NCT07061795

Brief Summary

Abstract Background: Prenatal home visits allow early risk detection and comprehensive care in the pregnant woman's own environment. Objective: To evaluate the effect of home-based prenatal care on health-promoting behaviors during pregnancy. Design and Setting: A randomized controlled trial conducted at a family health center between September and December 2024. Methods: A total of 200 pregnant women were randomly assigned to intervention (n=100) and control (n=100) groups. The intervention group received structured care via three monthly home visits; the control group received routine care. Data were collected using a personal information form and the Healthy Lifestyle Behaviors Scale in Pregnant (HLBS-P).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P50-P75 for not_applicable pregnancy

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable pregnancy

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 17, 2025

Completed
24 days until next milestone

First Posted

Study publicly available on registry

July 11, 2025

Completed
Last Updated

July 11, 2025

Status Verified

June 1, 2025

Enrollment Period

3 months

First QC Date

June 17, 2025

Last Update Submit

June 30, 2025

Conditions

Keywords

Prenatal CareHealth BehaviorMaternal Health ServicesRandomized Controlled TrialPatient Education as Topic

Outcome Measures

Primary Outcomes (1)

  • Health-promoting behavior score

    The change in health-promoting behavior score measured by the ealthy Lifestyle Behaviors Scale in Pregnant Women (HLBS-P). This scale includes subdimensions such as pregnancy responsibility, hygiene, nutrition, physical activity, travel, and acceptance of pregnancy. The Cronbach's alpha reliability coefficients for the scale range between 0.79 and 0.94. Higher scores on the scale indicate healthier lifestyle behaviors among pregnant women.

    Initially, second visit one month after baseline, third visit one month after second visit (There will be a total of 3 visits and it will last 3 months)

Study Arms (2)

Home visits group

EXPERIMENTAL
Behavioral: healthy living behaviors

routine follow-up

NO INTERVENTION

Healthy lifestyle behaviors of pregnant women given routine prenatal care

Interventions

Effect of prenatal care with home visits on healthy lifestyle behaviors during pregnancy

Home visits group

Eligibility Criteria

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

You may qualify if:

  • Gestational age less than 28 weeks Pregnancy record created by the Family Health Center

You may not qualify if:

  • Those who do not want to participate in the research Pregnant who do not speak Turkish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tokat Gaziosmanpaşa Üniversitesi

Tokat Merkez, Tokat Province, 60010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
phd student

Study Record Dates

First Submitted

June 17, 2025

First Posted

July 11, 2025

Study Start

September 1, 2024

Primary Completion

December 1, 2024

Study Completion

December 28, 2024

Last Updated

July 11, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

The IPD will not be shared because the data include sensitive health information and participants did not consent to data sharing.

Locations