Pedometers for Gestational Diabetes (PEG)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator:
University of Michigan
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00862602
First received: March 16, 2009
Last updated: September 9, 2010
Last verified: September 2010
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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 Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Type 2 Diabetes Risk in Women With Gestational Diabetes |
Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
Primary Outcome Measures:
- Weight loss [ Time Frame: Pre-post ] [ Designated as safety issue: No ]
- Glucose tolerance [ Time Frame: Pre-Post ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Hemoglobin A1c [ Time Frame: Pre-post ] [ Designated as safety issue: No ]
- Step counts [ Time Frame: Pre-Post ] [ Designated as safety issue: No ]
- Insulin [ Time Frame: Pre-post ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | July 2009 |
| Estimated Study Completion Date: | April 2011 |
| Estimated 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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders 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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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: NCT00862602
Please refer to this study by its ClinicalTrials.gov identifier: NCT00862602
Locations
| United States, Michigan | |
| University of Michigan Health System | |
| Ann Arbor, Michigan, United States, 48109 | |
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Michigan
Investigators
| Principal Investigator: | Catherine Kim, MD, MPH | University of Michigan |
More Information
| Responsible Party: | Catherine Kim, MD, MPH, University of Michigan Health System |
| ClinicalTrials.gov Identifier: | NCT00862602 History of Changes |
| Other Study ID Numbers: | K23DK071552 R03DK083332 |
| Study First Received: | March 16, 2009 |
| Last Updated: | September 9, 2010 |
| Health Authority: | United States: Federal Government United States: Institutional Review Board |
Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
|
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 |
ClinicalTrials.gov processed this record on September 26, 2016