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

July 2, 2023 updated by: Secil EKİZ ERİM, Kocaeli University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Kocaeli
      • İzmit, Kocaeli, Turkey, 41001
        • Kocaeli University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group Lifestyle counseling
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
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.
Behavioral: Sleep Hygiene Training
Sleep hygiene training will be given by the researcher. There will also be sleep hygiene training sections on the website.
No Intervention: Control group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Body Mass Index (BMI) from Baseline at 12 Week
Time Frame: 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).
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.
Time Frame: 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).
Baseline and Week 12
Change in waist and hip circumference from Baseline at 12 Week
Time Frame: 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 between day 1 and week 12 of the study.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Quality of Life from Baseline at 12 Week.
Time Frame: Baseline and Week 12
In the Impact of Weight on Quality of Life Instrument (IWQOL-Lite)
Baseline and Week 12
Change in Sleepiness from Baseline at 12 Week.
Time Frame: Baseline and Week 12
In the Epworth Sleepiness Scale (ESS) the lowest score that can be obtained from the scale
Baseline and Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kocaeli University

Collaborators

Sakarya University

Investigators

  • Study Director: Havva Sert, Assoc. Prof., Sakarya University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2021

Primary Completion (Actual)

April 26, 2023

Study Completion (Actual)

April 26, 2023

Study Registration Dates

First Submitted

December 3, 2020

First Submitted That Met QC Criteria

December 10, 2020

First Posted (Actual)

December 11, 2020

Study Record Updates

Last Update Posted (Actual)

July 6, 2023

Last Update Submitted That Met QC Criteria

July 2, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KOU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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