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

Exercise Clinical Trial

Official title:

Moderate-to-vigorous Physical Activity for Glycemic Control in Patients With Gestational Diabetes Mellitus: a Pilot Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01748305
• Other study ID #: e8631
• Status: Terminated
• Phase: N/A
• First received: December 10, 2012
• Last updated: October 22, 2015
• Start date: December 2012
• Est. completion date: December 2013

Study information

• Verified date: October 2015
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Exercise
• Gestational Diabetes Mellitus

Intervention

Behavioral:
• Moderate-to-vigorous intensity exercise
Moderate-to-vigorous intensity exercise three times per day for three weeks

Locations

Country	Name	City	State
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Need for medication for diabetes		3 weeks	No
Secondary	Birth weight		delivery	No
Secondary	A1c		delivery	No
Secondary	Mode of delivery		delivery	No