NCT07168967

Brief Summary

The aim of this study is to examine the relationship between the Planetary Health Diet (EAT-Lancet) dietary pattern, chronotype, and psychological well-being in obese individuals. A total of 97 individuals diagnosed with obesity were included in the study. A questionnaire form containing sociodemographic characteristics was administered to volunteers who agreed to participate in the study. In addition, participants' anthropometric measurements (body weight, height, waist and hip circumference, Body Mass Index (BMI)), biochemical parameters (fasting blood glucose, HbA1c, triglycerides, LDL-cholesterol, triglycerides, total cholesterol, C-reactive protein (CRP)), and nutritional status (food consumption record and frequency) were obtained. The Morningness-Eveningness Questionnaire was used to determine chronotype. The Psychological Well-Being Scale was used for psychological assessment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
97

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 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

September 1, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 4, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 11, 2025

Completed
Last Updated

September 11, 2025

Status Verified

September 1, 2025

Enrollment Period

3 months

First QC Date

September 4, 2025

Last Update Submit

September 5, 2025

Conditions

Keywords

ChronotypeObesityPsychological well-being

Outcome Measures

Primary Outcomes (19)

  • Questionnaire Form

    Sociodemographic characteristics of the individuals (age, gender, smoking and alcohol use, constipation status, swallowing-chewing problem) were questioned.

    3 months

  • Body Weight (BW)

    BW was measured using a calibrated digital scale placed on a flat, tiled surface. The scale was sensitive to 100 grams.

    3 months

  • Height

    Height was measured using a stadiometer with the participant's head positioned in the Frankfort plane and feet placed together.

    3 months

  • Waist Circumference (WC)

    WC was measured at the midpoint between the lowest rib and the iliac crest (cristal point) using a flexible measuring tape.

    3 months

  • Hip Circumference (HC)

    HC was measured at the widest point of the hips using a flexible measuring tape.

    3 months

  • Body Mass Index (BMI)

    BMI was calculated by dividing body weight (in kilograms) by the square of height (in meters): BMI = weight (kg) / height² (m²).

    3 months

  • Fasting Blood Glucose

    Fasting blood glucose was measured using standard laboratory techniques during routine outpatient visits.

    3 months

  • Triglycerides

    Triglyceride levels were measured via fasting blood samples analyzed in the outpatient clinic laboratory.

    3 months

  • LDL-Cholesterol

    LDL-cholesterol was measured from fasting serum samples using standard enzymatic colorimetric methods.

    3 months

  • Total Cholesterol

    Total cholesterol was measured using routine biochemical analysis in a certified laboratory.

    3 months

  • Albumin

    Serum albumin levels were measured using routine laboratory procedures in outpatient visits.

    3 months

  • Vitamin D

    Serum vitamin D (25(OH)D) levels were assessed using chemiluminescence immunoassay methods in the outpatient clinic laboratory.

    3 months

  • Folic Acid

    Serum folic acid levels were measured using standard automated immunoassay techniques.immunoassay methods in the outpatient clinic laboratory.

    3 months

  • Vitamin B12

    Serum vitamin B12 concentrations were measured using automated chemiluminescent immunoassay.immunoassay methods in the outpatient clinic laboratory.

    3 months

  • Food Frequency Questionnaire

    The foods consumed by individuals in the last month were evaluated across seven different groups, including five basic food groups (meat and meat products, milk and dairy products, bread and grains, vegetables and fruits, sugar and fats), beverages, and fast food. Participants were asked how often they consumed foods and beverages in these groups; responses were collected using the following options: "every meal," "every day," "5-6 days a week," "3-4 days a week," "1-2 days a week," "once every 15 days," "once a month," and "never." To determine the average daily consumption amounts based on consumption frequency, the following coefficients were used: 3 for "every meal," 1 for "every day," 0.7855 for "5-6 times a week," 0.498 for "3-4 times a week," 0.2145 for "1-2 times a week," 0.067 for "every 15 days," and 0.033 for "once a month.

    3 months

  • Evaluation of Food Consumption Records

    Responses regarding food consumption frequency were calculated using food consumption frequency calculations. The amounts of food and beverages consumed were multiplied by "3" for "every meal," '1' for "every day," "0.7855" for "5-6 times a week," "0.498" for "3-4 times a week," "0.2145" for "1-2 times a week," "0.067" for "every 15 days," and "0.033" for "once a month" to obtain the average daily amounts. Energy, macronutrients, and micronutrients were calculated using the daily intake amount.

    3 months

  • Planetary Health Diet (EAT-Lancet)

    In this study, the EAT-Lancet diet score was used. Adherence to the EAT-Lancet diet was scored based on the estimated average daily intake of 14 dietary components. Each component was rated as 0 (non-compliance) or 1 point (compliance), resulting in a total score ranging from 0 to 14 points.

    3 months

  • Chronotype Eating Pattern

    Individuals' chronotype eating patterns were determined using the Morning-Evening Questionnaire. The Morning-Evening Questionnaire consists of a total of 19 questions. The questionnaire contains questions about individuals' physical and psychological performance during a 24-hour period, which time of day they perform better, and their preferences regarding sleep and wakefulness times. As a result of the evaluation, those who scored between 70 and 86 were classified as "Definitely Morning Type"; those scoring between 59 and 69 are classified as "Close to Morning Type"; those scoring between 42 and 58 are classified as "Intermediate Type"; those scoring between 31 and 41 are classified as "Close to Evening Type"; and those scoring between 16 and 30 are classified as "Definitely Evening Type."

    3 months

  • Psychological Assessment

    Individuals were psychologically assessed using the Psychological Well-Being Scale. The scale defines many important elements, ranging from feeling satisfied with positive relationships to having a purposeful and meaningful life. There are 8 items on the scale. Each item is answered on a scale of 1 to 7, ranging from 1 (strongly disagree) to 7 (strongly agree). When all items are answered with "strongly disagree," the total test score is 8; when answered with "strongly agree," the total test score is 56. A high score on the test indicates that the individual has abundant psychological resources and strengths.

    3 months

Study Arms (1)

Individuals with obesity

This cohort includes adult participants diagnosed with obesity (BMI ≥30 kg/m²). No control group is included.

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study was designed as a cross-sectional study. The study was conducted on 97 individuals aged 19-64 who were diagnosed with obesity and volunteered to participate in the study at the Diet Clinic of Izzet Baysal Physical Therapy and Rehabilitation Education and Research Hospital.

You may qualify if:

  • Individuals over 19 years of age
  • Individuals who are literate
  • Individuals diagnosed with obesity

You may not qualify if:

  • Individuals who have had an acute infection or inflammatory disease within the past month
  • Individuals with chronic infectious or inflammatory diseases
  • Individuals with cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bolu Abant İzzet Baysal University, Faculty of Health Sciences

Bolu, Turkey (Türkiye)

Location

MeSH Terms

Conditions

ObesityPsychological Well-Being

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsPersonal SatisfactionBehavior

Study Officials

  • Nurefşan Konyalıgil Öztürk

    Abant Izzet Baysal University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. Prof. Dr

Study Record Dates

First Submitted

September 4, 2025

First Posted

September 11, 2025

Study Start

September 1, 2024

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

September 11, 2025

Record last verified: 2025-09

Locations