Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000417886
Ethics application status
Approved
Date submitted
12/04/2012
Date registered
13/04/2012
Date last updated
13/04/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Beijing Adolescent Obesity Peer Education
Scientific title
A pilot study to evaluate the feasibility and acceptability of a school-based peer education obesity program in adolescents in Beijing, China
Secondary ID [1] 280306 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 286265 0
Condition category
Condition code
Public Health 286486 286486 0 0
Health promotion/education
Diet and Nutrition 286520 286520 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention (September 2010 to December 2010):
1. Peer leaders recruitment and training
After the baseline assessment, four to eight peer leaders balanced by gender in each intervention class were selected by the class teacher from volunteer students based on their organization and oral expression ability, influence among students and sense of responsibility.
Then peer leaders in each intervention school were trained by research staff in three after-school 90-minute workshops over 3 consecutive days at school. The training covered four components: food choice, physical activity and sedentary behavior, carbonated drinks, and goal setting, which directly aimed at behavior change.
2. Peer education
Peer leaders then delivered four 40-minute peer education lessons to their classmates over four consecutive weeks in their classrooms.
3.Student action
Students were encouraged to maintain a healthy lifestyle based on the personal goals set in the fourth peer education lesson.
Intervention code [1] 284656 0
Prevention
Intervention code [2] 284677 0
Lifestyle
Intervention code [3] 284678 0
Behaviour
Comparator / control treatment
No intervention was implemented in the two control schools during the study.
Control group
Active

Outcomes
Primary outcome [1] 286929 0
Feasibility and acceptability of the peer education project that was evaluated by observing the peer education activities, in-depth interview with school teachers, focus group discussion with peer leaders and peers, semi-structural questionnaires. The evaluation was implemented by trained research staff.
Timepoint [1] 286929 0
Baseline: September 2010
On completion of intervention at 3 months: December 2010
Follow-up at 7-8 months: April-May 2011
Secondary outcome [1] 297010 0
Dietary behavior that was evaluated by validated 3-month Food Frequency Questionnaire
Timepoint [1] 297010 0
Baseline: September 2010
On completion of intervention at 3 months: December 2010
Follow-up at 7-8 months: April-May 2011
Secondary outcome [2] 297047 0
physical activity that was evaluated by validated 7-day physical activity questionnaire
Timepoint [2] 297047 0
Baseline: September 2010
On completion of intervention at 3 months: December 2010
Follow-up at 7-8 months: April-May 2011
Secondary outcome [3] 297048 0
Psychosoical mediators were evaluated by psychosocial mediators questionnaire on dietary behavior and physical activity
Timepoint [3] 297048 0
Baseline: September 2010
On completion of intervention at 3 months: December 2010
Follow-up at 7-8 months: April-May 2011

Eligibility
Key inclusion criteria
Students in grade 7 in the four junior high schools that had at least 160 students in grade 7
Minimum age
11 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Those with disease that influence energy metabolism

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A convenience sample of two small-sized and two large-sized junior high schools in Dongcheng District, Beijing were selected by the Dongcheng District Institute for Student Healthcare from schools with more than 160 students in grade 7. These schools were matched by school population size, and in each matched pair, one school was randomly allocated by research staff by throwing a coin to intervention or the control group. The allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
18/09/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
640
Accrual to date
Final
Recruitment outside Australia
Country [1] 4251 0
China
State/province [1] 4251 0
Beijing

Funding & Sponsors
Funding source category [1] 285075 0
Charities/Societies/Foundations
Name [1] 285075 0
The Nestle Foundation
Country [1] 285075 0
Switzerland
Primary sponsor type
Other
Name
The George Institute for Global Health, China
Address
Room B1302, Horizon Tower, No 6, Zhichun Road, Haidian District, Beijing 100088, PR China
Country
China
Secondary sponsor category [1] 283938 0
University
Name [1] 283938 0
The University of Sydney
Address [1] 283938 0
NSW 2006
Country [1] 283938 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287086 0
The Peking University Biomedical Ethics Committee
Ethics committee address [1] 287086 0
Ethics committee country [1] 287086 0
China
Date submitted for ethics approval [1] 287086 0
Approval date [1] 287086 0
29/10/2009
Ethics approval number [1] 287086 0
IRB00001052 - 09077
Ethics committee name [2] 287087 0
Human Research Ethics Committee, The University of Sydney, Australia
Ethics committee address [2] 287087 0
Ethics committee country [2] 287087 0
Australia
Date submitted for ethics approval [2] 287087 0
Approval date [2] 287087 0
26/03/2010
Ethics approval number [2] 287087 0
12046

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34049 0
Address 34049 0
Country 34049 0
Phone 34049 0
Fax 34049 0
Email 34049 0
Contact person for public queries
Name 17296 0
Zhaohui Cui
Address 17296 0
Room B1302, Horizon Tower, No 6, Zhichun Road, Haidian District, Beijing 100088, PR China
Country 17296 0
China
Phone 17296 0
86-10-82800577
Fax 17296 0
Email 17296 0
[email protected]
Contact person for scientific queries
Name 8224 0
Zhaohui Cui
Address 8224 0
Room B1302, Horizon Tower, No 6, Zhichun Road, Haidian District, Beijing 100088, PR China
Country 8224 0
China
Phone 8224 0
86-10-82800577
Fax 8224 0
Email 8224 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.