Pediatric ObesityNCT02228434
Study on the Tailored Intervention Strategy of Childhood Obesity Based on Monitoring Physical Activities and Dietary Behaviors
A study testing Monitoring and Tailored prescription, Happy 10 program and Specified nutrition education in people with Pediatric Obesity, run by Wang Jingjing at 1 site in China.
Trial summary
The project aims at developing the tailored intervention strategy of childhood obesity based on monitoring physical activities with accelerometer and dietary behaviors using diary. Read more about this study
- Who is it for?
- Ages 7 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Obesity
- What is being tested?
- Monitoring and Tailored prescription, Happy 10 program and Specified nutrition education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteChina
- Study dates
- May 2009to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 7 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Overweight and obese children from grade 1-5 primary schools
Who cannot join
- Students with any contraindication or physical diseases (heart, Lung, liver, kidney, other vital organs, endocrine diseases and drug side effects et al.) and psychological illnesses that may prevent them from participating in physical activity and eating a normal diet were excluded
Trial locations and contacts
1 site in 1 country.
China1 site
Insitute of Child and Adolescent Health, Peking University
Beijing, 100191
About this study
The project aims at developing the tailored intervention strategy of childhood obesity based on monitoring physical activities with accelerometer and dietary behaviors using diary. It probably raise the passion of obese children to control weight, form healthy life style, be effective in sustaining weight loss and early prevent adulthood diseases.
Read the detailed description
The overweight and obese primary school students from 1-5 grades will be recruited according to "Body Mass Index Reference for Screening Overweight and Obesity in Chinese School-age Children". The participants with will be allocated with schools as the unit to four groups: tailored intervention based on monitoring physical activity and dietary behaviors, exercise intervention group based on the Happy 10 program, nutrition education intervention group. The three intervention groups received the designed interventions for the duration of 1 year. Before and after the intervention, we will carry out a questionnaire survey, a physical measurement, a fitness test, and a metabolic markers detection
- Conditions
- Pediatric Obesity
- Being tested
- Monitoring and Tailored prescription, Happy 10 program, Specified nutrition education, General Health Education
- Keywords
- Childhood obesity, intervention, effectiveness, comparison
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monitoring and Tailored prescriptionBehavioural
Also called ZhiJi accelerometer UX-02 as physical activity monitor
Happy 10 programBehavioural
Also called happy 10 program developed by Center for Disease Control and Prevention, China
Specified nutrition educationBehavioural
General Health EducationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Tailored intervention group | Experimental | For the monitoring session, physical activity was assessed by accelerometer and dietary was assessed by diary. Based on the monitoring information, the individual tailored prescription, including the normative feedback and process feedback, were formed and delivered to children and parents. Children were encouraged to modify the behaviors according to the prescription.
Then, next monitoring circle was followed. In total, 7 monitoring round were completed. Receives: Behavioral: Monitoring and Tailored prescription; Behavioral: General Health Education |
| Happy 10 exercise group | Experimental | All the schools participating in this group were encouraged to take two Happy 10 sessions on each school day. Receives: Behavioral: Happy 10 program; Behavioral: General Health Education |
| Nutrition education group | Experimental | The nutrition intervention was mainly conducted based on the nutrition knowledge through health education lectures given by researchers. The lectures were given for eight times to students and twice to parents. Each lecture session lasted no less than 40 min. Receives: Behavioral: Specified nutrition education; Behavioral: General Health Education |
| Control group | No intervention | Receive no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body mass index
Measured: Baseline, 1-year post-intervention
Secondary outcomes (4)
Change in obesity-related anthropometric measurements
Measured: Baseline, 1-year post-intervention
Change of blood pressure
Measured: Baseline, 1-year post-intervention
Change of biomarkers for disease risk
Measured: Baseline, 1-year post-intervention
Change of attitude, knowledge, and behaviors on dietary and physical activity
Measured: Baseline, 1-year post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2014 (estimated)
- Study startMay 2009
- Primary completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pediatric 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wang Jingjing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wang Jingjing, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02228434
- Sponsor's protocol ID
- IRB00001052-10081
- Status last verified
- Aug 2014
- First submitted
- 27 Aug 2014
- Last updated
- 29 Aug 2014
- Results posted
- No
Publications
Wang JJ, Lau WC, Wang HJ, Ma J. Evaluation of a comprehensive intervention with a behavioural modification strategy for childhood obesity prevention: a nonrandomized cluster controlled trial. BMC Public Health. 2015 Dec 3;15:1206. doi: 10.1186/s12889-015-2535-2.
PubMed 26635229
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Tailored Intervention Strategy of Childhood Obesity Based on Monitoring Physical Activities and Dietary Behaviors
- ClinicalTrials.gov ID
- NCT02228434
- Acronym / sponsor ID
- IRB00001052-10081
- Conditions
- Pediatric Obesity
- Keywords
- Childhood obesity, intervention, effectiveness, comparison
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Wang JingjingUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Dec 2011 (actual)
- First posted
- 29 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The project aims at developing the tailored intervention strategy of childhood obesity based on monitoring physical activities with accelerometer and dietary behaviors using diary. It probably raise the passion of obese children to control weight, form healthy life style, be effective in sustaining weight loss and early prevent adulthood diseases.
Detailed description
The overweight and obese primary school students from 1-5 grades will be recruited according to "Body Mass Index Reference for Screening Overweight and Obesity in Chinese School-age Children". The participants with will be allocated with schools as the unit to four groups: tailored intervention based on monitoring physical activity and dietary behaviors, exercise intervention group based on the Happy 10 program, nutrition education intervention group. The three intervention groups received the designed interventions for the duration of 1 year. Before and after the intervention, we will carry out a questionnaire survey, a physical measurement, a fitness test, and a metabolic markers detection
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Tailored intervention group | Experimental | Behavioral: Monitoring and Tailored prescription, Behavioral: General Health EducationFor the monitoring session, physical activity was assessed by accelerometer and dietary was assessed by diary. Based on the monitoring information, the individual tailored prescription, including the normative feedback and process feedback, were formed and delivered to children and parents. Children were encouraged to modify the behaviors according to the prescription. Then, next monitoring circle was followed. In total, 7 monitoring round were completed. |
| Happy 10 exercise group | Experimental | Behavioral: Happy 10 program, Behavioral: General Health EducationAll the schools participating in this group were encouraged to take two Happy 10 sessions on each school day. |
| Nutrition education group | Experimental | Behavioral: Specified nutrition education, Behavioral: General Health EducationThe nutrition intervention was mainly conducted based on the nutrition knowledge through health education lectures given by researchers. The lectures were given for eight times to students and twice to parents. Each lecture session lasted no less than 40 min. |
| Control group | No intervention | –Receive no intervention |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Overweight and obese children from grade 1-5 primary schools
Key exclusion criteria (1 listed)
- Students with any contraindication or physical diseases (heart, Lung, liver, kidney, other vital organs, endocrine diseases and drug side effects et al.) and psychological illnesses that may prevent them from participating in physical activity and eating a normal diet were excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Monitoring and Tailored prescriptionAlso: ZhiJi accelerometer UX-02 as physical activity monitor | Behavioural | Tailored intervention group |
| Happy 10 programAlso: happy 10 program developed by Center for Disease Control and Prevention, China | Behavioural | Happy 10 exercise group |
| Specified nutrition education | Behavioural | Nutrition education group |
| General Health Education | Behavioural | Happy 10 exercise group, Nutrition education group, Tailored intervention group |
Primary outcome
Change in body mass index
Time frame: Baseline, 1-year post-intervention
4 secondary outcomes
Change in obesity-related anthropometric measurements
Time frame: Baseline, 1-year post-intervention
Change of blood pressure
Time frame: Baseline, 1-year post-intervention
Change of biomarkers for disease risk
Time frame: Baseline, 1-year post-intervention
Change of attitude, knowledge, and behaviors on dietary and physical activity
Time frame: Baseline, 1-year post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2014.
- Derived from this study: PubMed 26635229Wang JJ, Lau WC, Wang HJ, Ma J. Evaluation of a comprehensive intervention with a behavioural modification strategy for childhood obesity prevention: a nonrandomized cluster controlled trial. BMC Public Health. 2015 Dec 3;15:1206. doi: 10.1186/s12889-015-2535-2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Monitoring and Tailored prescription, Happy 10 program and Specified nutrition education in people with Pediatric Obesity, run by Wang Jingjing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body mass index (time frame: Baseline, 1-year post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02228434, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2014; AzTrials last refreshed its copy on 7 Nov 2026.