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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
Recruitment status was  Not yet recruiting
Sponsor:
Collaborators:
University of Michigan
Mater Mothers Hospital-Australia
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT01247753
First received: November 22, 2010
Last updated: February 1, 2011
Last verified: February 2011
  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: 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 National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:
  • Change in body weight [ Time Frame: pre-post ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 60
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)
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

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01247753

Contacts
Contact: Catherine Kim, MD 734-936-5216 cathkim@umich.edu

Locations
Australia, Queensland
Mater Mothers Hospital Not yet recruiting
South Brisbane, Queensland, Australia, 4101
Principal Investigator: David McIntyre, MD         
Sponsors and Collaborators
University of Michigan
Mater Mothers Hospital-Australia
  More Information

No publications provided

Responsible Party: Catherine Kim, Assistant Professor, University of Michgan
ClinicalTrials.gov Identifier: NCT01247753     History of Changes
Other Study ID Numbers: K23 DK71552-1
Study First Received: November 22, 2010
Last Updated: February 1, 2011
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on September 18, 2014