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ObesityNCT04665336

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

A study testing Circadian Timing Program and Sleep Hygiene Training in people with Obesity, run by Kocaeli University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 64 years
Conditions the study is for
Obesity
What is being tested?
Circadian Timing Program and Sleep Hygiene Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 siteTurkey (Türkiye)
Study dates
30 Jun 2021to 26 Apr 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Kocaeli University

    İzmit, Kocaeli, 41001

Other trials in Turkey (Türkiye)

About this study

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

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.

Read the 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.

Conditions
Obesity
Being tested
Circadian Timing Program, Sleep Hygiene Training
Keywords
obese, chronotype, eveningness, circadian rhythm, sleep quality
Medical subject headings
Obesity, Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Circadian Timing ProgramBehavioural

    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 TrainingBehavioural

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

Study groups in NCT04665336
Study groupRoleWhat they receive
Intervention Group Lifestyle counselingExperimentalObese 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.
Receives: Behavioral: Circadian Timing Program; Behavioral: Sleep Hygiene Training
Control groupNo interventionParticipants 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Change between day 1 and week 12 of the study.

  2. 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).

    Measured: 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.

    PUKI is a scale that can define the quality of sleep as "good or bad". Change = (Week 12 Measurement- Baseline Measurement).

    Measured: Baseline and Week 12

Secondary outcomes (2)

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

    In the Impact of Weight on Quality of Life Instrument (IWQOL-Lite)

    Measured: Baseline and Week 12

  2. Change in Sleepiness from Baseline at 12 Week.

    In the Epworth Sleepiness Scale (ESS) the lowest score that can be obtained from the scale

    Measured: Baseline and Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2020
  2. Study start30 Jun 2021
  3. Primary completion26 Apr 2023
  4. Study completion26 Apr 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized Controlled Trial
Masking
Single blind
Who is masked
Participant
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04665336
Sponsor's protocol ID
KOU
Status last verified
Jul 2023
First submitted
3 Dec 2020
Last updated
6 Jul 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 11316344

  • 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.

    PubMed 2748771

  • 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.

    PubMed 1798888

  • 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.

    PubMed 17922157

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

    PubMed 1027738

  • 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.

    PubMed 26660638

  • 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.

    PubMed 25852644

  • 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.

    PubMed 38652930

Questions about this trial

What is this clinical trial studying?

A study testing Circadian Timing Program and Sleep Hygiene Training in people with Obesity, run by Kocaeli University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Body Mass Index (BMI) from Baseline at 12 Week (time frame: Change between day 1 and week 12 of the study.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04665336, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2023.

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