Walking Exercise and Nutrition to Reduce Diabetes Risk for You (WENDY) (WENDY)
Primary Purpose
Diabetes, Gestational Diabetes Mellitus
Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Walking group
Sponsored by
About this trial
This is an interventional prevention trial for Diabetes
Eligibility Criteria
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
Exclusion Criteria:
Currently pregnant or planning to become pregnant in the next year; Current diabetes; Currently taking medications that interfere with glucose metabolism
Sites / Locations
- Mater Mothers Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
Outcomes
Primary Outcome Measures
Change in body weight
Secondary Outcome Measures
Change in insulin sensitivity
Change in physical activity
Full Information
NCT ID
NCT01247753
First Posted
November 22, 2010
Last Updated
May 19, 2017
Sponsor
University of Michigan
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Mater Mothers' Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01247753
Brief Title
Walking Exercise and Nutrition to Reduce Diabetes Risk for You (WENDY)
Acronym
WENDY
Official Title
Stepping Up to Health - Walking Exercise and Nutrition to Reduce Diabetes Risk for You (WENDY)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
March 1, 2011 (Actual)
Primary Completion Date
March 1, 2012 (Actual)
Study Completion Date
March 1, 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Mater Mothers' Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Gestational Diabetes Mellitus
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Walking group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in body weight
Time Frame
pre-post
Secondary Outcome Measure Information:
Title
Change in insulin sensitivity
Time Frame
pre-post
Title
Change in physical activity
Time Frame
pre-post
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Exclusion Criteria:
Currently pregnant or planning to become pregnant in the next year; Current diabetes; Currently taking medications that interfere with glucose metabolism
Facility Information:
Facility Name
Mater Mothers Hospital
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
12. IPD Sharing Statement
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Walking Exercise and Nutrition to Reduce Diabetes Risk for You (WENDY)
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