NCT07368465

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
3mo left

Started Jan 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress50%
Jan 2026Aug 2026

Study Start

First participant enrolled

January 2, 2026

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

January 13, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 26, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

February 19, 2026

Status Verified

February 1, 2026

Enrollment Period

5 months

First QC Date

January 13, 2026

Last Update Submit

February 17, 2026

Conditions

Keywords

physical activitynutritional statusanxiety

Outcome Measures

Primary Outcomes (1)

  • 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.

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

Secondary Outcomes (3)

  • Physical Activity Level (MET-hours per week)

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

  • Daily Energy Intake (kcal/day)

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

  • Pregnancy-Related Anxiety Score

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

Study Arms (1)

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.

Other: None (Observational Study)

Interventions

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.

Excessive GWG

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly women who are able to conceive are included in our study.
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • High-risk pregnancy
  • Multiple pregnancy
  • Having a chronic disease such as a systemic, neurological, orthopedic, etc.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezmialem Vakıf University

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Motor ActivityAnxiety Disorders

Interventions

Observation

Condition Hierarchy (Ancestors)

BehaviorMental Disorders

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Central Study Contacts

Ayşe Sena Manzak Dursun, PT, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 13, 2026

First Posted

January 26, 2026

Study Start

January 2, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

February 19, 2026

Record last verified: 2026-02

Locations