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
Protocol serial number 15046
Sponsor University of Leicester (UK)
Funder Seventh Framework Programme
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

jk208@leicester.ac.uk

Study information

Primary study designInterventional
Study designRandomised; Interventional; Design type: Process of Care
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific titleA cluster randomised controlled trial of a tailored intervention to improve the management of obesity/overweight in primary care
Study acronymTIGO - A tailored cluster RCT intervention
Study objectivesThe 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) studiedTopic: Primary Care Research Network for England; Subtopic: Not Assigned; Disease: All Diseases
InterventionAssessment 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 typeOther
Primary outcome measure(s)

Adherance to the NICE guidelines; Timepoint(s): The primary outcome is the proportion of overweight or obese patients for which the general practiti

Key secondary outcome measure(s)

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

Completion date01/11/2013

Eligibility

Participant type(s)Patient
Age groupAdult
SexAll
Target sample size at registration28
Key inclusion criteriaAll 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 criteriaGeneral practices outside EMSY net will be excluded.
Date of first enrolment02/09/2013
Date of final enrolment01/11/2013

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Department of Health Sciences
Leicester
LE1 6TP
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 27/05/2016 Yes No
Protocol article protocol 19/03/2014 Yes No
HRA research summary 28/06/2023 No No
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes

Editorial Notes

31/05/2016: Publication reference added.

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