Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000075987
Ethics application status
Not yet submitted
Date submitted
19/01/2011
Date registered
20/01/2011
Date last updated
20/01/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Walking for Exercise and Nutrition to prevent Diabetes for You (Wendy)
Scientific title
In overweight/obese women previously diagnosed with Gestational Diabetes, is an exercise and nutrition program more effective than standard care in terms of weight loss and increased regular activity to prevent Type 2 Diabetes?
Secondary ID [1] 253448 0
2076
Secondary ID [2] 253451 0
Clinical Trials.gov-NCT01247753
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post partum Gestational Diabetes 260999 0
Condition category
Condition code
Metabolic and Endocrine 259131 259131 0 0
Diabetes
Diet and Nutrition 259138 259138 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In addition to the same feedback and printed resources offered to women in the control group, women allocated to the intervention group will receive a specifically designed "USB pedometer". The pedometer is designed to be worn during waking hours, especially during exercise, and will allow the user to upload their data in to a tailored web based program that offers tips, ideas and motivation to the participants over the 3 month intervention. The user will be encouraged to log on weekly and will receive weekly goals, feedback on their walking progress, and messages and “tips” regarding diet and excercise, targeted at diabetes prevention. The program content will be designed in collaboration with the University of Michigan, where a similar project was performed in 2009 incorporating an exercise intervention without the dietary component.

The participants in this arm of the study will also receive a Nutritional Coaching course run by Dieticians. This consists of one individual session with a dietician for baseline dietary assessment and a personalised program, followed by 4 monthly group sessions informed by evidence based behavioural modification concepts with monthly followups by phone at a mutually agreed time. SMS text messaging will also be utilised if available as a contact point for reinforcement of health promotion messages.

To assess longer term effects, the intervention group participants will be offered a maintenance program for a further three months immediatley following the intervention. This will consist of monthly face-to-face consultaion and weight for 3 months. After this additional time they will be re-evaluated, where anthropometric observations, fasting blood tests and questionnaires relating to diet, activity and lifestylewill be repeated.
Intervention code [1] 257889 0
Lifestyle
Intervention code [2] 257893 0
Prevention
Comparator / control treatment
Standard care is defined as receiving widely available written information (Pamphlets) with general advice regarding diet and exercise.
Control group
Active

Outcomes
Primary outcome [1] 261986 0
Weight will be measured to the nearest 0.1 kg using a spring balance scale. Height will be measured with a wall mounted stadiometer to the nearest 0.5cm. Body composition will be determined using a multi-frequency bioelectrical impedance analyzer, with a measured resistance at a fixed frequency of 50Hz.
Timepoint [1] 261986 0
Baseline, then 3 months post completion of initial intervention, and 6months post intervention/maintenance depending on group allocation.
Secondary outcome [1] 268913 0
A secondary outcome will be objective measurement of physical activity, which will be assessed objectively using pedometers, worn only by the intervention group. The control group do not wear pedometers.These data will be supplemented with self-reported physical activity (for the same time period as the MTI assessment) using the Australian Women's Activity Survey (AWAS).
Timepoint [1] 268913 0
Baseline, then 3 months post completion of initial intervention, and 6months post intervention/maintenance depending on group allocation.
Secondary outcome [2] 268914 0
Another secondary outcome measure of this data will be changes in insulin resistance in the Control and Intervention groups will be compared using the Homeostasis Model Assessment (HOMA-IR).
Timepoint [2] 268914 0
Baseline, then 3 months post completion of initial intervention, and 6months post intervention/maintenance depending on group allocation.
Secondary outcome [3] 268921 0
Changes in diet quality change will be measured through the admiistration of validated tools such as the Fat, fibre Index . The Fat and Fibre behaviour Index will provide information realting to diet quality .
Timepoint [3] 268921 0
Baseline, then 3 months post completion of initial intervention, and 6months post intervention/maintenance depending on group allocation.
Secondary outcome [4] 268922 0
Changes in well being and lifestyle change will be measured through the admiistration of validated tools such as the Kessler Psychological Distress scale (K10). K10 is a scale measuring non-specific psychological distress and consists of 10 questions seeks to measure the level of current anxiety and depressive symptoms a person may have experienced in month prior to the interview .
Timepoint [4] 268922 0
Baseline, then 3 months post completion of initial intervention, and 6months post intervention/maintenance depending on group allocation.

Eligibility
Key inclusion criteria
been diagnosed as having and treated for GDM at the Mater Mothers Hospital.
given birth at the Mater Mothers’ Hospital in the previous 6 months to 2 years.
a BMI > 25kg/m2 based on current self reported height and weight.
routine access to a computer and possess adequate computer skills to navigate web sites and e-mail.
understood that the primary physical activity will be walking
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
currently pregnant or planning to be pregnant in the next year.
already diagnosed with T2DM.
not sufficiently fluent in spoken and written English to be able to fully participate in the study.
taking medications which interfere with glucose metabolism such as metformin or prednisone.
suffering from any mental or physical disability which would interfere with their participation in the study.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
102
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 258362 0
Charities/Societies/Foundations
Name [1] 258362 0
Mater Foundation
Country [1] 258362 0
Australia
Primary sponsor type
Individual
Name
Ann Peacock
Address
Mater Medical Research Institute
Level 3, Aubigny Place
Raymond Terrace,
South Brisbane 4101
Brisbane
Queensland
Country
Australia
Secondary sponsor category [1] 257509 0
Individual
Name [1] 257509 0
Professor H.D. McIntyre
Address [1] 257509 0
Mater Health Services,
Raymond Terrace,
South Brisbane 4101
Brisbane
Queensland
Country [1] 257509 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 260334 0
Ethics committee address [1] 260334 0
Ethics committee country [1] 260334 0
Date submitted for ethics approval [1] 260334 0
10/01/2011
Approval date [1] 260334 0
Ethics approval number [1] 260334 0

Summary
Brief summary
The prevalence of Gestational Diabetes (GDM) in Australia is approximately 5%-8%, with up to one third of all parous women who develop type 2 diabetes having a previous history of GDM . Research to determine strategies to delay or prevent the development of or progression to diabetes is vital, particularly in population groups that are at higher risk, such as GDM, and obese women (BMI.>25). A pilot randomised controlled trial (RCT) conducted at Mater Mothers Hospital suggested that a post partum intervention designed to increase physical activity in women with previous GDM may be feasible. A recent study in the United States recruited women with recent GDM into an RCT where the control group received usual care and the intervention group received a web based pedometer program. Dietary intervention has been proven to increase probability of weight loss, so a strategy of combining both a pedometer and nutrition based program may prove to be more successful in long term improvement in a healthy lifestyle to prevent type 2 diabetes.

The aim of this study is to develop long term statergies for women who develop GDM during their pregnancy and are overweight (BMI > 25) to improve their lifestyle to possibly prevent Type 2 diabetes. This randomised controlled trial is a pedometer - based inervention to encourage physical activity , combined with nutrition coaching, and will possibly result in an increased weight loss, improved insulin sensitivity and increased physical activity when compared with standard care. This project aims to take another step towards the larger scale issue of providing adequate, evidence based follow up care for women who develop GDM in their pregnancies.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32115 0
Address 32115 0
Country 32115 0
Phone 32115 0
Fax 32115 0
Email 32115 0
Contact person for public queries
Name 15362 0
Ann Peacock
Address 15362 0
Mater Medical Research Institute
Level 3 Aubigny Place,
Raymond Terrace,
South Brisbane 4101
Queensland
Country 15362 0
Australia
Phone 15362 0
+61 7 3163 2874
Fax 15362 0
Email 15362 0
[email protected]
Contact person for scientific queries
Name 6290 0
Ann Peacock
Address 6290 0
Mater Medical Research Institute
Level 3 Aubigny Place,
Raymond Terrace,
South Brisbane 4101
Queensland
Country 6290 0
Australia
Phone 6290 0
+61 7 3163 2874
Fax 6290 0
Email 6290 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
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