Weight LossNCT04953299
Investigating Remote Access, Group-based Functional Imagery Training in the Community
A study testing Functional Imagery training and NHS 12 week weight loss programme in people with Weight Loss and Health Economics, run by University of Plymouth.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Weight Loss, Health Economics, Quality of Life
- What is being tested?
- Functional Imagery training and NHS 12 week weight loss programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Oct 2021to Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
Prof. Jackie Andrade contact
About this study
Official title: 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.
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.
- Conditions
- Weight Loss, Health Economics, Quality of Life
- Being tested
- Functional Imagery training, NHS 12 week weight loss programme
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Imagery trainingBehavioural
Behavioural intervention focused upon motivation and reaching achievable goals.
NHS 12 week weight loss programmeBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Functional Imagery training | Experimental | 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. Receives: Behavioral: Functional Imagery training |
| Control | Active comparator | The control condition will ask participants to complete the 12 week NHS weight loss plan. Receives: Behavioral: NHS 12 week weight loss programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body mass index (BMI) change
kg/m2 where kg is a person's weight in kilograms and m2 is their height in metres squared
Measured: Change in BMI from baseline to 12 months
waist circumference change
Measured in centimetres
Measured: Change in waist circumference from baseline to 12 months
Secondary outcomes (3)
EQ-5D-5L change (EuroQol-5D-5L)
Questionnaire score maximum 25, minimum 5, lower scores refer to better outcomes.
Measured: 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.
Measured: Change in ICECAP-A score from baseline to 12 months
Health economics change
Descriptive score derived from a survey of service use
Measured: Change in service use from baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2021
- Study startOct 2021 (estimated)
- Primary completionOct 2021 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Weight LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Plymouth
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Responsible party
- Principal investigator, Sarah Greene, University of Plymouth
- Investigators
- Sarah Greene, Bsc, Ma, Principal investigator, University of Plymouth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04953299
- Sponsor's protocol ID
- FITRCT
- Status last verified
- Sep 2021
- First submitted
- 19 Jun 2021
- Last updated
- 29 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised data will be made available including BMI, waist measurement, questionnaire responses and interview transcripts.
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
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Control Trial of Remote Access, Group-based Functional Imagery Training Versus NHS 12 Week Online Programme in the Community
- ClinicalTrials.gov ID
- NCT04953299
- Acronym / sponsor ID
- FITRCT
- Conditions
- Weight Loss, Health Economics, Quality of Life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of PlymouthUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- Oct 2021 (estimated)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 7 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Functional Imagery training | Experimental | Behavioral: Functional Imagery trainingThe 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. |
| Control | Active comparator | Behavioral: NHS 12 week weight loss programmeThe control condition will ask participants to complete the 12 week NHS weight loss plan. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional Imagery trainingBehavioural intervention focused upon motivation and reaching achievable goals. | Behavioural | Functional Imagery training |
| NHS 12 week weight loss programmeThe 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. | Behavioural | Control |
Primary outcome
Body mass index (BMI) change
Time frame: Change in BMI from baseline to 12 months
kg/m2 where kg is a person's weight in kilograms and m2 is their height in metres squared
waist circumference change
Time frame: Change in waist circumference from baseline to 12 months
Measured in centimetres
3 secondary outcomes
EQ-5D-5L change (EuroQol-5D-5L)
Time frame: Change in EQ-5D-5L score from baseline to 12 months
ICECAP-A change (ICEpop CAPability measure for Adults)
Time frame: Change in ICECAP-A score from baseline to 12 months
Health economics change
Time frame: Change in service use from baseline to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
- Background: PubMed 30185920Solbrig 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.
- Individual participant dataSharing planned: Yes. Anonymised data will be made available including BMI, waist measurement, questionnaire responses and interview transcripts.
Related trials for Weight Loss
Not yet recruitingPhase 1/2
Tocilizumab Combined With First-Line Chemo-Immunotherapy in Metastatic Non-Small Cell Lung Cancer
Metastatic Non-Small Cell Lung Cancer, Cancer-Associated Weight Loss
Recruiting
Dry Weight Reduction Intervention Via Extra Ultrafiltration
Fluid Accumulation, Blood Pressure Management
Not yet recruiting
Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents
Binge Eating Disorder, Binge Eating
Not yet recruitingPhase 3
SYNCHRONIZE®-HERA: A Study to Test Whether Survodutide Helps Women Who Are Living With Overweight or Obesity and Are Going Through or Have Finished Menopause, to Lose Weight
Obesity
Active, not recruitingPhase 2
Effects of Brain Stimulation on Food Intake and Behavioral Weight Loss Treatment
Electric Stimulation Therapy, Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof. Jackie Andrade contact
Sarah Greene, Bsc, Ma principal investigator
University of Plymouth
Questions about this trial
What is this clinical trial studying?
A study testing Functional Imagery training and NHS 12 week weight loss programme in people with Weight Loss and Health Economics, run by University of Plymouth.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sarah Greene, Bsc, Ma (07496923808, sarah.greene@plymouth.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body mass index (BMI) change (time frame: Change in BMI from baseline to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04953299, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2021.