Optimizing Intervention Effects in Children and Adolescents
Primary Purpose
Childhood Obesity
Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Multi-faceted health promotion programme
Sponsored by
About this trial
This is an interventional prevention trial for Childhood Obesity
Eligibility Criteria
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.
Sites / Locations
- Ningbo First Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention group
Usual practice group
Arm Description
The students of this group will receive multi-faceted intervention activities toward weight management.
The students of this group will receive regular health education.
Outcomes
Primary Outcome Measures
change in body mass index (BMI)
weight and height will be combined to report BMI in kg/m^2
caculated by terminal value minus baseline value
Secondary Outcome Measures
change in BMI z- score
measures of relative weight adjusted for child age and sex
caculated by terminal value minus baseline value
change in blood glucose
caculated by terminal value minus baseline value
change in blood lipids
include TC, TG, LDL-C, HDL-C
caculated by terminal value minus baseline value
change in fasting insulin
caculated by terminal value minus baseline value
change in body fat percentage
caculated by terminal value minus baseline value
change in waist circumference
caculated by terminal value minus baseline value
change in weight
caculated by terminal value minus baseline value
change in cardiorespiratory endurance test
caculated by terminal value minus baseline value
Full Information
NCT ID
NCT05482165
First Posted
July 28, 2022
Last Updated
October 23, 2023
Sponsor
Ningbo No. 1 Hospital
Collaborators
Peking University
1. Study Identification
Unique Protocol Identification Number
NCT05482165
Brief Title
Optimizing Intervention Effects in Children and Adolescents
Official Title
Optimizing Intervention Effects in Children and Adolescents in Ningbo City
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ningbo No. 1 Hospital
Collaborators
Peking University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1800 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
The students of this group will receive multi-faceted intervention activities toward weight management.
Arm Title
Usual practice group
Arm Type
No Intervention
Arm Description
The students of this group will receive regular health education.
Intervention Type
Behavioral
Intervention Name(s)
Multi-faceted health promotion programme
Intervention Description
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
Primary Outcome Measure Information:
Title
change in body mass index (BMI)
Description
weight and height will be combined to report BMI in kg/m^2
caculated by terminal value minus baseline value
Time Frame
9months , 24 months and 36 months
Secondary Outcome Measure Information:
Title
change in BMI z- score
Description
measures of relative weight adjusted for child age and sex
caculated by terminal value minus baseline value
Time Frame
9months , 24 months and 36 months
Title
change in blood glucose
Description
caculated by terminal value minus baseline value
Time Frame
9 months
Title
change in blood lipids
Description
include TC, TG, LDL-C, HDL-C
caculated by terminal value minus baseline value
Time Frame
9 months
Title
change in fasting insulin
Description
caculated by terminal value minus baseline value
Time Frame
9 months
Title
change in body fat percentage
Description
caculated by terminal value minus baseline value
Time Frame
9 months
Title
change in waist circumference
Description
caculated by terminal value minus baseline value
Time Frame
9 months, 24 months and 36 months
Title
change in weight
Description
caculated by terminal value minus baseline value
Time Frame
9months, 24 months and 36 months
Title
change in cardiorespiratory endurance test
Description
caculated by terminal value minus baseline value
Time Frame
9 months, 24 months and 36 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Ningbo First Hospital
City
Ningbo
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
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Optimizing Intervention Effects in Children and Adolescents
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