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Pedometers for Gestational Diabetes (PEG)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00862602
First Posted: March 17, 2009
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.
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Catherine Kim, University of Michigan
  Purpose
Ten to 50% of women with gestational diabetes (GDM), or glucose intolerance first recognized during pregnancy, develop diabetes within 5 years after delivery. Although intensive interventions can reduce diabetes incidence in women with impaired glucose tolerance, it is unknown if such strategies would be effective in women with GDM. Women with recent GDM, even though no longer pregnant, face significant barriers to lifestyle modification, including caregiving responsibilities and low perception of risk. Web-based programs can reinforce physical activity through visual feedback of pedometer output, tailored messaging, education, and on-line communities. Such a program is currently available for adults with chronic disease and is led by Dr. Richardson, a co-PI on this application. Using data from focus group and survey work conducted by Dr. Kim, the other co-PI, this program can be modified to women with recent GDM. For Specific Aim 1, we propose to adapt a chronic disease web-based pedometer program to women with recent GDM. For Specific Aim 2, we propose to conduct a pilot and feasibility study of the program. The intervention will last 12 weeks.

Condition Intervention
Gestational Diabetes Behavioral: Stepping Up to Health

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Type 2 Diabetes Risk in Women With Gestational Diabetes

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Weight loss [ Time Frame: Pre-post ]
  • Glucose tolerance [ Time Frame: Pre-Post ]

Secondary Outcome Measures:
  • Hemoglobin A1c [ Time Frame: Pre-post ]
  • Step counts [ Time Frame: Pre-Post ]
  • Insulin [ Time Frame: Pre-post ]

Enrollment: 60
Actual Study Start Date: July 2009
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Stepping Up to Health
Behavioral: Stepping Up to Health
Internet-mediated pedometer-based intervention with gradually increasing goals and feedback on step counts. Also includes educational content targeted at women who have had gestational diabetes about exercise, diet & nutrition and prevention.
No Intervention: 2
Usual care group

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Gestational diabetes diagnosis within past three years
  • Access to computer with internet, USB port and Windows XP or Vista
  • Regular email user (weekly or more)
  • Can walk a block on her own
  • Sedentary (less than 150 minutes purposeful physical activity per week)

Exclusion Criteria:

  • Pregnancy
  • Unable to consent legally
  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): NCT00862602


Locations
United States, Michigan
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Catherine Kim, MD, MPH University of Michigan
  More Information

Responsible Party: Catherine Kim, associate professor, University of Michigan
ClinicalTrials.gov Identifier: NCT00862602     History of Changes
Other Study ID Numbers: K23DK071552 ( U.S. NIH Grant/Contract )
R03DK083332 ( U.S. NIH Grant/Contract )
First Submitted: March 16, 2009
First Posted: March 17, 2009
Last Update Posted: May 23, 2017
Last Verified: May 2017

Keywords provided by Catherine Kim, University of Michigan:
GDM
gestational diabetes
pregnancy
diabetes
walking
exercise
pedometer
online

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