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临床试验/NCT04953299
NCT04953299Unknown不适用

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

University of Plymouth0 个研究点目标入组 150 人开始时间: 2021年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
150
主要终点
Body mass index (BMI) change

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

The participants will not be masked to group allocation, data collection will be completed by a student apprentice blind to condition.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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

研究组 & 干预措施

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.

干预措施: Functional Imagery training (Behavioral)

Control

Active Comparator

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

干预措施: NHS 12 week weight loss programme (Behavioral)

结局指标

主要结局

Body mass index (BMI) change

时间窗: 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

时间窗: Change in waist circumference from baseline to 12 months

Measured in centimetres

次要结局

  • 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)
  • EQ-5D-5L change (EuroQol-5D-5L)(Change in EQ-5D-5L score from baseline to 12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sarah Greene

Principal Investigator

University of Plymouth

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