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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
University of Plymouth
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Weight Loss

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    June 19, 2021
    Last Updated
    September 28, 2021
    Sponsor
    University of Plymouth
    Collaborators
    National Institute for Health Research, United Kingdom
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    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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