Body Weight ChangesNCT06004193
Holiday Season Weight Change During Islamic Holidays
An observational study of Body Weight Changes, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Body Weight Changes
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 63 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2016to 15 Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Participants were recruited from a local activity center, which includes a gym as well as art studios, via bulletin board announcement.
Who may be able to join
- Age between 20 to 45 years
- Body mass index (BMI) between 18.5-40.0kg/m2
- Observing the Islamic holiday season.
Who cannot join
- Pregnant or lactating women
- Chronic metabolic diseases including type 1 or type 2 diabetes, any type of cancer, cardiovascular diseases
- 5kg 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University Nutrition and Dietetics Department
Ankara, 06100
About this study
Official title: Holiday Season Weight Change During Islamic Holidays and Effect of Exercise on Body Weight and Body Composition
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.
Read the detailed description
The purpose of this study is to determine the changes in nutrient consumption during the holiday season and to assess the changes in body weight, body composition, and blood pressure of exercising and non-exercising individuals at the end of this season. In the United States of America, the holiday season is the period between Thanksgiving and New Year's Day. In Turkey, the holiday season is defined as the period between the Feast of Ramadan and the Feast of Sacrifice. A total of 30 individuals who regularly exercise and 33 who do not exercise participated in the study. In this study, 3-day food consumption records were taken from the participants five times; before the holiday season, before Ramadan, during Ramadan, during Ramadan Feast, after Ramadan Feast, and during the Eid al-Adha period. The anthropometric measurements of the participants were measured before and after the holidays. The first measurement was taken before Ramadan, and the second was taken after Eid al-Adha. Physical activity was recorded in the pre-Ramadan period, once for non-exercising participants, and twice for exercising participants, on exercise and rest days.
- Conditions
- Body Weight Changes
- Being tested
- Exercise
- Keywords
- Holiday weight gain, Fasting, Body composition
- Medical subject headings
- Body Weight Changes, Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
At least 150 minutes of exercise in a week
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Exercise | |
| Non-exercisers | The group of non-exercisers includes individuals who do not have a habit of engaging in regular exercise. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight
Body weight measurements
Measured: 4 months
Body fat percentage
Body fat percentage measured with bioelectrical impedance analysis
Measured: 4 months
Dietary intake
24-hour dietary recall questionnaires were administered by researchers.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start1 May 2016
- Primary completion15 Dec 2016
- Study completion15 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body Weight ChangesStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeynep Goktas, Hacettepe University
- Investigators
- Zeynep Goktas, PhD, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06004193
- Sponsor's protocol ID
- GO 16/307
- Status last verified
- Aug 2023
- First submitted
- 16 Aug 2023
- Last updated
- 22 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Holiday Season Weight Change During Islamic Holidays and Effect of Exercise on Body Weight and Body Composition
- ClinicalTrials.gov ID
- NCT06004193
- Acronym / sponsor ID
- GO 16/307
- Conditions
- Body Weight Changes
- Keywords
- Holiday weight gain, Fasting, Body composition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 May 2016 (actual)
- Primary completion
- 15 Dec 2016 (actual)
- Study completion
- 15 Mar 2017 (actual)
- First posted
- 22 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The purpose of this study is to determine the changes in nutrient consumption during the holiday season and to assess the changes in body weight, body composition, and blood pressure of exercising and non-exercising individuals at the end of this season. In the United States of America, the holiday season is the period between Thanksgiving and New Year's Day. In Turkey, the holiday season is defined as the period between the Feast of Ramadan and the Feast of Sacrifice. A total of 30 individuals who regularly exercise and 33 who do not exercise participated in the study. In this study, 3-day food consumption records were taken from the participants five times; before the holiday season, before Ramadan, during Ramadan, during Ramadan Feast, after Ramadan Feast, and during the Eid al-Adha period. The anthropometric measurements of the participants were measured before and after the holidays. The first measurement was taken before Ramadan, and the second was taken after Eid al-Adha. Physical activity was recorded in the pre-Ramadan period, once for non-exercising participants, and twice for exercising participants, on exercise and rest days.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regular Exercisers | – | Behavioral: ExerciseThe group of regular exercisers includes individuals who engage in at least 150 minutes of exercise per week according to World Health Organization criteria. |
| Non-exercisers | – | –The group of non-exercisers includes individuals who do not have a habit of engaging in regular exercise. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Participants were recruited from a local activity center, which includes a gym as well as art studios, via bulletin board announcement.
Key inclusion criteria (3 listed)
- Age between 20 to 45 years
- Body mass index (BMI) between 18.5-40.0kg/m2
- Observing the Islamic holiday season.
Key exclusion criteria (6 listed)
- Pregnant or lactating women
- Chronic metabolic diseases including type 1 or type 2 diabetes, any type of cancer, cardiovascular diseases
- 5kg of weight gain or loss in the last 3 months
- Planning to lose weight or following a specific diet
- Exercising >300min/week
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseAt least 150 minutes of exercise in a week | Behavioural | Regular Exercisers |
Primary outcome
Body weight
Time frame: 4 months
Body weight measurements
Body fat percentage
Time frame: 4 months
Body fat percentage measured with bioelectrical impedance analysis
Dietary intake
Time frame: 4 months
24-hour dietary recall questionnaires were administered by researchers.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zeynep Goktas, PhD principal investigator
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Body Weight Changes, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight (time frame: 4 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2023.