The Effect of Circadian Timing Program on Obesity Management and Sleep Quality (NCT04665336) | Clinical Trial Compass
CompletedNot Applicable
The Effect of Circadian Timing Program on Obesity Management and Sleep Quality
Turkey (Türkiye)38 participantsStarted 2021-06-30
Plain-language 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.
Who can participate
Age range
18 Years – 64 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Body Mass Index (BMI) from Baseline at 12 Week
Timeframe: Change between day 1 and week 12 of the study.
2
Change in waist and hip circumference from Baseline at 12 Week
Timeframe: Change between day 1 and week 12 of the study.
3
Change from Baseline in Sleep Quality on The Pittsburgh Sleep Quality Index (PUKI) at Week 12.