PregnancyNCT07061795
Home Visits in Pregnancy and Healthy Lifestyle Behaviors
A study testing healthy living behaviors in people with Pregnancy and Prenatal Care, run by serpil toker at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Prenatal Care, Home Visits
- What is being tested?
- healthy living behaviors
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2024to 28 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Gestational age less than 28 weeks Pregnancy record created by the Family Health Center
Who cannot join
- Those who do not want to participate in the research Pregnant who do not speak Turkish
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Tokat Gaziosmanpaşa Üniversitesi
Tokat Merkez, Tokat Province, 60010
About this study
Official title: The Effect of Home Visits on Healthy Lifestyle Behaviors During Pregnancy
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.
Read more
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).
- Conditions
- Pregnancy, Prenatal Care, Home Visits
- Being tested
- healthy living behaviors
- Keywords
- Prenatal Care, Health Behavior, Maternal Health Services, Randomized Controlled Trial, Patient Education as Topic
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
healthy living behaviorsBehavioural
Effect of prenatal care with home visits on healthy lifestyle behaviors during pregnancy
| Study group | Role | What they receive |
|---|---|---|
| Home visits group | Experimental | Not described Receives: Behavioral: healthy living behaviors |
| routine follow-up | No intervention | Healthy lifestyle behaviors of pregnant women given routine prenatal care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start1 Sep 2024
- Primary completion1 Dec 2024
- Study completion28 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- serpil toker
- Sponsor type
- University, hospital or other
- Collaborators
- Tokat Gaziosmanpasa University
- Responsible party
- Sponsor-investigator, serpil toker, Tokat Gaziosmanpasa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07061795
- Sponsor's protocol ID
- 24-KAEK-079
- Status last verified
- Jun 2025
- First submitted
- 17 Jun 2025
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The IPD will not be shared because the data include sensitive health information and participants did not consent to data sharing.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Home Visits on Healthy Lifestyle Behaviors During Pregnancy
- ClinicalTrials.gov ID
- NCT07061795
- Acronym / sponsor ID
- 24-KAEK-079
- Conditions
- Pregnancy, Prenatal Care, Home Visits
- Keywords
- Prenatal Care, Health Behavior, Maternal Health Services, Randomized Controlled Trial, Patient Education as Topic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- serpil tokerUniversity, hospital or other
- Collaborators
- Tokat Gaziosmanpasa University
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 28 Dec 2024 (actual)
- First posted
- 11 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home visits group | Experimental | Behavioral: healthy living behaviors |
| routine follow-up | No intervention | –Healthy lifestyle behaviors of pregnant women given routine prenatal care |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Gestational age less than 28 weeks Pregnancy record created by the Family Health Center
Key exclusion criteria (1 listed)
- Those who do not want to participate in the research Pregnant who do not speak Turkish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| healthy living behaviorsEffect of prenatal care with home visits on healthy lifestyle behaviors during pregnancy | Behavioural | Home visits group |
Primary outcome
Health-promoting behavior score
Time frame: 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)
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2025.
- Individual participant dataSharing planned: No. The IPD will not be shared because the data include sensitive health information and participants did not consent to data sharing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing healthy living behaviors in people with Pregnancy and Prenatal Care, run by serpil toker at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health-promoting behavior score (time frame: 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2025.