NCT06004193

Brief Summary

The study involved 30 regular exercisers and 33 non-exercisers. Food records were collected five times: before the holiday season, before Ramadan, during Ramadan, during Ramadan Feast, and after Ramadan Feast, including the Eid al-Adha period. Anthropometric measurements were taken before and after holidays: initially before Ramadan and again after Eid al-Adha. Physical activity was recorded for both groups: once before Ramadan for non-exercisers and twice (on exercise and rest days) for exercisers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
63

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2017

Completed
6.4 years until next milestone

First Submitted

Initial submission to the registry

August 16, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 22, 2023

Completed
Last Updated

August 22, 2023

Status Verified

August 1, 2023

Enrollment Period

8 months

First QC Date

August 16, 2023

Last Update Submit

August 16, 2023

Conditions

Keywords

Holiday weight gainFastingBody composition

Outcome Measures

Primary Outcomes (3)

  • Body weight

    Body weight measurements

    4 months

  • Body fat percentage

    Body fat percentage measured with bioelectrical impedance analysis

    4 months

  • Dietary intake

    24-hour dietary recall questionnaires were administered by researchers.

    4 months

Study Arms (2)

Regular Exercisers

The group of regular exercisers includes individuals who engage in at least 150 minutes of exercise per week according to World Health Organization criteria.

Behavioral: Exercise

Non-exercisers

The group of non-exercisers includes individuals who do not have a habit of engaging in regular exercise.

Interventions

ExerciseBEHAVIORAL

At least 150 minutes of exercise in a week

Regular Exercisers

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Participants were recruited from a local activity center, which includes a gym as well as art studios, via bulletin board announcement.

You may qualify if:

  • Age between 20 to 45 years
  • Body mass index (BMI) between 18.5-40.0kg/m2
  • Observing the Islamic holiday season.

You may not qualify if:

  • Pregnant or lactating women
  • Chronic metabolic diseases including type 1 or type 2 diabetes, any type of cancer, cardiovascular diseases
  • kg of weight gain or loss in the last 3 months
  • Planning to lose weight or following a specific diet
  • Exercising \>300min/week
  • Medication use that might affect body weight or composition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University Nutrition and Dietetics Department

Ankara, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Body Weight ChangesFasting

Interventions

Exercise

Condition Hierarchy (Ancestors)

Body WeightSigns and SymptomsPathological Conditions, Signs and SymptomsFeeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Zeynep Goktas, PhD

    Hacettepe University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 16, 2023

First Posted

August 22, 2023

Study Start

May 1, 2016

Primary Completion

December 15, 2016

Study Completion

March 15, 2017

Last Updated

August 22, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations