Contact information
Type
Scientific
Primary contact
Dr Jane Krause
ORCID ID
Contact details
Department of Health Sciences
22-28 Princess Road West
Leicester
LE1 6TP
United Kingdom
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jk208@leicester.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
15046
Study information
Scientific title
A cluster randomised controlled trial of a tailored intervention to improve the management of obesity/overweight in primary care
Acronym
TIGO - A tailored cluster RCT intervention
Study hypothesis
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
13/LO/1157
Study design
Randomised; Interventional; Design type: Process of Care
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Quality of life
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
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 trial start date
02/09/2013
Overall trial end date
01/11/2013
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 28; UK Sample Size: 28
Participant exclusion criteria
General practices outside EMSY net will be excluded.
Recruitment start date
02/09/2013
Recruitment end date
01/11/2013
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Health Sciences
Leicester
LE1 6TP
United Kingdom
Funders
Funder type
Government
Funder name
Seventh Framework Programme
Alternative name(s)
EC Seventh Framework Programme, European Commission Seventh Framework Programme, EU Seventh Framework Programme, European Union Seventh Framework Programme, FP7
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24641767
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27233633
Publication citations
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Protocol
Krause J, Agarwal S, Bodicoat DH, Ring A, Shepherd D, Rogers S, Wensing M, Baker R, Evaluation of a tailored intervention to improve management of overweight and obesity in primary care: study protocol of a cluster randomised controlled trial., Trials, 2014, 15, 82, doi: 10.1186/1745-6215-15-82.
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Results
Goodfellow J, Agarwal S, Harrad F, Shepherd D, Morris T, Ring A, Walker N, Rogers S, Baker R, Cluster randomised trial of a tailored intervention to improve the management of overweight and obesity in primary care in England, Implement Sci, 2016 , 11, 1, 77.