Infant Sleep ProblemNCT05159141
The Role of Circadian Rhythm in the Effect of Sleep Intervention on Obesity Prevention in Early Childhood
A study testing Behavioral sleep intervention in people with Infant Sleep Problem, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 months to 2 yearsHealthy volunteers can take part
- Conditions the study is for
- Infant Sleep Problem
- What is being tested?
- Behavioral sleep intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 30 Dec 2024
- 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 2 months to 2 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.).
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai children's medicial center affiliated shanghai jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 2000127
About this study
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\ and\ 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.
Read the 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.
- Conditions
- Infant Sleep Problem
- Being tested
- Behavioral sleep intervention
- Keywords
- Sleep, Obesity prevention, Circadian rhythm, Children, Behavioral intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral sleep interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | Infant sleep monitoring (Actigraphy and sleep dairy) and parental surveys |
| Infant behavioral sleep intervention | Experimental | 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. Receives: Behavioral: Behavioral sleep intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 months old
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.
Measured: 6 months old
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.
Measured: 12 months old
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.
Measured: 2 years old
Children's anthropometrics
Weight in kilograms
Measured: 4 months old
Children's anthropometrics
Weight in kilograms
Measured: 6 months old
Children's anthropometrics
Weight in kilograms
Measured: 12 months old
Children's anthropometrics
Weight in kilograms
Measured: 2 years old
Children's anthropometrics
Length/height in centimeters
Measured: 4 months old
Children's anthropometrics
Length/height in centimeters
Measured: 6 months old
Children's anthropometrics
Length/height in centimeters
Measured: 12 months old
Children's anthropometrics
Length/height in centimeters
Measured: 2 years old
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
Measured: 4 months old
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
Measured: 6 months old
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
Measured: 12 months old
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
Measured: 2 years old
Children's anthropometrics
Arm circumference in centimeters
Measured: 6 months old
Children's anthropometrics
Arm circumference in centimeters
Measured: 12 months old
Children's anthropometrics
Arm circumference in centimeters
Measured: 2 years old
Children's anthropometrics
Triceps skinfold thicknesses in centimeters
Measured: 6 months old
Children's anthropometrics
Triceps skinfold thicknesses in centimeters
Measured: 12 months old
Children's anthropometrics
Triceps skinfold thicknesses in centimeters
Measured: 2 years old
Children's anthropometrics
Subscapular skinfold thicknesses in centimeters
Measured: 6 months old
Children's anthropometrics
Subscapular skinfold thicknesses in centimeters
Measured: 12 months old
Children's anthropometrics
Subscapular skinfold thicknesses in centimeters
Measured: 2 years old
Infant metabolism index
Blood total cholesterol level
Measured: 2 years old
Infant metabolism index
Blood high-density lipoprotein level
Measured: 2 years old
Infant metabolism index
Blood low-density lipoprotein level
Measured: 2 years old
Infant metabolism index
Blood triglycerides level
Measured: 2 years old
Infant metabolism index
Fasting blood glucose level
Measured: 2 years old
Infant metabolism index
Blood insulin level
Measured: 2 years old
Infant metabolism index
Blood ghrelin level
Measured: 2 years old
Infant metabolism index
Blood leptin level
Measured: 2 years old
Infant metabolism index
Blood adiponectin level
Measured: 2 years old
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.
Measured: 4 months old
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.
Measured: 6 months old
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.
Measured: 12 months old
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.
Measured: 2 years old
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2021
- Study start1 Jan 2022 (estimated)
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (43)Papers the sponsor has linked to this study.
- Other trials for Infant Sleep ProblemStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Infants are randomly assigned to one of two groups: Behavioral Sleep Intervention or Control.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sijia Gu, Shanghai Jiao Tong University School of Medicine
- Investigators
- Jiang Fan, PhD, Study chair, Shanghai children's medicial center affiliated shanghai jiaotong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05159141
- Sponsor's protocol ID
- SCMCIRB-Y2020006
- Status last verified
- Dec 2021
- First submitted
- 1 Apr 2021
- Last updated
- 15 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: not yet decided
Publications
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.
PubMed 31430260WHO-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.
PubMed 32622373Bluher M. Obesity: global epidemiology and pathogenesis. Nat Rev Endocrinol. 2019 May;15(5):288-298. doi: 10.1038/s41574-019-0176-8.
PubMed 30814686Sung 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.
PubMed 30548482Geserick 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.
PubMed 30281992Ward 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.
PubMed 29171811Juonala 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.
PubMed 22087679Franks 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.
PubMed 20147714Fontaine 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.
PubMed 12517229Prospective 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.
PubMed 19299006Hamilton 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.
PubMed 29271111Sonntag 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.
PubMed 26638187GBD 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.
PubMed 28604169Hale 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.
PubMed 31900098Zhu 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.
PubMed 30870662
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Circadian Rhythm in the Effect of Sleep Intervention on Obesity Prevention in Early Childhood
- ClinicalTrials.gov ID
- NCT05159141
- Acronym / sponsor ID
- SCMCIRB-Y2020006
- Conditions
- Infant Sleep Problem
- Keywords
- Sleep, Obesity prevention, Circadian rhythm, Children, Behavioral intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Jan 2022 (estimated)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 15 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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\ and\ 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Infants are randomly assigned to one of two groups: Behavioral Sleep Intervention or Control.
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –Infant sleep monitoring (Actigraphy and sleep dairy) and parental surveys |
| Infant behavioral sleep intervention | Experimental | Behavioral: Behavioral sleep interventionInterventionists 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. |
Who may qualify
- Ages
- 2 months to 2 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral sleep interventionThe 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. | Behavioural | Infant behavioral sleep intervention |
Primary outcome
Children's sleep condition
Time frame: 4 months old
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
Time frame: 6 months old
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
Time frame: 12 months old
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
Time frame: 2 years old
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
Time frame: 4 months old
Weight in kilograms
Children's anthropometrics
Time frame: 6 months old
Weight in kilograms
Children's anthropometrics
Time frame: 12 months old
Weight in kilograms
Children's anthropometrics
Time frame: 2 years old
Weight in kilograms
Children's anthropometrics
Time frame: 4 months old
Length/height in centimeters
Children's anthropometrics
Time frame: 6 months old
Length/height in centimeters
Children's anthropometrics
Time frame: 12 months old
Length/height in centimeters
Children's anthropometrics
Time frame: 2 years old
Length/height in centimeters
Children's anthropometrics
Time frame: 4 months old
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
Time frame: 6 months old
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
Time frame: 12 months old
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
Time frame: 2 years old
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
Time frame: 6 months old
Arm circumference in centimeters
Children's anthropometrics
Time frame: 12 months old
Arm circumference in centimeters
Children's anthropometrics
Time frame: 2 years old
Arm circumference in centimeters
Children's anthropometrics
Time frame: 6 months old
Triceps skinfold thicknesses in centimeters
Children's anthropometrics
Time frame: 12 months old
Triceps skinfold thicknesses in centimeters
Children's anthropometrics
Time frame: 2 years old
Triceps skinfold thicknesses in centimeters
Children's anthropometrics
Time frame: 6 months old
Subscapular skinfold thicknesses in centimeters
Children's anthropometrics
Time frame: 12 months old
Subscapular skinfold thicknesses in centimeters
Children's anthropometrics
Time frame: 2 years old
Subscapular skinfold thicknesses in centimeters
Infant metabolism index
Time frame: 2 years old
Blood total cholesterol level
Infant metabolism index
Time frame: 2 years old
Blood high-density lipoprotein level
Infant metabolism index
Time frame: 2 years old
Blood low-density lipoprotein level
Infant metabolism index
Time frame: 2 years old
Blood triglycerides level
Infant metabolism index
Time frame: 2 years old
Fasting blood glucose level
Infant metabolism index
Time frame: 2 years old
Blood insulin level
Infant metabolism index
Time frame: 2 years old
Blood ghrelin level
Infant metabolism index
Time frame: 2 years old
Blood leptin level
Infant metabolism index
Time frame: 2 years old
Blood adiponectin level
Children's circadian rhythm
Time frame: 4 months old
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
Time frame: 6 months old
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
Time frame: 12 months old
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
Time frame: 2 years old
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2021.
- Background: PubMed 31430260Komarzynski 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 publication: PubMed 32622373WHO-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 publication: PubMed 30814686Bluher M. Obesity: global epidemiology and pathogenesis. Nat Rev Endocrinol. 2019 May;15(5):288-298. doi: 10.1038/s41574-019-0176-8.
- Results publication: PubMed 30548482Sung 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 publication: PubMed 30281992Geserick 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 publication: PubMed 29171811Ward 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 publication: PubMed 22087679Juonala 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 publication: PubMed 20147714Franks 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 publication: PubMed 12517229Fontaine 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 publication: PubMed 19299006Prospective 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 publication: PubMed 29271111Hamilton 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 publication: PubMed 26638187Sonntag 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.
- Individual participant dataSharing planned: No. not yet decided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jiang Fan, PhD study chair
Shanghai children's medicial center affiliated shanghai jiaotong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral sleep intervention in people with Infant Sleep Problem, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 15 Dec 2021. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiang Fan, PhD (021-38626161, fanjiang@shsmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Children's sleep condition (time frame: 4 months old). The study lists 38 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 NCT05159141, which also lists 43 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 15 Dec 2021.