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Pediatric ObesityNCT02343588

A National School-based Health Lifestyles Interventions Among Chinese Children and Adolescents Against Obesity

A study testing The Health Lifestyles Interventions in people with Pediatric Obesity, run by Sun Yat-sen University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study was designed as a national multi-centered cluster randomized controlled trial involving more than 70,000 children and adolescents aged 7-18 years from 7 provinces in China. Read more about this study

Who is it for?
Ages 7 to 18 years
Conditions the study is for
Pediatric Obesity
What is being tested?
The Health Lifestyles Interventions
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70,000 participants
Where
No sites listed yet
Study dates
Sep 2013to Jan 2015
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 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • grade of 1 to 5 in primary schools and grade of 6 to 8 and 10 to 11 in secondary 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 in Seven Centers in China

The study was designed as a national multi-centered cluster randomized controlled trial involving more than 70,000 children and adolescents aged 7-18 years from 7 provinces in China. In each center, about 12-16 primary and secondary schools, with totally at least 10000 participants were randomly selected (Primary: Secondary=1:1). All of the selected schools were randomly allocated to either intervention or control group (Intervention: Control=1:1).The multi-components school-based and family-involved scheme was conducted within the intervention group for 9 month, while students in the control group followed their usual health practice. The intervention consisted of four components: a) Create supportive school and family environment, b) Health lifestyles education and related compulsory physical activities, c) Instruct and promote school physical education, d) Self-monitor obesity related behaviors. Four types of outcomes including anthropometric, behavioral, blood chemical and physical fitness were measured to assess the effectiveness of the intervention program.

Being tested
The Health Lifestyles Interventions
Keywords
Chinese multi-centered school based obesity intervention
Medical subject headings
Pediatric Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • The Health Lifestyles InterventionsBehavioural

    1. Creating supportive school and family environment, whole intervention periods;
    2. Health lifestyles educational strategies, 30min/week for education lessons and six times education activities;
    3. Instruct and promote school physical education, whole intervention periods;
    4. The monitoring and instruction of obesity related behaviors, once a week for physical activity and dietary behavioral log and once a month for parental monitor
Study groups in NCT02343588
Study groupRoleWhat they receive
The Health Lifestyles InterventionsExperimental1. Creating a supportive school, family and community environment; 2. Health lifestyles educational strategies; 3. Instruct and promote school physical education; 4. The monitoring and instruction of obesity related behaviors (focus group)
Receives: Behavioral: The Health Lifestyles Interventions
Receive no interventionNo interventionUsual practice

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in the prevalence of overweight and obesity

    Measured: Baseline, Month 9

Secondary outcomes (4)

  1. Change in obesity related anthropometric measurements (waist circumference, hip circumference, blood pressure and skin fold thickness)

    Measured: Baseline, Month 9

  2. Change in physical activity and dietary behaviors (Dietary, sedentary or physical activity behaviors and their determents, as measured by validated questionnaires (parent, children and school version)

    Measured: Baseline, Month 9

  3. Change in serum lipids and fasting glucose (fasting plasma glucose, fasting triglycerides, total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol)

    Measured: Baseline, Month 9

  4. Change in physical fitness (standing-board jump, 50 meters speed run, 50 meters × 8 shuttle run (primary students) and run 800/1000 meters (secondary school students)

    Measured: Baseline, Month 9

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2015 (estimated)
  2. Study startSep 2013
  3. Primary completionJun 2014
  4. Study completionJan 2015

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
70,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02343588
Sponsor's protocol ID
201202010
Status last verified
Jan 2015
First submitted
7 Jan 2015
Last updated
26 Jan 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Guo P, Zhou Y, Zou Z, Chen Y, Jing J, Ma Y, Song Y, Ling W, Ma J, Zhu Y. Effects of School-Based Lifestyle Interventions on Cardiovascular Health in Chinese Children and Adolescents: A Post Hoc Analysis of a National Multicenter Study. J Am Heart Assoc. 2025 Jan 7;14(1):e037371. doi: 10.1161/JAHA.124.037371. Epub 2024 Dec 20.

    PubMed 39704211

  • Guo P, Zhou Y, Zhu Y. Effects of a school-based lifestyle intervention on ideal cardiovascular health in Chinese children and adolescents: a national, multicentre, cluster-randomised controlled trial. Lancet Glob Health. 2023 Mar;11 Suppl 1:S14. doi: 10.1016/S2214-109X(23)00097-9.

    PubMed 36866471

  • Neil-Sztramko SE, Caldwell H, Dobbins M. School-based physical activity programs for promoting physical activity and fitness in children and adolescents aged 6 to 18. Cochrane Database Syst Rev. 2021 Sep 23;9(9):CD007651. doi: 10.1002/14651858.CD007651.pub3.

    PubMed 34555181

  • Dong Y, Zou Z, Wang H, Dong B, Hu P, Ma Y, Song Y, Ma J. National School-Based Health Lifestyles Intervention in Chinese Children and Adolescents on Obesity and Hypertension. Front Pediatr. 2021 May 28;9:615283. doi: 10.3389/fped.2021.615283. eCollection 2021.

    PubMed 34123956

  • Diao H, Wang H, Yang L, Li T. The impacts of multiple obesity-related interventions on quality of life in children and adolescents: a randomized controlled trial. Health Qual Life Outcomes. 2020 Jul 6;18(1):213. doi: 10.1186/s12955-020-01459-0.

    PubMed 32631401

  • Zou Z, Yang Z, Yang Z, Wang X, Gao D, Dong Y, Ma J, Ma Y. Association of high birth weight with overweight and obesity in Chinese students aged 6-18 years: a national, cross-sectional study in China. BMJ Open. 2019 May 22;9(5):e024532. doi: 10.1136/bmjopen-2018-024532.

    PubMed 31122966

Questions about this trial

What is this clinical trial studying?

A study testing The Health Lifestyles Interventions in people with Pediatric Obesity, run by Sun Yat-sen University.

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 26 Jan 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 the prevalence of overweight and obesity (time frame: Baseline, Month 9). 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 NCT02343588, which also lists 6 linked publications.

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 26 Jan 2015.

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