Childhood ObesitySCHOOL-TRENCT07184281
Effectiveness of School-Based Time-Restricted Eating for the Prevention and Control of Obesity in Children
A study testing 12-hour time-restricted eating and health education in people with Childhood Obesity and Childhood Obesity Pevention, run by Children's Hospital of Soochow University at 2 sites in China.
Trial summary
Childhood obesity has become a major global public health challenge. Obesity can not only affects children's physical and mental health during childhood but may also persist into adulthood, significantly increasing the risk of cardiovascular disease. Read more about this study
- Who is it for?
- Ages 8 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity, Childhood Obesity Pevention
- What is being tested?
- 12-hour time-restricted eating and health education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,380 participants
- Where
- 2 sitesChina
- Study dates
- 26 Sep 2025to 31 Jul 2027
- Phase
- Interventional
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 8 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
None listed.
Who cannot join
- All students in the selected classes will be the subject of the study after signing the informed consent, unless they have the following circumstances:
- Individuals with a history of heart disease, high blood pressure, diabetes, tuberculosis, asthma, hepatitis or nephritis;
- Individuals with secondary obesity: obesity due to endocrine disorders or side effects of medications;
- Individuals with abnormal growth and development, such as dwarfism, gigantism, etc;
- Individuals with physical deformities, including severe scoliosis, chicken breasts, claudication, significant O-leg/X-shaped legs;
- Individuals with limited athletic ability who are unable to participate in school physical activities;
Show all 11Show fewer
- Individuals who have lost weight by inducing vomiting or taking medication in the past 3 months;
- Individuals who have undergone prior bariatric surgery;
- Individuals with mental disorders or intellectual developmental disabilities, as well as aphasia;
- Individuals who have taken medications that affect appetite or weight within three months (e.g., antipsychotics, hypnotics, weight loss medications, insulin);
- Individuals who have plans to transfer within 2 years;
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Not yet recruiting
Children's Hospital of Soochow University
Suzhou, Jiangsu, 215123
Mengxuan Ye, MBBS, 18801542468, 624442531@qq.com
Xiaoyan Shi, PhD, xyshi@suda.edu.cn
- Recruiting
Wujiang Center for Disease Prevention and Control
Suzhou, Jiangsu, 215299
Aiming Lu, MPH, 0512-63160203, 13706252150@139.com
About this study
Official title: Effectiveness of School-Based Time-Restricted Eating for the Prevention and Control of Obesity in Children: A Cluster-Randomized Controlled Trial
Childhood obesity has become a major global public health challenge. Obesity can not only affects children's physical and mental health during childhood but may also persist into adulthood, significantly increasing the risk of cardiovascular disease. Therefore, effective prevention and control of childhood obesity can shift the prevention window forward and promote the prevention of cardiovascular disease. Recently, time-restricted eating (TRE) has gained attention in adult studies for its feasibility, as it involves "time control without calorie restriction," demonstrating weight loss effects comparable to energy restriction and higher feasibility. Here, the investigators designed a school-based cluster randomized controlled trial to investigate the effectiveness of 12-hour TRE in preventing and controlling childhood obesity. Schools were randomly assigned to either the intervention group or the control group, and participants were recruited from each school at the class level, ensuring that each group included at least 690 children. The control group received routine health education, while the intervention group received 12-hour TRE in addition to routine health education. After a 9-month intervention period (one academic year), the two groups will be compared in terms of weight management and childhood obesity prevalence.
Read the detailed description
Childhood obesity has become a major global public health challenge. With rapid economic development, the prevalence of childhood obesity in China has risen from 0.1% in 1985 to 7.3% in 2024. Childhood obesity not only affects children's physical and mental health during childhood but may also persist into adulthood, significantly increasing the risk of cardiovascular disease. Therefore, effective prevention and control of childhood obesity can shift the prevention window forward and promote the prevention of cardiovascular disease. The age distribution of childhood obesity shows that the peak incidence occurs between 7 and 12 years of age, making this a critical period for prevention and control. During this stage, children are in school, spending half their time there, and exhibit strong behavioral plasticity. Interventions based on school settings may be an effective approach to preventing and controlling childhood obesity. Previous experimental studies have shown that comprehensive school-based interventions (primarily including reducing overeating, high-energy diets, and sedentary behavior, while increasing physical activity) can significantly reduce BMI and childhood obesity prevalence, but their feasibility is limited. Recently, time-restricted eating (TRE) has gained attention in adult studies for its feasibility, as it involves "time control without calorie restriction," demonstrating weight loss effects comparable to energy restriction and higher feasibility. Therefore, the investigators hypothesize that a 12-hour TRE program implemented in schools may enhance the prevention and control of childhood obesity, but there is currently a lack of empirical evidence, particularly regarding its preventive effects on childhood obesity. Here, the investigators designed a school-based cluster randomized controlled trial to investigate the effectiveness of 12-hour TRE in preventing and controlling childhood obesity. Schools were randomly assigned to either the intervention group or the control group, and participants were recruited from each school at the class level, ensuring that each group included at least 690 children. The control group received routine health education, while the intervention group received 12-hour TRE in addition to routine health education. After a 9-month intervention period (one academic year), the two groups will be compared in terms of weight management and childhood obesity prevalence.
- Conditions
- Childhood Obesity, Childhood Obesity Pevention
- Being tested
- 12-hour time-restricted eating, health education
- Keywords
- childhood obesity, school-based intervention, time-restricted eating, cluster randomized trial
- Medical subject headings
- Pediatric Obesity, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
12-hour time-restricted eatingBehavioural
Based on the current health education model, the subjects in the experimental group were administered for 12 hours of TRE. Carry out the propaganda and education of the 12-hour TRE feeding mode, the core content is that the eating time window is limited to 12 hours/day, the last meal is no later than 19:00, the study subjects can freely choose the eating time window, do not restrict energy intake during eating, and during the fasting period, they are allowed to drink non-calorie, sugar-free drinks (water, tea, coffee). Record the time of eating every day.
health educationBehavioural
The current health education model is adopted, that is, health education is carried out in accordance with the "Guiding Outline for Health Education in Primary and Secondary Schools".
| Study group | Role | What they receive |
|---|---|---|
| TRE group | Experimental | Based on the current health education model, the subjects in the experimental group were administered for 12 hours of TRE. Receives: Behavioral: 12-hour time-restricted eating; Behavioral: health education |
| Control group | Active comparator | The current health education model is adopted, that is, health education is carried out in accordance with the "Guiding Outline for Health Education in Primary and Secondary Schools". Receives: Behavioral: health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in BMI-Z score
change in BMI-Z score from baseline
Measured: From enrollment to the end of treatment at 9 months
Secondary outcomes (7)
change in the prevalence of overweight or obesity
change in the prevalence of children with a BMI-Z score over 2 from baseline
Measured: From enrollment to the end of treatment at 9 months.
chang in BMI
change in BMI from baseline
Measured: From enrollment to the end of treatment at 9 months.
change in waist-to-hip ratio
change in waist-to-hip ratio from baseline
Measured: From enrollment to the end of treatment at 9 months.
change in blood pressure
change in blood pressure from baseline
Measured: From enrollment to the end of treatment at 9 months.
change in eating behavior
Change in eating behavior from baseline. The Child Eating Behavior Questionnaire (CEBQ), designed to assess children's eating scale styles, will be used in our study. It is a parent-report measure comprised of 35 items, each rated on a five-point Likert scale that ranges from never to always. It is made up of eight scales: Food responsiveness, Emotional over-eating, Enjoyment of food, Desire to drink, Satiety responsiveness, Slowness in eating, Emotional under-eating, and Food fussiness. The instrument is ideal for use in research investigating the early precursors of eating disorders or obesity.
Measured: From enrollment to the end of treatment at 9 months.
change in physical activity
Change in physical activity from baseline. The Physical Activity Questionnaire for Adolescents (PAQ-A), a self-report scale designed for use with school students, will be used to assess the physical activity in our study. It contains eight items intended to capture adolescents' recollections of their physical activity over the preceding 7 days. The first and last of the PAQ-A's eight items each contain a number of subitems from which a mean is initially calculated, and those two means are added to responses on the other six items to obtain a total from which the mean is calculated to produce a composite score ranging from 1 to 5, with higher scores indicating greater physical activity. A ninth question seeks information about anything that would have prevented respondents from engaging in their "normal physical activities" during the previous week.
Measured: From enrollment to the end of treatment at 9 months.
change in life quality
Change in life quality from baseline. The Quality of Life Scale for Children and Adolescents (QLSCA) is a Chinese version of the quality of life Scale for Children and Adolescents, consisting of 49 items for measuring 13 dimensions of students' lives, such as their relationships with teachers and parents, partnership with fellow students, learning abilities and attitudes, self-perception, physical well-being, negative emotions, attitudes towards homework, living environment convenience, social activities, sports capacity, self-satisfaction, and other unspecified factors. The QLSCA uses a five-point Likert-type scale to measure either frequency or intensity, with a recall period of two weeks. Scores were calculated for each dimension, with higher scores indicating a better quality of life.
Measured: From enrollment to the end of treatment at 9 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2025
- Study start26 Sep 2025
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- cluster randomized trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,380 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Soochow University
- Sponsor type
- University, hospital or other
- Collaborators
- Soochow University
- Responsible party
- Principal investigator, Xiaoyan Shi, Children's Hospital of Soochow University
- Investigators
- Xiaoyan Shi, PhD, Principal investigator, Children's Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07184281
- Sponsor's protocol ID
- SCHOOL-TRE
- Other IDs
- SYW2025048
- Acronym
- SCHOOL-TRE
- Status last verified
- Sep 2025
- First submitted
- 18 Aug 2025
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The unidentified patient data can be shared.