Suspended

Circadian Rhythm-Based Sleep Intervention for Early Childhood Obesity Prevention

Study Aim

This study aims to evaluate the impact of a circadian rhythm-based sleep intervention on preventing early childhood obesity, by measuring children's anthropometrics, circadian rhythm, sleep condition, and infant metabolism index.

What is being tested

Behavioral sleep intervention

Behavioral

Who is being recruted

From 2 Months to 2 Years

+11 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Interventional

Study Start: January 2022

See protocol details

Summary

Principal SponsorShanghai Jiao Tong University School of Medicine

Study ContactJiang Fan, PhD

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2022

Actual date on which the first participant was enrolled.

This study focuses on the role of circadian rhythms, or the body's internal clock, in preventing obesity in infants and young children through sleep interventions. The research aims to understand the correlation between daily rhythms of sleep, activity, illumination, and eating in infants and the characteristics of melatonin secretion, which is a gold standard for circadian rhythm under natural conditions. The study involves infants from 4 months to 2 years old, recruited from three communities. The goal is to establish a high reliability model of circadian rhythm prediction and to explore the effect of sleep intervention on infants' obesity prevention. Participants in this study will have their daily rhythms collected using a portable device called Actiwatch-2 and a daily log book. Saliva samples will be taken at seven different time points to determine melatonin levels. The study is a parallel multicenter randomized controlled trial, with two groups: a control group and an intervention group. The control group will follow routine child care, while the intervention group will receive evidence-based infant sleep intervention. The main outcomes measured will be 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.

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

NCT05159141

Principal SponsorShanghai Jiao Tong University School of Medicine

Study ContactJiang Fan, PhD

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

480 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 2 Months to 2 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

6 inclusion criteria required to participate

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;

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5 exclusion criteria prevent from participating

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;

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

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.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

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

Shanghai, ChinaOpen Shanghai children's medicial center affiliated shanghai jiaotong University School of Medicine in Google Maps

SuspendedOne Study Center