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Optimizing Intervention Effects in Children and Adolescents

Optimizing Intervention Effects in Children and Adolescents in Ningbo City

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05482165
Enrollment
1627
Registered
2022-08-01
Start date
2022-09-01
Completion date
2025-12-31
Last updated
2025-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Childhood Obesity

Brief summary

Childhood obesity is a significant public health concern worldwide. In China, childhood obesity has dramatically increased as the economy has grown quickly over the past decades. Effective strategies to reduce childhood obesity prevalence may help to prevent related chronic diseases in the whole population in the long term. This study aimed (1)to assess the effectiveness of the intervention compared with the usual practice in preventing childhood overweight and obesity; (2) to determine the sustainability of the intervention in preventing overweight and obesity; and (3) to evaluate the process and health economics of the intervention. The project will be carried out in six primary schools in Ningbo City, Zhejiang Province , those schools are randomly divided into two groups: the intervention group and the usual practice group. The participants of the study were students in the third grade of primary school, and the intervention will last for one academic year. This intervention programme will target the influencing factors of childhood obesity at both individual (student-focused activities) and environmental levels (a supportive family and school environment), with the intent to influence the knowledge, attitude and behaviours of school children.

Interventions

BEHAVIORALMulti-faceted health promotion programme

This intervention programme will target the influencing factors of childhood obesity to influence the knowledge, attitude and behaviours of school children. Students in the intervention group will receive the following interventions: * Develop and implement school policies related to weight loss * Distribute health education materials on diet and exercise to students * Carry out student health education courses

Sponsors

Peking University
CollaboratorOTHER
Ningbo No. 1 Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
8 Years to 10 Years
Healthy volunteers
Yes

Inclusion criteria

* Parents agree and support their children's weight loss, and students and parents have informed consent; * Students in third grade aged 8 to 10 years old.

Exclusion criteria

* medical history of heart disease, hypertension, diabetes, tuberculosis, asthma, hepatitis or nephritis; * obesity caused by endocrine diseases or side effects of drugs; * abnormal physical development like dwarfism or gigantism; * physical deformity such as severe scoliosis, pectus carinatum, limp, obvious O-leg or X-leg; * inability to participate in school sport activities; * a loss in weight by vomiting or taking drugs during the past 3 months.

Design outcomes

Primary

MeasureTime frameDescription
change in body mass index (BMI)9months , 24 months and 36 months* weight and height will be combined to report BMI in kg/m\^2 * caculated by terminal value minus baseline value

Secondary

MeasureTime frameDescription
change in blood glucose9 monthscaculated by terminal value minus baseline value
change in blood lipids9 months* include TC, TG, LDL-C, HDL-C * caculated by terminal value minus baseline value
change in fasting insulin9 monthscaculated by terminal value minus baseline value
change in BMI z- score9months , 24 months and 36 months* measures of relative weight adjusted for child age and sex * caculated by terminal value minus baseline value
change in waist circumference9 months, 24 months and 36 monthscaculated by terminal value minus baseline value
change in weight9months, 24 months and 36 monthscaculated by terminal value minus baseline value
change in cardiorespiratory endurance test9 months, 24 months and 36 monthscaculated by terminal value minus baseline value
change in body fat percentage9 monthscaculated by terminal value minus baseline value

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026