PregnancyNCT07368465
Determinant Factors in Excessive Gestational Weight Gain: Physical Activity, Nutritional Status, and Anxiety
An observational study of Pregnancy and Excessive Gestational Weight Gain, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to identify which of the following factors-physical activity level, nutritional status, or pregnancy-related anxiety-has the strongest influence on excessive gestational weight gain. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Excessive Gestational Weight Gain
- What is being tested?
- None (Observational Study)
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2026to 1 Aug 2027
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant women in the third trimester attending antenatal care clinics will be evaluated once and classified according to IOM-based gestational weight gain categories.
Who may be able to join
- Being in the 3rd trimester of pregnancy
- Being between 18 and 45 years old
- Having the intellectual capacity to understand and respond to what is read.
Who cannot join
- High-risk pregnancy
- Multiple pregnancy
- Having a chronic disease such as a systemic, neurological, orthopedic, etc.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bezmialem Vakıf University
Istanbul
Ayşe Sena Manzak Dursun, PT, PhD, Asisstant Prof., +905356735150, amanzak@bezmialem.edu.tr
About this study
This study aims to identify which of the following factors-physical activity level, nutritional status, or pregnancy-related anxiety-has the strongest influence on excessive gestational weight gain. Pregnant women in their third trimester who are being followed at Gebze Fatih State Hospital and meet the inclusion criteria will be referred to the Exercise Therapy Laboratory of the Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Bezmialem Vakıf University. After being informed about the study and providing written informed consent, participants will undergo a face-to-face assessment. Data will be collected prospectively using a demographic information form, the Pregnancy Physical Activity Questionnaire (PPAQ), a nutritional status assessment form, and a pregnancy-related anxiety questionnaire.
Read the detailed description
Excessive gestational weight gain is a significant public health concern due to its association with adverse maternal and neonatal outcomes. Multiple factors, including lifestyle behaviors and psychological status, may contribute to excessive weight gain during pregnancy. However, the relative contribution of physical activity, nutritional status, and pregnancy-related anxiety remains unclear.
The primary objective of this prospective observational study is to comprehensively determine which of these variables-physical activity level, nutritional status, or pregnancy-related anxiety-has the most significant effect on excessive gestational weight gain.
The study population will consist of pregnant women in their third trimester who are being followed with a diagnosis of pregnancy at Gebze Fatih State Hospital and who meet the predefined inclusion criteria. Eligible participants will be referred to the Exercise Therapy Laboratory of the Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Bezmialem Vakıf University.
After receiving detailed verbal and written information about the study, all participants will be asked to provide written informed consent prior to enrollment. Data collection will be conducted prospectively through face-to-face interviews.
Participants will complete the following assessment tools:
A demographic characteristics form, The Pregnancy Physical Activity Questionnaire (PPAQ) to assess physical activity levels, A nutritional status assessment form to evaluate dietary habits, A pregnancy-related anxiety questionnaire to assess anxiety levels associated with pregnancy.
The collected data will be analyzed to determine the relative impact of physical activity, nutritional status, and pregnancy-related anxiety on excessive gestational weight gain.
- Conditions
- Pregnancy, Excessive Gestational Weight Gain
- Being tested
- None (Observational Study)
- Keywords
- physical activity, nutritional status, anxiety
- Medical subject headings
- Motor Activity, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None (Observational Study)Other
This is an observational study. No intervention is assigned to participants. All assessments are conducted as part of routine data collection without any experimental or behavioral intervention.
| Study group | Role | What they receive |
|---|---|---|
| Excessive GWG | Participants will be assessed once in the third trimester and categorized into excessive and non-excessive gestational weight gain groups based on IOM recommendations. Physical activity, dietary intake, and pregnancy-related anxiety will be assessed concurrently. Receives: Other: None (Observational Study) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Excessive Gestational Weight Gain
Gestational weight gain classified as excessive or non-excessive according to the Institute of Medicine (IOM) recommendations adjusted for pre-pregnancy body mass index.
Measured: Single assessment during the third trimester (28-40 weeks of gestation)
Secondary outcomes (3)
Physical Activity Level (MET-hours per week)
hysical activity is assessed using the Pregnancy Physical Activity Questionnaire (PPAQ). The questionnaire includes 32 items covering household/care activities, occupational activities, and sports/exercise. Time spent in each activity is multiplied by standardized metabolic equivalent (MET) values to calculate energy expenditure, expressed as MET-hours per week (MET-h/week). Activities are classified by intensity as sedentary (<1.5 METs), light (1.5-3.0 METs), moderate (3.0-6.0 METs), or vigorous (>6.0 METs). Higher MET-hours per week indicate higher levels of physical activity (better outcome).
Measured: Single assessment during the third trimester (28-40 weeks of gestation)
Daily Energy Intake (kcal/day)
Dietary intake is assessed using a 24-hour dietary recall form. Total daily energy intake is calculated in kilocalories per day (kcal/day). Higher values indicate higher daily energy intake.
Measured: Single assessment during the third trimester (28-40 weeks of gestation)
Pregnancy-Related Anxiety Score
Pregnancy-related anxiety is assessed using the Pregnancy-Related Anxiety Scale. The scale consists of 33 items rated on a 4-point Likert scale and includes 9 subscales. Eleven items are reverse-coded. Total scores range from 33 to 132, with higher scores indicating higher levels of pregnancy-related anxiety (worse outcome). The scale has no established cut-off value and can be applied to both primiparous and multiparous pregnant women.
Measured: Single assessment during the third trimester (28-40 weeks of gestation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start2 Jan 2026
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
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.
- More trials run by Bezmialem Vakif 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşe Sena Manzak, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07368465
- Sponsor's protocol ID
- 2025/493
- Status last verified
- Jul 2026
- First submitted
- 13 Jan 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determinant Factors in Excessive Gestational Weight Gain: Physical Activity, Nutritional Status, and Anxiety
- ClinicalTrials.gov ID
- NCT07368465
- Acronym / sponsor ID
- 2025/493
- Conditions
- Pregnancy, Excessive Gestational Weight Gain
- Keywords
- physical activity, nutritional status, anxiety
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 2 Jan 2026 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 26 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.
This study aims to identify which of the following factors-physical activity level, nutritional status, or pregnancy-related anxiety-has the strongest influence on excessive gestational weight gain. Pregnant women in their third trimester who are being followed at Gebze Fatih State Hospital and meet the inclusion criteria will be referred to the Exercise Therapy Laboratory of the Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Bezmialem Vakıf University. After being informed about the study and providing written informed consent, participants will undergo a face-to-face assessment. Data will be collected prospectively using a demographic information form, the Pregnancy Physical Activity Questionnaire (PPAQ), a nutritional status assessment form, and a pregnancy-related anxiety questionnaire.
Detailed description
Excessive gestational weight gain is a significant public health concern due to its association with adverse maternal and neonatal outcomes. Multiple factors, including lifestyle behaviors and psychological status, may contribute to excessive weight gain during pregnancy. However, the relative contribution of physical activity, nutritional status, and pregnancy-related anxiety remains unclear.
The primary objective of this prospective observational study is to comprehensively determine which of these variables-physical activity level, nutritional status, or pregnancy-related anxiety-has the most significant effect on excessive gestational weight gain.
The study population will consist of pregnant women in their third trimester who are being followed with a diagnosis of pregnancy at Gebze Fatih State Hospital and who meet the predefined inclusion criteria. Eligible participants will be referred to the Exercise Therapy Laboratory of the Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Bezmialem Vakıf University.
After receiving detailed verbal and written information about the study, all participants will be asked to provide written informed consent prior to enrollment. Data collection will be conducted prospectively through face-to-face interviews.
Participants will complete the following assessment tools:
A demographic characteristics form, The Pregnancy Physical Activity Questionnaire (PPAQ) to assess physical activity levels, A nutritional status assessment form to evaluate dietary habits, A pregnancy-related anxiety questionnaire to assess anxiety levels associated with pregnancy.
The collected data will be analyzed to determine the relative impact of physical activity, nutritional status, and pregnancy-related anxiety on excessive gestational weight gain.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Excessive GWG | – | Other: None (Observational Study)Participants will be assessed once in the third trimester and categorized into excessive and non-excessive gestational weight gain groups based on IOM recommendations. Physical activity, dietary intake, and pregnancy-related anxiety will be assessed concurrently. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women in the third trimester attending antenatal care clinics will be evaluated once and classified according to IOM-based gestational weight gain categories.
Key inclusion criteria (3 listed)
- Being in the 3rd trimester of pregnancy
- Being between 18 and 45 years old
- Having the intellectual capacity to understand and respond to what is read.
Key exclusion criteria (3 listed)
- High-risk pregnancy
- Multiple pregnancy
- Having a chronic disease such as a systemic, neurological, orthopedic, etc.
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 |
|---|---|---|
| None (Observational Study)This is an observational study. No intervention is assigned to participants. All assessments are conducted as part of routine data collection without any experimental or behavioral intervention. | Other | Excessive GWG |
Primary outcome
Number of Participants with Excessive Gestational Weight Gain
Time frame: Single assessment during the third trimester (28-40 weeks of gestation)
Gestational weight gain classified as excessive or non-excessive according to the Institute of Medicine (IOM) recommendations adjusted for pre-pregnancy body mass index.
3 secondary outcomes
Physical Activity Level (MET-hours per week)
Time frame: Single assessment during the third trimester (28-40 weeks of gestation)
Daily Energy Intake (kcal/day)
Time frame: Single assessment during the third trimester (28-40 weeks of gestation)
Pregnancy-Related Anxiety Score
Time frame: Single assessment during the third trimester (28-40 weeks of gestation)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy and Excessive Gestational Weight Gain, run by Bezmialem Vakif 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 3 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: looking for participants now, as of the sponsor's last update on 21 Jul 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ayşe Sena Manzak Dursun, PT, PhD (+0905356735150, amanzak@bezmialem.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Excessive Gestational Weight Gain (time frame: Single assessment during the third trimester (28-40 weeks of gestation)). 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 21 Jul 2026.