NCT07184281Toboroz
Effectiveness of School-Based Time-Restricted Eating for the Prevention and Control of Obesity in Children
Effectiveness of School-Based Time-Restricted Eating for the Prevention and Control of Obesity in Children: A Cluster-Randomized Controlled Trial
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. szept. 30. · Több mint 12 hónapja nem frissült - kérdezd meg a helyszínt, nyitott-e még
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toboroz
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 1380 (tervezett)
- Első benyújtás
- 2025. aug. 18.
- Kezdés
- 2025. szept. 26.
- Elsődleges befejezés
- 2026. júl. 31.
- Fő szponzor
- Children's Hospital of Soochow University
- Betegségek
- Elhízás
- NCT-szám
- NCT07184281
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 1380
- 2025. szept. 26. és az elsődleges befejezés (2026. júl. 31.) között
- 2 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
Ki nem vehet részt
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Korábbi kezelés
- Individuals who have lost weight by inducing vomiting or taking medication in the past 3 months;
- Individuals who have undergone prior bariatric surgery;
- Individuals who have taken medications that affect appetite or weight within three months (e.g., antipsychotics, hypnotics, weight loss medications, insulin);
Más betegség
- 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 mental disorders or intellectual developmental disabilities, as well as aphasia;
Egyéb
- 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 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;
- Individuals who have plans to transfer within 2 years;
A regiszterben nem jelölt feltételek
- Eligibility criteria for schools:
- The principal agrees to accept the randomization process and adhere to the study protocol;
- The total number of fourth-year students in the school must be more than 50;
- Schools that have not implemented or plan to implement obesity prevention interventions;
- Non-boarding schools, Ethnic minority schools, or specialty schools;
- Schools that have no clear plans to relocate or close within the next 2 years;
- Eligibility criteria for classes:
- Class teachers are willing and actively involved in home-school liaison;
- Class sizes should be between 30 and 60 students;
- The class consists of fourth-grade students;
- Classes that have no clear plan to merge or cancel in the next 2 years;
Életkor a regiszterben: 8 év – 10 év · Nem: nők és férfiak · Egészséges önkénteseket is fogad
Helyszínek (2)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Children's Hospital of Soochow University | Suzhou | Kína | Toborzás még nem indult |
| Wujiang Center for Disease Prevention and Control | Suzhou | Kína | Toboroz |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.