NCT07315971

Brief Summary

The aim of this study is to determine the effect of health-promoting behavior education on the sleep quality and physical activity levels of pregnant women. 1.2. The research hypotheses are as follows: H0 hypotheses:

  • Ho (1): Education on healthy lifestyle behaviors during pregnancy does not affect sleep quality in pregnant women.
  • Ho (2): Education on healthy lifestyle behaviors during pregnancy does not affect physical activity levels in pregnant women. H1 hypotheses:
  • H1 (1): Education on healthy lifestyle behaviors during pregnancy improves sleep quality in pregnant women.
  • H1 (2): Education on healthy lifestyle behaviors during pregnancy increases physical activity levels in pregnant women. The study group received health promotion training for six weeks. Data were collected by administering the scales three times: before, immediately after, and one month later. The control group received no training and only underwent routine pregnancy examinations and follow-up at the family health center. The scales were administered at the same times as the pregnant women in the study group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2023

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

August 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 5, 2026

Completed
Last Updated

January 7, 2026

Status Verified

January 1, 2026

Enrollment Period

1 year

First QC Date

November 20, 2025

Last Update Submit

January 3, 2026

Conditions

Keywords

ExerciseEducationPregnancyNursingSleep

Outcome Measures

Primary Outcomes (2)

  • Physical Activity Questionnaire for Pregnant Women

    Physical Activity Questionnaire for Pregnant WomenThe Turkish validity and reliability of the scale, developed by Chasan Taber et al. in 2004, was determined by Çırak et al. It consists of 36 questions that determine the level of physical activity and exercise in pregnant women. This scale evaluates 32 activities performed by pregnant women: housework and care activities (n=13), occupational activities (n=5), sports and exercise activities (n=8), transportation (n=3), and sedentary lifestyle (n=3). The intensity of physical activity is expressed in METs (metabolic equivalents). In open-ended questions, the MET value of the activity is determined by referring to the Review. Activity intensities are grouped as sedentary (0.6 MET). Activity types are classified as housework/care activities, occupational activities, and sports/exercise. In this study, the Cronbach's alpha coefficient of the scale was found to be 0.65.

    28th week of pregnancy

  • The Pittsburgh Sleep Quality Index

    PSQI developed by Buysse et al. has been shown to have sufficient internal consistency (Cronbach's alpha = 0.80), test-retest reliability, and validity (Buysse et al. It was adapted into Turkish by Ağargün et al. The PSQI is a 19-item self-report scale that assesses sleep quality and disturbance over the past month. It consists of 24 questions: 19 self-report questions and 5 questions to be answered by a spouse or roommate. The 18 scored questions comprise 7 components: Subjective Sleep Quality, Sleep Latency, Sleep Duration, Habitual Sleep Efficiency, Sleep Disturbance, Sleep Medication Use, and Daytime Dysfunction. Each component is scored on a scale of 0-3. The total score of the 7 components gives the total scale score. The total score ranges from 0-21. A total score greater than 5 indicates "poor sleep quality". Permission was obtained for the scale's use. Cronbach's alpha coefficient of the scale was found to be 0.71.

    28th week of pregnancy

Secondary Outcomes (2)

  • Physical Activity Questionnaire for Pregnant Women

    33th week of pregnancy

  • The Pittsburgh Sleep Quality Index

    33th week of pregnancy

Other Outcomes (2)

  • Physical Activity Questionnaire for Pregnant Women

    38th gestational weeks

  • The Pittsburgh Sleep Quality Index

    38th gestational weeks

Study Arms (2)

experimental group

EXPERIMENTAL

The study group received training on health promotion during pregnancy in addition to usual care provided by health professionals.

Behavioral: HEALTH PROMOTION BEHAVIOR TRAINING

Control group

NO INTERVENTION

The control group continued to receive the routine care

Interventions

Exercise During Pregnancy When Should Exercise Be Started During Pregnancy? Which Exercises Are Recommended/Not Recommended During Pregnancy? How Intense Should Exercise Be During Pregnancy? How Long Should Exercise Last? Points to Consider When Exercising Exercise Examples Health Responsibility Pregnancy Monitoring Smoking During Pregnancy, Alcohol, and Substance Use During Pregnancy Sexuality During Pregnancy Hygiene and General Care During Pregnancy Sleep During Pregnancy Sleep Problems During Pregnancy Recommendations for Quality Sleep During Pregnancy Interpersonal Relationships Effective Communication Skills Stress Management Factors That Can Cause Stress During Pregnancy Positive Methods for Coping with Stress During Pregnancy The intervention group received 6 weeks of face-to-face training.

experimental group

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant women
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Pregnant women who were: • in the early third trimester,
  • had at least a primary school education,
  • had no communication barriers were included.

You may not qualify if:

  • Incomplete completion of the data collection tools used in the study,
  • Having a psychiatric diagnosis (major depression, psychotic disorders, intellectual disability),
  • Being pregnant under the age of 18,
  • Having a chronic disease (such as diabetes, heart disease, hypertension, cancer),
  • Not following the training programs included in the study (at least two trainings),

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aydın Adnan Menderes Üniversitesi

Aydin, 09100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Health BehaviorMotor ActivitySleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

BehaviorSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Safiye Özvurmaz, Phd

    Aydın Adnan Menderes University, Faculy of Nursing, Division Public Health Nursing

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Following recruitment, the pregnant women were divided into a study and a control group by randomization (1:2 randomization)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Ph.D.

Study Record Dates

First Submitted

November 20, 2025

First Posted

January 5, 2026

Study Start

August 1, 2023

Primary Completion

August 1, 2024

Study Completion

January 1, 2025

Last Updated

January 7, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request

Shared Documents
CSR
Time Frame
6 months after publication
Access Criteria
relevance to the topic of the study and approval of all co-authors within 1 month of receiving the request.

Locations