Clinical trial NCT04665336: The Effect of Circadian Timing Program on Obesity Management and Sleep Quality
Official title: The Effect of Circadian Timing Program Created for Obese Individuals With Evening Chronotype on Obesity Management and Sleep Quality
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: obese
chronotype
eveningness
circadian rhythm
sleep quality
Lead sponsor: Kocaeli University
Sponsor class: OTHER
Collaborators: name: Sakarya University
First posted: 2020-12-11
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Body Mass Index (BMI) from Baseline at 12 Week
timeFrame: Change between day 1 and week 12 of the study.
measure: Change in waist and hip circumference from Baseline at 12 Week
timeFrame: Change between day 1 and week 12 of the study.
measure: Change from Baseline in Sleep Quality on The Pittsburgh Sleep Quality Index (PUKI) at Week 12.
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Change in Quality of Life from Baseline at 12 Week.
timeFrame: Baseline and Week 12
measure: Change in Sleepiness from Baseline at 12 Week.
timeFrame: Baseline and Week 12
Other outcomes:
Locations:
city: İzmit
country: Turkey
facility: Kocaeli University
state: Kocaeli
Study officials:
affiliation: Sakarya University
name: Havva Sert, Assoc. Prof.
role: STUDY_DIRECTOR
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