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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Retrospectively registered

Titles & IDs
Public title
General practitioner and exercise physiologist interventions for decreasing primary cardiovascular risk in the overweight/obese general practice population - a pilot randomised control study
Scientific title
A 24-week pilot feasibility study comparing the effects of usual general practitioner care (control) with additional general practitioner or exercise physiologist consultations focused on weight and cardiovascular risk reduction, on measures of cardiovascular risk in overweight/obese adults in general practice.
Secondary ID [1] 251639 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular Disease 257222 0
Overweight 257223 0
Obesity 257231 0
Condition category
Condition code
Cardiovascular 257368 257368 0 0
Coronary heart disease
Diet and Nutrition 257369 257369 0 0

Study type
Description of intervention(s) / exposure
1. Usual general practitioner (GP) care plus five specific GP consultations at 5-weekly intervals over 24 weeks; consultations to focus on the management of weight and cardiovascular risk factors (e.g. diet, exercise).
2. Usual GP care plus five specific exercise physiologist (EP) appointments at 5-weekly intervals over 24 weeks; consultations to focus on the management of weight and cardiovascular risk factors (e.g. diet, exercise).
GPs and EPs were asked to focus the scheduled sessions on the management of weight and cardiovascular risk factors, in the way that they would normally do this. For GPs this was likely to be via advice, education, motivation, and referral to other health professionals. For EPs, this was likely advice, educations, motivation and the provision and supervision of practical exercises and training. GP sessions were estimated to be of 10 - 30 minutes duration, whilst EP sessions were estimated to be of 30 - 60 minutes duration. Participants underwent only 1 arm of the trial.
Intervention code [1] 256349 0
Intervention code [2] 256350 0
Intervention code [3] 256351 0
Comparator / control treatment
Usual general practitioner care. This refers to patients seeing their GP as needed or as recommended by their GP regarding any symptom(s)/complaint(s), just as they would if they were not involved in the study.
Control group

Primary outcome [1] 258271 0
Cardiovascular risk factor reduction measured by: weight (kg), body mass index (BMI), waist-to-hip ratios , mean blood pressure (mm Hg), fasting blood lipids (total cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol, triglycerides)(mg/dL), and fasting blood glucose (mmol/L)

Body mass / weight, with clothing, was measured to 0.1 kg accuracy using a Tanita Digital Lithium Scale (Model: HD-327). For participants exceeding the 150kg weight capacity for the Tanita Scale, weight was measured using a Seca Compact Electronic Scale (Model: 770), with a weight capacity of 200kg and graduation of 0.1kg.
Height was measured to 0.1cm accuracy using the stretch stature technique1 with a wall-mounted 200cm Stature Meter.
Body Mass Index (or Quetelet Index) was calculated using the universal formula: BMI = mass ((kg) / height (m))2 for each participant.
Waist and hip circumferences were measured to 0.1 cm accuracy with a Futaba (spring-loaded) Rotary 2m cloth measuring tape (Model: R-280) using protocols from the anthropometric standardisation reference manual2 by Lohman et al (1988).
Waist-hip ratio (waist circumference (cm)/hip circumference (cm)) was calculated for each participant.
Mean Blood Pressure (mm Hg) was measured using an Omron Digital Blood Pressure Monitor (Model: HEM-907). One participant required measurement using a medium-sized Omron Cuff (HEM-CR19) over the radial artery and above the ulna styloid process, with the cuff placed at heart level. For this participant, the Omron Automatic Wrist Blood Pressure Monitor (Model: IW2) was not used due to its smaller cuff size.
Fasting blood lipids (total cholesterol, HDL) cholesterol, LDL cholesterol, triglycerides)(mg/dL), and fasting blood glucose (mmol/L) were measured on a sample of blood collected from each patient via venesection, analysed at pathology laboratory using the Advia 2400 chemical system by Siemens, and their associated reagents.

[1. Lohman, T.G., Roche, A.F., & Martorell, R. (1988). Anthropometric Standardisation Reference Manual. Champaign, Illinois: Human Kinetics Books.
2. Kaminsky, L.A. (ed.) (2006). ACSM?s resource manual for Guidelines for exercise testing and prescription. Baltimore: Lippincott Williams and Wilkins.]
Timepoint [1] 258271 0
At baseline, 12 weeks and 24 weeks.
Primary outcome [2] 258272 0
Participant self-reported cardiovascular lifestyle risk factors: cigarette smoking, alcohol consumption, fruit and vegetable consumption, exercise.
Information collected via paper-based survey.
Timepoint [2] 258272 0
At baseline and 24 weeks.
Secondary outcome [1] 263945 0
Feasibility of the study, determined by measures including general practitioner and exercise physiologist recruitment, and participant recruitment and retention rates.
Timepoint [1] 263945 0
After completion of 24 week intervention.
Secondary outcome [2] 263960 0
The use of guidelines and intervention strategies employed by GPs and EPs for management of weight loss and cardiovascular risk, as reported by GPs and EPs in a paper-based survey.
Timepoint [2] 263960 0
At 24 weeks.
Secondary outcome [3] 263961 0
Participant self-reported effectiveness of the interventions and satisfaction with weight reduction.
Information collected via paper-based survey.
Timepoint [3] 263961 0
At 24 weeks.
Secondary outcome [4] 263971 0
Resting heart rate (beats / min) (measured using an Omron Digital Blood Pressure Monitor (Model: HEM-907)) and recovery rate (beats/min) using the "YMCA" 3-Minute Step Test protocol.
Timepoint [4] 263971 0
At baseline, 12 weeks and 24 weeks.

Key inclusion criteria
- Aged 18 years or older;
- Being overweight and having a body mass index (BMI) 27 or more;
- Able to speak and understand the English language;
- Able to understand the nature and requirements of the research project; AND
- Being considered medically fit to undertake all three arms of the trial by his / her GP.
Minimum age
18 Years
Maximum age
No limit
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
- Pregnant;
- Having known cardiovascular disease including acute coronary syndrome (ACS), previous ST elevation myocardial infarction (STEMI), angina, heart failure, clinically significant arrhythmia, or previous cardiac surgery

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Enrolling study subjects: GPs enrolled subjects by approaching consecutive patients who satisfied the inclusion criteria, providing them with a Patient Information Sheet and the opportunity to discuss the project and their potential involvement, and then seeking their consent to participate in the study.

Allocation concealment was used and consisted of sealed, opaque envelopes, which were indistinguishable externally and marked with a unique identifying code. Allocation was performed by the study’s exercise physiologist, after the enrolled participants completed all baseline assessments. The exercise physiologist did not have any involvement in the subject enrolment process.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A simple randomisation procedure was used.

Depending on the number of patients recruited at each practice, practices were given one or more batches of nine sealed, indistinguishable opaque envelopes. (For example, a practice recruiting 28 patients would be given four batches of nine envelopes; a practice recruiting 7 patients would be given one batch of nine envelopes). The shuffled envelope batches contained three allocations to each of the Control, GP and EP arms of the study. Each patient received one envelope, containing his / her group allocation. Participants’ allocations were recorded against their unique identifying numbers on a data collection spreadsheet.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

Intervention assignment
Other design features
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 2830 0
Recruitment postcode(s) [2] 2831 0
Recruitment postcode(s) [3] 2832 0
Recruitment postcode(s) [4] 2833 0

Funding & Sponsors
Funding source category [1] 256853 0
Name [1] 256853 0
The Royal Australian College of General Practitioners (RACGP)
Address [1] 256853 0
RACGP College House, 1 Palmerston Crescent, South Melbourne, Victoria. 3205
Country [1] 256853 0
Funding source category [2] 256854 0
Commercial sector/Industry
Name [2] 256854 0
Pfizer Pharmaceuticals
Address [2] 256854 0
38-42 Wharf Road, West Ryde NSW 2114; PO Box 57, West Ryde NSW 2114
Country [2] 256854 0
Primary sponsor type
Dr Marie-Louise Dick
Discipline of General Practice
School of Medicine
University of Queensland
Level 8, Health Sciences Building
Building 16/ 910
Royal Brisbane & Women’s Hospital
Herston QLD 4029
Secondary sponsor category [1] 256134 0
Name [1] 256134 0
University of Queensland
Address [1] 256134 0
The University of Queensland
Brisbane QLD 4072 Australia
Country [1] 256134 0

Ethics approval
Ethics application status
Ethics committee name [1] 258870 0
The University of Queensland's Medical Research Ethics Committee
Ethics committee address [1] 258870 0
Cumbrae-Stewart Building
Research Road
St Lucia
Brisbane Qld 4072 Australia
Telephone +61 7 3365 3559
Facsimile +61 7 3365 8383
Ethics committee country [1] 258870 0
Date submitted for ethics approval [1] 258870 0
Approval date [1] 258870 0
Ethics approval number [1] 258870 0

Brief summary
To investigate the feasibility of a community-based randomised control trial exploring the practices employed by general practitioners and exercise physiologists in the management of overweight/obese patients, and their effect on weight reduction and cardiovascular risk factors.
Trial website
Trial related presentations / publications
Conference presentation:
Dick, Marie-Louise, Harris, Lisa, Janamian, Tina, Schubert, Rebecca, Doust, Jenny. (2009). A pilot randomised control trial of general practitioner and exercise physiologist interventions to reduce primary cardiovascular risk in overweight patients. 2009 General Practice and Primary Health Care Research Conference, Melbourne 15-17 July, 2009. In: 2009 General Practice and Primary Health Care Research Conference: Program & Abstracts. Primary Health Care Research and Information Service, Australia.
Public notes

Principal investigator
Name 31078 0
Address 31078 0
Country 31078 0
Phone 31078 0
Fax 31078 0
Email 31078 0
Contact person for public queries
Name 14325 0
Dr Marie-Louise Dick
Address 14325 0
Discipline of General Practice
School of Medicine, University of Queensland, Level 8, Health Sciences Building, Building 16/ 910, Royal Brisbane & Women’s Hospital, Herston QLD 4029.
Country 14325 0
Phone 14325 0
+61 7 3365 5380
Fax 14325 0
+61 7 33465178
Email 14325 0
Contact person for scientific queries
Name 5253 0
Dr Marie-Louise Dick
Address 5253 0
Discipline of General Practice
School of Medicine, University of Queensland, Level 8, Health Sciences Building, Building 16/ 910, Royal Brisbane & Women’s Hospital, Herston QLD 4029.
Country 5253 0
Phone 5253 0
+61 7 3365 5380
Fax 5253 0
+61 7 33465178
Email 5253 0

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary