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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00647595
Enrollment
100
Registered
2008-03-31
Start date
2007-10-31
Completion date
2008-12-31
Last updated
2015-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Obesity, Pregnancy

Keywords

Obesity, Physical activity, Pregnancy, Diabetes mellitus

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.

Detailed description

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.

Interventions

BEHAVIORALExperimental group

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.

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Central adiposity6-8 weeks postpartum

Secondary

MeasureTime frame
glucoseduring pregnancy and postpartum
insulinduring pregnancy and postpartum
Leptin levelsduring pregnancy and postpartum
fetal adiposity35-36 weeks gestation
neonatal adipositybirth
cholesterolduring pregnancy and postpartum

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026