ClinicalTrials.gg
RecruitingNCT07368465Updated Jul 21, 2026

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

An observational study in Pregnancy and Excessive Gestational Weight Gain, sponsored by Bezmialem Vakif University. Recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-21.

Sponsored by Bezmialem Vakif University · Observational

From the registry’s dates

  • Started Jan 2026; still recruiting 10 months later.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
150
Ages
18 Years to 45 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 11 studies in Motor Activity by Bezmialem Vakif University — 3 open to participants now, 3 under way, none of them phase 3. Motor Activity · Bezmialem Vakif University.

Started
2026
the only one that year
Observational
6 of 11
1 open now
Registered
11th of 11
by date

Among the 11 studies in Motor Activity by Bezmialem Vakif University, this one is the only one that started in 2026, is one of 6 observational ones, and was the 11th registered.

By phase

11 studies; the count open now beside each. This study's row is marked.

Observationalthis study6 · 1 open
No phase5 · 2 open

By the year they started

First in 2015; this study’s year is marked. 1 started in 2026.

Size and results

Median enrollment 24 across the 5 interventional studies, 66 across the 6 observational. Of the 8 that completed or were terminated, 0 (0%) have results posted.

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02

Study 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.

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.

03

Conditions studied

  • Pregnancy
  • Excessive Gestational Weight Gain

Keywords

  • physical activity
  • nutritional status
  • anxiety
04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • High-risk pregnancy
  • Multiple pregnancy
  • Having a chronic disease such as a systemic, neurological, orthopedic, etc.
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
150 participants (estimated)
Target follow-up
1 Day
Patient registry
Yes

Groups and cohorts

  • 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

  • OtherNone (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.

06

What researchers measure

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.

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

Secondary outcomes

  1. 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).

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

  2. 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.

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

  3. 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.

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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jan 2026 (actual). Primary completion is estimated for Jun 2027, 16 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 13, 2026
First posted
Jan 26, 2026
StartActual
Jan 2, 2026
Primary completionEst.
Jun 1, 2027
CompletionEst.
Aug 1, 2027
Last update
Jul 21, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07368465
Responsible party
Ayşe Sena Manzak (Assistant Professor, Bezmialem Vakif University) — Principal investigator
First posted
Jan 26, 2026
Start date
Jan 2, 2026
Primary completion
Jun 1, 2027 (estimated)
Completion
Aug 1, 2027 (estimated)
Last update
Jul 21, 2026

Study contacts

Ayşe Sena Manzak Dursun, PT, PhD
Contact
amanzak@bezmialem.edu.tr
+0905356735150

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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