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Walking Exercise and Nutrition to Reduce Diabetes Risk for You (WENDY) (WENDY)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01247753
First Posted: November 24, 2010
Last Update Posted: May 23, 2017
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 evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Mater Mothers Hospital-Australia
Information provided by (Responsible Party):
Catherine Kim, University of Michigan
  Purpose

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 Intervention
Diabetes Gestational Diabetes Mellitus Behavioral: Walking group

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Stepping Up to Health - Walking Exercise and Nutrition to Reduce Diabetes Risk for You (WENDY)

Resource links provided by NLM:


Further study details as provided by Catherine Kim, University of Michigan:

Primary Outcome Measures:
  • Change in body weight [ Time Frame: pre-post ]

Secondary Outcome Measures:
  • Change in insulin sensitivity [ Time Frame: pre-post ]
  • Change in physical activity [ Time Frame: pre-post ]

Enrollment: 60
Actual Study Start Date: March 1, 2011
Study Completion Date: March 1, 2012
Primary Completion Date: March 1, 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention 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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Information from the National Library of Medicine

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


Locations
Australia, Queensland
Mater Mothers Hospital
South Brisbane, Queensland, Australia, 4101
Sponsors and Collaborators
University of Michigan
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Mater Mothers Hospital-Australia
  More Information

Responsible Party: Catherine Kim, associate professor, University of Michigan
ClinicalTrials.gov Identifier: NCT01247753     History of Changes
Other Study ID Numbers: K23 DK71552-1
K23DK071552 ( U.S. NIH Grant/Contract )
First Submitted: November 22, 2010
First Posted: November 24, 2010
Last Update Posted: May 23, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications