Holiday Season Weight Change During Islamic Holidays | NCT06004193

Studies
Holiday Season Weight Change During Islamic Holidays

NCT06004193

Sponsor

Hacettepe University

Status

Completed

Last Update Posted

Aug 22, 2023Actual

Enrollment

63Actual

Phase

Not provided

Conditions

Body Weight Changes

Interventions

Exercise

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2016Actual

Primary Completion Date

Dec 15, 2016Actual

Completion Date

Mar 15, 2017Actual

First Submitted Date

Aug 16, 2023

First Submission Date that Met QC Criteria

Aug 16, 2023

First Posted Date

Aug 22, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 16, 2023

Last Update Posted Date

Aug 22, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Zeynep Goktas, Principal Investigator, Hacettepe UniversityPrincipal Investigator

Lead Sponsor

Hacettepe UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

63Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Exercise	Behavioral	At least 150 minutes of exercise in a week	Regular Exercisers

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Zeynep Goktas, PhD	Hacettepe University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hacettepe University Nutrition and Dietetics Department		Ankara		06100	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001836	Body Weight Changes
D005215	Fasting

Ancestor Terms

ID	Term
D001835	Body Weight
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D005247	Feeding Behavior

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015444	Exercise

Ancestor Terms

ID	Term
D009043	Motor Activity
D009068	Movement
D009142	Musculoskeletal Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided