Trial Review

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
ACTRN12614000539639
Ethics application status
Approved
Date submitted
2/04/2014
Date registered
21/05/2014
Date last updated
18/01/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Healthy Living Program after Gestational Diabetes
Scientific title
A randomised controlled trial of lifestyle intervention to address post-partum health behaviours among women with recent gestational diabetes mellitus
Secondary ID [1] 284383 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
gestational diabetes 291552 0
diabetes 291553 0
Obesity and overweight 291597 0
Condition category
Condition code
Metabolic and Endocrine 291935 291935 0 0
Diabetes
Diet and Nutrition 291975 291975 0 0
Obesity
Reproductive Health and Childbirth 291976 291976 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Behavioural strategies to increase physical activity and improve diet over a period of 6 months:
ADOPTION PHASE: individualised one hour face-to-face counseling session with a dietitian addressing diet and physical activity, followed by telephone follow-up and a second one hour face-to-face counseling session one month later. Each participant’s baseline behaviors, health priorities and barriers to action will be used to assist in setting behavior change goals. A further telephone call, 2 text messages and a postcard will be used as additional means of reinforcement over the first 3 months.
MAINTENANCE PHASE: In the second 3 months there will be 3 further telephone calls, 3 mobile text messages, and 3 more postcards.

PHYSICAL ACTIVITY will be monitored by accelerometer and the Active Australia Questionnaire.
DIETARY BEHAVIOUR will be assessed by diet histories and 3 day food records.
Intervention code [1] 289113 0
Lifestyle
Intervention code [2] 289144 0
Behaviour
Comparator / control treatment
No intervention
Control group
Active

Outcomes
Primary outcome [1] 291837 0
achievement of physical activity guidelines.

measured by accelerometer and Active Australia Questionnaire.
Timepoint [1] 291837 0
6 months
Primary outcome [2] 291838 0
achievement of dietary guidelines

measured by diet history and 3 day food records.
Timepoint [2] 291838 0
6 months
Primary outcome [3] 291839 0
change in dietary macronutrient consumption

measured by diet history and 3 day food records.
Timepoint [3] 291839 0
6 months
Secondary outcome [1] 308342 0
Nil
Timepoint [1] 308342 0
N/A

Eligibility
Key inclusion criteria
women with gestational diabetes in the previous 3-36 months
overweight or obese
report an intention to adopt changes in physical activity or diet
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
already has diabetes
currently pregnant or planning pregnancy within the next 6 months
unable to or unfit to exercise due to chronic illness
on medication which may affect glucose or weight control
women who are precontemplators (ie not wanting to change) as defined by the behaviour change model
poor written and spoken english proficiency

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2009
Actual
6/10/2009
Date of last participant enrolment
Anticipated
Actual
30/03/2010
Date of last data collection
Anticipated
Actual
1/01/2011
Sample size
Target
100
Accrual to date
Final
59
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 289026 0
Self funded/Unfunded
Name [1] 289026 0
Country [1] 289026 0
Primary sponsor type
Hospital
Name
Westmead Hospital
Address
Hawkesbury Rd
Westmead NSW 2145
Country
Australia
Secondary sponsor category [1] 287699 0
None
Name [1] 287699 0
Address [1] 287699 0
Country [1] 287699 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
The study aims to determine if a comprehensive behavioural lifestyle intervention promoting physical activity and encouraging healthy diet can achieve short-term behaviour change in overweight/obese women with a recent history of gestational diabetes, in a real world setting.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 47470 0
Prof N Wah Cheung
Address 47470 0
Dept of Diabetes & Endocrinology
Westmead Hospital
Hawkesbury Rd
Westmead NSW 2145
Country 47470 0
Australia
Phone 47470 0
6102 98456796
Fax 47470 0
Email 47470 0
[email protected]
Contact person for public queries
Name 47471 0
Prof N Wah Cheung
Address 47471 0
Dept of Diabetes & Endocrinology
Westmead Hospital
Hawkesbury Rd
Westmead NSW 2145
Country 47471 0
Australia
Phone 47471 0
6102 9845 6796
Fax 47471 0
Email 47471 0
[email protected]
Contact person for scientific queries
Name 47472 0
Prof N Wah Cheung
Address 47472 0
Dept of Diabetes & Endocrinology
Westmead Hospital
Hawkesbury Rd
Westmead NSW 2145
Country 47472 0
Australia
Phone 47472 0
6102 9845 6796
Fax 47472 0
Email 47472 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.