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Completed

NCT Number: NCT04665336

The Effect of Circadian Timing Program 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.

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Key information

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kocaeli University

İzmit, Kocaeli, 41001, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Sleep Hygiene Training

Behavioral

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

Primary outcomes

  1. 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).

  2. 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).

  3. 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).

Secondary outcomes

  1. 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)

  2. 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

Sponsors and collaborators

Lead sponsor

Kocaeli University

Other

Collaborators

  • Sakarya University

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Dec 11, 2020
Registry last updated
Jul 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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