Pedometers for Gestational Diabetes

Study Overview
=================
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.

Official Title
-----------------
Type 2 Diabetes Risk in Women With Gestational Diabetes

Conditions
-----------------
Gestational Diabetes

Intervention / Treatment
-----------------
* Behavioral: Stepping Up to Health


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Stepping Up to Health | Behavioral: Stepping Up to Health<br>* 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.<br>|
| No Intervention: 2<br>Usual care group | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight loss |  | Pre-post | 
| Glucose tolerance |  | Pre-Post | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin A1c |  | Pre-post | 
| Step counts |  | Pre-Post | 
| Insulin |  | Pre-post | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GDM, gestational diabetes, pregnancy, diabetes, walking, exercise, pedometer, online