ObesityNCT07168967
EAT-Lancet Diet, Chronotype, and Well-Being in Obesity
An observational study of Obesity, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Obesity
- How many people
- 97 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2024to 1 Dec 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Individuals over 19 years of age
- Individuals who are literate
- Individuals diagnosed with obesity
Who cannot join
- Individuals who have had an acute infection or inflammatory disease within the past month
- Individuals with chronic infectious or inflammatory diseases
- Individuals with cancer
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bolu Abant İzzet Baysal University, Faculty of Health Sciences
Bolu
About this study
Official title: The Relationship Between Adherence to the EAT-Lancet Diet and Chronotype and Psychological Well-Being: A Study in Obese Individuals
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.
Read the detailed description
Mood disorders are common in obese individuals, and anxiety and depression often contribute to weight gain through emotional eating and inactivity. Therefore, including psychological support in obesity prevention and treatment programs is important for long-term weight loss goals. However, chronotype, which describes an individual's behavioral preferences such as sleep timing and eating, is also an important factor in determining both physical and mental health outcomes. An inappropriate chronotype has been associated with a more unfavorable body composition, poor mental health, and an increased risk of depression and anxiety. A review of the literature reveals no studies that simultaneously address the Planetary Health Diet (EAT-Lancet) dietary model, chronotype, and psychological well-being variables in obese individuals; this highlights the originality and necessity of the present study. The aim of this study is to examine the relationship between the EAT-Lancet dietary model, chronotype, and psychological well-being in obese individuals.
- Conditions
- Obesity
- Keywords
- Chronotype, Obesity, Psychological well-being
- Medical subject headings
- Obesity, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Individuals with obesity | This cohort includes adult participants diagnosed with obesity (BMI ≥30 kg/m²). No control group is included. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaire Form
Sociodemographic characteristics of the individuals (age, gender, smoking and alcohol use, constipation status, swallowing-chewing problem) were questioned.
Measured: 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.
Measured: 3 months
Height
Height was measured using a stadiometer with the participant's head positioned in the Frankfort plane and feet placed together.
Measured: 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.
Measured: 3 months
Hip Circumference (HC)
HC was measured at the widest point of the hips using a flexible measuring tape.
Measured: 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).
Measured: 3 months
Fasting Blood Glucose
Fasting blood glucose was measured using standard laboratory techniques during routine outpatient visits.
Measured: 3 months
Triglycerides
Triglyceride levels were measured via fasting blood samples analyzed in the outpatient clinic laboratory.
Measured: 3 months
LDL-Cholesterol
LDL-cholesterol was measured from fasting serum samples using standard enzymatic colorimetric methods.
Measured: 3 months
Total Cholesterol
Total cholesterol was measured using routine biochemical analysis in a certified laboratory.
Measured: 3 months
Albumin
Serum albumin levels were measured using routine laboratory procedures in outpatient visits.
Measured: 3 months
Vitamin D
Serum vitamin D (25(OH)D) levels were assessed using chemiluminescence immunoassay methods in the outpatient clinic laboratory.
Measured: 3 months
Folic Acid
Serum folic acid levels were measured using standard automated immunoassay techniques.immunoassay methods in the outpatient clinic laboratory.
Measured: 3 months
Vitamin B12
Serum vitamin B12 concentrations were measured using automated chemiluminescent immunoassay.immunoassay methods in the outpatient clinic laboratory.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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."
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start1 Sep 2024
- Primary completion1 Dec 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal 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
- Other
- Time perspective
- Prospective
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nurefşan KONYALIGİL ÖZTÜRK, Abant Izzet Baysal University
- Investigators
- Nurefşan Konyalıgil Öztürk, Principal investigator, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07168967
- Sponsor's protocol ID
- AIBU-BD-NKÖ-02
- Status last verified
- Sep 2025
- First submitted
- 4 Sep 2025
- Last updated
- 11 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Adherence to the EAT-Lancet Diet and Chronotype and Psychological Well-Being: A Study in Obese Individuals
- ClinicalTrials.gov ID
- NCT07168967
- Acronym / sponsor ID
- AIBU-BD-NKÖ-02
- Conditions
- Obesity
- Keywords
- Chronotype, Obesity, Psychological well-being
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 11 Sep 2025 (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 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.
Detailed description
Mood disorders are common in obese individuals, and anxiety and depression often contribute to weight gain through emotional eating and inactivity. Therefore, including psychological support in obesity prevention and treatment programs is important for long-term weight loss goals. However, chronotype, which describes an individual's behavioral preferences such as sleep timing and eating, is also an important factor in determining both physical and mental health outcomes. An inappropriate chronotype has been associated with a more unfavorable body composition, poor mental health, and an increased risk of depression and anxiety. A review of the literature reveals no studies that simultaneously address the Planetary Health Diet (EAT-Lancet) dietary model, chronotype, and psychological well-being variables in obese individuals; this highlights the originality and necessity of the present study. The aim of this study is to examine the relationship between the EAT-Lancet dietary model, chronotype, and psychological well-being in obese individuals.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individuals with obesity | – | –This cohort includes adult participants diagnosed with obesity (BMI ≥30 kg/m²). No control group is included. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Individuals over 19 years of age
- Individuals who are literate
- Individuals diagnosed with obesity
Key exclusion criteria (3 listed)
- Individuals who have had an acute infection or inflammatory disease within the past month
- Individuals with chronic infectious or inflammatory diseases
- Individuals with cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Questionnaire Form
Time frame: 3 months
Sociodemographic characteristics of the individuals (age, gender, smoking and alcohol use, constipation status, swallowing-chewing problem) were questioned.
Body Weight (BW)
Time frame: 3 months
BW was measured using a calibrated digital scale placed on a flat, tiled surface. The scale was sensitive to 100 grams.
Height
Time frame: 3 months
Height was measured using a stadiometer with the participant's head positioned in the Frankfort plane and feet placed together.
Waist Circumference (WC)
Time frame: 3 months
WC was measured at the midpoint between the lowest rib and the iliac crest (cristal point) using a flexible measuring tape.
Hip Circumference (HC)
Time frame: 3 months
HC was measured at the widest point of the hips using a flexible measuring tape.
Body Mass Index (BMI)
Time frame: 3 months
BMI was calculated by dividing body weight (in kilograms) by the square of height (in meters): BMI = weight (kg) / height² (m²).
Fasting Blood Glucose
Time frame: 3 months
Fasting blood glucose was measured using standard laboratory techniques during routine outpatient visits.
Triglycerides
Time frame: 3 months
Triglyceride levels were measured via fasting blood samples analyzed in the outpatient clinic laboratory.
LDL-Cholesterol
Time frame: 3 months
LDL-cholesterol was measured from fasting serum samples using standard enzymatic colorimetric methods.
Total Cholesterol
Time frame: 3 months
Total cholesterol was measured using routine biochemical analysis in a certified laboratory.
Albumin
Time frame: 3 months
Serum albumin levels were measured using routine laboratory procedures in outpatient visits.
Vitamin D
Time frame: 3 months
Serum vitamin D (25(OH)D) levels were assessed using chemiluminescence immunoassay methods in the outpatient clinic laboratory.
Folic Acid
Time frame: 3 months
Serum folic acid levels were measured using standard automated immunoassay techniques.immunoassay methods in the outpatient clinic laboratory.
Vitamin B12
Time frame: 3 months
Serum vitamin B12 concentrations were measured using automated chemiluminescent immunoassay.immunoassay methods in the outpatient clinic laboratory.
Food Frequency Questionnaire
Time frame: 3 months
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.
Evaluation of Food Consumption Records
Time frame: 3 months
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.
Planetary Health Diet (EAT-Lancet)
Time frame: 3 months
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.
Chronotype Eating Pattern
Time frame: 3 months
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."
Psychological Assessment
Time frame: 3 months
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.
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 11 Sep 2025.
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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.
Nurefşan Konyalıgil Öztürk principal investigator
Abant Izzet Baysal 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 Obesity, run by Abant Izzet Baysal 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 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 11 Sep 2025. 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?
Questionnaire Form (time frame: 3 months). The study lists 19 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 11 Sep 2025.