Investigating Remote Access, Group-based Functional Imagery Training in the Community

Randomised Control Trial of Remote Access, Group-based Functional Imagery Training Versus NHS 12 Week Online Programme in the Community

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Quality of Life; Weight Loss; Health Economics
• Intervention / Treatment: Behavioral: Functional Imagery training; Behavioral: NHS 12 week weight loss programme

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.

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sarah Greene, Bsc, Ma; Phone Number: 07496923808; Email: sarah.greene@plymouth.ac.uk
• Study Contact Backup: Name: Prof. Jackie Andrade; Email: jackie.andrade@plymouth.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Functional Imagery training; 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.	Behavioral: Functional Imagery training; Behavioural intervention focused upon motivation and reaching achievable goals.
Active Comparator: Control; The control condition will ask participants to complete the 12 week NHS weight loss plan.	Behavioral: NHS 12 week weight loss programme; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body mass index (BMI) change	kg/m2 where kg is a person's weight in kilograms and m2 is their height in metres squared	Change in BMI from baseline to 12 months
waist circumference change	Measured in centimetres	Change in waist circumference from baseline to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EQ-5D-5L change (EuroQol-5D-5L)	Questionnaire score maximum 25, minimum 5, lower scores refer to better outcomes.	Change in EQ-5D-5L score from baseline to 12 months
ICECAP-A change (ICEpop CAPability measure for Adults)	Questionnaire score, maximum 20 minimum 5, higher scores refer to better outcomes.	Change in ICECAP-A score from baseline to 12 months
Health economics change	Descriptive score derived from a survey of service use	Change in service use from baseline to 12 months

Collaborators and Investigators

• Sponsor: University of Plymouth
• Collaborators: National Institute for Health Research, United Kingdom
• Investigators: Principal Investigator: Sarah Greene, Bsc, Ma, University of Plymouth

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2021
• Primary Completion (Anticipated): October 1, 2021
• Study Completion (Anticipated): October 1, 2022

Study Registration Dates

• First Submitted: June 19, 2021
• First Submitted That Met QC Criteria: July 6, 2021
• First Posted (Actual): July 7, 2021

Study Record Updates

• Last Update Posted (Actual): September 29, 2021
• Last Update Submitted That Met QC Criteria: September 28, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss
• Other Study ID Numbers: FITRCT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No