NCT03822481

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 2, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 29, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 30, 2019

Completed
Last Updated

February 4, 2019

Status Verified

January 1, 2019

Enrollment Period

1.1 years

First QC Date

January 29, 2019

Last Update Submit

January 31, 2019

Conditions

Keywords

Post-Bariatric Surgery Weight-loss Diary

Outcome Measures

Primary Outcomes (1)

  • Weight loss

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

    3- months

Secondary Outcomes (4)

  • Mindfulness

    3- months

  • Mindful eating

    3- months

  • Grazing

    3- months

  • Eating Behaviours

    3- months

Study Arms (2)

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

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.

Interventions

A Mindful Eating Intervention

Also known as: MCD
Experimental

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heartlands Hospital

Birmingham, West Midlands, B9 5SS, United Kingdom

Location

Related Publications (1)

  • 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: 24215123BACKGROUND

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: One group given the MCD (experimental) other group not given the MCD (control).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2019

First Posted

January 30, 2019

Study Start

October 2, 2017

Primary Completion

November 1, 2018

Study Completion

November 1, 2018

Last Updated

February 4, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Individual Participant Data will not be shared outside of BCU.

Locations