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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04665336
• Other study ID #: KOU
• Status: Completed
• Phase: N/A
• Start date: June 30, 2021
• Est. completion date: April 26, 2023

Study information

• Verified date: July 2023
• Source: Kocaeli University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: April 26, 2023
• Est. primary completion date: April 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Turkey	Kocaeli University	Izmit	Kocaeli

Sponsors (2)

Lead Sponsor	Collaborator
Kocaeli University	Sakarya University

Country where clinical trial is conducted

Turkey, 

References & Publications (7)

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. — View Citation

Horne JA, Ostberg O. A self-assessment questionnaire to determine morningness-eveningness in human circadian rhythms. Int J Chronobiol. 1976;4(2):97-110. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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	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
Secondary	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