Pedometers for Gestational Diabetes (PEG)

This study has been completed.

Sponsor:

Collaborator:

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Information provided by (Responsible Party):

Catherine Kim, University of Michigan

ClinicalTrials.gov Identifier:

NCT00862602

First received: March 16, 2009

Last updated: May 19, 2017

Last verified: May 2017

History of Changes

Purpose

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.

Condition	Intervention
Gestational Diabetes	Behavioral: Stepping Up to Health


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Prevention
Official Title:	Type 2 Diabetes Risk in Women With Gestational Diabetes

Further study details as provided by Catherine Kim, University of Michigan:

Primary Outcome Measures:

Weight loss [ Time Frame: Pre-post ]
Glucose tolerance [ Time Frame: Pre-Post ]

Secondary Outcome Measures:

Hemoglobin A1c [ Time Frame: Pre-post ]
Step counts [ Time Frame: Pre-Post ]
Insulin [ Time Frame: Pre-post ]


Enrollment:	60
Actual Study Start Date:	July 2009
Study Completion Date:	November 2010
Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Stepping Up to Health	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.
No Intervention: 2 Usual care group

Eligibility


Ages Eligible for Study:	18 Years to 99 Years (Adult, Senior)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00862602

Locations


United States, Michigan
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109

Sponsors and Collaborators

University of Michigan

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators


Principal Investigator:	Catherine Kim, MD, MPH	University of Michigan

More Information


Responsible Party:	Catherine Kim, associate professor, University of Michigan
ClinicalTrials.gov Identifier:	NCT00862602 History of Changes
Other Study ID Numbers:	K23DK071552 ( U.S. NIH Grant/Contract ) R03DK083332 ( U.S. NIH Grant/Contract )
Study First Received:	March 16, 2009
Last Updated:	May 19, 2017

Keywords provided by Catherine Kim, University of Michigan:


GDM gestational diabetes pregnancy diabetes	walking exercise pedometer online

Additional relevant MeSH terms:


Diabetes Mellitus Diabetes, Gestational Glucose Metabolism Disorders	Metabolic Diseases Endocrine System Diseases Pregnancy Complications

ClinicalTrials.gov processed this record on August 23, 2017

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