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CompletedNCT07315971Updated Jan 7, 2026

The Effect Of Health Development Behavıour Traınıng In Pregnancyon Sleep Qualıty And Physıcal Actıvıty Levels

An interventional study of HEALTH PROMOTION BEHAVIOR TRAINING in Health Behavior, Physical Activity and Sleep Quality, sponsored by Aydin Adnan Menderes University. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 49 Years. Per ClinicalTrials.gov, last updated 2026-01-07.

Sponsored by Aydin Adnan Menderes University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 2 years 3 months after the study started (first participant enrolled Aug 2023, registered Nov 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
57
Allocation
Randomized
Ages
18 Years to 49 Years
Sex
Female
01

Study 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.

Read the detailed description

This study is a pre-test post-test randomized controlled experimental research. The population of the study consisted of 620 pregnant women, and the sample included a total of 57 pregnant women, with 27 in the experimental group and 30 in the control group. Prior to the intervention, individual interviews were conducted, and written consent was obtained from the participants. Subsequently, the questionnaire prepared by the researcher, the Pittsburgh Sleep Quality Index (PSQI), and the Pregnancy Physical Activity Questionnaire (PPAQ) were administered. The experimental group received health-promoting behavior education for six weeks, with sessions held once a week for 30 minutes at a Family Health Center, in a room designated by the center's staff during working hours. At the end of the training, the scales were administered again, and one month after the completion of the education, the PSQI and PPAQ were re-administered. The data obtained from the study were analyzed using the SPSS 25.0 package program at a 95% confidence interval and a significance level of 0.05. The normal distribution of the data was evaluated using the Kolmogorov-Smirnov test. Parametric tests were used when normal distribution assumptions were met, and non-parametric tests were applied when these assumptions were not satisfied.

02

Conditions studied

  • Health Behavior
  • Physical Activity
  • Sleep Quality

Keywords

  • Exercise
  • Education
  • Pregnancy
  • Nursing
  • Sleep
03

In context

Health Behavior

228 studies on the registry are indexed under Health Behavior; 94 are open to participants now.

This study's enrollment of 57 is below the median of 118 across 195 interventional studies indexed under Health Behavior.

Browse Health Behavior studies →

Lead sponsor

Aydin Adnan Menderes University is the lead sponsor of 236 studies on the registry; 54 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 49 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Pregnant women who were: • in the early third trimester,

    • had at least a primary school education,
    • had no communication barriers were included.

Exclusion criteria

Exclusion Criteria:

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),
  • Multiple pregnancy were considered exclusion criteria.
  • Not following the training programs included in the study (at least two trainings),
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
57 participants (actual)

Study arms

  • Experimental
    experimental group

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

    Behavioral: HEALTH PROMOTION BEHAVIOR TRAINING

  • No intervention
    Control group

    The control group continued to receive the routine care

Interventions

  • BehavioralHEALTH PROMOTION BEHAVIOR TRAINING

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 28th week of pregnancy

  2. 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.

    Time frame: 28th week of pregnancy

Secondary outcomes

  1. Physical Activity Questionnaire for Pregnant Women

    The 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.

    Time frame: 33th week of pregnancy

  2. 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. 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.

    Time frame: 33th week of pregnancy

Other outcomes

  1. Physical Activity Questionnaire for Pregnant Women

    The 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.

    Time frame: 38th gestational weeks

  2. 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. 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.

    Time frame: 38th gestational weeks

07

Study locations

1 site
  • Aydın Adnan Menderes Üniversitesi
    Aydin, 09100, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: Yes — The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request

Supporting information: Csr

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07315971
Lead sponsor
Aydin Adnan Menderes University
Responsible party
Fatma Kurt (Dr. Ph.D., Aydin Adnan Menderes University) — Principal investigator
First posted
Jan 5, 2026
Start date
Aug 1, 2023
Primary completion
Aug 1, 2024
Completion
Jan 1, 2025
Last update
Jan 7, 2026

Study contacts

Safiye Özvurmaz, Phd
study director · Aydın Adnan Menderes University, Faculy of Nursing, Division Public Health Nursing

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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