- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00862602
Pedometers for Gestational Diabetes (PEG)
May 19, 2017 updated by: Catherine Kim, University of Michigan
Type 2 Diabetes Risk in Women With Gestational Diabetes
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109
- University of Michigan Health System
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 99 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Weight loss
Time Frame: Pre-post
|
Pre-post
|
Glucose tolerance
Time Frame: Pre-Post
|
Pre-Post
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Hemoglobin A1c
Time Frame: Pre-post
|
Pre-post
|
Step counts
Time Frame: Pre-Post
|
Pre-Post
|
Insulin
Time Frame: Pre-post
|
Pre-post
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Catherine Kim, MD, MPH, University of Michigan
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2009
Primary Completion (Actual)
November 1, 2010
Study Completion (Actual)
November 1, 2010
Study Registration Dates
First Submitted
March 16, 2009
First Submitted That Met QC Criteria
March 16, 2009
First Posted (Estimate)
March 17, 2009
Study Record Updates
Last Update Posted (Actual)
May 23, 2017
Last Update Submitted That Met QC Criteria
May 19, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- K23DK071552 (U.S. NIH Grant/Contract)
- R03DK083332 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Gestational Diabetes
-
IRCCS Burlo GarofoloCompletedGestational Diabetes | Gestational Diabetes Mellitus | Pregnancy-Induced Diabetes | Diabetes Mellitus, Gestational | Diabetes, Pregnancy InducedIsrael, Italy, Netherlands, Slovenia, Sri Lanka
-
UPECLIN HC FM Botucatu UnespCompletedGestational Diabetes Mellitus | Pregestational Diabetes Mellitus | Mild Gestational HyperglycemiaBrazil
-
Assistance Publique - Hôpitaux de ParisCompleted
-
University of Texas Southwestern Medical CenterCompletedMild Gestational DiabetesUnited States
-
Royal College of Surgeons, IrelandHealth Research Board, IrelandUnknownPre-Gestational Diabetes
-
University of Colorado, DenverKaiser PermanenteCompletedGestational Diabetes MellitusUnited States
-
Intermountain Health Care, Inc.Withdrawn
-
McGill University Health Centre/Research Institute...The Lawson FoundationCompletedGestational Diabetes Mellitus With Baby DeliveredCanada
-
Woman'sBaton Rouge Area FoundationCompletedGestational Diabetes MellitusUnited States
-
Brigham and Women's HospitalUniversity of Colorado, DenverCompletedGestational Diabetes MellitusUnited States
Clinical Trials on Stepping Up to Health
-
Robert Wood Johnson FoundationCompletedCoronary Artery Disease | Obesity | Type 2 Diabetes
-
McMaster UniversityYMCA Hamilton/Burlington/Brantford; City of HamiltonRecruitingMobility LimitationCanada
-
Beni-Suef UniversityCairo University; Medical Center Hospital, libyaCompletedCoronary Artery DiseaseEgypt
-
University of South FloridaTemple University; National Institute on Disability, Independent Living, and... and other collaboratorsRecruitingMental Illness | Behavior Disorders | Psychiatric Diagnosis | Psychiatric Disorders | Severe Mental Illness | Psychiatric Diseases | Psychiatric IllnessUnited States
-
University of PennsylvaniaCompletedCervical CancerUnited States
-
Leipzig Heart Institute GmbHCompletedCardiac Implantable Electronic DevicesGermany
-
Medtronic Spinal and BiologicsMedtronic Bakken Research CenterRecruitingSpinal Deformity | Spinal Degenerative Disorder | Spinal Trauma | Spinal Fusion Failure | Spinal Tumor CaseUnited States
-
Virginia Commonwealth UniversityAgency for Healthcare Research and Quality (AHRQ)Enrolling by invitation
-
West Park Healthcare CentreCompleted
-
Mary LacyNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Active, not recruiting