Obesity Clinical Trial
Official title:
The Influence of Evidence-based Educational Materials and Local Resources in Improving Physical Activity-related Outcomes Among Pregnant Women
Verified date | September 2019 |
Source | Western Kentucky University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Despite the well-established benefits of physical activity, only 23% of pregnant women report
exercising in accordance with guidelines recommended by the American Congress of
Obstetricians and Gynecologists. Further, pregnant women report receiving little or no advice
about physical activity during pregnancy from their health care provider; thus, the
scientific evidence supporting physical activity during pregnancy does not appear to be
translating into the clinic and the community. The goal of this project is to determine if
the distribution of evidence-based educational materials and local resources will increase
knowledge regarding the benefits of physical activity during pregnancy, patient-provider
communication about physical activity during pregnancy, and physical activity levels during
pregnancy.
Hypothesis A: Pregnant women who receive evidence-based educational materials and local
resources will have increased knowledge regarding the benefits of physical activity during
pregnancy.
Hypothesis B: Pregnant women who receive evidence-based educational materials and local
resources will have more communication with their health care provider about physical
activity.
Hypothesis C: Pregnant women who receive educational information and local resources will
report increased physical activity levels.
Hypothesis D: Pregnant women who receive evidence-based educational materials and local
resources will have improved pregnancy outcomes including lower gestational weight gain,
lower insulin resistance (as determined by their clinical oral glucose tolerance test), and
healthier neonatal birthweight.
Status | Completed |
Enrollment | 71 |
Est. completion date | June 30, 2019 |
Est. primary completion date | June 30, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 44 Years |
Eligibility |
Inclusion Criteria: - Age 18-44 - Confirmed singleton viable pregnancy - English-Speaking Exclusion criteria: - Multiple gestation pregnancy - Inability to provide voluntary informed consent - Any medical condition (pregnancy-related or not) that would preclude exercise |
Country | Name | City | State |
---|---|---|---|
United States | Graves Gilbert Obstetric Clinic | Bowling Green | Kentucky |
Lead Sponsor | Collaborator |
---|---|
Western Kentucky University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in knowledge regarding physical activity during pregnancy | Validated survey tools from previous studies (and tested in a separate cohort of local women) | Change in knowledge from baseline (8-12 weeks) to late gestation (32-34 weeks) | |
Primary | Change in physical activity levels | Mi-Band devices will be worn on the wrist for one week at each time point | Change in steps per day from baseline (8-12 weeks) to late gestation (32-34 weeks) | |
Secondary | Patient-provider communication | Previously used surveys developed by the PI | This will be assessed at the end of pregnancy (32-34 weeks) by both the patient and the provider | |
Secondary | Gestational weight gain | Total weight gained during pregnancy | Change in body weight from pre-pregnancy (self-reported at enrollment (kg) to the very end of pregnancy(~40 weeks gestation) (kg)) | |
Secondary | Insulin resistance | Oral glucose tolerance test results | 28 weeks gestation | |
Secondary | Infant birth weight | Self-reported weight of the baby at the time of delivery | At study completion, ~ 40 weeks gestation |
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