Condition category
Nutritional, Metabolic, Endocrine
Date applied
09/08/2013
Date assigned
09/08/2013
Last edited
31/05/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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
-
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 patient’s 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

Sponsor information

Organisation

University of Leicester (UK)

Sponsor details

Gwendolen Road
Leicester
LE5 4PW
United Kingdom

Sponsor type

University/education

Website

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

Belgium

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

  1. 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.

  2. 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.

Additional files

Editorial Notes

31/05/2016: Publication reference added.