Clinical trial NCT03822481: Mindful Construal Diaries: Can the MCD Increase Mindfulness and Mindful Eating in Bariatric Surgery Patients
Official title: Mindful Construal Diaries: Can the MCD Increase Mindfulness and Mindful Eating in Bariatric Surgery Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Post-Bariatric Surgery Weight-loss Diary
Lead sponsor: Birmingham City University
Sponsor class: OTHER
First posted: 2019-01-30
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: One group given the MCD (experimental) other group not given the MCD (control).
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Weight loss
timeFrame: 3- months
Secondary outcomes:
measure: Mindfulness
timeFrame: 3- months
measure: Mindful eating
timeFrame: 3- months
measure: Grazing
timeFrame: 3- months
measure: Eating Behaviours
timeFrame: 3- months
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: Heartlands Hospital
state: West Midlands
Study officials:
References:
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.