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Trial registered on ANZCTR


Registration number
ACTRN12610000346077
Ethics application status
Approved
Date submitted
23/04/2010
Date registered
29/04/2010
Date last updated
11/07/2012
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
Nil
Universal Trial Number (UTN)
U1111-1114-7596
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
Obesity

Intervention/exposure
Study type
Interventional
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
Lifestyle
Intervention code [2] 256350 0
Behaviour
Intervention code [3] 256351 0
Prevention
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
Active

Outcomes
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.

Eligibility
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
Sex
Both males and females
Can healthy volunteers participate?
No
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
Treatment
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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
14/05/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 2830 0
4077
Recruitment postcode(s) [2] 2831 0
4151
Recruitment postcode(s) [3] 2832 0
4305
Recruitment postcode(s) [4] 2833 0
4067

Funding & Sponsors
Funding source category [1] 256853 0
Other
Name [1] 256853 0
The Royal Australian College of General Practitioners (RACGP)
Country [1] 256853 0
Australia
Funding source category [2] 256854 0
Commercial sector/Industry
Name [2] 256854 0
Pfizer Pharmaceuticals
Country [2] 256854 0
Australia
Primary sponsor type
Individual
Name
Dr Marie-Louise Dick
Address
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
Australia
Secondary sponsor category [1] 256134 0
University
Name [1] 256134 0
University of Queensland
Address [1] 256134 0
The University of Queensland
Brisbane QLD 4072 Australia
Country [1] 256134 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258870 0
The University of Queensland's Medical Research Ethics Committee
Ethics committee address [1] 258870 0
Ethics committee country [1] 258870 0
Australia
Date submitted for ethics approval [1] 258870 0
Approval date [1] 258870 0
14/09/2007
Ethics approval number [1] 258870 0
2007001085

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

Contacts
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
Australia
Phone 14325 0
+61 7 3365 5380
Fax 14325 0
+61 7 33465178
Email 14325 0
[email protected]
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
Australia
Phone 5253 0
+61 7 3365 5380
Fax 5253 0
+61 7 33465178
Email 5253 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.