Clinical trial NCT06865014: Cognitive and Psychomotor Skills and Behavioural Changes During Ramadan in Women
Official title: Changes in Sleep Patterns, Dietary Intake, Cognitive Skills, Anticipation Time and Physical Activity Levels During Ramadan in Healthy Young Women
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Fasting, Intermittent
Food Habits
Sleep
Keywords: Physical Fitness
Body Composition
Cognitive Skills
Ramadan Fasting
Anticipation Time
Lead sponsor: Abant Izzet Baysal University
Sponsor class: OTHER
First posted: 2025-03-07
Enrollment: 22
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Twenty two healthy, moderately active young women who regularly fast during the month Ramadan will be the participants in this study.

Brief summary: This study will observe the participants fasting during the month ramadan. Descriptive characteristics and assessments of sleep, food consumption, body composition, cognitive skills, anticipation time, and physical activity will be conducted before, during and after ramadan.

Detailed description: The aim of this is investigating the changes in sleep patterns, dietary intake, cognitive skills, anticipation time and physical activity levels during Ramadan in healthy young women.

After giving information about the research, participants' descriptive characteristics such as age, height, body weight, body fat percentage, and chronotype (Morningness-Eveningness Questionnaire) will be determined and recorded. Participants' sleep patterns (Actigraphy and Pittsburgh Sleep Quality Index), food consumption (BEBIS), cognitive skills (Stroop test, Letter digit test), anticipation time (Bassin Anticipation Timer), and physical activity levels (International Physical Activity Questionnaire) will be assessed before Ramadan (Pre-R), in the first week of Ramadan (FW-R), in the last week of Ramadan (LW-R) and after Ramadan (Post-R). Additionally, body composition measurements will be taken in Pre-R, LW-R and Post-R. The completion of questionnaires and scales will be conducted individually in a quiet environment. Sleep records will be obtained using an actigraphy device in the participants' own sleep environments. Other measurements will be conducted at the University Performance and Exercise Physiology Laboratory under controlled temperature (22-24°C) and humidity (50-60%).

Eligibility criteria: Inclusion Criteria:

* Voluntariness: Participants must be willing to participate in the study voluntarily and provide informed consent.
* Absence of any health issues
* No chronic sleep problems
* No use of sleep medication
* Fasting throughout the study period during the month Ramadan

Exclusion Criteria:

* Complications During the Intervention: Participants who experience any complications during the month Ramadan while fasting.
* Irregular fasting behavior during Ramadan

Primary outcomes:
measure: Actigraphy
timeFrame: Pre-test, following one week first mid-test, following three weeks second mid-test and following two weeks post-test
measure: Body weight measurement
timeFrame: Pre-test, following one month mid-test and following another one month post-test
measure: Body fat percentage
timeFrame: Pre-test, following one month mid-test and following another one month post-test
measure: Food consumption assessment
timeFrame: Pre-test, following one week first mid-test, following three weeks second mid-test and following two weeks post-test
measure: Stroop test
timeFrame: Pre-test, following one week first mid-test, following three weeks second mid-test and following two weeks post-test
measure: Letter Digit Substitution Test
timeFrame: Pre-test, following one week first mid-test, following three weeks second mid-test and following two weeks post-test
measure: Anticipation time measurement
timeFrame: Pre-test, following one week first mid-test, following three weeks second mid-test and following two weeks post-test
measure: Physical activity level assessment
timeFrame: Pre-test, following one week first mid-test, following three weeks second mid-test and following two weeks post-test
Secondary outcomes:
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Pre-test, following one month mid-test and following another one month post-test
measure: Chronotype assessment
timeFrame: Only once in the pre-test
Other outcomes:
Locations:
city: Bolu
country: Turkey
facility: Bolu Abant İzzet Baysal University, Faculty of Sport Sciences,
Study officials:
affiliation: Bolu Abant İzzet Baysal University, Faculty of Sport Sciences, Department of Coaching Education
name: Umid Karli, PhD
role: PRINCIPAL_INVESTIGATOR
References: