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

Sponsor
Kocaeli University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04665336
Collaborator
Sakarya University (Other)
36
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2
16.1
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Circadian Timing Program
  • Behavioral: Sleep Hygiene Training
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
36 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized Controlled TrialRandomized Controlled Trial
Masking:
Single (Participant)
Primary Purpose:
Supportive Care
Official Title:
The Effect of Circadian Timing Program Created for Obese Individuals With Evening Chronotype on Obesity Management and Sleep Quality
Actual Study Start Date :
Jun 30, 2021
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Nov 1, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Change in Body Mass Index (BMI) from Baseline at 12 Week [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-Hip Ratio (WHR) from Baseline at 12 Week [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. [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).

  4. Change in Quality of Life from Baseline at 12 Week. [Baseline and Week 12]

    In the Impact of Weight on Quality of Life Instrument (IWQOL-Lite) the lowest score that can be obtained from the scale is 0, and the highest score is 100. According to the scale scoring; The lower the score, the lower the quality of life, and the higher the score, the higher the quality of life.

  5. Change in Sleepiness from Baseline at 12 Week. [Baseline and Week 12]

    In the Epworth Sleepiness Scale (ESS) the lowest score that can be obtained from the scale is 0, and the highest score is 24. ESS scores of 11-24 represent increasing levels of 'excessive daytime sleepiness' (EDS).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 64 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kocaeli University İzmit Kocaeli Turkey 41001

Sponsors and Collaborators

  • Kocaeli University
  • Sakarya University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Secil EKİZ ERİM, Research Assistant, Msc, Kocaeli University
ClinicalTrials.gov Identifier:
NCT04665336
Other Study ID Numbers:
  • KOU
First Posted:
Dec 11, 2020
Last Update Posted:
Mar 31, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Secil EKİZ ERİM, Research Assistant, Msc, Kocaeli University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 31, 2022