Pedometers for Gestational Diabetes (PEG)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 or disease	Intervention/treatment	Phase
Gestational Diabetes	Behavioral: Stepping Up to Health	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	60 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
Official Title:	Type 2 Diabetes Risk in Women With Gestational Diabetes
Actual Study Start Date :	July 2009
Actual Primary Completion Date :	November 2010
Actual Study Completion Date :	November 2010

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. Weight loss [ Time Frame: Pre-post ]
2. Glucose tolerance [ Time Frame: Pre-Post ]

Secondary Outcome Measures :

1. Hemoglobin A1c [ Time Frame: Pre-post ]
2. Step counts [ Time Frame: Pre-Post ]
3. Insulin [ Time Frame: Pre-post ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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 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