- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07368465
Determinant Factors in Excessive Gestational Weight Gain: Physical Activity, Nutritional Status, and Anxiety
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Ayşe Sena Manzak Dursun, PT, PhD
- Phone Number: +0905356735150
- Email: amanzak@bezmialem.edu.tr
Study Locations
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-
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Istanbul, Turkey (Türkiye)
- Recruiting
- Bezmialem Vakıf University
-
Contact:
- Ayşe Sena Manzak Dursun, PT, PhD, Asisstant Prof.
- Phone Number: +905356735150
- Email: amanzak@bezmialem.edu.tr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- High-risk pregnancy
- Multiple pregnancy
- Having a chronic disease such as a systemic, neurological, orthopedic, etc.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants with Excessive Gestational Weight Gain
Time Frame: Single assessment during the third trimester (28-40 weeks of gestation)
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Gestational weight gain classified as excessive or non-excessive according to the Institute of Medicine (IOM) recommendations adjusted for pre-pregnancy body mass index.
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Single assessment during the third trimester (28-40 weeks of gestation)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Physical Activity Level (MET-hours per week)
Time Frame: Single assessment during the third trimester (28-40 weeks of gestation)
|
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).
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Single assessment during the third trimester (28-40 weeks of gestation)
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Daily Energy Intake (kcal/day)
Time Frame: Single assessment during the third trimester (28-40 weeks of gestation)
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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.
|
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)
|
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.
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Single assessment during the third trimester (28-40 weeks of gestation)
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025/493
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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