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Recruiting NCT07368465

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

Observational Pregnancy Excessive Gestational Weight Gain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: None (Observational Study).
Who it may be relevant to
Registry conditions: Pregnancy, Excessive Gestational Weight Gain. Basic parameters: 18 years — 45 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Other 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.

Primary outcome measures

  • Number of Participants with Excessive Gestational Weight Gain [Time frame: Single assessment during the third trimester (28-40 weeks of gestation)]
Secondary outcome measures (3)
  • 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)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Turkey (Türkiye) · 1 center
  • Bezmialem Vakıf University — Istanbul

Identifiers

NCT: NCT07368465 · 2025/493

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗