CClinicalTrials.gg
Status unknownNCT04953299Updated Sep 29, 2021

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

An interventional study of Functional Imagery training and NHS 12 week weight loss programme in Weight Loss, Health Economics and Quality of Life, sponsored by University of Plymouth. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-29.

Sponsored by University of Plymouth · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Weight Loss
  • Health Economics
  • Quality of Life

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03

In context

Weight Loss

1,766 studies on the registry are indexed under Weight Loss; 277 are open to participants now.

This study's planned enrollment of 150 is above the median of 73 across 1,496 interventional studies indexed under Weight Loss.

Browse Weight Loss studies →

Lead sponsor

University of Plymouth is the lead sponsor of 46 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
150 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • BehavioralFunctional Imagery training

    Behavioural intervention focused upon motivation and reaching achievable goals.

  • BehavioralNHS 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.

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What researchers measure

Primary outcomes

  1. Body mass index (BMI) change

    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

  2. waist circumference change

    Measured in centimetres

    Time frame: Change in waist circumference from baseline to 12 months

Secondary outcomes

  1. EQ-5D-5L change (EuroQol-5D-5L)

    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

  2. ICECAP-A change (ICEpop CAPability measure for Adults)

    Questionnaire score, maximum 20 minimum 5, higher scores refer to better outcomes.

    Time frame: Change in ICECAP-A score from baseline to 12 months

  3. Health economics change

    Descriptive score derived from a survey of service use

    Time frame: Change in service use from baseline to 12 months

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Study locations

No study locations are listed for this record.

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References and documents

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. PubMed 30185920 ↗

Individual participant data

Plan to share: Yes — Anonymised data will be made available including BMI, waist measurement, questionnaire responses and interview transcripts.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 29, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04953299
Lead sponsor
University of Plymouth
Collaborators
National Institute for Health Research, United Kingdom
Responsible party
Sarah Greene (Principal Investigator, University of Plymouth) — Principal investigator
First posted
Jul 7, 2021
Start date
Oct 2021 (estimated)
Primary completion
Oct 2021 (estimated)
Completion
Oct 2022 (estimated)
Last update
Sep 29, 2021

Study contacts

Sarah Greene, Bsc, Ma
Contact
sarah.greene@plymouth.ac.uk
07496923808
Prof. Jackie Andrade
Contact
jackie.andrade@plymouth.ac.uk
Sarah Greene, Bsc, Ma
principal investigator · University of Plymouth

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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