The Effect of Circadian Timing Program Created for Obese Individuals With Evening Chronotype on Obesity Management and Sleep Quality
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Change from Baseline in Sleep Quality on The Pittsburgh Sleep Quality Index (PUKI) at Week 12.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change from Baseline in Sleep Quality on The Pittsburgh Sleep Quality Index (PUKI) at Week 12.
时间窗: Baseline and Week 12
PUKI is a scale that can define the quality of sleep as "good or bad". Change = (Week 12 Measurement- Baseline Measurement).
Change in waist and hip circumference from Baseline at 12 Week
时间窗: Change between day 1 and week 12 of the study.
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 in Body Mass Index (BMI) from Baseline at 12 Week
时间窗: Change between day 1 and week 12 of the study.
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).
次要结局
- Change in Sleepiness from Baseline at 12 Week.(Baseline and Week 12)
- Change in Quality of Life from Baseline at 12 Week.(Baseline and Week 12)
研究者
Secil EKİZ ERİM
Research Assistant, Msc
Kocaeli University