- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03242174
Health Behaviors in Pregnancy
August 28, 2023 updated by: Leanne Redman, Pennington Biomedical Research Center
To assess health and lifestyle behavior of pregnant women in Baton Rouge including women receiving traditional obstetrical prenatal care and delivering in a hospital and those receiving prenatal care from a midwife and delivering at the birth center.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
It is of scientific interest to learn what the health and lifestyle behaviors are for women receiving prenatal care in a non-traditional birth center and the impact of these behaviors on pregnancy and birth outcomes.Participants will be offered a questionnaire packet to complete at a prenatal appointment in the third trimester of pregnancy by their obstetrical prenatal care provider.
The questionnaire packet will take approximately 10-15 minutes to complete.
Study Type
Observational
Enrollment (Estimated)
1000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Abby D. Altazan, M.S.
- Phone Number: 2257632801
- Email: abby.duhe@pbrc.edu
Study Locations
-
-
Louisiana
-
Baton Rouge, Louisiana, United States, 70808
- Recruiting
- Pennington Biomedical Research Center
-
Principal Investigator:
- Leanne M Redman, Ph.D.
-
Contact:
- Abby D Altazan, M.S.
- Phone Number: 225-763-2801
- Email: abby.duhe@pbrc.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
Pregnant women in the third trimester of pregnancy ≥ 28 weeks GA will be offered the opportunity to participate in this study at the time of a prenatal appointment ≥ 28 weeks GA
Description
Inclusion Criteria:
- Pregnant women in the third trimester of pregnancy ≥ 28 weeks GA
Exclusion Criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Ecologic or Community
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Traditional Obstetrical Prenatal Care
Pregnant women receiving traditional obstetrical prenatal care and delivering in a hospital will be offered the Health Behavior questionnaire packet at third trimester prenatal appointment
|
Any pregnant woman offered the questionnaire at her prenatal appointment in the third trimester can complete
|
Prenatal Care from Midwife
Pregnant women receiving prenatal care from a midwife and delivering at the birth center will be offered the Health Behavior questionnaire packet at third trimester prenatal appointment
|
Any pregnant woman offered the questionnaire at her prenatal appointment in the third trimester can complete
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Eating Habits
Time Frame: 1 Day
|
Eating Habits assessed by Eating Habits Questionnaire
|
1 Day
|
Eating Habits
Time Frame: 1 Day
|
Eating Habits assessed by Rapid Eating Assessment for Participants-Shortened Version
|
1 Day
|
Mindful Eating
Time Frame: 1 Day
|
Mindful Eating assessed by Mindful Eating Questionnaire
|
1 Day
|
Physical Activity
Time Frame: 1 Day
|
Physical Activity assessed by Nurses Health Study II Physical Activity Questionnaire
|
1 Day
|
Frequency of Weighing
Time Frame: 1 Day
|
Frequency of Weighing by Frequency of Weighing Questionnaire
|
1 Day
|
Sedentary Behavior
Time Frame: 1 Day
|
Sedentary Behavior by Sedentary Behavior Questionnaire
|
1 Day
|
Functional health and well-being
Time Frame: 1 Day
|
Quality of life measure that assesses functional health and well-being from the participant's point of view by 12 Item Short Form Health Survey by RAND
|
1 Day
|
Sleep Habits
Time Frame: 1 Day
|
Sleep Habits by Sleep Questionnaire
|
1 Day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Leanne M Redman, Ph.D., Pennington Biomedical Research Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 11, 2017
Primary Completion (Estimated)
June 1, 2024
Study Completion (Estimated)
June 1, 2024
Study Registration Dates
First Submitted
July 31, 2017
First Submitted That Met QC Criteria
August 2, 2017
First Posted (Actual)
August 8, 2017
Study Record Updates
Last Update Posted (Actual)
August 29, 2023
Last Update Submitted That Met QC Criteria
August 28, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- PBRC 2017-036
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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