Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001192673
Ethics application status
Approved
Date submitted
3/11/2014
Date registered
12/11/2014
Date last updated
17/03/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
"The Change Program" - a pilot feasibility study of a weight management program in Australian general practice
Scientific title
A pilot feasibility study of a General Practitioner delivered weight management program for overweight and obese adults in primary care.
Secondary ID [1] 285482 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 293266 0
Overweight 293267 0
Condition category
Condition code
Diet and Nutrition 293534 293534 0 0
Obesity
Public Health 293771 293771 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A general practitioner delivered weight management program.The Change Program consists of a GP Handbook, Patient Workbook and a template that is to be integrated into the general practice software. The Program content is based on current Australian guidelines for the management of overweight and obesity in primary care. The program is divided into three sections: Nutrition, Physical Activity and Behavioural Interventions. The Program is flexible in its delivery to suit both the patient and GP, however the suggested appointments are: fortnightly for the first three months, then monthly if the patient is happy with their progress. The full program runs over the course of two years. This pilot study will follow each patient for a minimum of 6 months.

The Program provides both GP information and patient factsheets and worksheets in the three domains (nutrition, physical activity and behavioural supports). The information in the factsheets is based on current Australian guidelines for nutrition and physical activity. The behavioural supports are based on cognitive behavioural techniques including goal setting, self monitoring and stimulus control.

The worksheets do not all need to be done in session, but can be completed by the patient at home and aid discussion with their GP. The Program also encourages the ongoing recording of the following data: BMI, waist circumference, blood pressure, relevant biochemical profile as well as a patient well-being score.

At the completion of the Program the patient can continue to be monitored by their GP as part of the usual GP/patient relationship and ongoing care.

Adherence will be monitored via the GP - we will collect information on appointment schedules, timing and interactions with other health professionals as appropriate.
Intervention code [1] 290421 0
Lifestyle
Intervention code [2] 290560 0
Behaviour
Intervention code [3] 290591 0
Treatment: Other
Comparator / control treatment
As this is a pilot feasibility study there will not be a comparator, this is a trial testing the operationalisation of the program prior to undertaking a cluster randomised controlled trial.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 293356 0
Feasibility of "The Change Program" when implemented in general practice
This will be assessed using both quantatative and qualitative measures. Patient and GP interviews; Online web based survey tool at initiation, half way and endpoint. Quantatative measures will include appointment attendance, time in consultation, time to recruitment, withdrawal rate. Survey used is designed specifically for this study.
Timepoint [1] 293356 0
Six months
This will be assessed using both quantatative and qualitative measures. Patient and GP interviews; Online web based survey tool at initiation, half way and endpoint. Quantatative measures will include appointment attendance, time in consultation, time to recruitment, withdrawal rate. Survey used is designed specifically for this study.
Secondary outcome [1] 310836 0
Acceptability of "The Change Program" to general practitioners and patients
Timepoint [1] 310836 0
3 months and 6 months
Patient and GP interviews; Online web based survey tool at initiation, half way and endpoint of pilot. Survey used is designed specifically for this pilot.

Eligibility
Key inclusion criteria
BMI over 25
English speaking and literate
Aged over 18 years
Has visited the GP at least 3 times in the last 2 years
Score of 6 or more on the AUSDRISK tool (Australian Type 2 Diabetes Risk Assessment Tool - validated tool for future risk of developing diabetes)
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
BMI over 40
Uncontrolled medical or mental health condition
History of eating disorder
Pregnancy
Breastfeeding
Age over 65 years
Taking weight loss medications
Past or scheduled bariatric surgery
Current history of diabetes, congestive heart failure, chronic renal failure, chronic obstructive pulmonary disease
Significant immobility

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
As this is a pilot feasibility study to assess practicality and operationalisation of the program there will only be an intervention arm.
Patients will be assessed as suitability by their general practitioners and invited to participate. There will also be advertising material within the general practice to encourage patients to self-nominate.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
29/12/2014
Actual
17/04/2015
Date of last participant enrolment
Anticipated
Actual
1/08/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
23
Recruitment in Australia
Recruitment state(s)
ACT,NSW

Funding & Sponsors
Funding source category [1] 290084 0
University
Name [1] 290084 0
Australian National University
Australian Primary Health Care Research Institute
Country [1] 290084 0
Australia
Primary sponsor type
University
Name
Australian National University
Address
Academic Unit of General Practice
ANU Medical School
PO Box 11
Woden ACT 2606
Country
Australia
Secondary sponsor category [1] 288782 0
None
Name [1] 288782 0
Nil
Address [1] 288782 0
Nil
Country [1] 288782 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291790 0
Australian National University Human Research Ethics Committee
Ethics committee address [1] 291790 0
Ethics committee country [1] 291790 0
Australia
Date submitted for ethics approval [1] 291790 0
14/11/2014
Approval date [1] 291790 0
06/03/2015
Ethics approval number [1] 291790 0

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

Contacts
Principal investigator
Name 52046 0
Dr Elizabeth Ann Sturgiss
Address 52046 0
Academic Unit of General Practice
Australian National University Medical School
PO Box 11
Woden
ACT 2606
Country 52046 0
Australia
Phone 52046 0
+61262444941
Fax 52046 0
Email 52046 0
[email protected]
Contact person for public queries
Name 52047 0
Elizabeth Sturgiss
Address 52047 0
Academic Unit of General Practice
Australian National University Medical School
PO Box 11
Woden
ACT 2606
Country 52047 0
Australia
Phone 52047 0
+61262444953
Fax 52047 0
+61262444105
Email 52047 0
[email protected]
Contact person for scientific queries
Name 52048 0
Elizabeth Ann Sturgiss
Address 52048 0
Academic Unit of General Practice
Australian National University Medical School
PO Box 11
Woden
ACT 2606
Country 52048 0
Australia
Phone 52048 0
+61262442222
Fax 52048 0
Email 52048 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
Dimensions AIFeasibility and acceptability of a physician-delivered weight management programme2016https://doi.org/10.1093/fampra/cmw105
N.B. These documents automatically identified may not have been verified by the study sponsor.