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

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

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.

Study Overview

• Status: Terminated
• Conditions: Exercise; Gestational Diabetes Mellitus
• Intervention / Treatment: Behavioral: Moderate-to-vigorous intensity exercise

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Moderate-to-vigorous intensity exercise; Moderate-to-vigorous intensity exercise three times per day for three weeks	Behavioral: Moderate-to-vigorous intensity exercise; Moderate-to-vigorous intensity exercise three times per day for three weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Need for medication for diabetes	3 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Birth weight	delivery
A1c	delivery
Mode of delivery	delivery

Collaborators and Investigators

• Sponsor: Oregon Health and Science University
• Investigators: Study Director: Jessica Voge, MD, Oregon Health and Science University

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: December 10, 2012
• First Submitted That Met QC Criteria: December 11, 2012
• First Posted (Estimate): December 12, 2012

Study Record Updates

• Last Update Posted (Estimate): October 23, 2015
• Last Update Submitted That Met QC Criteria: October 22, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: GDM; A1GDM; A2GDM
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Diabetes Mellitus; Diabetes, Gestational
• Other Study ID Numbers: e8631