NCT07096427

Brief Summary

This randomized controlled, open-label trial evaluated the effects of education based on Pender's Health Promotion Model, delivered through virtual reality or printed educational booklets, on healthy lifestyle behaviors in pregnant women. The study was conducted at two family health centers in Istanbul, Turkey, between April 2025 and February 2026. A total of 102 primigravida pregnant women at 12-16 weeks of gestation were randomly assigned in equal numbers to a virtual reality education group, a booklet-based education group, or a routine-care control group. Both intervention groups received three weekly educational sessions followed by five monthly motivational interviewing telephone calls, while the control group received routine prenatal care. Healthy lifestyle behaviors and depression, anxiety, and stress symptoms were assessed at baseline and at 36-38 weeks of gestation. Ninety-five participants completed the study and were included in the analyses.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
102

participants targeted

Target at P25-P50 for not_applicable pregnancy

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable pregnancy

Geographic Reach
1 country

2 active sites

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

Study Start

First participant enrolled

April 1, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 24, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 31, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2026

Completed
Last Updated

September 18, 2026

Status Verified

September 1, 2026

Enrollment Period

10 months

First QC Date

July 24, 2025

Last Update Submit

September 15, 2026

Conditions

Keywords

PregnancyPrenatal EducationHealth PromotionHealth Promotion BehaviorVirtual RealityPender's Health Promotion Model

Outcome Measures

Primary Outcomes (1)

  • Healthy Lifestyle Behaviors in Pregnancy Scale Total and Subscale Scores Following the Intervention Period

    The Healthy Lifestyle Behaviors in Pregnancy Scale is a 29-item, 5-point Likert-type scale comprising six subscales: pregnancy responsibility (4-20 points), hygiene (4-20 points), nutrition (9-45 points), physical activity (3-15 points), travel (5-25 points), and acceptance of pregnancy (4-20 points). The total score ranges from 29 to 145. Higher total and subscale scores indicate healthier lifestyle behaviors during pregnancy. Following the intervention period, total and subscale scores were compared among the virtual reality-supported education, booklet-supported education, and routine-care groups.

    Following the intervention period (36-38 weeks of gestation).

Secondary Outcomes (1)

  • Depression Anxiety Stress Scale-21 Subscale Scores Following the Intervention Period

    Following the intervention period (36-38 weeks of gestation).

Study Arms (3)

Virtual Reality Education

EXPERIMENTAL

Participants received education based on Pender's Health Promotion Model through immersive 360-degree virtual reality videos in three weekly sessions. The virtual reality video durations were approximately 25, 28, and 12 minutes. Following the educational sessions, participants received five monthly motivational interviewing telephone calls, each lasting approximately 20 minutes.

Behavioral: Virtual Reality-Based Prenatal Education

Booklet-Based Education

EXPERIMENTAL

Participants received the same educational content based on Pender's Health Promotion Model through a printed booklet in three weekly face-to-face sessions, each lasting approximately 15-30 minutes. Following the educational sessions, participants received five monthly motivational interviewing telephone calls, each lasting approximately 20 minutes.

Behavioral: Booklet-Based Prenatal Education

Routine Care

NO INTERVENTION

Participants received routine prenatal care provided at the family health centers. No additional education, motivational interviewing, or interim assessment was provided during the study.

Interventions

This behavioral intervention consisted of prenatal education based on Pender's Health Promotion Model delivered through immersive 360-degree virtual reality videos. The content focused on healthy lifestyle behaviors during pregnancy, including nutrition, physical activity, stress management, and health responsibility. Participants viewed the videos using virtual reality headsets in three weekly sessions. The video durations were approximately 25, 28, and 12 minutes. Following the educational sessions, participants received five monthly motivational interviewing telephone calls, each lasting approximately 20 minutes.

Virtual Reality Education

This behavioral intervention consisted of prenatal education based on Pender's Health Promotion Model delivered through a printed booklet. The educational content was identical to that provided to the virtual reality group and focused on healthy lifestyle behaviors during pregnancy, including nutrition, physical activity, stress management, and health responsibility. The education was delivered in three weekly face-to-face sessions, each lasting approximately 15-30 minutes. Following the educational sessions, participants received five monthly motivational interviewing telephone calls, each lasting approximately 20 minutes.

Booklet-Based Education

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Pregnant women aged 18-35 years
  • Being at 12-16 weeks of gestation at enrollment
  • Being primigravida
  • Having no chronic disease or health condition affecting healthy lifestyle behaviors
  • Being able to communicate and provide informed consent

You may not qualify if:

  • Having a high-risk pregnancy at enrollment, including gestational diabetes, preeclampsia, multiple pregnancy, or threatened preterm labor
  • Having a psychiatric disorder or communication impairment that could prevent participation
  • Having previously participated in a similar educational program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Gençosman Aile Sağlığı Merkezi

Istanbul, Güngören, 34165, Turkey (Türkiye)

Location

Kagithane 13 Nolu Aile Sağlığı Merkezi

Istanbul, Kagithane, 34408, Turkey (Türkiye)

Location

Related Publications (10)

  • Estrella-Juarez F, Requena-Mullor M, Garcia-Gonzalez J, Lopez-Villen A, Alarcon-Rodriguez R. Effect of Virtual Reality and Music Therapy on the Physiologic Parameters of Pregnant Women and Fetuses and on Anxiety Levels: A Randomized Controlled Trial. J Midwifery Womens Health. 2023 Jan;68(1):35-43. doi: 10.1111/jmwh.13413. Epub 2022 Nov 16.

  • Jerald, J. (2015). The VR Book: Human-Centered Design for Virtual Reality. Morgan & Claypool.

    RESULT
  • Permatasari TAE, Rizqiya F, Kusumaningati W, Suryaalamsah II, Hermiwahyoeni Z. The effect of nutrition and reproductive health education of pregnant women in Indonesia using quasi experimental study. BMC Pregnancy Childbirth. 2021 Mar 4;21(1):180. doi: 10.1186/s12884-021-03676-x.

  • Goodarzi-Khoigani M, Baghiani Moghadam MH, Nadjarzadeh A, Mardanian F, Fallahzadeh H, Mazloomy-Mahmoodabad S. Impact of Nutrition Education in Improving Dietary Pattern During Pregnancy Based on Pender's Health Promotion Model: A Randomized Clinical Trial. Iran J Nurs Midwifery Res. 2018 Jan-Feb;23(1):18-25. doi: 10.4103/ijnmr.IJNMR_198_16.

  • American College of Obstetricians and Gynecologists. (2023). Nutrition During Pregnancy. Retrieved from https://www.acog.org/womens-health/faqs/nutrition-during-pregnancy.

    RESULT
  • Physical Activity and Exercise During Pregnancy and the Postpartum Period: ACOG Committee Opinion, Number 804. Obstet Gynecol. 2020 Apr;135(4):e178-e188. doi: 10.1097/AOG.0000000000003772.

  • Estebsari F, Dastoorpoor M, Mostafaei D, Khanjani N, Khalifehkandi ZR, Foroushani AR, Aghababaeian H, Taghdisi MH. Design and implementation of an empowerment model to prevent elder abuse: a randomized controlled trial. Clin Interv Aging. 2018 Apr 17;13:669-679. doi: 10.2147/CIA.S158097. eCollection 2018.

  • Mohamadian, H., Eftekhar Ardebili, H., Rahimi Foroushani, A., Taghdisi, M. H., & Shojaiezade, D. (2011). Evaluation of Pender's health promotion model for predicting adolescent girls' quality of life. Journal of School of Public Health & Institute of Public Health Research, 8(4).

    RESULT
  • Malakouti J, Sehhati F, Mirghafourvand M, Nahangi R. Relationship between Health Promoting Lifestyle and Perceived Stress in Pregnant Women with Preeclampsia. J Caring Sci. 2015 Jun 1;4(2):155-63. doi: 10.15171/jcs.2015.016. eCollection 2015 Jun.

  • Lin YH, Tsai EM, Chan TF, Chou FH, Lin YL. Health promoting lifestyles and related factors in pregnant women. Chang Gung Med J. 2009 Nov-Dec;32(6):650-61.

MeSH Terms

Conditions

Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: This study uses a parallel assignment model in which participants are randomly assigned to one of three groups: (1) a virtual reality-based education group, (2) a booklet-based education group, or (3) a routine care control group. All interventions are delivered concurrently, and participants remain in their assigned group throughout the study period.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 24, 2025

First Posted

July 31, 2025

Study Start

April 1, 2025

Primary Completion

January 20, 2026

Study Completion

February 25, 2026

Last Updated

September 18, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared because data sharing was not included in the informed consent process.

Locations