OverweightNCT06614075
Diet Quality and Diabetes Risk in Overweight and Obese Adults
An observational study of Overweight and Obesity, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this observational study is to learn about the relationship between diabetes risk with sociodemographic characteristics, lifestyle and diet quality in overweight and obese individuals. Read more about this study
- Who is it for?
- Ages 19 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Questionnaire and anthropometric measurement
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,840 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2024to 15 Jun 2024
- How long will I take part?
- 1 Day
- 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 19 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Community sample in Ankara, Turkey
Who may be able to join
- Body mass index (BMI) ≥25 kg/m²
Who cannot join
- Diabetes mellitus
- Psychiatric disorders
- Pregnant and lactating
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Yıldırım Beyazıt University
Ankara, Çubuk, 06760
About this study
Official title: The Relationship Between Sociodemographic Characteristics, Lifestyle, and Diet Quality With Diabetes Risk in Overweight and Obese Adults
The goal of this observational study is to learn about the relationship between diabetes risk with sociodemographic characteristics, lifestyle and diet quality in overweight and obese individuals. The main question it aims to answer is:
Is there a relationship between diabetes risk and diet quality in overweight and obese individuals?
Participants who are overweight and obese will answer survey questions about sociodemographic characteristics and lifestyle behaviors. 24 hour dietary recalls will be taken to evaluate diet quality. FINDRISC questionnaire will be applied to assess diabetes risk.
- Conditions
- Overweight, Obesity
- Being tested
- Questionnaire and anthropometric measurement
- Keywords
- diabetes mellitus, obesity, diet
- Medical subject headings
- Overweight, Obesity, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire and anthropometric measurementBehavioural
Questionnaire including sociodemographic characteristics, lifestyle habits, body weight, height, dietary assessment and diabetes risk; Anthropometric measurement including waist circumference
| Study group | Role | What they receive |
|---|---|---|
| Adults | Overweight and obese adults Receives: Behavioral: Questionnaire and anthropometric measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Finnish Diabetes Risk Score (FINDRISC)
Scores can range from a minimum of 0 to a maximum of 26 points. According to the FINDRISC scoring system, scores are classified as follows: a score of less than 7 indicates low risk, 7-11 indicates mild risk, 12-14 indicates moderate risk, 15-20 indicates high risk, and a score of less than 20 indicates very high risk.
Measured: Baseline
Healthy eating index-2015 (HEI-2015)
A 24 hour dietary recall was used to assess dietary intake. Nutrient intake obtained from dietary recalls were evaluated using Ebispro for Windows, Stuttgart, Germany; Turkish Version (BeBiS 9). The HEI- 2015 and its sub-scores are calculated based on the quantity of food and nutrient intake per 1,000 kilocalories consumed by individuals. HEI-2015 scores range from a minimum of 0 to a maximum of 100. Based on the calculated scores, a score greater than 80 indicates good diet quality, a score between 51 and 80 is categorized as moderate diet quality, and a score of 50 or less is defined as poor diet quality.
Measured: Baseline
Secondary outcomes (5)
Sociodemographic characteristics
number and percentage
Measured: Baseline
Lifestyle habits
number and percentage
Measured: Baseline
Body weight
Body weight in kg
Measured: Baseline
Height
Height in cm
Measured: Baseline
Waist circumference
waist circumference in cm
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start15 Jan 2024
- Primary completion15 Jun 2024
- Study completion15 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by Ankara Yildirim Beyazıt 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 1,840 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rahime Evra KARAKAYA, Ankara Yildirim Beyazıt University
- Investigators
- Rahime E Karakaya, PhD, Principal investigator, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06614075
- Sponsor's protocol ID
- AnkaraYBU-KARAKAYA002
- Status last verified
- Sep 2024
- First submitted
- 20 Sep 2024
- Last updated
- 26 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Karakaya RE, Elibol E. The relationship between sociodemographic characteristics, lifestyle, and diet quality with diabetes risk in overweight and obese Turkish adults. BMC Public Health. 2025 Jan 2;25(1):5. doi: 10.1186/s12889-024-21248-4.
PubMed 39748361
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Sociodemographic Characteristics, Lifestyle, and Diet Quality With Diabetes Risk in Overweight and Obese Adults
- ClinicalTrials.gov ID
- NCT06614075
- Acronym / sponsor ID
- AnkaraYBU-KARAKAYA002
- Conditions
- Overweight, Obesity
- Keywords
- diabetes mellitus, obesity, diet
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,840 participants (actual)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 15 Jun 2024 (actual)
- Study completion
- 15 Jun 2024 (actual)
- First posted
- 26 Sep 2024 (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 goal of this observational study is to learn about the relationship between diabetes risk with sociodemographic characteristics, lifestyle and diet quality in overweight and obese individuals. The main question it aims to answer is:
Is there a relationship between diabetes risk and diet quality in overweight and obese individuals?
Participants who are overweight and obese will answer survey questions about sociodemographic characteristics and lifestyle behaviors. 24 hour dietary recalls will be taken to evaluate diet quality. FINDRISC questionnaire will be applied to assess diabetes risk.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults | – | Behavioral: Questionnaire and anthropometric measurementOverweight and obese adults |
Who may qualify
- Ages
- 19 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Community sample in Ankara, Turkey
Key inclusion criteria (1 listed)
- Body mass index (BMI) ≥25 kg/m²
Key exclusion criteria (3 listed)
- Diabetes mellitus
- Psychiatric disorders
- Pregnant and lactating
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 |
|---|---|---|
| Questionnaire and anthropometric measurementQuestionnaire including sociodemographic characteristics, lifestyle habits, body weight, height, dietary assessment and diabetes risk; Anthropometric measurement including waist circumference | Behavioural | Adults |
Primary outcome
Finnish Diabetes Risk Score (FINDRISC)
Time frame: Baseline
Scores can range from a minimum of 0 to a maximum of 26 points. According to the FINDRISC scoring system, scores are classified as follows: a score of less than 7 indicates low risk, 7-11 indicates mild risk, 12-14 indicates moderate risk, 15-20 indicates high risk, and a score of less than 20 indicates very high risk.
Healthy eating index-2015 (HEI-2015)
Time frame: Baseline
A 24 hour dietary recall was used to assess dietary intake. Nutrient intake obtained from dietary recalls were evaluated using Ebispro for Windows, Stuttgart, Germany; Turkish Version (BeBiS 9). The HEI- 2015 and its sub-scores are calculated based on the quantity of food and nutrient intake per 1,000 kilocalories consumed by individuals. HEI-2015 scores range from a minimum of 0 to a maximum of 100. Based on the calculated scores, a score greater than 80 indicates good diet quality, a score between 51 and 80 is categorized as moderate diet quality, and a score of 50 or less is defined as poor diet quality.
5 secondary outcomes
Sociodemographic characteristics
Time frame: Baseline
Lifestyle habits
Time frame: Baseline
Body weight
Time frame: Baseline
Height
Time frame: Baseline
Waist circumference
Time frame: Baseline
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 26 Sep 2024.
- Derived from this study: PubMed 39748361Karakaya RE, Elibol E. The relationship between sociodemographic characteristics, lifestyle, and diet quality with diabetes risk in overweight and obese Turkish adults. BMC Public Health. 2025 Jan 2;25(1):5. doi: 10.1186/s12889-024-21248-4.
- 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.
Rahime E Karakaya, PhD principal investigator
Ankara Yildirim Beyazıt 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 Overweight and Obesity, run by Ankara Yildirim Beyazıt 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 1 inclusion and 3 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 26 Sep 2024. 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?
Finnish Diabetes Risk Score (FINDRISC) (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06614075, which also lists 1 linked publication.
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 26 Sep 2024.