Walking Exercise and Nutrition to Reduce Diabetes Risk for You (WENDY) (WENDY)
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|ClinicalTrials.gov Identifier: NCT01247753|
Recruitment Status : Completed
First Posted : November 24, 2010
Last Update Posted : May 23, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Gestational Diabetes Mellitus||Behavioral: Walking group||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Stepping Up to Health - Walking Exercise and Nutrition to Reduce Diabetes Risk for You (WENDY)|
|Actual Study Start Date :||March 1, 2011|
|Actual Primary Completion Date :||March 1, 2012|
|Actual Study Completion Date :||March 1, 2012|
Behavioral: 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.
|No Intervention: Control|
- Change in body weight [ Time Frame: pre-post ]
- Change in insulin sensitivity [ Time Frame: pre-post ]
- Change in physical activity [ Time Frame: pre-post ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01247753
|Mater Mothers Hospital|
|South Brisbane, Queensland, Australia, 4101|