Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001021662
Ethics application status
Approved
Date submitted
31/07/2014
Date registered
24/09/2014
Date last updated
24/09/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Better management of weight in general practice
Scientific title
Impact on obese patients with low health literacy of general practice nurse delivered “prevention navigation” on patient-reported receipt of weight loss advice and referral, health literacy and lifestyle behaviours.
Secondary ID [1] 285032 0
Nil
Universal Trial Number (UTN)
U1111-1159-4897
Trial acronym
BMWGP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 292541 0
Low health literacy 292542 0
Condition category
Condition code
Diet and Nutrition 292848 292848 0 0
Obesity
Public Health 293022 293022 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
One practice nurse in each intervention practice will be trained as Prevention Navigator to assist patients to attend community-based referral programs and services.
The practice level intervention involves:
1.One clinical audit report and face to face 1.5-hour long meeting with general practitioners (GPs) and Prevention Navigators in own practices to identify priorities and strategies for improvement in the assessment and management of obese patients;
2. One 3-hour long training session (for GPs and PNs including the Prevention Navigators) which will cover management of obese patients across the 5As of the chronic disease model approach – Assess, Advise,Agree, Assist and Arrange.
3. Prevention Navigators will be trained the concept of care navigation and their role in this.
4. Results from the health literacy screening are discussed at one 1.5-hour long meeting involving GPs and Prevention Navigators in own practices.

The clinical level intervention involves:
1. Patients in the waiting room will be screened for low health literacy (using three validated questions translated into several languages). Those that are eligible and consent are invited to attend a Health Check visit with the Prevention Navigators.
2. At the Health Check visit, which will be approximately 30 minutes long,the patient will receive brief advice, set goals related to weight loss, be referred to community-based services or programs and makes a follow up appointment with the GP or Prevention Navigator.

The intervention will be provided over a period of 6 months.
Intervention code [1] 289862 0
Early detection / Screening
Intervention code [2] 289863 0
Lifestyle
Intervention code [3] 289864 0
Behaviour
Comparator / control treatment
Standard treatment.
GPs and practice nurses will continue to manage obese patients for weight loss as per their normal standard practice including obesity assessment, weight loss treatment, referrals and follow-ups.
Control group
Active

Outcomes
Primary outcome [1] 292720 0
Practice nurses' self-reported behaviour and confidence in assessing obese patients with low health literacy and providing advice and referral to community-based lifestyle modification programs for weight loss.
Self-reported behaviour and confidence will be assessed using 7-point and 5-point scales respectively in a survey.
Timepoint [1] 292720 0
Baseline and 12 months after baseline
Primary outcome [2] 292721 0
Patients report, in past six months, of
*receiving assessment, advice and referral for weight loss

*attending/using community-based weight loss lifestyle modification programs referred to.
Timepoint [2] 292721 0
Baseline and 6 and 12 months after baseline
Primary outcome [3] 292722 0
Patients' health literacy related to weight loss.

This will be assessed using a 5-point scale in a survey.
Timepoint [3] 292722 0
Baseline and 12 months after baseline
Secondary outcome [1] 309548 0
Patient self-reported intake of dietary portions of fruit and vegetables per day

The survey is developed by us and has been used in our previous research
Timepoint [1] 309548 0
Baseline and 6 and 12 months after baseline
Secondary outcome [2] 309550 0
Patient self-reported use of high fat food
The survey is developed by us and has been used in our previous research
Timepoint [2] 309550 0
Baseline and 6 and 12 months after baseline
Secondary outcome [3] 309704 0
Patient self-reported consumption of alcohol
The survey is developed by us and has been used in our previous research
Timepoint [3] 309704 0
Baseline and 6 and 12 months after baseline
Secondary outcome [4] 309705 0
Patient self-reported minutes of moderate and/or vigorous intensity physical activity per week
The survey is developed by us and has been used in our previous research
Timepoint [4] 309705 0
Baseline and 6 and 12 months after baseline
Secondary outcome [5] 310410 0
Patient measured weight
Timepoint [5] 310410 0
Baseline and 12 months
Secondary outcome [6] 310412 0
The total cost of health service use
Data linkage to Medicare and Pharmaceutical Benefit Scheme records
Timepoint [6] 310412 0
12 months
Secondary outcome [7] 310413 0
Health-related quality of life

This will be assessed by SF-12v2 Health Survey
Timepoint [7] 310413 0
Baseline and 12 months

Eligibility
Key inclusion criteria
*Visited a participating GP at least once in the last 12 month
*BMI >=30
*Can complete the health literacy screening questionnaire in English or one of the languages the questionnaire has been translated into
*Identified with low health literacy: the combined score of the three health literacy questions is >10 or if the score is <=10, the score of question C alone is >=3
*Patient willing to return for a Health Check with the Prevention Navigator
*Does not have any exclusion criterion
Minimum age
40 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
*Heart disease
*Stroke
*Insulin-treated diabetes
*Chronic renal impairment (eGFR < 60 mls/minute/1.73m2)
*Previous bariatric surgery
*Bariatric surgery planned in the next 12 months
*Treated with orlistat or phentermine.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Procedure:
Once a patient’s name is entered in the practice’s patient appointment list, a pre-installed software assesses the patient for: age (40-70 years), being an active practice attendee, being a patient of a participating GP and having none of the exclusion criteria.
The software automatically prints out the health literacy screening questionnaire which will also include patient's clinical information and consent form.
The reception staff gives the patient the printout and Patient Information sheet and ask them to complete the health literacy screening questionnaire in the waiting room and to give it to their GP when they go in for the appointment.
For patients who can’t complete the survey in English but can complete it in a language for which translated Health Literacy questionnaire and Patient Information Sheet is available, the reception staff give patients the translated forms. Patients who can’t complete the health literacy questionnaire in English or in the common languages spoken in the practice self-opt out from the Study.
The GP scores the health literacy questionnaire, completes the section on patient’ willingness to come back to see the Prevention Navigator, and assesses the overall patient eligibility. If the patient is eligible, the GP invites the patient to consent.
In Control practices, the GP also checks the waist circumference and weight and calculates the body mass index. In Intervention practices, the Prevention Navigators record this information at the time of Health Checks.

Randomisation:
Central randomisation of practices by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size estimates are based on a two-sided test of significance at alpha=0.05, beta= 0.8 and 20% loss to follow up and effect sizes and standard deviations are based on our previous research.

We will examine change in the primary and secondary outcomes between the intervention and control practices, after adjusting for baseline differences. We will analyse patient variables for within and between practice differences using multilevel linear and logistic regression techniques that adjust for clustering by practice and multiple imputation to adjust for missing values. Analyses will be conducted on an ITT principle.

Effect sizes:
Outcome (Design effect [30 patients/practice]; Effect size/different proportions)
*Advice on diet (2.48; 25%)
*Advice on physical activity (2.02;25%)
*Referral/attendance for diet (1.75;25%)
*Referral/attendance physical activity (1.32; 25%)
*Mean Health Literacy score (1.41; 0.4)
*Mean diet score (1.03; 0.4)
*Mean physical activity score (1.52; 0.4)
*Mean BMI (2.10;0.5)

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/10/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA

Funding & Sponsors
Funding source category [1] 289670 0
Government body
Name [1] 289670 0
Australian Primary Health Care Research Institute
Country [1] 289670 0
Australia
Primary sponsor type
Individual
Name
Professor Mark Harris
Address
Centre for Primary Health Care and Equity
Level 3, AGSM Building
Kensington Campus
UNSW Australia
Sydney NSW 2052
Country
Australia
Secondary sponsor category [1] 288362 0
None
Name [1] 288362 0
Address [1] 288362 0
Country [1] 288362 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291406 0
UNSW Australia Human Research Ethics Advisory Panel (HREAP)
Ethics committee address [1] 291406 0
Ethics committee country [1] 291406 0
Australia
Date submitted for ethics approval [1] 291406 0
04/02/2014
Approval date [1] 291406 0
14/03/2014
Ethics approval number [1] 291406 0
2014-7-05
Ethics committee name [2] 291407 0
University of Adelaide Human Research Ethics Committee
Ethics committee address [2] 291407 0
Ethics committee country [2] 291407 0
Australia
Date submitted for ethics approval [2] 291407 0
22/05/2014
Approval date [2] 291407 0
06/06/2014
Ethics approval number [2] 291407 0
RM: 0000019137

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 50114 0
Prof Mark Harris
Address 50114 0
Centre for Primary Health Care and Equity
Level 3, AGSM Building
Kensington Campus
UNSW Australia
Sydney NSW 2052
Country 50114 0
Australia
Phone 50114 0
+61 2 9385 1547
Fax 50114 0
+61 2 9385 8404
Email 50114 0
[email protected]
Contact person for public queries
Name 50115 0
Mark Harris
Address 50115 0
Centre for Primary Health Care and Equity
Level 3, AGSM Building
Kensington Campus
UNSW Australia
Sydney NSW 2052
Country 50115 0
Australia
Phone 50115 0
+61 2 9385 1547
Fax 50115 0
+61 2 9385 8404
Email 50115 0
[email protected]
Contact person for scientific queries
Name 50116 0
Mark Harris
Address 50116 0
Centre for Primary Health Care and Equity
Level 3, AGSM Building
Kensington Campus
UNSW Australia
Sydney NSW 2052
Country 50116 0
Australia
Phone 50116 0
+61 2 9385 1547
Fax 50116 0
+61 2 9385 8404
Email 50116 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
SourceTitleYear of PublicationDOI
EmbaseResearch protocol: Management of obesity in patients with low health literacy in primary health care.2015https://dx.doi.org/10.1186/s40608-015-0036-6
N.B. These documents automatically identified may not have been verified by the study sponsor.