ANZCTR - Registration

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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]

Nil known

Universal Trial Number (UTN)

Nil

Trial acronym

Nil

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Pre-diabetes

Diabetes

Obesity

Condition category

Condition code

Metabolic and Endocrine

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]

Lifestyle

Intervention code [2]

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]

Primary Outcome 1: body weight (self-reported)

Timepoint [1]

Timepoint: at baseline and at 6, 12, months after intervention commencement

Primary outcome [2]

Diabetes Diagnosis - self reported

Timepoint [2]

Timepoint 6 and 12 months

Primary outcome [3]

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]

Baseline 6 and 12 months

Secondary outcome [1]

Waist circumference - self report

Timepoint [1]

Baseline 6 and 12 months

Secondary outcome [2]

General Health (SF12)

Timepoint [2]

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?

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]

Government body

Name [1]

The Health Administration Corporation (HAC), NSW Health

Address [1]

Level 7, 73 Miller Street, North Sydney NSW 2060

Country [1]

Australia

Funding source category [2]

Other

Name [2]

Inner West Sydney Medicare Local Limited

Address [2]

Level 1, 158 Liverpool Road, Ashfield NSW 2131

Country [2]

Australia

Funding source category [3]

Other

Name [3]

WentWest Limited trading as Western Sydney Medicare Local

Address [3]

Level 1, 85 Flushcombe Road, Blacktown NSW 2148

Country [3]

Australia

Primary sponsor type

University

Name

University of Sydney

Address

University of Sydney, Sydney, NSW 2006

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Health Low Risk Subcommittee of the University of Sydney HREC

Ethics committee address [1]

Chair Human Ethics Integrity Portfolio
Margaret Telfer Building
University of Sydney
Sydney
NSW 2006

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

10/07/2013

Ethics approval number [1]

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

Prof Stephen Colagiuri

Address

The Boden Institute, University of Sydney, Medical Foundation Building K25, 92-94 Parramatta Road, Camperdown NSW 2050

Country

Australia

Phone

+61 2 9036 3104

Fax

+61 2 9036 3176

[email protected]

Contact person for public queries

Name

Shelley Kay

Address

The Boden Institute, University of Sydney, Medical Foundation Building K25, 92-94 Parramatta Road, Camperdown NSW 2050

Country

Australia

Phone

+61 2 9036 3104

Fax

+61 2 9036 3176

[email protected]

Contact person for scientific queries

Name

Stephen Colagiuri

Address

The Boden Institute, University of Sydney, Medical Foundation Building K25, 92-94 Parramatta Road, Camperdown NSW 2050

Country

Australia

Phone

+61 2 9036 3104

Fax

+61 2 9036 3176

[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.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically