Moderate-to-vigorous Physical Activity for Glycemic Control in Patients With Gestational Diabetes Mellitus
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ClinicalTrials.gov Identifier: NCT01748305 |
Recruitment Status :
Terminated
(Recruitment issues.)
First Posted : December 12, 2012
Last Update Posted : October 23, 2015
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Sponsor:
Oregon Health and Science University
Information provided by (Responsible Party):
Antonio E. Frias, Oregon Health and Science University
Tracking Information | |||||||
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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 |
Need for medication for diabetes [ Time Frame: 3 weeks ] | ||||||
Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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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 |
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Condition ICMJE |
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Intervention ICMJE | Behavioral: Moderate-to-vigorous intensity exercise
Moderate-to-vigorous intensity exercise three times per day for three weeks
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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
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Terminated | ||||||
Actual Enrollment ICMJE |
14 | ||||||
Original Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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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 |