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

NCT ID: NCT01748305

Last Updated: 2015-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2013-12-31

Brief Summary

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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

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Conditions

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Gestational Diabetes Mellitus Exercise

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Moderate-to-vigorous intensity exercise

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

Group Type EXPERIMENTAL

Moderate-to-vigorous intensity exercise

Intervention Type BEHAVIORAL

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

Interventions

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Moderate-to-vigorous intensity exercise

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Oregon Health and Science University

OTHER

Sponsor Role lead

Responsible Party

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Antonio E. Frias

MD, MFM

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Antonio Frias, MD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Jessica Voge, MD

Role: STUDY_DIRECTOR

Oregon Health and Science University

Locations

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Oregon Health & Science University

Portland, Oregon, United States

Site Status

Countries

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United States

Other Identifiers

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e8631

Identifier Type: -

Identifier Source: org_study_id

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