NCT03242174

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
143

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 31, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 8, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

October 11, 2017

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 23, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 23, 2023

Completed
Last Updated

April 6, 2025

Status Verified

April 1, 2025

Enrollment Period

6 years

First QC Date

July 31, 2017

Last Update Submit

April 3, 2025

Conditions

Outcome Measures

Primary Outcomes (8)

  • Eating Habits

    Eating Habits assessed by Eating Habits Questionnaire

    1 Day

  • Eating Habits

    Eating Habits assessed by Rapid Eating Assessment for Participants-Shortened Version

    1 Day

  • Mindful Eating

    Mindful Eating assessed by Mindful Eating Questionnaire

    1 Day

  • Physical Activity

    Physical Activity assessed by Nurses Health Study II Physical Activity Questionnaire

    1 Day

  • Frequency of Weighing

    Frequency of Weighing by Frequency of Weighing Questionnaire

    1 Day

  • Sedentary Behavior

    Sedentary Behavior by Sedentary Behavior Questionnaire

    1 Day

  • Functional health and well-being

    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

    Sleep Habits by Sleep Questionnaire

    1 Day

Study Arms (2)

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

Other: Health Behavior Questionnaire Packet

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

Other: Health Behavior Questionnaire Packet

Interventions

Any pregnant woman offered the questionnaire at her prenatal appointment in the third trimester can complete

Prenatal Care from MidwifeTraditional Obstetrical Prenatal Care

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • Pregnant women in the third trimester of pregnancy ≥ 28 weeks GA

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Study Officials

  • Leanne M Redman, Ph.D.

    Pennington Biomedical Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 31, 2017

First Posted

August 8, 2017

Study Start

October 11, 2017

Primary Completion

October 23, 2023

Study Completion

October 23, 2023

Last Updated

April 6, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations