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Trial details imported from

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Registration number
Ethics application status
Date submitted
Date registered
Date last updated

Titles & IDs
Public title
Walking Exercise and Nutrition to Reduce Diabetes Risk for You (WENDY)
Scientific title
Stepping Up to Health - Walking Exercise and Nutrition to Reduce Diabetes Risk for You (WENDY)
Secondary ID [1] 0 0
Secondary ID [2] 0 0
K23 DK71552-1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 0 0
Gestational Diabetes Mellitus 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Reproductive Health and Childbirth 0 0 0 0
Fetal medicine and complications of pregnancy

Study type
Description of intervention(s) / exposure
Behaviour - Walking group

Experimental: Intervention -

No Intervention: Control -

Behaviour: Walking group
Internet-mediated pedometer-based walking program with gradually increasing step count goals and feedback on step counts. Also includes nutritional coaching course consisting of 1 individual session with a dietician, 4 group sessions, and monthly follow-up. Oral glucose tolerance tests pre and post-intervention.

Intervention code [1] 0 0
Comparator / control treatment
Control group

Primary outcome [1] 0 0
Change in body weight
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Change in insulin sensitivity
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Change in physical activity
Timepoint [2] 0 0

Key inclusion criteria
Diagnosis of gestational diabetes mellitus and given birth in the preceding 6 months to 3
years; 18 years of age or older; BMI >= 25; Routine access to a computer; Adequate computer
skills to navigate websites and email; Speak and understand English well enough to
participate in the study
Minimum age
18 Years
Maximum age
No limit
Can healthy volunteers participate?
Key exclusion criteria
Currently pregnant or planning to become pregnant in the next year; Current diabetes;
Currently taking medications that interfere with glucose metabolism

Study design
Purpose of the study
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
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Mater Mothers Hospital - South Brisbane
Recruitment postcode(s) [1] 0 0
4101 - South Brisbane

Funding & Sponsors
Primary sponsor type
University of Michigan
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Name [2] 0 0
Mater Mothers' Hospital
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Brief summary
The prevalence of Gestational Diabetes Mellitus (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 overweight women (BMI>=25). Currently, follow-up or post-partum support for
women who develop GDM is limited to advice to complete a 6 week post-partum oral glucose
tolerance test to exclude overt diabetes, to be repeated annually. A pilot randomized
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
walking program. Although the results of this study are limited, they did show an increase in
pedometer steps/day between baseline and end of study. 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 for long term improvement of a
healthy lifestyle to prevent type 2 diabetes.

Study hypothesis: A pedometer based intervention to encourage physical activity, combined
with nutrition coaching in women with recent GDM and BMI >= 25 will result in increased
weight loss, improved insulin sensitivity and increased physical activity when compared with
standard care.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications