The Effect of Circadian Timing Program on Obesity Management and Sleep Quality
NCT ID: NCT04665336
Last Updated: 2023-07-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
38 participants
INTERVENTIONAL
2021-06-30
2023-04-26
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Intervention Group Lifestyle counseling
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.
Circadian Timing Program
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.
Sleep Hygiene Training
Sleep hygiene training will be given by the researcher. There will also be sleep hygiene training sections on the website.
Control group
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.
No interventions assigned to this group
Interventions
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Circadian Timing Program
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.
Sleep Hygiene Training
Sleep hygiene training will be given by the researcher. There will also be sleep hygiene training sections on the website.
Eligibility Criteria
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Inclusion Criteria
* Being an obese adult (BMI ≥ 30.0 kg / m²)
* Being in the age group of 18 and over
* Having the evening chronotype (Individuals with a late sleep period)
* Having a calorie-based diet according to body mass index and adapting to his diet
* To know how to read and write
* Not to have sensory losses such as sight and hearing
* Not being physically, cognitively or mentally obstructed to participate in the research
* To be open to communication and cooperation
* To have and use internet access
* Having a smart phone
Exclusion Criteria
* Traveling in time zones in the last 4 weeks
* Having an eating or psychiatric disorder
* Alcohol addiction
* Nursing mothers who are pregnant or lactating (giving birth in the past two years)
* Do not use antiobesity medication
* New diagnosis of hyperlipidemia and diabetes and drug initiation (in dose adjustment for less than 3 months)
* Heavy exercise or a sedentary lifestyle
* Being on insulin therapy
* Having a risk of hypoglycemia
* Having Chronic Obstructive Pulmonary Disease, Sleep Apnea, Celiac, Severe Anemia, disease / illnesses
18 Years
64 Years
ALL
No
Sponsors
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Sakarya University
OTHER
Kocaeli University
OTHER
Responsible Party
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Secil EKİZ ERİM
Research Assistant, Msc
Principal Investigators
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Havva Sert, Assoc. Prof.
Role: STUDY_DIRECTOR
Sakarya University
Locations
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Kocaeli University
İzmit, Kocaeli, Turkey (Türkiye)
Countries
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References
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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.
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.
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.
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.
Horne JA, Ostberg O. A self-assessment questionnaire to determine morningness-eveningness in human circadian rhythms. Int J Chronobiol. 1976;4(2):97-110.
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.
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.
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.
Other Identifiers
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KOU
Identifier Type: -
Identifier Source: org_study_id
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