Pedometers for Gestational Diabetes

Gestational Diabetes Clinical Trial

— PEG  

Official title:

Type 2 Diabetes Risk in Women With Gestational Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00862602
• Other study ID #: K23DK071552
• Secondary ID: K23DK071552R03DK
• Status: Completed
• Phase: N/A
• First received: March 16, 2009
• Last updated: May 19, 2017
• Start date: July 2009
• Est. completion date: November 2010

Study information

• Verified date: May 2017
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes

Intervention

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.

Locations

Country	Name	City	State
United States	University of Michigan Health System	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight loss		Pre-post
Primary	Glucose tolerance		Pre-Post
Secondary	Hemoglobin A1c		Pre-post
Secondary	Step counts		Pre-Post
Secondary	Insulin		Pre-post