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OpenTrials
Completed

NCT Number: NCT00647595

Effect of Physical Activity on Metabolic Syndrome in Pregnancy & Fetal Outcome

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Madigan Army Medical Center

Joint Base Lewis McChord, Washington, 98431, United States

About this study

Obesity and overweight have become important public health problems in the United States, and measures are urgently needed to address these issues. For many women, pregnancy is a time of excessive weight gain and decreases in physical fitness, both of which may be followed by postpartum weight retention. Women who develop hypertension or diabetes mellitus during pregnancy are at higher risk for development of these disorders in the future. Because of the implications of pregnancy-related weight gain and the metabolic changes during pregnancy for future maternal health, interventions to maintain or improve fitness during pregnancy may have important downstream health effects. In addition, maternal metabolic parameters and the intra-uterine environment have important implications for neonatal outcomes and subsequent child health. This study will provide data about the effects of an intervention to increase vigorous physical activity during pregnancy on short-term maternal and fetal outcomes.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Experimental group

Behavioral

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.

Primary outcomes

  1. Central adiposity

    Time frame: 6-8 weeks postpartum

Secondary outcomes

  1. Leptin levels

    Time frame: during pregnancy and postpartum

  2. glucose

    Time frame: during pregnancy and postpartum

  3. insulin

    Time frame: during pregnancy and postpartum

  4. cholesterol

    Time frame: during pregnancy and postpartum

  5. fetal adiposity

    Time frame: 35-36 weeks gestation

  6. neonatal adiposity

    Time frame: birth

Sponsors and collaborators

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Nih

Registry information

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Mar 31, 2008
Registry last updated
Apr 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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