Pediatric ObesityNCT02074332
Study on Obesity Intervention With Physical Exercise Among Students in Changping District, Beijing
A study testing Physical activity guidance and Health education in people with Pediatric Obesity, run by Hai-Jun Wang.
Trial summary
The primary objective of this study is to assess the effectiveness of a school based physical activity programme on obesity and related health outcomes in young schoolchildren. Read more about this study
- Who is it for?
- Ages 7 to 15 years
- Conditions the study is for
- Pediatric Obesity
- What is being tested?
- Physical activity guidance and Health education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 921 participants
- Where
- No sites listed yet
- Study dates
- Sep 2012to Feb 2014
- 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 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Grade of 2 to 5 in elementary schools and grade of 1 to 2 in middle schools.
Who cannot join
- Suffering or any history of disabilities, cardiovascular diseases, asthma, metabolic diseases, etc.
About this study
Official title: Development and Application of Appropriate Technology for Obesity Prevention and Control -- Study on Personalized Aerobic and Appropriate Exercise Technology
The primary objective of this study is to assess the effectiveness of a school based physical activity programme on obesity and related health outcomes in young schoolchildren.
- Conditions
- Pediatric Obesity
- Being tested
- Physical activity guidance, Health education
- Keywords
- Obesity, Physical activity, Schoolchildren, Intervention Studies
- Medical subject headings
- Pediatric Obesity, Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity guidanceBehavioural
Also called Physical activity programme
Physical education class amelioration Additional physical activities for overweight\&obese students Family physical activities Parent involvement
Health educationBehavioural
Knowledge of obesity prevention and control
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Physical activity guidance Health education Receives: Behavioral: Physical activity guidance; Behavioral: Health education |
| Control | 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 (BMI)
Measured: Baseline, Month 3
Secondary outcomes (5)
Change in obesity-related anthropometric measurements
Measured: Baseline, Month 3
Change in serum lipids and fasting glucose
Measured: Baseline，Month 3
Change in dietary and physical activity behaviors
Measured: Baseline, Month 3
Change in physical fitness
Measured: Baseline, Month 3
Change in percentage of overweight&obesity
Measured: Baseline, 3 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2014 (estimated)
- Study startSep 2012
- Primary completionJan 2013
- Study completionFeb 2014
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
- 921 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hai-Jun Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hai-Jun Wang, Peking University
- Investigators
- Hai-Jun Wang, PhD, Study director, Institute of Child and Adolescent Health,Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02074332
- Sponsor's protocol ID
- IRB00001052-12046
- Status last verified
- Apr 2015
- First submitted
- 26 Feb 2014
- Last updated
- 29 Apr 2015
- Results posted
- No
Publications
Li XH, Lin S, Guo H, Huang Y, Wu L, Zhang Z, Ma J, Wang HJ. Effectiveness of a school-based physical activity intervention on obesity in school children: a nonrandomized controlled trial. BMC Public Health. 2014 Dec 16;14:1282. doi: 10.1186/1471-2458-14-1282.
PubMed 25510313
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Application of Appropriate Technology for Obesity Prevention and Control -- Study on Personalized Aerobic and Appropriate Exercise Technology
- ClinicalTrials.gov ID
- NCT02074332
- Acronym / sponsor ID
- IRB00001052-12046
- Conditions
- Pediatric Obesity
- Keywords
- Obesity, Physical activity, Schoolchildren, Intervention Studies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 921 participants (actual)
- Lead sponsor
- Hai-Jun WangUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 28 Feb 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 primary objective of this study is to assess the effectiveness of a school based physical activity programme on obesity and related health outcomes in young schoolchildren.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Physical activity guidance, Behavioral: Health educationPhysical activity guidance Health education |
| Control | No intervention | –Receive no intervention |
Who may qualify
- Ages
- 7 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Grade of 2 to 5 in elementary schools and grade of 1 to 2 in middle schools.
Key exclusion criteria (1 listed)
- Suffering or any history of disabilities, cardiovascular diseases, asthma, metabolic diseases, etc.
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 |
|---|---|---|
| Physical activity guidanceAlso: Physical activity programmePhysical education class amelioration Additional physical activities for overweight\&obese students Family physical activities Parent involvement | Behavioural | Intervention |
| Health educationKnowledge of obesity prevention and control | Behavioural | Intervention |
Primary outcome
Change in body mass index (BMI)
Time frame: Baseline, Month 3
5 secondary outcomes
Change in obesity-related anthropometric measurements
Time frame: Baseline, Month 3
Change in serum lipids and fasting glucose
Time frame: Baseline，Month 3
Change in dietary and physical activity behaviors
Time frame: Baseline, Month 3
Change in physical fitness
Time frame: Baseline, Month 3
Change in percentage of overweight&obesity
Time frame: Baseline, 3 Month
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 Apr 2015.
- Derived from this study: PubMed 25510313Li XH, Lin S, Guo H, Huang Y, Wu L, Zhang Z, Ma J, Wang HJ. Effectiveness of a school-based physical activity intervention on obesity in school children: a nonrandomized controlled trial. BMC Public Health. 2014 Dec 16;14:1282. doi: 10.1186/1471-2458-14-1282.
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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.
Hai-Jun Wang, PhD study director
Institute of Child and Adolescent Health,Peking University
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity guidance and Health education in people with Pediatric Obesity, run by Hai-Jun Wang.
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 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
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 (BMI) (time frame: Baseline, Month 3). 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 NCT02074332, 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 Apr 2015.