The Effect of Circadian Timing Program on Obesity Management and Sleep Quality

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Effect of Circadian Timing Program Created for Obese Individuals With Evening Chronotype on Obesity Management and Sleep Quality

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Circadian Timing Program
* Behavioral: Sleep Hygiene Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Being followed in Kocaeli University Hospital Obesity Outpatient Clinic 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: Insomnia, regular sleep, shift work 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Controlled Trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group Lifestyle counseling<br>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. | Behavioral: Circadian Timing Program<br>* 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.<br>Behavioral: Sleep Hygiene Training<br>* Sleep hygiene training will be given by the researcher. There will also be sleep hygiene training sections on the website.<br>|
| No Intervention: Control group<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | Baseline and Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obese, chronotype, eveningness, circadian rhythm, sleep quality