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NCT Number: NCT07368465

Determinant Factors in Excessive Gestational Weight Gain: Physical Activity, Nutritional Status, and Anxiety

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.

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Key information

Conditions

Pregnancy Anxiety Disorders Behavior Excessive Gestational Weight Gain Mental Disorders Motor Activity

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Bezmialem Vakıf University

Istanbul, Turkey (Türkiye)

Location status: Recruiting

Location contact

Ayşe Sena Manzak Dursun, PT, PhD, Asisstant Prof.

CONTACT

[email protected]

+905356735150

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

  2. Daily Energy Intake (kcal/day)

    Time frame: Single assessment during the third trimester (28-40 weeks of gestation)

    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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ayşe Sena Manzak Dursun, PT, PhD

CONTACT

[email protected]

+0905356735150

Sponsors and collaborators

Lead sponsor

Bezmialem Vakif University

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 26, 2026
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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