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Moderate-to-vigorous Physical Activity for Glycemic Control in Patients With Gestational Diabetes Mellitus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01748305
Recruitment Status : Terminated (Recruitment issues.)
First Posted : December 12, 2012
Last Update Posted : October 23, 2015
Sponsor:
Information provided by (Responsible Party):
Antonio E. Frias, Oregon Health and Science University

Tracking Information
First Submitted Date  ICMJE December 10, 2012
First Posted Date  ICMJE December 12, 2012
Last Update Posted Date October 23, 2015
Study Start Date  ICMJE December 2012
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 11, 2012)		 Need for medication for diabetes [ Time Frame: 3 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 11, 2012)
  • Birth weight [ Time Frame: delivery ]
  • A1c [ Time Frame: delivery ]
  • Mode of delivery [ Time Frame: delivery ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Moderate-to-vigorous Physical Activity for Glycemic Control in Patients With Gestational Diabetes Mellitus
Official Title  ICMJE Moderate-to-vigorous Physical Activity for Glycemic Control in Patients With Gestational Diabetes Mellitus: a Pilot Study
Brief Summary Patients with newly diagnosed gestational diabetes will be recruited. The control group with get routine diet and exercise counseling. The intervention group will be instructed to get moderate-to-vigorous intensity exercise; they will walk on a treadmill one time with supervision in order to be instructed how hard to work. All participants will keep an exercise log for 3 weeks and will wear an accelerometer for 1 week. The primary outcome is glucose control, specifically the need for medication in treatment of their diabetes. The hypothesis is that moderate or greater intensity exercise will better control glucose and lead to less need for medication management.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Gestational Diabetes Mellitus
  • Exercise
Intervention  ICMJE Behavioral: Moderate-to-vigorous intensity exercise
Moderate-to-vigorous intensity exercise three times per day for three weeks
Study Arms  ICMJE Experimental: Moderate-to-vigorous intensity exercise
Moderate-to-vigorous intensity exercise three times per day for three weeks
Intervention: Behavioral: Moderate-to-vigorous intensity exercise
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: October 22, 2015)		 14
Original Estimated Enrollment  ICMJE
 (submitted: December 11, 2012)		 64
Actual Study Completion Date  ICMJE December 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • gestational diabetes mellitus
  • singelton pregnancy
  • 18 years old or older
  • no medical contraindications to exercise

Exclusion Criteria:

  • multiple gestation
  • non-English speaking
  • unable to exercise
  • preexisting diabetes
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01748305
Other Study ID Numbers  ICMJE e8631
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Antonio E. Frias, Oregon Health and Science University
Study Sponsor  ICMJE Oregon Health and Science University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Antonio Frias, MD Oregon Health and Science University
Study Director: Jessica Voge, MD Oregon Health and Science University
PRS Account Oregon Health and Science University
Verification Date October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP