Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12618000331235
Ethics application status
Approved
Date submitted
28/02/2018
Date registered
6/03/2018
Date last updated
6/03/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A Community Jury on initiating weight management conversations in Primary Care
Scientific title
A Community Jury on initiating weight management conversations in Primary Care
Secondary ID [1] 294192 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 306824 0
Condition category
Condition code
Public Health 305932 305932 0 0
Health promotion/education
Diet and Nutrition 305955 305955 0 0
Obesity

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
We will conduct a community jury (CJ) to elicit informed community preferences for GPs initiating conversations about weight management in primary care. This Community Jury will consider two interconnected questions about potential provision of weight management advice within primary care. Firstly, should GPs be initiating discussions about weight management? And secondly, if so, when: a) opportunistically, b) in the context of disease prevention, c) in the context of disease management or d) other?

The CJ will consist of one group of 15 participants and will be facilitated by Dr Rae Thomas, a Psychologist with over 20 years experience. We will conduct the Community Jury over two days (Saturday and Sunday). On Day 1, following consent, participants will complete a brief pre-jury survey. We will provide the participants with expert presenter biographies and handouts of their presentations. The participants will listen to a 20-minute voice-over-power point presentation from experts with a further 10 minutes after each presentation for questions and answers directly to the experts via mobile phone. Participants will hear presentations from experts in obesity, primary care, and weight management. The first expert will provide a scientific overview of obesity. The second will present an overview of the available resources and services for weight management in the Gold Coast. The third and fourth experts will represent differing views on whether GPs should be initiating these conversations; one will present in support of this and the other will present against.

The presentations will be followed by a facilitated discussion to elicit participants’ reflections and responses to the information presented. These discussions will be led by an experienced facilitator (RT), who will facilitate discussion, ensure all participants have an equal chance to voice opinions, record questions, and note any participant concerns.

At the start of Day 2 the jury will be asked to reflect on the discussions from Day 1 and to put forward any additional questions for the experts. The experts will provide answers to any identified questions via speaker-phone. The jury will then deliberate without a facilitator present on the 2 questions put to the jury about initiating conversations about weight management within primary care. Participants will deliberate until a consensus or impasse is reached and present their decision to the facilitator and researchers.
Intervention code [1] 300484 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 304964 0
Our primary outcome will be juror recommendations for the posed question: should GPs be initiating discussions about weight management? This will be assessed through transcribed audio recordings of the recommendations presented by the jury at the end of the 2 days. Reasons for the recommendation and the mechanisms and dynamic processes of the community jury will be explored using thematic analysis.
Timepoint [1] 304964 0
End of Community jury (i.e. after two days of presentations and deliberation)
Secondary outcome [1] 343756 0
The time point at which jurors achieve consistency in their individual responses to the jury question (i.e. enough information has been given for the jury to no longer change their answer). Individual responses to the primary jury question: Should GPs be initiating discussions about weight management? will be recorded throughout the weekend. Responses will be on a 5 point Likert Scale from 1 (Strongly Disagree) to 5 (Strongly Agree).
Timepoint [1] 343756 0
End of Community jury (i.e. after two days of presentations and deliberation)
Secondary outcome [2] 343757 0
Desire for a discussion about weight management to be initiated with participants by their GP. Throughout the weekend, participants will be asked if they would want their GP to initiate a discussion about weight management with them, with responses on a 5 point Likert Scale from 1 (Strongly Disagree) to 5 (Strongly Agree).
Timepoint [2] 343757 0
End of Community jury (i.e. after two days of presentations and deliberation).
Secondary outcome [3] 343758 0
Knowledge about obesity and weight management in primary care will be assessed through a survey designed specifically for this study.
Timepoint [3] 343758 0
End of Community jury (i.e. after two days of presentations and deliberation).
Secondary outcome [4] 343759 0
Attitudes towards GPs initiating conversations about weight management will be assessed through a survey designed specifically for this study.
Timepoint [4] 343759 0
End of Community Jury (i.e. after two days of presentations and deliberation).

Eligibility
Key inclusion criteria
Individuals with a body mass index greater than or equal to 25 (Calculated from self-reported heights and weights), as this is the clinically determined cut-off for overweight.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(i) unable to provide informed consent due to mental incapacity or active psychotic illness, or (ii) unable to speak or understand English.

Study design
Purpose
Psychosocial
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Quantitative and qualitative analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
9/03/2018
Actual
Date of last participant enrolment
Anticipated
10/03/2018
Actual
Date of last data collection
Anticipated
11/03/2018
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 298823 0
Government body
Name [1] 298823 0
Australia Endeavour Award
Country [1] 298823 0
Australia
Funding source category [2] 298824 0
Government body
Name [2] 298824 0
NHMRC
Country [2] 298824 0
Australia
Funding source category [3] 298825 0
Charities/Societies/Foundations
Name [3] 298825 0
Yorkshire Cancer Research University Academic Fellowship
Country [3] 298825 0
United Kingdom
Primary sponsor type
University
Name
Bond University
Address
14 University Drive, Robina Queensland 4226
Country
Australia
Secondary sponsor category [1] 298021 0
None
Name [1] 298021 0
Address [1] 298021 0
Country [1] 298021 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299772 0
Bond University Human Research Ethics Committee
Ethics committee address [1] 299772 0
Ethics committee country [1] 299772 0
Australia
Date submitted for ethics approval [1] 299772 0
Approval date [1] 299772 0
16/01/2018
Ethics approval number [1] 299772 0

Summary
Brief summary
There is a growing body of evidence that identifies obesity as a major risk factor for a number of diseases, including Type 2 diabetes, cardiovascular disease and some cancers. In Australia, the prevalence of overweight and obesity has been increasing; 63% of adults were classed as overweight or obese in 2014-15, up from 57% in 1995. The National Health and Medical Research Council clinical practice guidelines for the management of overweight and obesity in adults, adolescents and children in Australia identifies primary care as playing an important role in weight management. Obesity has also recently been classified as a disease by the Royal Australian College of General Practice (RACGP), and there are increasing calls for primary care to screen for overweight and obesity. Previous studies suggest few patients attending general practice in Australia are weighed, and few at risk patients are given advice or referred to other services. Identified barriers include concerns about upsetting patients and perceptions that effective interventions are lacking. Few studies have evaluated the impact of weight management interventions delivered by primary care practitioners, but there is some evidence that GP referrals to programmes outside of the primary care setting can be effective, though studies are limited. Initiating weight management conversations in primary care is therefore a controversial issue, and there is a need to explore the views of those directly affected by overweight and obesity. Community Juries are a deliberative democracy technique that involve providing a jury, made up of community members, with expert information about both sides of a controversial issue. The jury then deliberate amongst themselves, and are asked to form a consensus or majority “verdict” on the topic question, which can influence health policy decision-making.
The aim of this Community Jury is to elicit the views of well-informed people with overweight and obesity about the role of GPs in initiating conversations about weight management.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 81518 0
Dr Rebecca Beeken
Address 81518 0
Leeds Institute of Health Sciences
University of Leeds
Level 10, Worsley Building,
Clarendon Way,
Leeds, LS2 9NL
Country 81518 0
United Kingdom
Phone 81518 0
+44 113 343 3228
Fax 81518 0
Email 81518 0
[email protected]
Contact person for public queries
Name 81519 0
Dr Rebecca Beeken
Address 81519 0
Leeds Institute of Health Sciences
University of Leeds
Level 10, Worsley Building,
Clarendon Way,
Leeds, LS2 9NL
Country 81519 0
United Kingdom
Phone 81519 0
+44 113 343 3228
Fax 81519 0
Email 81519 0
[email protected]
Contact person for scientific queries
Name 81520 0
Dr Rebecca Beeken
Address 81520 0
Leeds Institute of Health Sciences
University of Leeds
Level 10, Worsley Building,
Clarendon Way,
Leeds, LS2 9NL
Country 81520 0
United Kingdom
Phone 81520 0
+44 113 343 3228
Fax 81520 0
Email 81520 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.