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Evidence-based Educational Materials and Local Resources for Improving Exercise-related Outcomes During Pregnancy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03504267
Recruitment Status : Active, not recruiting
First Posted : April 20, 2018
Last Update Posted : April 29, 2019
Sponsor:
Information provided by (Responsible Party):
Western Kentucky University

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Pregnancy Related Obesity Other: Physical Activity Education and Resources Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: The Influence of Evidence-based Educational Materials and Local Resources in Improving Physical Activity-related Outcomes Among Pregnant Women
Actual Study Start Date : May 1, 2016
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Physical Activity Group
The PAG (physical activity) group will receive evidence-based educational information as well as a list of local resources for pursuing physical activity.
Other: Physical Activity Education and Resources
The intervention involves receiving evidence-based educational brochures as well as a list of local facilities where the participant can work out at no-cost to them,

No Intervention: Standard of Care Group
The SOC (standard of care) group will receive no additional information beyond standard-of-care brochures and information



Primary Outcome Measures :
  1. Change in knowledge regarding physical activity during pregnancy [ Time Frame: Change in knowledge from baseline (8-12 weeks) to late gestation (32-34 weeks) ]
    Validated survey tools from previous studies (and tested in a separate cohort of local women)

  2. Change in physical activity levels [ Time Frame: Change in steps per day from baseline (8-12 weeks) to late gestation (32-34 weeks) ]
    Mi-Band devices will be worn on the wrist for one week at each time point


Secondary Outcome Measures :
  1. Patient-provider communication [ Time Frame: This will be assessed at the end of pregnancy (32-34 weeks) by both the patient and the provider ]
    Previously used surveys developed by the PI

  2. Gestational weight gain [ Time Frame: Change in body weight from pre-pregnancy (self-reported at enrollment (kg) to the very end of pregnancy(~40 weeks gestation) (kg)) ]
    Total weight gained during pregnancy

  3. Insulin resistance [ Time Frame: 28 weeks gestation ]
    Oral glucose tolerance test results

  4. Infant birth weight [ Time Frame: At study completion, ~ 40 weeks gestation ]
    Self-reported weight of the baby at the time of delivery



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Ages Eligible for Study:   18 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03504267


Locations
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United States, Kentucky
Graves Gilbert Obstetric Clinic
Bowling Green, Kentucky, United States, 42101
Sponsors and Collaborators
Western Kentucky University
Investigators
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Principal Investigator: Rachel A Tinius, PhD Western Kentucky University

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Responsible Party: Western Kentucky University
ClinicalTrials.gov Identifier: NCT03504267     History of Changes
Other Study ID Numbers: 16-225
5P20GM1034 ( Other Grant/Funding Number: NIH NIGMS IDeA Grant )
First Posted: April 20, 2018    Key Record Dates
Last Update Posted: April 29, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Western Kentucky University:
physical activity
exercise
patient-provider communication