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

NCT04665336 | Completed DMC

• 1 other identifier: KOU
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

obese; chronotype; eveningness; circadian rhythm; sleep quality

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Change in Quality of Life from Baseline at 12 Week.

  Baseline and Week 12

• Change in Sleepiness from Baseline at 12 Week.

  Baseline and Week 12

Study Arms (2)

Intervention Group Lifestyle counseling

EXPERIMENTAL

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; Behavioral: Sleep Hygiene Training

Control group

NO INTERVENTION

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.

Interventions

Circadian Timing Program BEHAVIORAL

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.

Intervention Group Lifestyle counseling

Sleep Hygiene Training BEHAVIORAL

Sleep hygiene training will be given by the researcher. There will also be sleep hygiene training sections on the website.

Intervention Group Lifestyle counseling

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kocaeli University: lead
• Sakarya University: collaborator

Study Sites (1)

Kocaeli University

İzmit, Kocaeli, 41001, Turkey (Türkiye)

Location

Related Publications (8)

• 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.

  PMID: 11316344 BACKGROUND

• 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.

  PMID: 2748771 BACKGROUND

• 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.

  PMID: 1798888 BACKGROUND

• 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.

  PMID: 17922157 BACKGROUND

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

  PMID: 1027738 BACKGROUND

• 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.

  PMID: 26660638 BACKGROUND

• 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.

  PMID: 25852644 BACKGROUND

• Ekiz Erim S, Sert H. The effect of circadian timing program for evening-chronotype individuals with obesity on obesity management and sleep quality: A randomized controlled trial. Sleep Med. 2024 Jul;119:58-72. doi: 10.1016/j.sleep.2024.04.017. Epub 2024 Apr 16.

  PMID: 38652930 DERIVED

MeSH Terms

Conditions

Obesity; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Havva Sert, Assoc. Prof.

  Sakarya University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant, Msc

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: December 3, 2020
• First Posted: December 11, 2020
• Study Start: June 30, 2021
• Primary Completion: April 26, 2023
• Study Completion: April 26, 2023
• Last Updated: July 6, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)