Health BehaviorNCT07315971
The Effect Of Health Development Behavıour Traınıng In Pregnancyon Sleep Qualıty And Physıcal Actıvıty Levels
A study testing HEALTH PROMOTION BEHAVIOR TRAINING in people with Health Behavior and Physical Activity, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Health Behavior, Physical Activity, Sleep Quality
- What is being tested?
- HEALTH PROMOTION BEHAVIOR TRAINING
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2023to 1 Jan 2025
- 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 18 to 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant women who were: • in the early third trimester,
- had at least a primary school education,
- had no communication barriers were included.
Who cannot join
- 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),
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Aydın Adnan Menderes Üniversitesi
Aydin, 09100
About this study
Official title: The Effect Of Health Development Behavıour Traınıng In Pregnancy On Sleep Qualıty And Physıcal Actıvıty Levels: A Randomızed Controlled Experımental Study
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:
Read more
- 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.
- Conditions
- Health Behavior, Physical Activity, Sleep Quality
- Being tested
- HEALTH PROMOTION BEHAVIOR TRAINING
- Keywords
- Exercise, Education, Pregnancy, Nursing, Sleep
- Medical subject headings
- Health Behavior, Motor Activity, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HEALTH PROMOTION BEHAVIOR TRAININGBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | The study group received training on health promotion during pregnancy in addition to usual care provided by health professionals. Receives: Behavioral: HEALTH PROMOTION BEHAVIOR TRAINING |
| Control group | No intervention | The control group continued to receive the routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 28th week of pregnancy
Secondary outcomes (2)
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.
Measured: 33th 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. 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.
Measured: 33th week of pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2026
- Study start1 Aug 2023
- Primary completion1 Aug 2024
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes UniversityThe sponsor's other registered studies.
- 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
- Model description
- Following recruitment, the pregnant women were divided into a study and a control group by randomization (1:2 randomization)
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Kurt, Aydin Adnan Menderes University
- Investigators
- Safiye Özvurmaz, Phd, Study director, Aydın Adnan Menderes University, Faculy of Nursing, Division Public Health Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07315971
- Sponsor's protocol ID
- E-21347915-050.04.04-264603l
- Other IDs
- Randomızed Controlled Experıme
- Status last verified
- Jan 2026
- First submitted
- 20 Nov 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request
Publications
Kurt F, Ozvurmaz S. Effects of health promotion behavior education in pregnancy on sleep quality and physical activity: a randomized controlled trial. BMC Pregnancy Childbirth. 2026 Jul 28;26(1):1211. doi: 10.1186/s12884-026-09710-0.
PubMed 42919252
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Health Development Behavıour Traınıng In Pregnancy On Sleep Qualıty And Physıcal Actıvıty Levels: A Randomızed Controlled Experımental Study
- ClinicalTrials.gov ID
- NCT07315971
- Acronym / sponsor ID
- E-21347915-050.04.04-264603l
- Conditions
- Health Behavior, Physical Activity, Sleep Quality
- Keywords
- Exercise, Education, Pregnancy, Nursing, Sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 5 Jan 2026 (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.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Following recruitment, the pregnant women were divided into a study and a control group by randomization (1:2 randomization)
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Behavioral: HEALTH PROMOTION BEHAVIOR TRAININGThe study group received training on health promotion during pregnancy in addition to usual care provided by health professionals. |
| Control group | No intervention | –The control group continued to receive the routine care |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Pregnant women who were: • in the early third trimester,
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| HEALTH PROMOTION BEHAVIOR TRAININGExercise 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. | Behavioural | experimental group |
Primary outcome
Physical Activity Questionnaire for Pregnant Women
Time frame: 28th week of pregnancy
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.
The Pittsburgh Sleep Quality Index
Time frame: 28th week of pregnancy
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.
2 secondary outcomes
Physical Activity Questionnaire for Pregnant Women
Time frame: 33th week of pregnancy
The Pittsburgh Sleep Quality Index
Time frame: 33th week of pregnancy
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 7 Jan 2026.
- Derived from this study: PubMed 42919252Kurt F, Ozvurmaz S. Effects of health promotion behavior education in pregnancy on sleep quality and physical activity: a randomized controlled trial. BMC Pregnancy Childbirth. 2026 Jul 28;26(1):1211. doi: 10.1186/s12884-026-09710-0.
- Individual participant dataSharing planned: Yes. The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request
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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.
Safiye Özvurmaz, Phd study director
Aydın Adnan Menderes University, Faculy of Nursing, Division Public Health Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HEALTH PROMOTION BEHAVIOR TRAINING in people with Health Behavior and Physical Activity, run by Aydin Adnan Menderes University 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 3 inclusion and 6 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 7 Jan 2026. 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?
Physical Activity Questionnaire for Pregnant Women (time frame: 28th week of pregnancy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07315971, which also lists 1 linked publication.
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 7 Jan 2026.