Healthy Weight Management Project for Overweight and Obesity Children
Primary Purpose
Obesity
Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Lifestyle intervention
Sponsored by
About this trial
This is an interventional treatment trial for 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 and 10 years old;
- students with childhood overweight/obesity defined according to the criteria for Chinese children and adolescents.
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
Treatment group
Usual practice group
Arm Description
Treatment activity on lifestyle interventions will target the dietary and exercise factors of childhood obesity.
No intervention
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
change in controlled attenuation parameters (CAP)
CAP will be detected by Fibroscan
caculated by terminal value minus baseline value
Change in liver stiffness measurement (LSM)
LSM will be detected by Fibroscan
caculated by terminal value minus baseline value
Secondary Outcome Measures
Change in BMI z- score
BMI z- score are 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
change in ALT(alanine transaminase)
caculated by terminal value minus baseline value
Full Information
NCT ID
NCT05482191
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
NCT05482191
Brief Title
Healthy Weight Management Project for Overweight and Obesity Children
Official Title
Healthy Weight Management Project for Overweight and Obesity Children 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. Nonalcoholic fatty liver disease (NAFLD) is tightly associated with obesity, in China, the prevalence of NAFLD in obesity children is 40.0%,the main interventions for NAFLD are lifestyle interventions. Effective strategies to helping students lose weight and alleviate NAFLD through lifestyle interventions may help promote the physical and mental health of obese students.
This study aimed (1)to assess the effectiveness of the intervention compared with the usual practice in treating childhood overweight and obesity; (2) to determine the sustainability of the treatment in preventing overweight and obesity; (3) to help alleviate or reverse NAFLD in obesity children.
Children with overweight and obesity in six primary schools in Ningbo City, Zhejiang Province will be seleted and randomly divided into two groups: the treatment group and the usual practice group. The participants of the study were students in the third grade of primary school, and the treatment will last for one academic year. This treatment activity on lifestyle interventions will target the dietary and exercise factors of childhood obesity.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment group
Arm Type
Experimental
Arm Description
Treatment activity on lifestyle interventions will target the dietary and exercise factors of childhood obesity.
Arm Title
Usual practice group
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle intervention
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 treatment 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
Diet and exercise instruction by professional nutritionist using internet applet
Take part in sports activities that are organized by the sports health teacher during school hours.
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
3 months,9 months , 24 months and 36 months
Title
change in controlled attenuation parameters (CAP)
Description
CAP will be detected by Fibroscan
caculated by terminal value minus baseline value
Time Frame
3 months,9 months , 24 months and 36 months
Title
Change in liver stiffness measurement (LSM)
Description
LSM will be detected by Fibroscan
caculated by terminal value minus baseline value
Time Frame
3 months,9 months , 24 months and 36 months
Secondary Outcome Measure Information:
Title
Change in BMI z- score
Description
BMI z- score are measures of relative weight adjusted for child age and sex
caculated by terminal value minus baseline value
Time Frame
3 months,9 months , 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
3 months and 9 months
Title
change in waist circumference
Description
caculated by terminal value minus baseline value
Time Frame
3 months,9 months , 24 months and 36 months
Title
change in weight
Description
caculated by terminal value minus baseline value
Time Frame
3 months,9 months , 24 months and 36 months
Title
change in cardiorespiratory endurance test
Description
caculated by terminal value minus baseline value
Time Frame
3 months,9 months , 24 months and 36 months
Title
change in ALT(alanine transaminase)
Description
caculated by terminal value minus baseline value
Time Frame
9 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 and 10 years old;
students with childhood overweight/obesity defined according to the criteria for Chinese children and adolescents.
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
Learn more about this trial
Healthy Weight Management Project for Overweight and Obesity Children
We'll reach out to this number within 24 hrs