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| Name | Class |
|---|---|
| Sakarya University | OTHER |
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This study, it was aimed to examine the effect of circadian timing program created for obese individuals with evening chronotype on obesity management and sleep quality.
The importance of chronotype, which reflects individual preferences in sleep timing and other behaviors, for obesity is mostly unknown. Morning types are more successful in long-term weight control than evening type chronotypes. Those with a sleep preference in the evening and a long sleep time have a higher rate of being overweight / obese than those with a morning preference and sufficient sleep time. Evening-type circadian preferences are indirectly related to food addiction. Individuals with the evening chronotype tend to have higher BMI and unhealthy eating habits.
Although a direct link between chronotype and obesity has not yet been demonstrated, based on the negative health consequences in evening chronotypes; In this study, it is assumed that success in obesity management will increase with well-timed circadian / sleep cycles, adequate sleep time and quality sleep in obese individuals with evening chronotype.
Therefore, in this study, it was aimed to examine the effect of circadian timing program created for obese individuals with evening chronotype on obesity management and sleep quality.
This study will be conducted in an experimental design, in a randomized controlled manner, in accordance with its purpose. The universe of the study will be obese individuals followed in Kocaeli University Hospital Obesity Outpatient Clinic. As a result of the power analysis performed to determine the sample size, the number of individuals in each group was determined as n = 18. The sample of the study will be 36 individuals in total. Participants will be selected to the intervention and control groups by simple randomization method.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group Lifestyle counseling | Experimental | Obese individuals with evening chronotype will be trained on sleep hygiene in order to create behavioral changes in line with circadian rhythms and an intervention program called "Circadian Timing Program" which was created by the researcher in line with the relevant literature will be implemented for 12 weeks. This program includes sleep hygiene recommendations and regulation of daylight exposure, sleep, meal, caffeine intake and exercise times. To determine participants' sleep times they will be asked to keep a sleep diary and sleep records will be taken with the smart bracelet. Participants will be given a password to access the research website. The website of the study will be used for the training, control, motivation and communication of the Participants. |
|
| Control group | No Intervention | Participants will be asked to follow their normal daily lifestyle, maintain normal sleep and eating habits and no further instructions or suggestions will be provided during the study. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Circadian Timing Program | Behavioral | Sleep hygiene training will be provided to the participants. They will be asked to make lifestyle changes according to the "Circadian Timing Program" created by the researcher. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Body Mass Index (BMI) from Baseline at 12 Week | Measurements will be made with body analysis device and height meter in the outpatient clinic. The Body-Mass Index is calculated by dividing the person's weight in kilograms by the square of the person's height in meters (kg / m²). Change = (Week 12 Measurement- Baseline Measurement). | Change between day 1 and week 12 of the study. |
| Change in waist and hip circumference from Baseline at 12 Week | Waist and hip circumference is measured with a tape measure, graduated in centimetres, . The waist-hip ratio is calculated as waist measurement divided by hip measurement W ÷ H. Change = (Week 12 Measurement- Baseline Measurement). | Change between day 1 and week 12 of the study. |
| Change from Baseline in Sleep Quality on The Pittsburgh Sleep Quality Index (PUKI) at Week 12. | PUKI is a scale that can define the quality of sleep as "good or bad". Change = (Week 12 Measurement- Baseline Measurement). | Baseline and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Quality of Life from Baseline at 12 Week. | In the Impact of Weight on Quality of Life Instrument (IWQOL-Lite) | Baseline and Week 12 |
| Change in Sleepiness from Baseline at 12 Week. | In the Epworth Sleepiness Scale (ESS) the lowest score that can be obtained from the scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Havva Sert, Assoc. Prof. | Sakarya University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kocaeli University | İzmit | Kocaeli | 41001 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11316344 | Background | Kolotkin RL, Crosby RD, Kosloski KD, Williams GR. Development of a brief measure to assess quality of life in obesity. Obes Res. 2001 Feb;9(2):102-11. doi: 10.1038/oby.2001.13. | |
| 2748771 | Background | Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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Randomized Controlled Trial
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| Sleep Hygiene Training | Behavioral | Sleep hygiene training will be given by the researcher. There will also be sleep hygiene training sections on the website. |
|
| Baseline and Week 12 |
| 1798888 | Background | Johns MW. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep. 1991 Dec;14(6):540-5. doi: 10.1093/sleep/14.6.540. |
| 17922157 | Background | Izci B, Ardic S, Firat H, Sahin A, Altinors M, Karacan I. Reliability and validity studies of the Turkish version of the Epworth Sleepiness Scale. Sleep Breath. 2008 May;12(2):161-8. doi: 10.1007/s11325-007-0145-7. |
| 1027738 | Background | Horne JA, Ostberg O. A self-assessment questionnaire to determine morningness-eveningness in human circadian rhythms. Int J Chronobiol. 1976;4(2):97-110. |
| 26660638 | Background | Ross KM, Graham Thomas J, Wing RR. Successful weight loss maintenance associated with morning chronotype and better sleep quality. J Behav Med. 2016 Jun;39(3):465-71. doi: 10.1007/s10865-015-9704-8. Epub 2015 Dec 10. |
| 25852644 | Background | Nohara K, Yoo SH, Chen ZJ. Manipulating the circadian and sleep cycles to protect against metabolic disease. Front Endocrinol (Lausanne). 2015 Mar 23;6:35. doi: 10.3389/fendo.2015.00035. eCollection 2015. |
| 38652930 | Derived | Ekiz Erim S, Sert H. The effect of circadian timing program for evening-chronotype individuals with obesity on obesity management and sleep quality: A randomized controlled trial. Sleep Med. 2024 Jul;119:58-72. doi: 10.1016/j.sleep.2024.04.017. Epub 2024 Apr 16. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |