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Pedometers for Gestational Diabetes (PEG)

Primary Purpose

Gestational Diabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stepping Up to Health
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gestational Diabetes focused on measuring GDM, gestational diabetes, pregnancy, diabetes, walking, exercise, pedometer, online

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Michigan Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

1

2

Arm Description

Stepping Up to Health

Usual care group

Outcomes

Primary Outcome Measures

Weight loss
Glucose tolerance

Secondary Outcome Measures

Hemoglobin A1c
Step counts
Insulin

Full Information

First Posted
March 16, 2009
Last Updated
May 19, 2017
Sponsor
University of Michigan
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT00862602
Brief Title
Pedometers for Gestational Diabetes
Acronym
PEG
Official Title
Type 2 Diabetes Risk in Women With Gestational Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
July 2009 (Actual)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes
Keywords
GDM, gestational diabetes, pregnancy, diabetes, walking, exercise, pedometer, online

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Stepping Up to Health
Arm Title
2
Arm Type
No Intervention
Arm Description
Usual care group
Intervention Type
Behavioral
Intervention Name(s)
Stepping Up to Health
Intervention Description
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.
Primary Outcome Measure Information:
Title
Weight loss
Time Frame
Pre-post
Title
Glucose tolerance
Time Frame
Pre-Post
Secondary Outcome Measure Information:
Title
Hemoglobin A1c
Time Frame
Pre-post
Title
Step counts
Time Frame
Pre-Post
Title
Insulin
Time Frame
Pre-post

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine Kim, MD, MPH
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Pedometers for Gestational Diabetes

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