Pedometers for Gestational Diabetes
PEG
Type 2 Diabetes Risk in Women With Gestational Diabetes
2 other identifiers
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 16, 2009
CompletedFirst Posted
Study publicly available on registry
March 17, 2009
CompletedStudy Start
First participant enrolled
July 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedMay 23, 2017
May 1, 2017
1.3 years
March 16, 2009
May 19, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Weight loss
Pre-post
Glucose tolerance
Pre-Post
Secondary Outcomes (3)
Hemoglobin A1c
Pre-post
Step counts
Pre-Post
Insulin
Pre-post
Study Arms (2)
1
EXPERIMENTALStepping Up to Health
2
NO INTERVENTIONUsual care group
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Pregnancy
- Unable to consent legally
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Michigan Health System
Ann Arbor, Michigan, 48109, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Catherine Kim, MD, MPH
University of Michigan
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- associate professor
Study Record Dates
First Submitted
March 16, 2009
First Posted
March 17, 2009
Study Start
July 1, 2009
Primary Completion
November 1, 2010
Study Completion
November 1, 2010
Last Updated
May 23, 2017
Record last verified: 2017-05