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Pedometers for Gestational Diabetes (PEG)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
University of Michigan
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00862602
First received: March 16, 2009
Last updated: September 9, 2010
Last verified: September 2010
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Type 2 Diabetes Risk in Women With Gestational Diabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:
  • Weight loss [ Time Frame: Pre-post ] [ Designated as safety issue: No ]
  • Glucose tolerance [ Time Frame: Pre-Post ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hemoglobin A1c [ Time Frame: Pre-post ] [ Designated as safety issue: No ]
  • Step counts [ Time Frame: Pre-Post ] [ Designated as safety issue: No ]
  • Insulin [ Time Frame: Pre-post ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: July 2009
Estimated Study Completion Date: April 2011
Estimated 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 and older
Genders 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
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
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Michigan
Investigators
Principal Investigator: Catherine Kim, MD, MPH University of Michigan
  More Information

No publications provided

Responsible Party: Catherine Kim, MD, MPH, University of Michigan Health System
ClinicalTrials.gov Identifier: NCT00862602     History of Changes
Other Study ID Numbers: K23 DK71552, R03DK083332
Study First Received: March 16, 2009
Last Updated: September 9, 2010
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
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 May 16, 2013