Investigating Remote Access, Group-based Functional Imagery Training in the Community
Primary Purpose
Weight Loss, Health Economics, Quality of Life
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Functional Imagery training
NHS 12 week weight loss programme
Sponsored by

About this trial
This is an interventional treatment trial for Weight Loss
Eligibility Criteria
Inclusion Criteria:
- Aged over 18 years
- BMI over 30 kg/m2
- Access to an internet accessible device with camera and microphone facilities such as a smartphone, laptop, tablet or PC
- Access to weighing scales and a tape measure to self-report weight and waist measurements.
Exclusion Criteria:
- Current pregnancy
- Not fluent in English at a level that would allow them to participate in a group
- Not willing to be randomised
- Not willing to be part of a group
- Not able to complete baseline data
- Unable to give informed consent
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Functional Imagery training
Control
Arm Description
The FIT sessions will occur weekly for four weeks and last an hour per session. The sessions will be conducted over Zoom. Sessions will be facilitated by the PI who is trained in FIT, and attended by 4 participants.
The control condition will ask participants to complete the 12 week NHS weight loss plan.
Outcomes
Primary Outcome Measures
Body mass index (BMI) change
kg/m2 where kg is a person's weight in kilograms and m2 is their height in metres squared
waist circumference change
Measured in centimetres
Secondary Outcome Measures
EQ-5D-5L change (EuroQol-5D-5L)
Questionnaire score maximum 25, minimum 5, lower scores refer to better outcomes.
ICECAP-A change (ICEpop CAPability measure for Adults)
Questionnaire score, maximum 20 minimum 5, higher scores refer to better outcomes.
Health economics change
Descriptive score derived from a survey of service use
Full Information
NCT ID
NCT04953299
First Posted
June 19, 2021
Last Updated
September 28, 2021
Sponsor
University of Plymouth
Collaborators
National Institute for Health Research, United Kingdom
1. Study Identification
Unique Protocol Identification Number
NCT04953299
Brief Title
Investigating Remote Access, Group-based Functional Imagery Training in the Community
Official Title
Randomised Control Trial of Remote Access, Group-based Functional Imagery Training Versus NHS 12 Week Online Programme in the Community
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 2021 (Anticipated)
Primary Completion Date
October 2021 (Anticipated)
Study Completion Date
October 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Plymouth
Collaborators
National Institute for Health Research, United Kingdom
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The rise in obesity over the last two decades has led to an increased need to support individuals to lose weight but also reduce costs for healthcare settings. A review of group interventions for those with severe obesity concluded that group interventions are not only cost effective but also have good outcomes in terms of weight loss. A systematic review of individual and group based interventions for treating obesity found that group interventions were more effective but that the domain needed to be further explored.
Functional Imagery Training is a theoretically informed intervention that utilises client's intrinsic motivation to elicit effective behaviour change. It has drawn upon aspects of motivational interviewing and the use of imagery to develop an intervention that has been effective in many aspects including maintained weight loss when used on a 1:1 basis.
The investigators will conduct a Randomised Control Trial to test group-based delivery of FIT using the virtual platform Zoom versus the NHS 12 week online program as the current standard of what individuals seeking to lose weight can access independently.
Detailed Description
In England two thirds of the population are overweight, as defined by a body mass index (BMI) of 25 kg/m2 or more and nearly half of these have obesity as defined by a BMI of 30 kg/m-2 or more. Subsequently healthcare costs increase alongside the increasing prevalence of obesity and overweight with approximately 1.8% of the National Health Services (NHS) government budget and around 7.1% of all deaths being attributed to elevated BMI in 2014. Alongside the increased health risk associated with obesity, perceived quality of life declines also with increasing BMI. Tackling the obesity epidemic could therefore lead to better physical and mental health amongst a high proportion of the population.
The rise in obesity over the last two decades has led to an increased need to support individuals to lose weight but also reduce intervention costs. A review of group interventions for tier 3 services (severe obesity/ those with co-morbidities) found that group interventions are a cost effective method of treatment which demonstrate good results in terms of weight loss. Including the role of behaviour change in weight management is vital in ensuring the adoption and maintenance of new, long term skills which will help support maintaining weight loss.
Functional Imagery Training (FIT) is a theoretically informed intervention that utilises clients' intrinsic motivation and mental imagery to elicit effective behaviour change. It uses the well- established, person-centred approach of motivational interviewing. The mental imagery exercises are designed to strengthen motivation, consolidate plans for change, and build the person's confidence that they can succeed. Research demonstrates the emotive power of mental imagery and the shift from short-term rewards to longer term goals. Delivered face to face, one-to-one, FIT has been shown to elicit behaviour changes to support weight loss over a sustained period of 12 months. The investigators conducted a randomised controlled trial of one-to-one FIT compared to motivational interviewing which demonstrated those in the FIT group experienced greater weight loss at 6 months post-allocation compared to the motivational interview group and continued weight loss for the FIT group only at 12m, 6 months after intervention ended. There is a need to establish if FIT remains efficacious and cost-effective when delivered to groups.
The investigators will conduct a randomised control trial to test group-based delivery of FIT using the virtual platform Zoom. The current climate surrounding the increased need for remote-accessed services has allowed the investigators to explore the potential use of FIT online. There are many benefits to remote access interventions including reduced costs and travel time for the patients, more convenience and flexibility for patients and the reduced amount of clinic time for practitioners and patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss, Health Economics, Quality of Life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two groups of participants- one acts a control group and accesses the NHS 12 week programme the other group receives the FIT intervention.
Masking
Outcomes Assessor
Masking Description
The participants will not be masked to group allocation, data collection will be completed by a student apprentice blind to condition.
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Functional Imagery training
Arm Type
Experimental
Arm Description
The FIT sessions will occur weekly for four weeks and last an hour per session. The sessions will be conducted over Zoom. Sessions will be facilitated by the PI who is trained in FIT, and attended by 4 participants.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
The control condition will ask participants to complete the 12 week NHS weight loss plan.
Intervention Type
Behavioral
Intervention Name(s)
Functional Imagery training
Intervention Description
Behavioural intervention focused upon motivation and reaching achievable goals.
Intervention Type
Behavioral
Intervention Name(s)
NHS 12 week weight loss programme
Intervention Description
The plan is designed to help individuals lose weight at a safe rate of 0.5kg to 1kg (1lb to 2lb) each week by sticking to a daily calorie allowance and introducing exercise.
Primary Outcome Measure Information:
Title
Body mass index (BMI) change
Description
kg/m2 where kg is a person's weight in kilograms and m2 is their height in metres squared
Time Frame
Change in BMI from baseline to 12 months
Title
waist circumference change
Description
Measured in centimetres
Time Frame
Change in waist circumference from baseline to 12 months
Secondary Outcome Measure Information:
Title
EQ-5D-5L change (EuroQol-5D-5L)
Description
Questionnaire score maximum 25, minimum 5, lower scores refer to better outcomes.
Time Frame
Change in EQ-5D-5L score from baseline to 12 months
Title
ICECAP-A change (ICEpop CAPability measure for Adults)
Description
Questionnaire score, maximum 20 minimum 5, higher scores refer to better outcomes.
Time Frame
Change in ICECAP-A score from baseline to 12 months
Title
Health economics change
Description
Descriptive score derived from a survey of service use
Time Frame
Change in service use from baseline to 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged over 18 years
BMI over 30 kg/m2
Access to an internet accessible device with camera and microphone facilities such as a smartphone, laptop, tablet or PC
Access to weighing scales and a tape measure to self-report weight and waist measurements.
Exclusion Criteria:
Current pregnancy
Not fluent in English at a level that would allow them to participate in a group
Not willing to be randomised
Not willing to be part of a group
Not able to complete baseline data
Unable to give informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah Greene, Bsc, Ma
Phone
07496923808
Email
sarah.greene@plymouth.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Prof. Jackie Andrade
Email
jackie.andrade@plymouth.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah Greene, Bsc, Ma
Organizational Affiliation
University of Plymouth
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymised data will be made available including BMI, waist measurement, questionnaire responses and interview transcripts.
IPD Sharing Time Frame
The data will be available once all the data has been analysed and submitted to a peer reviewed journal for publication. The full anonymised data set will then be available indefinitely.
IPD Sharing Access Criteria
The anonymised data will be open-access.
Citations:
PubMed Identifier
30185920
Citation
Solbrig L, Whalley B, Kavanagh DJ, May J, Parkin T, Jones R, Andrade J. Functional imagery training versus motivational interviewing for weight loss: a randomised controlled trial of brief individual interventions for overweight and obesity. Int J Obes (Lond). 2019 Apr;43(4):883-894. doi: 10.1038/s41366-018-0122-1. Epub 2018 Sep 5.
Results Reference
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Investigating Remote Access, Group-based Functional Imagery Training in the Community
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