NCT00647595

Brief Summary

The purpose of this study is to examine the effect of exercise during pregnancy upon maternal metabolism, including weight gain, fat distribution, and levels of glucose and cholesterol. We will also conduct a pilot study to examine the feasibility of studying the health of infants born to women in this study.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P25-P50 for phase_3 obesity

Timeline
Completed

Started Oct 2007

Shorter than P25 for phase_3 obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 27, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 31, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

April 22, 2015

Status Verified

February 1, 2010

Enrollment Period

1.2 years

First QC Date

March 27, 2008

Last Update Submit

April 21, 2015

Conditions

ObesityPregnancyDiabetes Mellitus

Keywords

ObesityPhysical activityPregnancyDiabetes mellitus

Outcome Measures

Primary Outcomes (1)

  • Central adiposity

    6-8 weeks postpartum

Secondary Outcomes (6)

  • Leptin levels

    during pregnancy and postpartum

  • glucose

    during pregnancy and postpartum

  • insulin

    during pregnancy and postpartum

  • cholesterol

    during pregnancy and postpartum

  • fetal adiposity

    35-36 weeks gestation

  • +1 more secondary outcomes

Study Arms (2)

A

EXPERIMENTAL

Women in this group will exercise 3x per week at a moderate/vigorous level for 45 min per session through their 36 week of pregnancy.

Behavioral: Experimental group

B

NO INTERVENTION

Women in this group will continue their usual activities throughout their pregnancy.

Interventions

Experimental groupBEHAVIORAL

Intervention group will exercise 3 times per week at moderate-vigorous intensity for 45 minutes per session. Control group women will continue their usual physical activity throughout pregnancy.

A

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Pregnant women 18-45 years old receiving prenatal care at MAMC

You may not qualify if:

  • Women do not have a gallbladder
  • Who do not speak English
  • Are over 14 weeks pregnant at study entry
  • Do not plan to deliver at MAMC
  • Have medical contraindications
  • Unwilling to participate in exercise intervention program
  • Are under 18 years of age
  • Currently engaged in a regular vigorous exercise program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Madigan Army Medical Center

Joint Base Lewis McChord, Washington, 98431, United States

Location

MeSH Terms

Conditions

ObesityDiabetes MellitusMotor Activity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseasesBehavior

Study Officials

  • Cynthia W Ko, MD MS

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

March 27, 2008

First Posted

March 31, 2008

Study Start

October 1, 2007

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

April 22, 2015

Record last verified: 2010-02

Locations

US(1)