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The Role of Circadian Rhythm in the Effect of Sleep Intervention on Obesity Prevention in Early Childhood

Primary Purpose

Infant Sleep Problem

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Behavioral sleep intervention
Sponsored by
Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infant Sleep Problem focused on measuring Sleep, Obesity prevention, Circadian rhythm, Children, Behavioral intervention

Eligibility Criteria

2 Months - 2 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Infants and young children: age 4 months, 6 months, 12 months, and 2 years old;
  • term single birth (37-42 weeks of gestation);
  • health inactive disease;
  • normal Griffiths developmental assessment;
  • natural vaginal delivery or social cesarean section;
  • Apgar score greater than 7 at birth for 1 or 5 minute.

Exclusion Criteria:

  • Infants and young children: birth weight < 2500 g;
  • premature or multiple births;
  • prenatal ultrasonography indicating intrauterine growth retardation;
  • severe organic diseases of the baby after birth that have been hospitalized for treatment;
  • congenital malformations or diseases affecting the feeding of the baby (cleft lip and palate, metabolic diseases, etc.).

Sites / Locations

  • Shanghai children's medicial center affiliated shanghai jiaotong University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

control

Infant behavioral sleep intervention

Arm Description

Infant sleep monitoring (Actigraphy and sleep dairy) and parental surveys

Interventionists collaborate with the family to design a tailored sleep intervention strategy, which involves appropriate sleep schedule and bedtime routine, putting the child to bed while still sleepy rather than when already asleep, and waiting 1 to 2 minutes before attending to the child during nocturnal awakenings. Parents are educated to implement the behavioral protocol at bedtime and subsequent night wakings.

Outcomes

Primary Outcome Measures

Children's sleep condition
A 7-day assessment of children's sleep condition was conducted by using Actiwatch (AMI) and a sleep diary. AMI is a sleep assessment system based on monitoring individual activity whose evaluation point is based on the sleep diary.
Children's sleep condition
A 7-day assessment of children's sleep condition was conducted by using Actiwatch (AMI) and a sleep diary. AMI is a sleep assessment system based on monitoring individual activity whose evaluation point is based on the sleep diary.
Children's sleep condition
A 7-day assessment of children's sleep condition was conducted by using Actiwatch (AMI) and a sleep diary. AMI is a sleep assessment system based on monitoring individual activity whose evaluation point is based on the sleep diary.
Children's sleep condition
A 7-day assessment of children's sleep condition was conducted by using Actiwatch (AMI) and a sleep diary. AMI is a sleep assessment system based on monitoring individual activity whose evaluation point is based on the sleep diary.
Children's anthropometrics
Weight in kilograms
Children's anthropometrics
Weight in kilograms
Children's anthropometrics
Weight in kilograms
Children's anthropometrics
Weight in kilograms
Children's anthropometrics
Length/height in centimeters
Children's anthropometrics
Length/height in centimeters
Children's anthropometrics
Length/height in centimeters
Children's anthropometrics
Length/height in centimeters
Children's anthropometrics
Weight and height will be combined to report BMI (calculated by weight divided by the square of length/height) in kg/m^2
Children's anthropometrics
Weight and height will be combined to report BMI (calculated by weight divided by the square of length/height) in kg/m^2
Children's anthropometrics
Weight and height will be combined to report BMI (calculated by weight divided by the square of length/height) in kg/m^2
Children's anthropometrics
Weight and height will be combined to report BMI (calculated by weight divided by the square of length/height) in kg/m^2
Children's anthropometrics
Arm circumference in centimeters
Children's anthropometrics
Arm circumference in centimeters
Children's anthropometrics
Arm circumference in centimeters
Children's anthropometrics
Triceps skinfold thicknesses in centimeters
Children's anthropometrics
Triceps skinfold thicknesses in centimeters
Children's anthropometrics
Triceps skinfold thicknesses in centimeters
Children's anthropometrics
Subscapular skinfold thicknesses in centimeters
Children's anthropometrics
Subscapular skinfold thicknesses in centimeters
Children's anthropometrics
Subscapular skinfold thicknesses in centimeters
Infant metabolism index
Blood total cholesterol level
Infant metabolism index
Blood high-density lipoprotein level
Infant metabolism index
Blood low-density lipoprotein level
Infant metabolism index
Blood triglycerides level
Infant metabolism index
Fasting blood glucose level
Infant metabolism index
Blood insulin level
Infant metabolism index
Blood ghrelin level
Infant metabolism index
Blood leptin level
Infant metabolism index
Blood adiponectin level
Children's circadian rhythm
Saliva melatonin levels at 7 Time Points (09: 00, 13: 00, 17: 00, 21: 00, 01: 00, 05: 00 and 09: 00) as the gold standard for circadian rhythms of biological clocks under natural environment.
Children's circadian rhythm
Saliva melatonin levels at 7 Time Points (09: 00, 13: 00, 17: 00, 21: 00, 01: 00, 05: 00 and 09: 00) as the gold standard for circadian rhythms of biological clocks under natural environment.
Children's circadian rhythm
Saliva melatonin levels at 7 Time Points (09: 00, 13: 00, 17: 00, 21: 00, 01: 00, 05: 00 and 09: 00) as the gold standard for circadian rhythms of biological clocks under natural environment.
Children's circadian rhythm
Saliva melatonin levels at 7 Time Points (09: 00, 13: 00, 17: 00, 21: 00, 01: 00, 05: 00 and 09: 00) as the gold standard for circadian rhythms of biological clocks under natural environment.

Secondary Outcome Measures

Full Information

First Posted
April 1, 2021
Last Updated
December 1, 2021
Sponsor
Shanghai Jiao Tong University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT05159141
Brief Title
The Role of Circadian Rhythm in the Effect of Sleep Intervention on Obesity Prevention in Early Childhood
Official Title
The Role of Circadian Rhythm in the Effect of Sleep Intervention on Obesity Prevention in Early Childhood
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2022 (Anticipated)
Primary Completion Date
December 30, 2024 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Jiao Tong University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Over the last 40 years, obesity has increased dramatically among all age groups, especially in infants and young children, and became an important global public health challenge, thus early prevention is the highest priority. Emerging studies have found that infant sleep intervention is very likely to become one of the most important strategies for early obesity prevention. However, its action path is not clear, making the target of sleep intervention relatively vague. The role of circadian rhythm in human health status has received increasing attention in recent years. Both animal experiment-based studies and adult clinic-based studies have found significant effect of the circadian rhythm on obesity and other metabolic disorders. Therefore, the present research will establish a community-based 1:1 parallel multi-center randomized controlled trial of sleep intervention cohort in communities with highly rapid weight gain at the early infancy stage. Investigators will collect daily rhythm data, including sleep-wake rhythm, rest-activity rhythm, light-dark cycle, and feeding-fasting, as well as the real-world golden standard of circadian rhythm assessed by seven times saliva melatonin, to test the impact of the sleep intervention program, to determine the causal mechanism of circadian rhythm in the occurrence&nbsp;and&nbsp; development of obesity and metabolic disorder early in life. Our study will provide a new theoretical basis for the establishment of the stable circadian rhythm for the prevention of infant obesity, which has important public health significance.
Detailed Description
Research content 1.1 Study on the Reliability and Validity of Daily Circadian Rhythm of Infant and Young Child Behavior and Establishment of Circadian Circadian Rhythm Prediction Model In three study communities, 10 infants aged 4 months, 6 months, 12 months and 2 years old were recruited, with a total of 120 infants. Daily rhythms of sleep, activity, illumination and eating were collected by using portable device Actiwatch-2 and daily log book. Saliva at 7 time points (09: 00, 13: 00, 17: 00, 21: 00, 01: 00, 05: 00 and 09: 00) were collected to determine the level of melatonin as the gold standard for circadian rhythm of biological clocks under natural environment. The correlation between daily circadian rhythms and characteristics of melatonin secretion was determined. A model with high reliability was established by mathematical modeling. 1.2 Multicenter Cohort Study of Effects of Sleep Intervention on Metabolic Function in Childhood Obesity Methods: A 1: 1 parallel multicenter randomized controlled trial was conducted to recruit 80 infants from each of the control group and the intervention group at 28 days after birth. The control group was followed up for 5 times (28 days, 2 months, 4 months, 6 months and 12 months) of evidence-based infant sleep intervention on the basis of routine child care, and followed up until 2 years old. The main outcomes were changes in BMI z at 0-6 months of age and metabolic markers of obesity at 2 years of age, such as BMI z, subcutaneous fat, body composition and blood biochemistry. On the basis of descriptive analysis, the effects of sleep intervention on infant obesity metabolism and daily rhythm were determined, and the causal mechanism of circadian rhythm, obesity metabolic index and other factors were determined by using Bayesian causal network. 1.3 Verification of Predictive Models for Circadian Rhythms of Behavioral Clocks In the second part of the three study communities, the two groups were randomly selected 20 cases, a total of 120 infants and children. At 4 months, 6 months, 12 months and 2 years of age after birth, saliva samples were collected at 2 time points in addition to Actiwatch-2 and daily rhythm data, and melatonin levels were measured to validate the rhythm prediction model. Research objectives Based on the concept of early prevention, this project focuses on the role of circadian rhythms in infant sleep intervention to prevent obesity and accomplishes the following two objectives: 2.1 To determine the intensity of correlation between the daily rhythm of infants and the characteristics of melatonin secretion rhythm of gold standard. Over mathematical modeling to establish high reliability and validity of behavioral biological clock circadian rhythm prediction model in infants and young children to verify and apply to sleep intervention multicenter cohort study. 2.2 To explore the effect of sleep intervention on infants by establishing a standard multicenter cohort of infant sleep intervention It is of great public health significance to provide high quality evidence for early prevention and control of childhood obesity and to design more pertinent prevention and control strategies.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infant Sleep Problem
Keywords
Sleep, Obesity prevention, Circadian rhythm, Children, Behavioral intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Infants are randomly assigned to one of two groups: Behavioral Sleep Intervention or Control.
Masking
ParticipantOutcomes Assessor
Masking Description
Trial participants and individuals assessing the outcomes are blinded to the participant's condition
Allocation
Randomized
Enrollment
480 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control
Arm Type
No Intervention
Arm Description
Infant sleep monitoring (Actigraphy and sleep dairy) and parental surveys
Arm Title
Infant behavioral sleep intervention
Arm Type
Experimental
Arm Description
Interventionists collaborate with the family to design a tailored sleep intervention strategy, which involves appropriate sleep schedule and bedtime routine, putting the child to bed while still sleepy rather than when already asleep, and waiting 1 to 2 minutes before attending to the child during nocturnal awakenings. Parents are educated to implement the behavioral protocol at bedtime and subsequent night wakings.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral sleep intervention
Intervention Description
The intervention consists of an infant behavioral sleep protocol. In the tailored intervention approach, parents are asked to implement the behavioral protocol at bedtime and at subsequent night wakings.
Primary Outcome Measure Information:
Title
Children's sleep condition
Description
A 7-day assessment of children's sleep condition was conducted by using Actiwatch (AMI) and a sleep diary. AMI is a sleep assessment system based on monitoring individual activity whose evaluation point is based on the sleep diary.
Time Frame
4 months old
Title
Children's sleep condition
Description
A 7-day assessment of children's sleep condition was conducted by using Actiwatch (AMI) and a sleep diary. AMI is a sleep assessment system based on monitoring individual activity whose evaluation point is based on the sleep diary.
Time Frame
6 months old
Title
Children's sleep condition
Description
A 7-day assessment of children's sleep condition was conducted by using Actiwatch (AMI) and a sleep diary. AMI is a sleep assessment system based on monitoring individual activity whose evaluation point is based on the sleep diary.
Time Frame
12 months old
Title
Children's sleep condition
Description
A 7-day assessment of children's sleep condition was conducted by using Actiwatch (AMI) and a sleep diary. AMI is a sleep assessment system based on monitoring individual activity whose evaluation point is based on the sleep diary.
Time Frame
2 years old
Title
Children's anthropometrics
Description
Weight in kilograms
Time Frame
4 months old
Title
Children's anthropometrics
Description
Weight in kilograms
Time Frame
6 months old
Title
Children's anthropometrics
Description
Weight in kilograms
Time Frame
12 months old
Title
Children's anthropometrics
Description
Weight in kilograms
Time Frame
2 years old
Title
Children's anthropometrics
Description
Length/height in centimeters
Time Frame
4 months old
Title
Children's anthropometrics
Description
Length/height in centimeters
Time Frame
6 months old
Title
Children's anthropometrics
Description
Length/height in centimeters
Time Frame
12 months old
Title
Children's anthropometrics
Description
Length/height in centimeters
Time Frame
2 years old
Title
Children's anthropometrics
Description
Weight and height will be combined to report BMI (calculated by weight divided by the square of length/height) in kg/m^2
Time Frame
4 months old
Title
Children's anthropometrics
Description
Weight and height will be combined to report BMI (calculated by weight divided by the square of length/height) in kg/m^2
Time Frame
6 months old
Title
Children's anthropometrics
Description
Weight and height will be combined to report BMI (calculated by weight divided by the square of length/height) in kg/m^2
Time Frame
12 months old
Title
Children's anthropometrics
Description
Weight and height will be combined to report BMI (calculated by weight divided by the square of length/height) in kg/m^2
Time Frame
2 years old
Title
Children's anthropometrics
Description
Arm circumference in centimeters
Time Frame
6 months old
Title
Children's anthropometrics
Description
Arm circumference in centimeters
Time Frame
12 months old
Title
Children's anthropometrics
Description
Arm circumference in centimeters
Time Frame
2 years old
Title
Children's anthropometrics
Description
Triceps skinfold thicknesses in centimeters
Time Frame
6 months old
Title
Children's anthropometrics
Description
Triceps skinfold thicknesses in centimeters
Time Frame
12 months old
Title
Children's anthropometrics
Description
Triceps skinfold thicknesses in centimeters
Time Frame
2 years old
Title
Children's anthropometrics
Description
Subscapular skinfold thicknesses in centimeters
Time Frame
6 months old
Title
Children's anthropometrics
Description
Subscapular skinfold thicknesses in centimeters
Time Frame
12 months old
Title
Children's anthropometrics
Description
Subscapular skinfold thicknesses in centimeters
Time Frame
2 years old
Title
Infant metabolism index
Description
Blood total cholesterol level
Time Frame
2 years old
Title
Infant metabolism index
Description
Blood high-density lipoprotein level
Time Frame
2 years old
Title
Infant metabolism index
Description
Blood low-density lipoprotein level
Time Frame
2 years old
Title
Infant metabolism index
Description
Blood triglycerides level
Time Frame
2 years old
Title
Infant metabolism index
Description
Fasting blood glucose level
Time Frame
2 years old
Title
Infant metabolism index
Description
Blood insulin level
Time Frame
2 years old
Title
Infant metabolism index
Description
Blood ghrelin level
Time Frame
2 years old
Title
Infant metabolism index
Description
Blood leptin level
Time Frame
2 years old
Title
Infant metabolism index
Description
Blood adiponectin level
Time Frame
2 years old
Title
Children's circadian rhythm
Description
Saliva melatonin levels at 7 Time Points (09: 00, 13: 00, 17: 00, 21: 00, 01: 00, 05: 00 and 09: 00) as the gold standard for circadian rhythms of biological clocks under natural environment.
Time Frame
4 months old
Title
Children's circadian rhythm
Description
Saliva melatonin levels at 7 Time Points (09: 00, 13: 00, 17: 00, 21: 00, 01: 00, 05: 00 and 09: 00) as the gold standard for circadian rhythms of biological clocks under natural environment.
Time Frame
6 months old
Title
Children's circadian rhythm
Description
Saliva melatonin levels at 7 Time Points (09: 00, 13: 00, 17: 00, 21: 00, 01: 00, 05: 00 and 09: 00) as the gold standard for circadian rhythms of biological clocks under natural environment.
Time Frame
12 months old
Title
Children's circadian rhythm
Description
Saliva melatonin levels at 7 Time Points (09: 00, 13: 00, 17: 00, 21: 00, 01: 00, 05: 00 and 09: 00) as the gold standard for circadian rhythms of biological clocks under natural environment.
Time Frame
2 years old

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Infants and young children: age 4 months, 6 months, 12 months, and 2 years old; term single birth (37-42 weeks of gestation); health inactive disease; normal Griffiths developmental assessment; natural vaginal delivery or social cesarean section; Apgar score greater than 7 at birth for 1 or 5 minute. Exclusion Criteria: Infants and young children: birth weight < 2500 g; premature or multiple births; prenatal ultrasonography indicating intrauterine growth retardation; severe organic diseases of the baby after birth that have been hospitalized for treatment; congenital malformations or diseases affecting the feeding of the baby (cleft lip and palate, metabolic diseases, etc.).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiang Fan, PhD
Phone
021-38626161
Email
fanjiang@shsmu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiang Fan, PhD
Organizational Affiliation
Shanghai children's medicial center affiliated shanghai jiaotong University School of Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Shanghai children's medicial center affiliated shanghai jiaotong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
2000127
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
not yet decided
Citations:
PubMed Identifier
31430260
Citation
Komarzynski S, Bolborea M, Huang Q, Finkenstadt B, Levi F. Predictability of individual circadian phase during daily routine for medical applications of circadian clocks. JCI Insight. 2019 Sep 19;4(18):e130423. doi: 10.1172/jci.insight.130423.
Results Reference
background
PubMed Identifier
32622373
Citation
WHO-UNICEF- Lancet Commissioners. After COVID-19, a future for the world's children? Lancet. 2020 Aug 1;396(10247):298-300. doi: 10.1016/S0140-6736(20)31481-1. Epub 2020 Jul 2. No abstract available.
Results Reference
result
PubMed Identifier
30814686
Citation
Bluher M. Obesity: global epidemiology and pathogenesis. Nat Rev Endocrinol. 2019 May;15(5):288-298. doi: 10.1038/s41574-019-0176-8.
Results Reference
result
PubMed Identifier
30548482
Citation
Sung H, Siegel RL, Torre LA, Pearson-Stuttard J, Islami F, Fedewa SA, Goding Sauer A, Shuval K, Gapstur SM, Jacobs EJ, Giovannucci EL, Jemal A. Global patterns in excess body weight and the associated cancer burden. CA Cancer J Clin. 2019 Mar;69(2):88-112. doi: 10.3322/caac.21499. Epub 2018 Dec 12.
Results Reference
result
PubMed Identifier
30281992
Citation
Geserick M, Vogel M, Gausche R, Lipek T, Spielau U, Keller E, Pfaffle R, Kiess W, Korner A. Acceleration of BMI in Early Childhood and Risk of Sustained Obesity. N Engl J Med. 2018 Oct 4;379(14):1303-1312. doi: 10.1056/NEJMoa1803527.
Results Reference
result
PubMed Identifier
29171811
Citation
Ward ZJ, Long MW, Resch SC, Giles CM, Cradock AL, Gortmaker SL. Simulation of Growth Trajectories of Childhood Obesity into Adulthood. N Engl J Med. 2017 Nov 30;377(22):2145-2153. doi: 10.1056/NEJMoa1703860.
Results Reference
result
PubMed Identifier
22087679
Citation
Juonala M, Magnussen CG, Berenson GS, Venn A, Burns TL, Sabin MA, Srinivasan SR, Daniels SR, Davis PH, Chen W, Sun C, Cheung M, Viikari JS, Dwyer T, Raitakari OT. Childhood adiposity, adult adiposity, and cardiovascular risk factors. N Engl J Med. 2011 Nov 17;365(20):1876-85. doi: 10.1056/NEJMoa1010112.
Results Reference
result
PubMed Identifier
20147714
Citation
Franks PW, Hanson RL, Knowler WC, Sievers ML, Bennett PH, Looker HC. Childhood obesity, other cardiovascular risk factors, and premature death. N Engl J Med. 2010 Feb 11;362(6):485-93. doi: 10.1056/NEJMoa0904130.
Results Reference
result
PubMed Identifier
12517229
Citation
Fontaine KR, Redden DT, Wang C, Westfall AO, Allison DB. Years of life lost due to obesity. JAMA. 2003 Jan 8;289(2):187-93. doi: 10.1001/jama.289.2.187.
Results Reference
result
PubMed Identifier
19299006
Citation
Prospective Studies Collaboration; Whitlock G, Lewington S, Sherliker P, Clarke R, Emberson J, Halsey J, Qizilbash N, Collins R, Peto R. Body-mass index and cause-specific mortality in 900 000 adults: collaborative analyses of 57 prospective studies. Lancet. 2009 Mar 28;373(9669):1083-96. doi: 10.1016/S0140-6736(09)60318-4. Epub 2009 Mar 18.
Results Reference
result
PubMed Identifier
29271111
Citation
Hamilton D, Dee A, Perry IJ. The lifetime costs of overweight and obesity in childhood and adolescence: a systematic review. Obes Rev. 2018 Apr;19(4):452-463. doi: 10.1111/obr.12649. Epub 2017 Dec 22.
Results Reference
result
PubMed Identifier
26638187
Citation
Sonntag D, Ali S, De Bock F. Lifetime indirect cost of childhood overweight and obesity: A decision analytic model. Obesity (Silver Spring). 2016 Jan;24(1):200-6. doi: 10.1002/oby.21323. Epub 2015 Dec 6.
Results Reference
result
PubMed Identifier
28604169
Citation
GBD 2015 Obesity Collaborators; Afshin A, Forouzanfar MH, Reitsma MB, Sur P, Estep K, Lee A, Marczak L, Mokdad AH, Moradi-Lakeh M, Naghavi M, Salama JS, Vos T, Abate KH, Abbafati C, Ahmed MB, Al-Aly Z, Alkerwi A, Al-Raddadi R, Amare AT, Amberbir A, Amegah AK, Amini E, Amrock SM, Anjana RM, Arnlov J, Asayesh H, Banerjee A, Barac A, Baye E, Bennett DA, Beyene AS, Biadgilign S, Biryukov S, Bjertness E, Boneya DJ, Campos-Nonato I, Carrero JJ, Cecilio P, Cercy K, Ciobanu LG, Cornaby L, Damtew SA, Dandona L, Dandona R, Dharmaratne SD, Duncan BB, Eshrati B, Esteghamati A, Feigin VL, Fernandes JC, Furst T, Gebrehiwot TT, Gold A, Gona PN, Goto A, Habtewold TD, Hadush KT, Hafezi-Nejad N, Hay SI, Horino M, Islami F, Kamal R, Kasaeian A, Katikireddi SV, Kengne AP, Kesavachandran CN, Khader YS, Khang YH, Khubchandani J, Kim D, Kim YJ, Kinfu Y, Kosen S, Ku T, Defo BK, Kumar GA, Larson HJ, Leinsalu M, Liang X, Lim SS, Liu P, Lopez AD, Lozano R, Majeed A, Malekzadeh R, Malta DC, Mazidi M, McAlinden C, McGarvey ST, Mengistu DT, Mensah GA, Mensink GBM, Mezgebe HB, Mirrakhimov EM, Mueller UO, Noubiap JJ, Obermeyer CM, Ogbo FA, Owolabi MO, Patton GC, Pourmalek F, Qorbani M, Rafay A, Rai RK, Ranabhat CL, Reinig N, Safiri S, Salomon JA, Sanabria JR, Santos IS, Sartorius B, Sawhney M, Schmidhuber J, Schutte AE, Schmidt MI, Sepanlou SG, Shamsizadeh M, Sheikhbahaei S, Shin MJ, Shiri R, Shiue I, Roba HS, Silva DAS, Silverberg JI, Singh JA, Stranges S, Swaminathan S, Tabares-Seisdedos R, Tadese F, Tedla BA, Tegegne BS, Terkawi AS, Thakur JS, Tonelli M, Topor-Madry R, Tyrovolas S, Ukwaja KN, Uthman OA, Vaezghasemi M, Vasankari T, Vlassov VV, Vollset SE, Weiderpass E, Werdecker A, Wesana J, Westerman R, Yano Y, Yonemoto N, Yonga G, Zaidi Z, Zenebe ZM, Zipkin B, Murray CJL. Health Effects of Overweight and Obesity in 195 Countries over 25 Years. N Engl J Med. 2017 Jul 6;377(1):13-27. doi: 10.1056/NEJMoa1614362. Epub 2017 Jun 12.
Results Reference
result
PubMed Identifier
31900098
Citation
Hale L, Troxel W, Buysse DJ. Sleep Health: An Opportunity for Public Health to Address Health Equity. Annu Rev Public Health. 2020 Apr 2;41:81-99. doi: 10.1146/annurev-publhealth-040119-094412. Epub 2020 Jan 3.
Results Reference
result
PubMed Identifier
30870662
Citation
Zhu B, Shi C, Park CG, Zhao X, Reutrakul S. Effects of sleep restriction on metabolism-related parameters in healthy adults: A comprehensive review and meta-analysis of randomized controlled trials. Sleep Med Rev. 2019 Jun;45:18-30. doi: 10.1016/j.smrv.2019.02.002. Epub 2019 Feb 10.
Results Reference
result
PubMed Identifier
31125517
Citation
Piovezan RD, Hirotsu C, Moizinho R, de Sa Souza H, D'Almeida V, Tufik S, Poyares D. Associations between sleep conditions and body composition states: results of the EPISONO study. J Cachexia Sarcopenia Muscle. 2019 Oct;10(5):962-973. doi: 10.1002/jcsm.12445. Epub 2019 May 24.
Results Reference
result
PubMed Identifier
19243786
Citation
Jiang F, Zhu S, Yan C, Jin X, Bandla H, Shen X. Sleep and obesity in preschool children. J Pediatr. 2009 Jun;154(6):814-8. doi: 10.1016/j.jpeds.2008.12.043. Epub 2009 Feb 24.
Results Reference
result
PubMed Identifier
25124976
Citation
Jiang YR, Spruyt K, Chen WJ, Shen XM, Jiang F. Somatic growth of lean children: the potential role of sleep. World J Pediatr. 2014 Aug;10(3):245-50. doi: 10.1007/s12519-014-0500-2. Epub 2014 Aug 15.
Results Reference
result
PubMed Identifier
25104839
Citation
Jiang YR, Spruyt K, Chen WJ, Mei H, Sun WQ, Wang Y, Li SH, Luo ZC, Shen XM, Jiang F. Associations between parent-reported sleep duration and adiposity in Chinese early adolescents. J Public Health (Oxf). 2015 Jun;37(2):277-85. doi: 10.1093/pubmed/fdu049. Epub 2014 Aug 7.
Results Reference
result
PubMed Identifier
31952028
Citation
Deng Y, Wang G, Ye X, Jiang Y, Lin Q, Dong S, Song Y, Zhu L, Meng M, Li W, Zhu Q, Sun W, Jiang F. The association between 25-hydroxyvitamin D levels and children's sleep-wake patterns: a prospective cohort study. Sleep Med. 2020 Mar;67:207-214. doi: 10.1016/j.sleep.2019.11.1252. Epub 2019 Dec 12.
Results Reference
result
PubMed Identifier
30088009
Citation
Paul IM, Savage JS, Anzman-Frasca S, Marini ME, Beiler JS, Hess LB, Loken E, Birch LL. Effect of a Responsive Parenting Educational Intervention on Childhood Weight Outcomes at 3 Years of Age: The INSIGHT Randomized Clinical Trial. JAMA. 2018 Aug 7;320(5):461-468. doi: 10.1001/jama.2018.9432.
Results Reference
result
PubMed Identifier
27271455
Citation
Savage JS, Birch LL, Marini M, Anzman-Frasca S, Paul IM. Effect of the INSIGHT Responsive Parenting Intervention on Rapid Infant Weight Gain and Overweight Status at Age 1 Year: A Randomized Clinical Trial. JAMA Pediatr. 2016 Aug 1;170(8):742-9. doi: 10.1001/jamapediatrics.2016.0445. Erratum In: JAMA Pediatr. 2016 Dec 1;170(12):1230.
Results Reference
result
PubMed Identifier
30101329
Citation
Taylor RW, Gray AR, Heath AM, Galland BC, Lawrence J, Sayers R, Healey D, Tannock GW, Meredith-Jones KA, Hanna M, Hatch B, Taylor BJ. Sleep, nutrition, and physical activity interventions to prevent obesity in infancy: follow-up of the Prevention of Overweight in Infancy (POI) randomized controlled trial at ages 3.5 and 5 y. Am J Clin Nutr. 2018 Aug 1;108(2):228-236. doi: 10.1093/ajcn/nqy090.
Results Reference
result
PubMed Identifier
28242860
Citation
Taylor BJ, Gray AR, Galland BC, Heath AM, Lawrence J, Sayers RM, Cameron S, Hanna M, Dale K, Coppell KJ, Taylor RW. Targeting Sleep, Food, and Activity in Infants for Obesity Prevention: An RCT. Pediatrics. 2017 Mar;139(3):e20162037. doi: 10.1542/peds.2016-2037.
Results Reference
result
PubMed Identifier
30633544
Citation
Hernandez-Garcia J, Navas-Carrillo D, Orenes-Pinero E. Alterations of circadian rhythms and their impact on obesity, metabolic syndrome and cardiovascular diseases. Crit Rev Food Sci Nutr. 2020;60(6):1038-1047. doi: 10.1080/10408398.2018.1556579. Epub 2019 Jan 11.
Results Reference
result
PubMed Identifier
30274603
Citation
Albrecht U, Ripperger JA. Circadian Clocks and Sleep: Impact of Rhythmic Metabolism and Waste Clearance on the Brain. Trends Neurosci. 2018 Oct;41(10):677-688. doi: 10.1016/j.tins.2018.07.007. Epub 2018 Sep 25.
Results Reference
result
PubMed Identifier
29038118
Citation
Kuhlman SJ, Craig LM, Duffy JF. Introduction to Chronobiology. Cold Spring Harb Perspect Biol. 2018 Sep 4;10(9):a033613. doi: 10.1101/cshperspect.a033613.
Results Reference
result
PubMed Identifier
29615393
Citation
Lewis P, Foster RG, Erren TC. Ticking time bomb? High time for chronobiological research. EMBO Rep. 2018 May;19(5):e46073. doi: 10.15252/embr.201846073. Epub 2018 Apr 3.
Results Reference
result
PubMed Identifier
30602736
Citation
Panda S. The arrival of circadian medicine. Nat Rev Endocrinol. 2019 Feb;15(2):67-69. doi: 10.1038/s41574-018-0142-x. No abstract available.
Results Reference
result
PubMed Identifier
29047447
Citation
Burki T. Nobel Prize awarded for discoveries in circadian rhythm. Lancet. 2017 Oct 14;390(10104):e25. doi: 10.1016/S0140-6736(17)32661-2. Epub 2017 Oct 12. No abstract available.
Results Reference
result
PubMed Identifier
22483041
Citation
Mohawk JA, Green CB, Takahashi JS. Central and peripheral circadian clocks in mammals. Annu Rev Neurosci. 2012;35:445-62. doi: 10.1146/annurev-neuro-060909-153128. Epub 2012 Apr 5.
Results Reference
result
PubMed Identifier
33222161
Citation
Flanagan A, Bechtold DA, Pot GK, Johnston JD. Chrono-nutrition: From molecular and neuronal mechanisms to human epidemiology and timed feeding patterns. J Neurochem. 2021 Apr;157(1):53-72. doi: 10.1111/jnc.15246. Epub 2020 Dec 10.
Results Reference
result
PubMed Identifier
31915891
Citation
Mason IC, Qian J, Adler GK, Scheer FAJL. Impact of circadian disruption on glucose metabolism: implications for type 2 diabetes. Diabetologia. 2020 Mar;63(3):462-472. doi: 10.1007/s00125-019-05059-6. Epub 2020 Jan 8.
Results Reference
result
PubMed Identifier
31427142
Citation
Chellappa SL, Vujovic N, Williams JS, Scheer FAJL. Impact of Circadian Disruption on Cardiovascular Function and Disease. Trends Endocrinol Metab. 2019 Oct;30(10):767-779. doi: 10.1016/j.tem.2019.07.008. Epub 2019 Aug 16.
Results Reference
result
PubMed Identifier
21233390
Citation
Rust MJ, Golden SS, O'Shea EK. Light-driven changes in energy metabolism directly entrain the cyanobacterial circadian oscillator. Science. 2011 Jan 14;331(6014):220-3. doi: 10.1126/science.1197243.
Results Reference
result
PubMed Identifier
15845877
Citation
Turek FW, Joshu C, Kohsaka A, Lin E, Ivanova G, McDearmon E, Laposky A, Losee-Olson S, Easton A, Jensen DR, Eckel RH, Takahashi JS, Bass J. Obesity and metabolic syndrome in circadian Clock mutant mice. Science. 2005 May 13;308(5724):1043-5. doi: 10.1126/science.1108750. Epub 2005 Apr 21.
Results Reference
result
PubMed Identifier
31138896
Citation
Jones ME, Schoemaker MJ, McFadden EC, Wright LB, Johns LE, Swerdlow AJ. Night shift work and risk of breast cancer in women: the Generations Study cohort. Br J Cancer. 2019 Jul;121(2):172-179. doi: 10.1038/s41416-019-0485-7. Epub 2019 May 29.
Results Reference
result
PubMed Identifier
29440150
Citation
Vetter C, Dashti HS, Lane JM, Anderson SG, Schernhammer ES, Rutter MK, Saxena R, Scheer FAJL. Night Shift Work, Genetic Risk, and Type 2 Diabetes in the UK Biobank. Diabetes Care. 2018 Apr;41(4):762-769. doi: 10.2337/dc17-1933. Epub 2018 Feb 12.
Results Reference
result
PubMed Identifier
31494051
Citation
Lin QM, Spruyt K, Leng Y, Jiang YR, Wang GH, Dong SM, Mei H, Jiang F. Cross-cultural disparities of subjective sleep parameters and their age-related trends over the first three years of human life: A systematic review and meta-analysis. Sleep Med Rev. 2019 Dec;48:101203. doi: 10.1016/j.smrv.2019.07.006. Epub 2019 Aug 5.
Results Reference
result
PubMed Identifier
26866932
Citation
Ray S, Reddy AB. Cross-talk between circadian clocks, sleep-wake cycles, and metabolic networks: Dispelling the darkness. Bioessays. 2016 Apr;38(4):394-405. doi: 10.1002/bies.201500056. Epub 2016 Feb 11.
Results Reference
result
PubMed Identifier
25065908
Citation
Goncalves BS, Adamowicz T, Louzada FM, Moreno CR, Araujo JF. A fresh look at the use of nonparametric analysis in actimetry. Sleep Med Rev. 2015 Apr;20:84-91. doi: 10.1016/j.smrv.2014.06.002. Epub 2014 Jun 20.
Results Reference
result
PubMed Identifier
9852606
Citation
Yamazaki S, Kerbeshian MC, Hocker CG, Block GD, Menaker M. Rhythmic properties of the hamster suprachiasmatic nucleus in vivo. J Neurosci. 1998 Dec 15;18(24):10709-23. doi: 10.1523/JNEUROSCI.18-24-10709.1998.
Results Reference
result
PubMed Identifier
4008613
Citation
Attanasio A, Borrelli P, Gupta D. Circadian rhythms in serum melatonin from infancy to adolescence. J Clin Endocrinol Metab. 1985 Aug;61(2):388-90. doi: 10.1210/jcem-61-2-388.
Results Reference
result

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The Role of Circadian Rhythm in the Effect of Sleep Intervention on Obesity Prevention in Early Childhood

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