title>Mindful Construal Diaries: Can the MCD Increase Mindfulness and Mindful Eating in Bariatric Surgery Patients</brief_title>
  <official_title>Mindful Construal Diaries: Can the MCD Increase Mindfulness and Mindful Eating in Bariatric Surgery Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Birmingham City University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Birmingham City University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study aims to test the Mindful Construal Diary (MCD- a mindful eating intervention)&#xD;
      initially developed by Mantzios and Wilson. The diary aims to facilitate weight-loss, while&#xD;
      also promoting a present centred awareness to current food consumption. There has yet to be&#xD;
      any research testing the MCD in clinical populations.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      (BSP = Bariatric surgery patients) The MCD is an intervention that consists of 10 questions&#xD;
      an individual must consider prior to eating, and revisit while eating. Mindfulness refers to&#xD;
      being consciously aware in the present moment and being accepting to emotions, and in&#xD;
      practice, ME can be defined as an awareness to thoughts, feelings and emotions related to&#xD;
      current food consumption (e.g., portion size, feelings of hunger/satiety, and healthfulness&#xD;
      of food). Being underpinned by both concepts, the MCD intervention prompts individuals to&#xD;
      consider aspects of their meal by generating a more focused perspective to the experience of&#xD;
      eating. Current applications of mindfulness in health-related settings are promising,&#xD;
      benefits include long-term weight-loss, and decreases in symptoms associated with physical&#xD;
      and psychiatric disorders. Although the MCD is similarly associated with weight-loss,&#xD;
      existing literature on its utility within the bariatric surgery population is scant.&#xD;
      Furthermore, as weight regain is often observed post-surgery, it is important to explore how&#xD;
      the MCD can help BSP overcome this obstacles. Furthermore, as the MCD is yet to be applied to&#xD;
      BSP, this research will also establish whether the MCD is effective in promoting mindfulness,&#xD;
      ME and subsequent weight-loss in this population. The potential benefits of this research are&#xD;
      broad, as it can help establish a novel approach to effective weight-loss in BSP, and equip&#xD;
      health care practitioners with a cost-effective weight-loss intervention. This research will&#xD;
      employ a mixed-method design, where participants will be asked to maintain use of the MCD&#xD;
      when eating for a three month period, and at their usual care visit complete questionnaires&#xD;
      and an interview. Participants will be recruited from Heartland Hospital's Bariatric Clinic.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2, 2017</start_date>
  <completion_date type="Actual">November 1, 2018</completion_date>
  <primary_completion_date type="Actual">November 1, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>One group given the MCD (experimental) other group not given the MCD (control).</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Weight loss</measure>
    <time_frame>3- months</time_frame>
    <description>Weight loss - reduction in weight (kg) or body mass index (BMI)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mindfulness</measure>
    <time_frame>3- months</time_frame>
    <description>Questionnaire - Five Facet Mindfulness Questionnaire - Short Form (FFMQ-SF; Bohlmeijer, Klooster, Fledderus, Veehof &amp; 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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mindful eating</measure>
    <time_frame>3- months</time_frame>
    <description>Questionnaire - Mindful Eating Scale (Hulbert-Williams, Joy &amp; 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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Grazing</measure>
    <time_frame>3- months</time_frame>
    <description>Questionnaire- The Grazing Scale (Lane &amp; 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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Eating Behaviours</measure>
    <time_frame>3- months</time_frame>
    <description>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'.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Experimental</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants in this arm were required to eat as normal and were not given the MCD until the study was complete.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mindful Construal Diary</intervention_name>
    <description>A Mindful Eating Intervention</description>
    <arm_group_label>Experimental</arm_group_label>
    <other_name>MCD</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years old or above&#xD;
&#xD;
          -  Bariatric surgery patients cared for at Heartlands Hospital&#xD;
&#xD;
          -  English speakers (reading and writing)&#xD;
&#xD;
          -  Post bariatric surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Under the age of 18 years old&#xD;
&#xD;
          -  A lack of capacity&#xD;
&#xD;
          -  Not cared for at Heartlands Hospital&#xD;
&#xD;
          -  Non-english speakers (reading and writing inc)&#xD;
&#xD;
          -  Special communication needs&#xD;
&#xD;
          -  Severe mental health illness&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Heartlands Hospital</name>
      <address>
        <city>Birmingham</city>
        <state>West Midlands</state>
        <zip>B9 5SS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>24215123</PMID>
  </reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 29, 2019</study_first_submitted>
  <study_first_submitted_qc>January 29, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>January 31, 2019</last_update_submitted>
  <last_update_submitted_qc>January 31, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 4, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Post-Bariatric Surgery Weight-loss Diary</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Individual Participant Data will not be shared outside of BCU.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03822481
org study id: Bahia #004.17 BLSS FAEC
secondary id: 226930
nct id: NCT03822481
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
(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.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: One group given the MCD (experimental) other group not given the MCD (control).
primary purpose: Supportive Care
masking: None (Open Label)
measure: Weight loss
time frame: 3- months
description: Weight loss - reduction in weight (kg) or body mass index (BMI)
measure: Mindfulness
time frame: 3- months
description: 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.
measure: Mindful eating
time frame: 3- months
description: 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.
measure: Grazing
time frame: 3- months
description: 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.
measure: Eating Behaviours
time frame: 3- months
description: 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'.
arm group label: Experimental
arm group type: Experimental
description: 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
arm group label: Control
arm group type: No Intervention
description: Participants in this arm were required to eat as normal and were not given the MCD until the study was complete.
intervention type: Behavioral
intervention name: Mindful Construal Diary
description: A Mindful Eating Intervention
arm group label: Experimental
other name: MCD
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United Kingdom
citation: 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.
PMID: 24215123
responsible party type: Sponsor
sharing ipd: No
ipd description: Individual Participant Data will not be shared outside of BCU.