Walking Exercise and Nutrition to Reduce Diabetes Risk for You (WENDY)
Recruitment status was Not yet recruiting
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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Stepping Up to Health - Walking Exercise and Nutrition to Reduce Diabetes Risk for You (WENDY)|
- Change in body weight [ Time Frame: pre-post ] [ Designated as safety issue: No ]
- Change in insulin sensitivity [ Time Frame: pre-post ] [ Designated as safety issue: No ]
- Change in physical activity [ Time Frame: pre-post ] [ Designated as safety issue: No ]
|Study Start Date:||March 2011|
|Estimated Study Completion Date:||September 2012|
|Estimated Primary Completion Date:||March 2012 (Final data collection date for primary outcome measure)|
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|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01247753
|Contact: Catherine Kim, MDfirstname.lastname@example.org|
|Mater Mothers Hospital||Not yet recruiting|
|South Brisbane, Queensland, Australia, 4101|
|Principal Investigator: David McIntyre, MD|