A cluster randomised controlled trial of a tailored intervention to improve the management of obesity/overweight in primary care

ISRCTN	ISRCTN07457585
DOI	https://doi.org/10.1186/ISRCTN07457585
Secondary identifying numbers	15046

Submission date: 09/08/2013
Registration date: 09/08/2013
Last edited: 31/05/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Jane Krause
Scientific

Department of Health Sciences
22-28 Princess Road West
Leicester
LE1 6TP
United Kingdom

Email	jk208@leicester.ac.uk

Study information

Study design	Randomised; Interventional; Design type: Process of Care
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	GP practice
Study type	Quality of life
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet
Scientific title	A cluster randomised controlled trial of a tailored intervention to improve the management of obesity/overweight in primary care
Study acronym	TIGO - A tailored cluster RCT intervention
Study objectives	The aim of our study is to improve the quality of obesity care delivered by primary healthcare teams. Traditional interventions such as educational sessions for healthcare professionals related to NICE guidelines on obesity have only limited effectiveness. We have developed valid, feasible and efficient methods of tailoring implementation to the treatment of obesity. Tailoring involves designing an intervention to overcome the specific limiting factors or barriers experienced by a particular group of health care professionals to providing improved health care, which in this case is care in accordance with the NICE guidelines for Obesity. This study has developed and will examine a tailored intervention of improving the implementation of the NICE guidelines for Obesity in primary care practices.
Ethics approval(s)	13/LO/1157
Health condition(s) or problem(s) studied	Topic: Primary Care Research Network for England; Subtopic: Not Assigned; Disease: All Diseases
Intervention	Assessment of lifestyle, determinants addressed: 1. Ways to assess willingness to change 2. Resources to motivate and inform patients In order for a weight loss intervention to be successful the patient needs to be ready and willing to make changes to their lifestyle. If the patient is not ready and willing to do so, it is likely the intervention will fail. The NICE guidelines recommend that health care professionals assess a patients lifestyle, co-morbidities and willingness to change. This can be difficult to as; Determining overweight/obesity, Determinants addressed: 1. Acceptable ways to raise and discuss the issue of weight with patients 2. How to effectively measure waist circumference The issue of raising weight with patients is complex, and if raised inappropriately patients are often resistant to discuss their weight or follow a proposed weight loss intervention. Our previous study found that health care professionals found it difficult to find acceptable ways to raise the issue of weight with patients. The intervention aims; Management, Determinants addressed: 1. Lack of prescriptive information 2. Lack of knowledge Many patients felt that they were aware of the concept of healthy eating, and the need to reduce their calorie intake in order to lose weight. But they felt more prescriptive advice would be of benefit. Patients interviewed in study 2 felt that the advice provided by commercial slimming clubs on portion sizes and guidance on a more prescriptive diet would be beneficial. The intervention will provide health care professionals; Ongoing support, We will also offer intervention teams monthly telephone calls with the obesity lead and provide practices with a closed list of contacts to enable them to create a support network with other intervention teams.; Referral, Determinants addressed: 1. Lack of information on referral pathways There are many community run programmes and initiatives in primary care to improve health and assist weight loss. Some of these programmes are available for patients to self-refer into, while others require a referral from a health care professional. Study 2 found that many health care professionals were not aware of the services on offer and how to refer patients to them. The intervention aims to provide health care professionals; Follow Up Length: 9 month(s); Study Entry : Registration and One or More Randomisations
Intervention type	Other
Primary outcome measure	Adherance to the NICE guidelines; Timepoint(s): The primary outcome is the proportion of overweight or obese patients for which the general practiti
Secondary outcome measures	1. Lifestyle assessment: The proportion of patients with a record of lifestyle assessment 2. Percentage weight loss: The percentage of obese patients who change weight (lost or gained) over the intervention period 3. Referral: Referral to external weight loss services 4. Weight change: The mean weight change per patient over the intervention period
Overall study start date	02/09/2013
Completion date	01/11/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	Planned Sample Size: 28; UK Sample Size: 28
Key inclusion criteria	All general practices in EMSY net will be invited to participate in the study. Primary care teams must have an up-to-date knowledge of obesity and be aware of the NICE recommendations for the treatment of overweight and obesity in adults. Target Gender: Male & Female; Upper Age Limit 85 years ; Lower Age Limit 16 years
Key exclusion criteria	General practices outside EMSY net will be excluded.
Date of first enrolment	02/09/2013
Date of final enrolment	01/11/2013

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Department of Health Sciences

Leicester
LE1 6TP
United Kingdom

Sponsor information

University of Leicester (UK)
University/education

Gwendolen Road
Leicester
LE5 4PW
England
United Kingdom

"ROR"	https://ror.org/04h699437

Funders

Funder type

Government

Seventh Framework Programme
Government organisation / National government

Alternative name(s): EC Seventh Framework Programme, European Commission Seventh Framework Programme, EU Seventh Framework Programme, European Union Seventh Framework Programme, FP7

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	19/03/2014		Yes	No
Results article	results	27/05/2016		Yes	No
HRA research summary			28/06/2023	No	No

Editorial Notes

31/05/2016: Publication reference added.