Overview

This trial is active, not recruiting.

Condition gestational diabetes
Treatment stepping up to health
Sponsor National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator University of Michigan
Start date July 2009
End date November 2010
Trial size 60 participants
Trial identifier NCT00862602, K23 DK71552, R03DK083332

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
Stepping Up to Health
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)
Usual care group

Primary Outcomes

Measure
Weight loss
time frame: Pre-post
Glucose tolerance
time frame: Pre-Post

Secondary Outcomes

Measure
Hemoglobin A1c
time frame: Pre-post
Step counts
time frame: Pre-Post
Insulin
time frame: Pre-post

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title Type 2 Diabetes Risk in Women With Gestational Diabetes
Principal investigator Catherine Kim, MD, MPH
Trial information was received from ClinicalTrials.gov and was last updated in September 2010.
Information provided to ClinicalTrials.gov by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).