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

NCT04953299 | Unknown

• 1 other identifier: FITRCT
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Weight Loss; Health Economics; Quality of Life

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• EQ-5D-5L change (EuroQol-5D-5L)

  Change in EQ-5D-5L score from baseline to 12 months

• ICECAP-A change (ICEpop CAPability measure for Adults)

  Change in ICECAP-A score from baseline to 12 months

• Health economics change

  Change in service use from baseline to 12 months

Study Arms (2)

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.

Behavioral: Functional Imagery training

Control

ACTIVE COMPARATOR

The control condition will ask participants to complete the 12 week NHS weight loss plan.

Behavioral: NHS 12 week weight loss programme

Interventions

Functional Imagery training BEHAVIORAL

Behavioural intervention focused upon motivation and reaching achievable goals.

Functional Imagery training

NHS 12 week weight loss programme BEHAVIORAL

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.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Plymouth: lead
• National Institute for Health Research, United Kingdom: collaborator

Related Publications (1)

• 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.

  PMID: 30185920 BACKGROUND

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sarah Greene, Bsc, Ma

  University of Plymouth

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Greene, Bsc, Ma

CONTACT

07496923808; sarah.greene@plymouth.ac.uk

Prof. Jackie Andrade

CONTACT

jackie.andrade@plymouth.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The participants will not be masked to group allocation, data collection will be completed by a student apprentice blind to condition.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Two groups of participants- one acts a control group and accesses the NHS 12 week programme the other group receives the FIT intervention.

Study Record Dates

• First Submitted: June 19, 2021
• First Posted: July 7, 2021
• Study Start: October 1, 2021
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2022
• Last Updated: September 29, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• 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.
• Access Criteria: The anonymised data will be open-access.