An interventional study of Behavioral sleep intervention in Infant Sleep Problem, sponsored by Shanghai Jiao Tong University School of Medicine. Status unknown at 1 site in China. Open to participants aged 2 Months to 2 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-12-15.
Sponsored by Shanghai Jiao Tong University School of Medicine · Not applicable, Interventional, and Treatment
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.
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.
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.
324 studies on the registry are indexed under Dyssomnias; 51 are open to participants now.
This study's planned enrollment of 480 is above the median of 60 across 251 interventional studies indexed under Dyssomnias.
Browse Dyssomnias studies →Shanghai Jiao Tong University School of Medicine is the lead sponsor of 358 studies on the registry; 104 are open to participants now.
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Exclusion Criteria:
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.
Behavioral: Behavioral sleep intervention
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 2 years old
Children's anthropometrics
Weight in kilograms
Time frame: 4 months old
Children's anthropometrics
Weight in kilograms
Time frame: 6 months old
Children's anthropometrics
Weight in kilograms
Time frame: 12 months old
Children's anthropometrics
Weight in kilograms
Time frame: 2 years old
Children's anthropometrics
Length/height in centimeters
Time frame: 4 months old
Children's anthropometrics
Length/height in centimeters
Time frame: 6 months old
Children's anthropometrics
Length/height in centimeters
Time frame: 12 months old
Children's anthropometrics
Length/height in centimeters
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 2 years old
Children's anthropometrics
Arm circumference in centimeters
Time frame: 6 months old
Children's anthropometrics
Arm circumference in centimeters
Time frame: 12 months old
Children's anthropometrics
Arm circumference in centimeters
Time frame: 2 years old
Children's anthropometrics
Triceps skinfold thicknesses in centimeters
Time frame: 6 months old
Children's anthropometrics
Triceps skinfold thicknesses in centimeters
Time frame: 12 months old
Children's anthropometrics
Triceps skinfold thicknesses in centimeters
Time frame: 2 years old
Children's anthropometrics
Subscapular skinfold thicknesses in centimeters
Time frame: 6 months old
Children's anthropometrics
Subscapular skinfold thicknesses in centimeters
Time frame: 12 months old
Children's anthropometrics
Subscapular skinfold thicknesses in centimeters
Time frame: 2 years old
Infant metabolism index
Blood total cholesterol level
Time frame: 2 years old
Infant metabolism index
Blood high-density lipoprotein level
Time frame: 2 years old
Infant metabolism index
Blood low-density lipoprotein level
Time frame: 2 years old
Infant metabolism index
Blood triglycerides level
Time frame: 2 years old
Infant metabolism index
Fasting blood glucose level
Time frame: 2 years old
Infant metabolism index
Blood insulin level
Time frame: 2 years old
Infant metabolism index
Blood ghrelin level
Time frame: 2 years old
Infant metabolism index
Blood leptin level
Time frame: 2 years old
Infant metabolism index
Blood adiponectin level
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 2 years old
Plan to share: No — not yet decided
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Shanghai Jiao Tong University School of Medicine