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Trial registered on ANZCTR


Registration number
ACTRN12613000913774
Ethics application status
Approved
Date submitted
6/08/2013
Date registered
15/08/2013
Date last updated
15/08/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Diabetes Prevention Programs Project DP3: Testing the acceptability and effectiveness of different interventions and modalities
Scientific title
People at high risk of developing diabetes receive a lifestyle modification program by face-to-face group sessions or interactive group webinar or telephone counselling with the main outcome being weight loss after 12 months.
Secondary ID [1] 282993 0
Nil known
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pre-diabetes 289802 0
Diabetes
 289803 0
Obesity 289819 0
Condition category
Condition code
Metabolic and Endocrine 290154 290154 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants partake in only one program. They are offered the choice of one of 3 programs in their area - Inner Western Sydney: Live Life Well face to face; Live Life Well webinar; Get Healthy Phone Service and Western Sydney: Shape face to face; Live Life Well webinar; Get Healthy Phone Service.

1. The Get Healthy Information and Coaching Service is a free, confidential, individually tailored telephone service funded by the NSW Ministry of Health. It aims to reduce the risks of lifestyle related chronic disease by providing evidence-based information and advice about: Healthy eating; Being physically active; Achieving and maintaining a healthy weight. A health professional conducts an initial telephone assessment followed by 13 telephone coaching calls over the next 6 months.


The Initial Consultation has an approximate duration of 25 – 30 minutes or beyond. There is no urgency to stop at 30 minutes and the individual requirements of the communication dictate the length of the conversation.
The follow up calls last on average 5 to 15 minutes but may be longer depending on the individual situation. These calls are to to offer support and motivation.


2. The Live Life Well Face to Face program includes an individual consultation with a trained lifestyle officer followed by 3, 2-hour group sessions within the Inner West Medicare Local area. Each session includes information regarding exercise, healthy eating, how to change behavior and maintain it. Participants receive individualised goals and plans regarding what to eat, what exercise to do and how to do it. Participants will receive ongoing support through qualified lifestyle officers via follow-up telephone calls conducted at 3, 6, 9 and 12 month intervals.

The initial consultation is approximately 60 – 90 minutes.
For each group (of approximately 8 – 10 participants), the 3 x 2 hour sessions are held over 3 consecutive weeks in one month. A schedule of times and dates is provided when participants choose a program. The LLW face to face program is scheduled for September and October and further scheduling is to be announced. The support telephone calls take between 10 and 20 minutes but may be more or less depending on the circumstances.


3. The Live Life Well webinars. The Live Life Well online program includes an individual consultation on a web platform followed by 3 x 2-hour group sessions conducted by a qualified exercise physiologist and/or diabetes educator. Each session includes information regarding exercise, healthy eating, how to change behavior and maintain it. Participants receive individualised goals and plans regarding what to eat, what exercise to do and how to do it. To participate in this option participants are required to have a stable internet connection, a phone or headphones, a recent version of Adobe Flash Player and a quiet place to listen. Follow-up support telephone/skype calls are conducted at 3, 6, 9 and 12 month intervals.

The initial consultation is conducted on skype or telephone with an approximate duration of 60 – 90 minutes. For each group (of approximately 8 – 10 participants), the 3 x 2 hour web-sessions are held over 3 consecutive weeks in one month. A schedule of times and dates is provided when participants choose a program. The support skype/telephone calls take between 10 and 20 minutes but may be more or less depending on the circumstances.

4. SHAPE sessions for health and physical exercise program (SHAPE) is an 8-session, face-to-face, health and fitness program for people who are at risk of developing Type 2 diabetes or heart disease conducted through the Western Sydney Medicare Local area. Exercise physiologists and/or dietiticians will lead the sessions, which include: an initial assessment with an Allied Health Professional to assess current fitness levels, lifestyle choices and set personal goals; 8 Healthy lifestyle group sessions combining diet and nutritional education with group exercise activities; a final assessment with an Allied Health Professional to measure progress throughout the program; and a post-program plan to ensure ongoing progress and self-management. The Initial assessment is approximately 90 minutes including anthropometric data, submaximal aerobic power test, blood pressure, resting heart rate, exercise, self-efficacy and nutritional questionnaires.

The duration and frequency of the group sessions are 1 x 1 hour session per week for 8 weeks over a period of 8 to 10 weeks.
Follow-up support telephone calls are conducted at 3, 6, 9 and 12 month intervals.These calls take between 10 and 20 minutes but may be more or less depending on the circumstances.

With regard to monitoring adherence, throughout the programs, each intervention arm records attendance and is required to submit this information to the BODEN.

The Boden Institute at the University of Sydney will be externally evaluating and comparing outcomes via self-report weight, waist circumference and diagnosed diabetes, as well as physical activity, fat and fibre eating behavior and quality of life scores.
Intervention code [1] 287690 0
Lifestyle
Intervention code [2] 287691 0
Prevention
Comparator / control treatment
The comparator group is this study is an active group which will receive the SDPP intervention (details of which are provided in the citations).

The SDPP was not registered as a clinical trial as it was a translational research project not an efficacy trial.

Specific Publications include:
The Sydney Diabetes Prevention Program: a community-based translational study. Colagiuri S, Vita P, Cardona-Morrell M, Singh MF, Farrell L, Milat A, Haas M, Bauman A. BMC Public Health. 2010 Jun 10;10:328. doi: 10.1186/1471-2458-10-328. PMID: 20534170 [PubMed - indexed for MEDLINE]

Factors influencing participant enrolment in a diabetes prevention program in general practice: lessons from the Sydney diabetes prevention program.
Laws RA, Vita P, Venugopal K, Rissel C, Davies D, Colagiuri S.
BMC Public Health. 2012 Sep 24;12:822. doi: 10.1186/1471-2458-12-822. PMID:23006577 [PubMed - indexed for MEDLINE]
Control group
Active

Outcomes
Primary outcome [1] 290183 0
Primary Outcome 1: body weight (self-reported)
Timepoint [1] 290183 0
Timepoint: at baseline and at 6, 12, months after intervention commencement
Primary outcome [2] 290200 0
Diabetes Diagnosis - self reported
Timepoint [2] 290200 0
Timepoint 6 and 12 months
Primary outcome [3] 290201 0
Physical acitivity - The Active Australia Survey Questions asked in a telephone interview with a University of Sydney Research Assistant Australian Institute of Health and Welfare (AIHW). The Active Australia Survey: a guide and manual for implementation, analysis and reporting. Canberra AIHW; 2003.
Timepoint [3] 290201 0
Baseline 6 and 12 months
Secondary outcome [1] 304068 0
Waist circumference - self report
Timepoint [1] 304068 0
Baseline 6 and 12 months
Secondary outcome [2] 304094 0
General Health (SF12)
Timepoint [2] 304094 0
Baseline 6 and 12 months

Eligibility
Key inclusion criteria
Screening, recruitment and referral will be undertaken by the two Medicare Locals (IWSML and WSML). Eligible participants will be English-speaking and 40-65 years old, have completed an AUSDRISK >12, and have diabetes excluded, and medical clearance from a doctor.
Minimum age
40 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The exclusion criteria are determined by the General Practitioner

They are:
type 1 or 2 diabetes
pregnancy
untreated severe aortic stenosis or other structural heart disease end stage congestive heart failure progressive or terminal cancer severe cognitive impairment or behavioural disturbance malignant arrhythmias unstable CAD

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The study is a nonrandomised trial
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The study is a nonrandomised trial
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
N/A
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size is derived from our experience with the SDPP. In the SDPP we had a main cohort of approximately 1,100 participants but we also tested the feasibility of the intervention in a group of Mandarin-speaking Chinese people and Arabic-speaking people. We also tested delivering the program via telephone coaching rather than via face-to-face groups. In each of these sub-groups we recruited approximately 100 people and found this sufficient to test feasibility and demonstrate non-inferiority of the intervention compared with the main cohort.

The situation is similar in this project where the objectives include testing feasibility of the different modes of program delivery and non-inferiority compared with the established SDPP face-to-face group intervention.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
400
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 287748 0
Government body
Name [1] 287748 0
The Health Administration Corporation (HAC), NSW Health
Country [1] 287748 0
Australia
Funding source category [2] 287749 0
Other
Name [2] 287749 0
Inner West Sydney Medicare Local Limited
Country [2] 287749 0
Australia
Funding source category [3] 287750 0
Other
Name [3] 287750 0
WentWest Limited trading as Western Sydney Medicare Local
Country [3] 287750 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
University of Sydney, Sydney, NSW 2006
Country
Australia
Secondary sponsor category [1] 286471 0
None
Name [1] 286471 0
Address [1] 286471 0
Country [1] 286471 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289696 0
Health Low Risk Subcommittee of the University of Sydney HREC
Ethics committee address [1] 289696 0
Chair Human Ethics Integrity Portfolio
Margaret Telfer Building
University of Sydney
Sydney
NSW 2006
Ethics committee country [1] 289696 0
Australia
Date submitted for ethics approval [1] 289696 0
Approval date [1] 289696 0
10/07/2013
Ethics approval number [1] 289696 0
2013/293

Summary
Brief summary
Proposal
Aim
To compare the effectiveness and cost-effectiveness of several different diabetes prevention programs including face to face groups, phone only interventions and those that use the internet to deliver lifestyle modification programs.

Research design
Screening, recruitment and referral
Screening, recruitment and referral will be undertaken by the two Medicare Locals (IWSML and WSML). Eligible participants will be English-speaking 40-65 years, have completed an AUSDRISK >12, and have diabetes excluded, and medical clearance from a doctor.
Target number of referrals (i.e. participants who are allocated to one of the four programs (see below).

IWSML = 200 participants
WSML = 200 participants

Diabetes Prevention Programs
Once eligible participants will be referred to a central point in each ML. The ‘Program Coordinator’ in each ML will contact the eligible participants explain the study, confirm interest and motivation, obtain consent and give them a choice to take up one of the four programs available in each of their ML areas. There will be a slight variation in each ML as follows:
Inner West Sydney ML:
Get Healthy Service [phone only]
Prevent Diabetes Live Life Well [face-to-face and phone]
Prevent Diabetes Live Life Well [internet and phone]
50 in each stream and 100 in PDLLW face to face group program

Western Sydney ML:
Get Healthy Service [phone only]
SHAPE [face-to-face and phone]
Prevent Diabetes Live Life Well [internet and phone]
50 in each stream and 100 in SHAPE program

The programs will have to be offered in random order to each participant to avoid a possible bias here. Once the numbers for each arm have been reached then the participant will be told that they only have a choice of what is left. In this research design the PDLLW face-to-face program is the reference group that we will compare the three others to.
It has been estimated that a sample size of 100 participants in each arm will be sufficient to detect between 1-1.5kgs weight difference at the 12-month evaluation between groups. The follow up period has been set as short-term evaluation 6-months from entry into the program and medium-term – 12 months from baseline. This allows completion of the intensive intervention 3-month phase and both short-term and medium term effects to be assessed.
Evaluation outcomes
It is proposed that once participants have been referred and agreed to be in one of the four arms but before they begin one they will be contacted by Computer Assisted Telephone Interviewers from the Boden to assess the main outcomes.

Weight/Height
Physical Activity
Dietary assessment
Waist circumference

A welcome pack with a letter and tape measure will be sent to participants advising them to have their weight and waist circumference measures ready to report. In addition, sociodemographics and other relevant information will be collected by CATI.

Primary outcomes:
The primary goals assessed as follows:
Weight (self-report)
Physical Activity: Active Australia questions at baseline and 12-months collected as part of the CATI.
Nutrition: Fat and Fibre index could be measured by CATI or a 3-day non-weighed food diary collected at baseline at the 12-month review.

Secondary outcomes:
Waist circumference (self-report)
General health will be measured using the SF12.

CATI to be repeated at 6 and 12 months after baseline.
Trial website
N/A
Trial related presentations / publications
Public notes
The University will provide the deliverables described in the Project Brief below to The Health Administration Corporation (HAC), NSW Health prior to 1 April 2015

Project Description
The program grant is for the Diabetes Prevention Programs Project.
To compare the effectiveness of several different diabetes prevention
programs including face to face groups, phone only interventions and those
that use the internet to deliver lifestyle modification programs.
Program Brief
Services provided by Boden Institute:
Develop web version of PDLLW
Implement web version of PDLLW to 100 participants (50 from IWSML)
Include the phone only Oet Healthy Information and Coaching Service to 100 participants (50 from IWSML) in overall evaluation
Implement face to face PDLLW (SDPP) to 100 participants (IWSML)

Reports provided by Boden Institute:
Program evaluation on the web version of PDLLW
Evaluation on the effectiveness of several different diabetes prevention
programs (web version of PDLLW (for IWSML and WSML), Get Healthy Information and Coaching Service (for IWSML and WSML) and the SHAPE program (for WSML)) compared to the PDLLW face to face (IWSML).

Periormance Criteria:
Final product of a web version of PDLLW
Implement web version of SDPP to 100 participants
Implement face to face SDPP to 100 participants
Include phone only Get Healthy Information and Coaching Service to 50 (IWSML) participants in evaluation
Completion of ongoing reports where necessary
Completion of final evaluation report by 31st March 2015

MilestoneslDeliverables
Milestones Due Date
Membership of the Project Steering Committee Ongoing.
Completion of final evaluation report 31st March 2015

Contacts
Principal investigator
Name 42022 0
Prof Stephen Colagiuri
Address 42022 0
The Boden Institute, University of Sydney, Medical Foundation Building K25, 92-94 Parramatta Road, Camperdown NSW 2050
Country 42022 0
Australia
Phone 42022 0
+61 2 9036 3104
Fax 42022 0
+61 2 9036 3176
Email 42022 0
[email protected]
Contact person for public queries
Name 42023 0
Shelley Kay
Address 42023 0
The Boden Institute, University of Sydney, Medical Foundation Building K25, 92-94 Parramatta Road, Camperdown NSW 2050
Country 42023 0
Australia
Phone 42023 0
+61 2 9036 3104
Fax 42023 0
+61 2 9036 3176
Email 42023 0
[email protected]
Contact person for scientific queries
Name 42024 0
Stephen Colagiuri
Address 42024 0
The Boden Institute, University of Sydney, Medical Foundation Building K25, 92-94 Parramatta Road, Camperdown NSW 2050
Country 42024 0
Australia
Phone 42024 0
+61 2 9036 3104
Fax 42024 0
+61 2 9036 3176
Email 42024 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



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