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

NCT05159141 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 480

Last updated 2021-12-15

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Shanghai Jiao Tong University School of Medicine

    lead OTHER

Principal Investigators

  • Jiang Fan, PhD · Shanghai children's medicial center affiliated shanghai jiaotong University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
2 Months
Max Age
2 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2024-12-30
Completion
2024-12-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05159141 on ClinicalTrials.gov