Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000338066
Ethics application status
Approved
Date submitted
22/04/2010
Date registered
28/04/2010
Date last updated
5/12/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Mothers after Gestational Diabetes in Australia (MAGDA)
Scientific title
Mothers After Gestational Diabetes in Australia (MAGDA) study. Preventing diabetes in pregnancy from progressing to type 2 diabetes.
Secondary ID [1] 251657 0
Nil
Universal Trial Number (UTN)
Trial acronym
MAGDA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gestational Diabetes Mellitus 257233 0
Condition category
Condition code
Public Health 257370 257370 0 0
Other public health
Metabolic and Endocrine 257371 257371 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A six session group behaviour intervention program was run.The first session, an individual session with participant and facilitator, a risk assessment and goal setting session was facilitatored either face to face or over the phone, if difficulties meeting up arose. The individual session took up to an hour to complete. The remaining 5 sessions commenced two weeks after the individual session and were group based, at two week intervals. Topics included: physical activity, fats, fibre, sleep. Each session was run for approximately 2 hours, each with up to 12 participants. The sessions were run by specially trained facilitators who have a health-related background, the intention was to have the same facilitator run all the sessions for the same group, independently as to build a rapport with the participants. Along with the topics listed before each session covered goal setting, motivation and managing setbacks. At three and six months, there was a telephone follow up, maintenance sessions with the same facilitator that took the group sessions. An additional amendment allowed a small group of women in the study (31) to receive a telephone based lifestyle intervention program. These participants had NOT attended the MAGDA face to face group intervention. To differentiate this group the intervention was called TeleMAGDA. The intervention was based on the same topics as the group based MAGDA program but was done over seven, individual, 30-60 minute telephone coaching sessions, again one every 2 weeks. As for MAGDA the phone coach/facilitator was run by specially trained facilitators who had a health-related background, the intention was to have the same facilitator run all the sessions for the same individual.
Intervention code [1] 256352 0
Lifestyle
Intervention code [2] 256376 0
Prevention
Intervention code [3] 256377 0
Behaviour
Comparator / control treatment
A control group will receive usual care from their General Practitioner (GP) for the 12 month period. Usual care will vary depending on the care plan prepared by each GP. Each care plan will be prepared by the GP (independent of the study), and information will collected by the study at the end of the 12 month period. At the end of the 12 months, control participants will be offered the Lifestyle Intervention Program.
Control group
Active

Outcomes
Primary outcome [1] 258279 0
The estimation of reduction in the risk of type 2 diabetes imputed form the outcomes of clinical trials, using extrapolation of the changes in weight and waist circumference. Previous research has shown that by using an international benchmark study (The Diabetes Prevention Study) as a reference population, a single pretest and post test study design can be used to calculate diabetes risk reduction.
Timepoint [1] 258279 0
Baseline, 3 months or following the group sessions, whichever is later (intervention group only) and 12 months
Primary outcome [2] 300401 0
Weight, waist, fasting glucose levels. All procedures are to follow the international recommendations outlined in the WHO MONICA Protocol and the European Health Risk Monitoring Project. All primary outcome measures were collected by trained nurse or phlebotomist. Standard operating procedures were followed and quality of data collection was assessed quarterly. Weight was measured by a Weight Scale MS3200 (Charder). Participants removed all heavy garments and shoes and emptied their pockets. The scale was placed on a hard surface and weight measured in kg. Waist circumference was measured using a tape measure – brand Seca 203. Waist was measured at a level midway between the lower rib margin and the iliac crest with a tape around the body in a horizontal position. Waist circumference was recorded to the resolution of the tape measure rule to the closest 1mm with data collector at eye level. Fasting glucose was measured by serum assay via venepuncture following a minimum of 8 hours fasting.
Timepoint [2] 300401 0
Baseline and at 12 months (+/- 3 months)
Secondary outcome [1] 263949 0
Comparative information from clinical measures (blood pressure, hip measurements, and blood lipids/fats/glucose) from intervention and control participants. More specifically, blood pressure will be assessed using a simple mercury sphygmomanometer; hip measurements will be taken using a plastic tailors measuring tape; and blood lipids/fats and glucose will be assessed by blood analysis of blood taken from the vein in the antecubital fossa.
Timepoint [1] 263949 0
Baseline, 3 months or following the group sessions, whichever is later (intervention group only) and 12 months
Secondary outcome [2] 263950 0
Comparative information from behavioural measures (as assessed by validated clinical tools, including: Hospital Depression and Anxiety Scale, Fat and Fibre barometer and Quality of Life Questionnaire) from intervention and control participants
Timepoint [2] 263950 0
Baseline and 12 months (+/-3 months)
Secondary outcome [3] 263951 0
Health economic information about the Lifestyle program (and comparison with usual care) will be assessed by combining the cost data with the clinical and behaviuoral data to produce a range of incremental cost-effectiveness ratios (ICER). This ICER will be comapred to a reference threshold (i.e $50,000 per quality-adjusted life years (QALY)) to determine 'value for money'. The modelled evaluation will use a Markov appraoch to estimate the health impacts of changes in diabetes risk status over the lifetime of participants.
Timepoint [3] 263951 0
12 months from baseline

Eligibility
Key inclusion criteria
Women with a diagnosis of Gestational Diabetes who gave birth after 1/1/2007 at participating hospitals will be invited to participate. All potential participants will have an oral glucose tolerance test to confirm that they do not have diabetes prior to entering the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
*Established diabetes (T1DM or T2DM)
*Severe mental illness in the last three months
*Substance abuse (illicit drugs) in the last three months
*Myocardial infarction in the last three months
*Difficulty with English
*Pregnant at any time during the study (from baseline screening to 12 months post-baseline
*Involved in a post-natal lifestyle-based intervention or a similar clinical trial which may impact primary clinical outcomes
*Surgical or medical intervention to treat obesity

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All women who receive a diagnosis of gestational diabetes will be invited to participate. All potential participants will be screened for diabetes. Once diabetes has been excluded, participants will be randomly allocated into the intervention or control groups. The block randomisation will be generated by creating separate randomisation lists for each ‘venue’ or ‘stratum’.
Each list will be supplied as a separate file and imported into the current MAGDA management database which selects the next available sequence number for the venu/stratum. This sequence number is displayed along with the assignment code (control or intervention) to the user in the randomisation office
Individual participants will be randomised into the intervention or control arm after the baseline blood results have been received by the MAGDA DPP Project Manager/ RA. If the participant does not have diabetes, the MAGDA DPP Project Manager/ RA will notify the or Sr Program Manager will randomize the participant using the MAGDA management database. The participant will be informed of the outcome of randomisation along with the results from The block randomisation will be generated by creating separate randomisation lists for each ‘venue’ or ‘stratum’
Each list will be supplied as a separate file and imported into the current MAGDA management database which selects the next available sequence number for the venu/stratum. This sequence number is displayed along with the assignment code (control or intervention) to the user in the randomisation office.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The block randomisation will be generated by creating separate randomisation lists for each ‘venue’ or ‘stratum’.
Each list will be supplied as a separate file and imported into the current MAGDA management database which selects the next available sequence number for the venu/stratum. This sequence number is displayed along with the assignment code (control or intervention) to the user in the randomisation office
Individual participants will be randomised into the intervention or control arm after the baseline blood results have been received by the MAGDA DPP Project Manager/ RA. If the participant does not have diabetes, the MAGDA DPP Project Manager/ RA will notify the or Sr Program Manager will randomize the participant using the MAGDA management database. The participant will be informed of the outcome of randomisation along with the results from The block randomisation will be generated by creating separate randomisation lists for each ‘venue’ or ‘stratum’
Each list will be supplied as a separate file and imported into the current MAGDA management database which selects the next available sequence number for the venu/stratum. This sequence number is displayed along with the assignment code (control or intervention) to the user in the randomisation office.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample Size - With a sample with a sample size of more than 215 in each arm, the trial is powered to detect an effect size of 0.27 (assuming mean difference between intervention and control groups 0.14 mmol/L, within group standard deviation 0.5 mmol/L) for fasting plasma glucose over 12 months with a two-sided test conducted at the 5% significance level and 80% power. This effect size is supported by the results of the GGT DPP and Finnish DPS, and, to allow for 25% dropout within trial arms, the total number of participants to be recruited is 574 (287 in each arm).
Data Analysis - Clinical measures and changes (between baseline and follow-up) in outcomes of GDM-DPP women will be compared with measurements of the control group. The difference in the change in outcome measures (e.g. waist circumference) between the two studied groups will be analysed using t-tests and mixed-model analyses. The intention-to-treat principle will be adhered to and analyses of all outcome variables will be conducted using information from all randomized women according to the treatment and stratum to which they were assigned during the randomization process. Sensitivity analyses, from which women with major protocol deviations will be excluded, will be conducted on the three primary outcome variables. Major protocol deviations will be defined in the Statistical Analysis Plan and include but are not limited to: established diabetes and pregnancy at any time on study.
The analysis of usual care in the identification, management, and costs of diabetes and its risk factors will be conducted in the registered population using health economic and statistical methods.
Regression analysis, including logistic regression, will be used to identify baseline variables that predict successful outcomes and adherence.
The reduction in the risk of diabetes will be estimated from the outcomes of published clinical trials of diabetes prevention, using extrapolation of the changes in fasting plasma glucose, weight and waist circumference across all time periods.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2011
Actual
25/07/2012
Date of last participant enrolment
Anticipated
31/12/2013
Actual
25/06/2014
Date of last data collection
Anticipated
Actual
1/06/2015
Sample size
Target
574
Accrual to date
Final
574
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 7066 0
The Royal Women's Hospital - Parkville
Recruitment hospital [2] 7067 0
Sunshine Hospital - St Albans
Recruitment hospital [3] 7068 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment hospital [4] 7069 0
Womens and Childrens Hospital - North Adelaide
Recruitment postcode(s) [1] 2838 0
3052
Recruitment postcode(s) [2] 2839 0
5112

Funding & Sponsors
Funding source category [1] 256858 0
Government body
Name [1] 256858 0
National Health & Medical Research Council (NHMRC)
Country [1] 256858 0
Australia
Primary sponsor type
Individual
Name
James Dunbar
Address
Greater Green Traingle
University Department of Rural Health
Flinders and Deakin Universities
PO Box 423 Warrnambool, Victoria 3280
Country
Australia
Secondary sponsor category [1] 256128 0
Individual
Name [1] 256128 0
James Best
Address [1] 256128 0
School of Medicine
Faculty of Medicine, Dentistry & Health Sciences
The University of Melbourne, Carlton, Vic 3010
Country [1] 256128 0
Australia
Secondary sponsor category [2] 256129 0
Individual
Name [2] 256129 0
Edward Janus
Address [2] 256129 0
The Western Hospital
Gordon Street
Footscray, Vic, 3011
Country [2] 256129 0
Australia
Secondary sponsor category [3] 256130 0
Individual
Name [3] 256130 0
Rob Carter
Address [3] 256130 0
Rm F2.18, Building F
Deakin University
221 Burwood Hwy, Burwood, Vic, 3125
Country [3] 256130 0
Australia
Secondary sponsor category [4] 256131 0
Individual
Name [4] 256131 0
Jeremy Oats
Address [4] 256131 0
The Royal Women's Hospital
Locked Bag 300
Parkville, Vic, 3052
Country [4] 256131 0
Australia
Secondary sponsor category [5] 256132 0
Individual
Name [5] 256132 0
Timothy Skinner
Address [5] 256132 0
Rural Clinical School
University of Tasmania
Private Bag 3513 Hospitals' Campus Brickport Road 7320
Burnie
Tasmania
Country [5] 256132 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258872 0
The Royal Women's Hospital
Ethics committee address [1] 258872 0
Ethics committee country [1] 258872 0
Australia
Date submitted for ethics approval [1] 258872 0
Approval date [1] 258872 0
14/04/2010
Ethics approval number [1] 258872 0
10/06/2010
Ethics committee name [2] 288474 0
Deakin University HREC
Ethics committee address [2] 288474 0
Ethics committee country [2] 288474 0
Australia
Date submitted for ethics approval [2] 288474 0
Approval date [2] 288474 0
19/03/2010
Ethics approval number [2] 288474 0
2010-005
Ethics committee name [3] 288475 0
HREC, Queen Elizabeth Hospital, the Lyell McEwin Hospital and Modbury Hospital
Ethics committee address [3] 288475 0
Ethics committee country [3] 288475 0
Australia
Date submitted for ethics approval [3] 288475 0
Approval date [3] 288475 0
26/08/2011
Ethics approval number [3] 288475 0
2011109
Ethics committee name [4] 288476 0
Melbourne Health HREC
Ethics committee address [4] 288476 0
Ethics committee country [4] 288476 0
Australia
Date submitted for ethics approval [4] 288476 0
Approval date [4] 288476 0
21/04/2010
Ethics approval number [4] 288476 0
2010.008
Ethics committee name [5] 288477 0
South Australia Health HREC
Ethics committee address [5] 288477 0
Ethics committee country [5] 288477 0
Australia
Date submitted for ethics approval [5] 288477 0
Approval date [5] 288477 0
02/06/2010
Ethics approval number [5] 288477 0
339/02/2013
Ethics committee name [6] 288478 0
Southern Adelaide Clinical HREC (covering Flinders University)
Ethics committee address [6] 288478 0
Ethics committee country [6] 288478 0
Australia
Date submitted for ethics approval [6] 288478 0
Approval date [6] 288478 0
04/11/2010
Ethics approval number [6] 288478 0
330/10
Ethics committee name [7] 288479 0
HREC Tasmania Network (University of Tasmania)
Ethics committee address [7] 288479 0
Ethics committee country [7] 288479 0
Australia
Date submitted for ethics approval [7] 288479 0
Approval date [7] 288479 0
23/11/2011
Ethics approval number [7] 288479 0
H12159

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

Contacts
Principal investigator
Name 31084 0
Prof James Dunbar
Address 31084 0
Greater Green Triangle University Department of Rural Health Flinders and Deakin Universities, Warrnambool, Vic, 3280
Country 31084 0
Australia
Phone 31084 0
+61 3 5563 3504
Fax 31084 0
Email 31084 0
[email protected]
Contact person for public queries
Name 14331 0
Prof James Dunbar
Address 14331 0
Greater Green Triangle University Department of Rural Health
Flinders and Deakin Universities
Warrnambool, Vic, 3280
Country 14331 0
Australia
Phone 14331 0
+61 3 5563 3504
Fax 14331 0
+61 3 5563 3144
Email 14331 0
[email protected]
Contact person for scientific queries
Name 5259 0
Prof James Dunbar
Address 5259 0
Greater Green Triangle University Department of Rural Health
Flinders and Deakin Universities
Warrnambool, Vic, 3280
Country 5259 0
Australia
Phone 5259 0
+61 3 5563 3504
Fax 5259 0
Email 5259 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
EmbaseMothers after Gestational Diabetes in Australia (MAGDA): A Randomised Controlled Trial of a Postnatal Diabetes Prevention Program.2016https://dx.doi.org/10.1371/journal.pmed.1002092
EmbaseThe effect of a diabetes prevention program on dietary quality in women with previous gestational diabetes.2019https://dx.doi.org/10.1186/s12905-019-0788-0
EmbaseWeight change and cardiometabolic outcomes in postpartumwomen with history of gestational diabetes.2019https://dx.doi.org/10.3390/nu11040922
N.B. These documents automatically identified may not have been verified by the study sponsor.