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Trial registered on ANZCTR


Registration number
ACTRN12618000590268
Ethics application status
Approved
Date submitted
13/03/2018
Date registered
17/04/2018
Date last updated
17/04/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Healthy Homework: A physical activity and nutrition intervention for children
Scientific title
Healthy Homework: Effects of a school-based health intervention for children's physical activity, nutrition, and body size.
Secondary ID [1] 293438 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Child obesity 305610 0
Physical inactivity 305611 0
Condition category
Condition code
Public Health 304833 304833 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Healthy Homework was an eight-week curriculum-based homework schedule, complemented by an in-class teaching resource, designed to promote physical activity and healthy eating in children (curriculum resources may be provided upon request). The programme was developed under the guidance of an advisory committee comprising experienced health and education professionals (including classroom teachers) with regular input from children and parents. Healthy Homework was based on several established behaviour change theories (including the theory of reasoned action, the theory of planned behaviour, and social-cognitive theory), and was designed to support the achievement objectives associated with the Health and Physical Education strand of the New Zealand Curriculum. The research team provided professional learning for the teachers of the three intervention classes at each intervention school, and to one lead teacher in each of the control schools (who were permitted to implement the programme at the conclusion of the final follow-up point). The professional learning protocol was standardised across all schools, and necessitated one half-day release per teacher.

At the start of the intervention, all children in participating classes received a homework booklet organised into weekly topics that each contained one physical activity and one nutrition component (e.g., walking and fruit/vegetables, screen time and breakfast, fitness and cooking). Three practical homework options were provided for each topic, and the children were directed by their teacher to complete at least one physical activity and one nutrition task per topic (e.g., organising family walks, walking to and from school, limiting screen time, testing the fitness of the family, eating 5+ fruit and vegetables each day, comparing food labels at the supermarket, helping with dinner, preparing a healthy lunch box). Blue or purple rubber wristbands were provided each week for children who completed their homework obligations, with a black colour reserved for those who completed all six tasks on a given week. The Healthy Homework classroom curriculum resource was designed to provide sufficient educational content and in-class exercises for three 1.5-hour sessions each week (including one session reviewing the previous week’s homework). Furthermore, an online portal was developed and monitored to allow teachers to access resources and record student compliance, and to enable children to share homework-related updates with other participants (including those in other schools).
Intervention code [1] 299681 0
Lifestyle
Intervention code [2] 300873 0
Behaviour
Comparator / control treatment
Active control: usual school curriculum. All control schools were offered the intervention, including all resources and support, after the final follow=up data collection (6 months post-intervention).
Control group
Active

Outcomes
Primary outcome [1] 304037 0
Weekday in-school physical activity: Physical activity was assessed using sealed NL-1000 pedometers (New Lifestyles Inc, Lee’s Summit, MO) over five consecutive days (three weekdays, two weekend days). These pedometers have a multiday memory function that automatically stores step counts by day of week for up to seven days. Two pedometers were assigned to each child: one clearly labelled ‘School’ and the other ‘Home’. The ‘School’ pedometer was worn during school hours, while the ‘Home’ pedometer was left inside a collection tray in the classroom. At the conclusion of the school day, each child placed their ‘School’ pedometer in the tray and attached their ‘Home’ pedometer. Upon arrival at school the next day, the teacher reminded the children to switch over their pedometers again. This approach was taken as it removed the need for teachers to coordinate a lengthy collection and handout process, and allowed the differentiation of in-school and out-of-school physical activity, while using a cost-effective but objective measurement device.
Timepoint [1] 304037 0
Baseline, immediately post-intervention, 6-months follow-up
Primary outcome [2] 305492 0
Weekday out-of-school physical activity: Physical activity was assessed using sealed NL-1000 pedometers (New Lifestyles Inc, Lee’s Summit, MO) over five consecutive days (three weekdays, two weekend days). These pedometers have a multiday memory function that automatically stores step counts by day of week for up to seven days. Two pedometers were assigned to each child: one clearly labelled ‘School’ and the other ‘Home’. The ‘School’ pedometer was worn during school hours, while the ‘Home’ pedometer was left inside a collection tray in the classroom. At the conclusion of the school day, each child placed their ‘School’ pedometer in the tray and attached their ‘Home’ pedometer. Upon arrival at school the next day, the teacher reminded the children to switch over their pedometers again. This approach was taken as it removed the need for teachers to coordinate a lengthy collection and handout process, and allowed the differentiation of in-school and out-of-school physical activity, while using a cost-effective but objective measurement device.
Timepoint [2] 305492 0
Baseline, immediately post-intervention, 6-months follow-up
Primary outcome [3] 305494 0
Weekend physical activity: Physical activity was assessed using sealed NL-1000 pedometers (New Lifestyles Inc, Lee’s Summit, MO) over five consecutive days (three weekdays, two weekend days). These pedometers have a multiday memory function that automatically stores step counts by day of week for up to seven days. Two pedometers were assigned to each child: one clearly labelled ‘School’ and the other ‘Home’. The ‘School’ pedometer was worn during school hours, while the ‘Home’ pedometer was left inside a collection tray in the classroom. At the conclusion of the school day, each child placed their ‘School’ pedometer in the tray and attached their ‘Home’ pedometer. Upon arrival at school the next day, the teacher reminded the children to switch over their pedometers again. This approach was taken as it removed the need for teachers to coordinate a lengthy collection and handout process, and allowed the differentiation of in-school and out-of-school physical activity, while using a cost-effective but objective measurement device.
Timepoint [3] 305494 0
Baseline, immediately post-intervention, 6-months follow-up
Secondary outcome [1] 340777 0
Key dietary patterns were estimated using the Children’s Dietary Questionnaire (CDQ), a parental proxy report that has been validated in children aged 4-16 years. The CDQ focuses on patterns of food intake over the previous 24 hours and/or seven days rather than actual amounts and types of foods consumed. The four dietary subscales selected for analyses in this study were: (1) daily fruit consumption, (2) daily vegetable consumption, (3) weekly fast food consumption, and (4) weekly soft drink consumption. These subscales were selected given their alignment with the New Zealand Food and Nutrition Guidelines, and the high prevalence of soft drink consumption in New Zealand youth.
Timepoint [1] 340777 0
Baseline, immediately post-intervention, 6-months follow-up
Secondary outcome [2] 340778 0
Body mass index: Standing height was measured to the nearest millimetre with a portable stadiometer (SECA 213, Hamberg, Germany) and weight was measured to the nearest 0.1 kg on a digital scale (SECA 813, Hamberg, Germany). Body mass index (BMI) was calculated as weight (kg) divided by squared height (m2).
Timepoint [2] 340778 0
Baseline, immediately post-intervention, 6-months follow-up
Secondary outcome [3] 345450 0
Screen time: Questions pertaining to the frequency and duration of television, computer and gaming console use were assessed via parental proxy questionnaire administered during the consent process.
Timepoint [3] 345450 0
Baseline, immediately post-intervention, 6-months follow-up
Secondary outcome [4] 345451 0
Parental physical activity: Physical activity levels of parents of child participants were assessed by sending home one NL-2000 pedometer and requesting that the parent wear it for seven consecutive days.
Timepoint [4] 345451 0
Baseline, immediately post-intervention, 6-months follow-up

Eligibility
Key inclusion criteria
Eligibility criteria for the schools were as follows: a roll of over 100 students, location within Auckland or Dunedin cities, and a contributing, full primary, or composite structure that included at least one class each of students in school years 3-5. All children in three classes per school were invited to participate in the measurements.
Minimum age
7 Years
Maximum age
10 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/07/2011
Date of last participant enrolment
Anticipated
Actual
24/07/2012
Date of last data collection
Anticipated
Actual
7/04/2013
Sample size
Target
800
Accrual to date
Final
675
Recruitment outside Australia
Country [1] 9681 0
New Zealand
State/province [1] 9681 0
Auckland
Country [2] 9682 0
New Zealand
State/province [2] 9682 0
Otago

Funding & Sponsors
Funding source category [1] 298067 0
Government body
Name [1] 298067 0
Health Research Council of New Zealand
Country [1] 298067 0
New Zealand
Primary sponsor type
University
Name
Auckland University of Technology
Address
55 Wellesley St E, Auckland, 1010
Country
New Zealand
Secondary sponsor category [1] 298185 0
University
Name [1] 298185 0
University of Otago
Address [1] 298185 0
362 Leith St, North Dunedin, Dunedin 9016
Country [1] 298185 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299083 0
Auckland University of Technology Ethics Committee
Ethics committee address [1] 299083 0
Ethics committee country [1] 299083 0
New Zealand
Date submitted for ethics approval [1] 299083 0
12/07/2010
Approval date [1] 299083 0
11/08/2010
Ethics approval number [1] 299083 0
10/159

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

Contacts
Principal investigator
Name 79242 0
A/Prof Scott Duncan
Address 79242 0
Auckland University of Technology, 55 Wellesley St E, Auckland, 1010
Country 79242 0
New Zealand
Phone 79242 0
+6499219999
Fax 79242 0
Email 79242 0
scott.duncan@aut.ac.nz
Contact person for public queries
Name 79243 0
Scott Duncan
Address 79243 0
Auckland University of Technology, 55 Wellesley St E, Auckland, 1010
Country 79243 0
New Zealand
Phone 79243 0
+6499219999
Fax 79243 0
Email 79243 0
scott.duncan@aut.ac.nz
Contact person for scientific queries
Name 79244 0
Scott Duncan
Address 79244 0
Auckland University of Technology, 55 Wellesley St E, Auckland, 1010
Country 79244 0
New Zealand
Phone 79244 0
+6499219999
Fax 79244 0
Email 79244 0
scott.duncan@aut.ac.nz

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
SourceTitleYear of PublicationDOI
EmbaseEfficacy of a compulsory homework programme for increasing physical activity and improving nutrition in children: A cluster randomised controlled trial.2019https://dx.doi.org/10.1186/s12966-019-0840-3
N.B. These documents automatically identified may not have been verified by the study sponsor.