Condition category
Nutritional, Metabolic, Endocrine
Date applied
27/04/2012
Date assigned
27/04/2012
Last edited
08/09/2015
Prospective/Retrospective
Retrospectively 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

University of Leicester
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

12024

Study information

Scientific title

Tailored implementation of guidelines for obesity barriers study: a randomised controlled trial

Acronym

Study hypothesis

The aim of our study is to improve the quality of obesity care delivered by health professionals and teams. Traditional interventions such as educational sessions related to the NICE guidelines on obesity have only limited effectiveness. We plan to develop 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. However, methods for identifying the most important barriers health professionals face in delivering appropriate care are not well developed. Therefore, we need to evaluate and test different methods for identifying barriers and enablers for improving obesity care. A wide range of methods can be used to identify barriers and enablers.
The methods we plan to use are:
1. Brainstorming with health professionals (two sessions with between 610 participants)
2. Focus groups with health professionals (two sessions with between 610 participants
3. Interviews of health professionals (a minimum of 8 professionals)
4. Interviews with patients (a minimum of 8 patients)
5. Questionnaire based on a checklist

These methods will be used in head to head comparisons for each chronic condition (in England, primary care management of obesity) in order to evaluate which methods are most appropriate to use, and to which contexts and settings they are most applicable. The comparisons will to some extent be designed as diagnostic studies, the methods being compared on the extent to which they identify all the barriers and enablers. The analysis will compare methods in terms of process (the time, resources and expertise required), and outcomes (the range and completeness of barriers and enablers identified.

More details can be found at http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=12024

Ethics approval

ref: 12/NW/0106

Study design

Randomised interventional trial

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 the contact details below to request a patient information sheet

Condition

Obesity

Intervention

Management of Obesity: this project aims to assess the management of obesity within primary care, and to identify the barriers and enablers to care.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Assess the barriers and enablers to obesity care within the NHS

Secondary outcome measures

No secondary outcome measures

Overall trial start date

30/03/2012

Overall trial end date

31/05/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Health professionals invited to participate in the study will be a mix of male and female participants, participants with a range of work experience, both in duration and a mix of clinical workers and managers.
2. A mix of health professionals will be used in order to ensure the perspectives of different groups are obtained, for example, doctors, nurses, dietitians etc. at different grade levels.
3. The patients should currently be receiving or have previously received weight reduction treatment.
4. Patients with different stages of the condition, different ages, gender, social status and so forth
5. Male and female participants
6. Minimum age 18 years

Participant type

Mixed

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 350; UK Sample Size: 350

Participant exclusion criteria

1. Health professionals who have no exeperiance in delivering weight management care
2. Patients who have not recently been treated for weight reduction

Recruitment start date

30/03/2012

Recruitment end date

31/05/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Leicester
Leicester
LE1 6TP
United Kingdom

Sponsor information

Organisation

University of Leicester (UK)

Sponsor details

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

Sponsor type

University/education

Website

http://www2.le.ac.uk/

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

Publication citations

Additional files

Editorial Notes