Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609001016224
Ethics application status
Approved
Date submitted
19/11/2009
Date registered
23/11/2009
Date last updated
9/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Outcome evaluation of the Nepean and Blue Mountains Diabetes Integration Program and the Sessions for Health and Physical Exercise Program
Scientific title
In patients with type 2 diabetes what is the impact of exercise and diet group therapy on participants' knowledge and self-reported diet and exercise activity, their self-reported health status, and their weight, body mass index (BMI) and waist circumference? (Uncontrolled before-and-after design)
Universal Trial Number (UTN)
U1111-1112-5769
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes 252244 0
Condition category
Condition code
Metabolic and Endocrine 252430 252430 0 0
Diabetes
Public Health 252431 252431 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be invited to attend eight one-hour group therapy sessions over a total of eight weeks. The sessions will address exercise and diet in type 2 diabetes, and will be run by an exercise physiologist with assistance from a dietician.
Intervention code [1] 241577 0
Lifestyle
Comparator / control treatment
No comparator - before & after design
Control group
Uncontrolled

Outcomes
Primary outcome [1] 253307 0
Proportion of participants attaining diet and exercise targets for people living with type 2 diabetes (self-report)
Timepoint [1] 253307 0
Start, end and three months following completion of group therapy program. There is an additional site for the project, and participants from this site will not be asked to complete a three-month questionaire.
Secondary outcome [1] 262351 0
Weight
Timepoint [1] 262351 0
Start and completion of group therapy program
Secondary outcome [2] 262392 0
Waist circumference
Timepoint [2] 262392 0
Start and completion of group therapy program
Secondary outcome [3] 262393 0
Knowledge of appropriate diet & exercise in self-management of type 2 diabetes - by questionnaire
Timepoint [3] 262393 0
Start, end and three months following completion of group therapy program. There is an additional site for the project, and participants from this site will not be asked to complete a three-month questionaire.
Secondary outcome [4] 262394 0
Self-reported health status - by questionnaire
Timepoint [4] 262394 0
Start, end and three months following completion of group therapy program. There is an additional site for the project, and participants from this site will not be asked to complete a three-month questionaire.
Secondary outcome [5] 262395 0
Satisfaction with program - by questionnaire
Timepoint [5] 262395 0
At completion of group therapy program

Eligibility
Key inclusion criteria
Type 2 diabetes
Referred for group therapy (exercise and diet) by general practitioner
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

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)
All patients referred to the group therapy program will be invited to participate in the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
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
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
23/11/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
112
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 244056 0
Self funded/Unfunded
Name [1] 244056 0
Nepean Division of General Practice
Country [1] 244056 0
Australia
Primary sponsor type
Other
Name
Nepean Division of General Practice
Address
PO Box 903
Penrith NSW 2751
Country
Australia
Secondary sponsor category [1] 251403 0
Charities/Societies/Foundations
Name [1] 251403 0
WentWest Ltd
Address [1] 251403 0
20 Wentworth Street Parramatta NSW 2150
Country [1] 251403 0
Australia
Other collaborator category [1] 965 0
University
Name [1] 965 0
Department of General Practice
Address [1] 965 0
Sydney Medical School - Western
The University of Sydney
PO Box 154
Westmead NSW 2145
Country [1] 965 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258151 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 258151 0
The University of Sydney
NSW 2006
Ethics committee country [1] 258151 0
Australia
Date submitted for ethics approval [1] 258151 0
Approval date [1] 258151 0
29/10/2009
Ethics approval number [1] 258151 0
10-2009/12186

Summary
Brief summary
This is a before and after evaluation of the impact of group exercise and diet therapy for people with type 2 diabetes. Participants will be assessed at the start of eight one-hour sessions, after the final session, and again three months later. At each time point they will report their exercise and diet activity, and their health status. Their weight, waist circumference and knowledge will also be assessed
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30531 0
Address 30531 0
Country 30531 0
Phone 30531 0
Fax 30531 0
Email 30531 0
Contact person for public queries
Name 13778 0
Phillipa Tyldsley
Address 13778 0
Nepean Division of General Practice
PO Box 903
Penrith NSW 2751
Country 13778 0
Australia
Phone 13778 0
+61 2 4721 1150
Fax 13778 0
+61 2 4721 1176
Email 13778 0
[email protected]
Contact person for scientific queries
Name 4706 0
Professor Tim Usherwood
Address 4706 0
Department of General Practice
Sydney Medical School - Western
University of Sydney
PO Box 154
Westmead NSW 2145
Country 4706 0
Australia
Phone 4706 0
+61 2 9845 8163
Fax 4706 0
+61 2 9845 8166
Email 4706 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.