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

NCT05159141 | Unknown DMC

• 1 other identifier: SCMCIRB-Y2020006
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 1

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\ 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.

Conditions

Infant Sleep Problem

Keywords

Sleep; Obesity prevention; Circadian rhythm; Children; Behavioral intervention

Outcome Measures

Primary Outcomes (38)

• 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.

  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.

  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.

  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.

  2 years old

• Children's anthropometrics

  Weight in kilograms

  4 months old

• Children's anthropometrics

  Weight in kilograms

  6 months old

• Children's anthropometrics

  Weight in kilograms

  12 months old

• Children's anthropometrics

  Weight in kilograms

  2 years old

• Children's anthropometrics

  Length/height in centimeters

  4 months old

• Children's anthropometrics

  Length/height in centimeters

  6 months old

• Children's anthropometrics

  Length/height in centimeters

  12 months old

• Children's anthropometrics

  Length/height in centimeters

  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

  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

  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

  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

  2 years old

• Children's anthropometrics

  Arm circumference in centimeters

  6 months old

• Children's anthropometrics

  Arm circumference in centimeters

  12 months old

• Children's anthropometrics

  Arm circumference in centimeters

  2 years old

• Children's anthropometrics

  Triceps skinfold thicknesses in centimeters

  6 months old

• Children's anthropometrics

  Triceps skinfold thicknesses in centimeters

  12 months old

• Children's anthropometrics

  Triceps skinfold thicknesses in centimeters

  2 years old

• Children's anthropometrics

  Subscapular skinfold thicknesses in centimeters

  6 months old

• Children's anthropometrics

  Subscapular skinfold thicknesses in centimeters

  12 months old

• Children's anthropometrics

  Subscapular skinfold thicknesses in centimeters

  2 years old

• Infant metabolism index

  Blood total cholesterol level

  2 years old

• Infant metabolism index

  Blood high-density lipoprotein level

  2 years old

• Infant metabolism index

  Blood low-density lipoprotein level

  2 years old

• Infant metabolism index

  Blood triglycerides level

  2 years old

• Infant metabolism index

  Fasting blood glucose level

  2 years old

• Infant metabolism index

  Blood insulin level

  2 years old

• Infant metabolism index

  Blood ghrelin level

  2 years old

• Infant metabolism index

  Blood leptin level

  2 years old

• Infant metabolism index

  Blood adiponectin level

  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.

  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.

  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.

  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.

  2 years old

Study Arms (2)

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.

Behavioral: Behavioral sleep intervention

Interventions

Behavioral sleep intervention BEHAVIORAL

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.

Infant behavioral sleep intervention

Eligibility Criteria

• Age: 2 Months - 2 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.).

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

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

Shanghai, Shanghai Municipality, 2000127, China

Location

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Study Officials

• Jiang Fan, PhD

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

  STUDY CHAIR

Central Study Contacts

Jiang Fan, PhD

CONTACT

021-38626161; fanjiang@shsmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Trial participants and individuals assessing the outcomes are blinded to the participant's condition
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: staff of Research Department

Model Details: Infants are randomly assigned to one of two groups: Behavioral Sleep Intervention or Control.

Study Record Dates

• First Submitted: April 1, 2021
• First Posted: December 15, 2021
• Study Start: January 1, 2022
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: December 15, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)