NCT06614075

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,840

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2024

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

January 15, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 20, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 26, 2024

Completed
Last Updated

September 26, 2024

Status Verified

September 1, 2024

Enrollment Period

5 months

First QC Date

September 20, 2024

Last Update Submit

September 24, 2024

Conditions

Keywords

diabetes mellitusobesitydiet

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Baseline

Secondary Outcomes (5)

  • Sociodemographic characteristics

    Baseline

  • Lifestyle habits

    Baseline

  • Body weight

    Baseline

  • Height

    Baseline

  • Waist circumference

    Baseline

Study Arms (1)

Adults

Overweight and obese adults

Behavioral: Questionnaire and anthropometric measurement

Interventions

Questionnaire including sociodemographic characteristics, lifestyle habits, body weight, height, dietary assessment and diabetes risk; Anthropometric measurement including waist circumference

Adults

Eligibility Criteria

Age19 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Community sample in Ankara, Turkey

You may qualify if:

  • Body mass index (BMI) ≥25 kg/m²

You may not qualify if:

  • Diabetes mellitus
  • Psychiatric disorders
  • Pregnant and lactating

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Yıldırım Beyazıt University

Ankara, Çubuk, 06760, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

OverweightObesityDiabetes Mellitus

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Rahime E Karakaya, PhD

    Ankara Yildirim Beyazıt University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 20, 2024

First Posted

September 26, 2024

Study Start

January 15, 2024

Primary Completion

June 15, 2024

Study Completion

June 15, 2024

Last Updated

September 26, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations