Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001524280
Ethics application status
Approved
Date submitted
6/09/2018
Date registered
11/09/2018
Date last updated
19/03/2021
Date data sharing statement initially provided
13/08/2019
Date results information initially provided
19/03/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Promoting physical activity in children through family-based intervention: The “Active 1+FUN” program
Scientific title
Promoting physical activity in children through family-based intervention: Protocol of the “Active 1+FUN” randomized controlled trial
Secondary ID [1] 295643 0
None
Universal Trial Number (UTN)
Trial acronym
Active 1+FUN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical inactivity 308982 0
Condition category
Condition code
Public Health 307878 307878 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
“Active 1+FUN” is a family-based intervention designed using the tenets of self-determination theory. The intervention was designed to help parents support their children’s basic psychological needs for competence (by providing informational feedback and optimal challenges), autonomy (by exploring a variety of activities and reducing controlling behaviors), and relatedness (by increasing co-physical activity between parents and child).

The main intervention period will last for approximately 6 months, the length of intervention may vary among participating schools because of the differences of their academic calendars (exam periods, public or school holidays, and school activities would be avoided during the intervention to minimize disturbances to regular school activities). Participants will attend ten biweekly 90-minute intervention sessions. Each session will consist of two parts, a 30-minute interactive workshop followed by a 60-minute activity session. An additional booster session will be provided approximately three months after the tenth intervention session. Both fathers and mothers will be invited to the intervention sessions, and at least one parent must be present during each intervention session. Intervention sessions will be led by activity leaders trained by the investigators. Specifically, all activity leaders will receive two half-day workshops before they begin leading these classes. Each session will be lead by two activity leaders.

Storytelling will be adopted as the fundamental teaching strategy in the interactive workshops. This strategy is known to be engaging (Morgan et al., 2016) and will help to facilitate participants’ understanding of the following essential concepts: (i) tenets of self-determination theory (SDT), (ii) benefits of routinizing physical activity, (iii) time management methods, and (iv) parenting practices. There will be different stories and themes for each of workshops, which will start with a short presentation to highlight the important message of the day. Then, each workshop will be followed by interactive activities and discussions between and within families. All video and written teaching materials for these sessions will be prepared by the research team. In line with SDT, one important goal of the workshops is to teach parents how to support their children’s basic psychological needs in various contexts and scenarios and avoid using external control. Role play activities will be embedded in workshops to enable learning and sharing in a more relaxed manner.

In the second part of the intervention sessions, parents and children will participate in physical activity together. These sessions will highlight the concepts of MVPA (i.e., huff and puff activity), FMS, motivation, and “co-physical activity”. There will be a gameplay period within the session, using innovative tools and methods, such as methods previously developed by Ha, Lonsdale, Lubans, and Ng (2017). These will be followed by a skill development period using the following sports equipment, including skipping rope, soft volleyball, sponge flying disc, which will be given to participants for free. The aim is to improve participants’ (children and parents) FMS proficiency. Researchers have found that these skills are important determinants of physical activity participation (Lubans, Morgan, Cliff, Barnett, & Okely, 2010). Hence improving such skills in children and parents may increase their future participation in physical activity, beyond the intervention period. Both parents of children will be invited to take part in the intervention sessions specifically chosen sessions will be more tailored for mothers or fathers, respectively. The corresponding parent will be strongly encouraged to take part in these classes, even though they may be unable to attend other sessions.

Apart from the workshops and activity sessions, there will be weekly parent-child physical activity homework that will encourage participants to spend at least 30 minutes in total per week to engage in parent-child physical activity. Physical activity homework is an effective means to promote physical activity of students outside of school hours (Duncan et al., 2011; Fairclough et al., 2013; Kriemler et al., 2010), as such parent-child physical activity homework will also promote the physical activity level of both parents and children. An activity logbook will be given to each family to encourage parent-child physical activity planning and to self-report and provide descriptions regarding the relevant parent-child physical activities they have done (e.g., date and time, with whom, the types of co-physical activity and duration). Also, each family will receive two 15-minute consultation sessions during the intervention period. Essentially, each family will receive consultations on how to overcome barriers to engaging in physical activity as a family unit. They will receive scheduling help to identify time gaps for family activities. Families will be encouraged to begin a healthier lifestyle and will be prompt to provide reciprocal reinforcement (i.e., parents and children reinforcing each other simultaneously; (Morgan et al., 2014)). Participants will be assisted to set short- and long-term goals for each family member during the consultations. A research assistant will be trained specifically to provide such consultations. Furthermore, online materials regarding the interactive workshops and FMS will be provided to all the participants. Descriptions about the required FMS in various kinds of sports will be provided. Participants can easily make comparisons between different sports and reflect on their own strengths and weaknesses. A booster session with fun physical activities will be provided to the participants approximately 3 months after the 6-month main intervention period.
Intervention code [1] 301959 0
Lifestyle
Intervention code [2] 301960 0
Behaviour
Comparator / control treatment
The experimental group will receive an approximately six-month intervention, while the wait-list control group will only receive it one year later.
Control group
Active

Outcomes
Primary outcome [1] 306855 0
The primary outcome of the study is the children’s moderate-to-vigorous physical activity (MVPA). Children’s mean time spent in daily MVPA over a five-day period will be measured using ActiGraph wGT3X-BT accelerometers worn at the waist. Using Evenson and colleagues’ criteria, the sum of daily minutes spent in moderate and vigorous activity will be used as a measure for MVPA. Fifteen-second epochs will be used. Cases will be considered valid if participants wore the accelerometer for at least eight hours on a minimum of three days, with at least one weekend day.
Timepoint [1] 306855 0
Accelerometry measurements will be taken at baseline, at the end of the intervention period (i.e., over the tenth intervention session), and post-intervention follow-up (i.e., one year after the baseline measurement).
Secondary outcome [1] 349953 0
Parents’ mean time spent in daily MVPA over a five-day period will be measured using ActiGraph wGT3X-BT accelerometers worn at the waist. Using Freedson and colleagues’ criteria, the sum of daily minutes spent in moderate and vigorous activity will be used as a measure for MVPA. Fifteen-second epochs will be used. Cases will be considered valid if participants wore the accelerometer for at least eight hours on a minimum of three days, with at least one weekend day.
Timepoint [1] 349953 0
Accelerometry measurements will be taken at baseline, at the end of the intervention period (i.e., over the tenth intervention session), and post-intervention follow-up (i.e., one year after the baseline measurement).
Secondary outcome [2] 349954 0
Children's fundamental movement skills competency selected from the Test of Gross Motor Development-3) will be assessed using the protocol by Chan, Ha, Ng, and Lubans (in press). Specifically, the composite scores from the tests for kick, catch, overhand throw, and one-hand forehand strike will be measured.
Timepoint [2] 349954 0
Measurements will be taken at baseline, at the end of the intervention period (i.e., over the tenth intervention session), and post-intervention follow-up (i.e., one year after the baseline measurement).
Secondary outcome [3] 349955 0
Participants’ height and weight will be measured to calculate their BMI. Height will be measured using a standard stadiometer; weight will be measured using a digital scale. This outcome will be used as a pseudo-measure of their physical health.
Timepoint [3] 349955 0
Measurements will be taken at baseline, at the end of the intervention period (i.e., over the tenth intervention session), and post-intervention follow-up (i.e., one year after the baseline measurement).
Secondary outcome [4] 349995 0
Children’s perceived need support and control will be measured using an adapted version of Perceived Parental Autonomy Support Scale (Joussemet, Mageau, & Koestner, 2014).
Timepoint [4] 349995 0
Measurements will be taken at baseline, at the end of the intervention period (i.e., over the tenth intervention session), and post-intervention follow-up (i.e., one year after the baseline measurement).
Secondary outcome [5] 349996 0
Parents' provision of need support and psychological control will be measured. Parents will be asked to self-report the frequency in which they use need supportive strategies in relation to their children’s physical activity behaviors, using a adapted version of the Perceived Parental Autonomy Support Scale (Joussemet et al., 2014).
Timepoint [5] 349996 0
Measurements will be taken at baseline, at the end of the intervention period (i.e., over the tenth intervention session), and post-intervention follow-up (i.e., one year after the baseline measurement).
Secondary outcome [6] 349997 0
Children's basic psychological needs satisfaction and thwarting will be measured using the scale used in the study of Ng, Ntoumanis, Thøgersen-Ntoumani, Stott, and Hindle (2013).
Timepoint [6] 349997 0
Measurements will be taken at baseline, at the end of the intervention period (i.e., over the tenth intervention session), and post-intervention follow-up (i.e., one year after the baseline measurement).
Secondary outcome [7] 349999 0
Children's well-being will be measured by using the Cantonese versions of the KIDSCREEN health-related quality of life questionnaire (Ng, Burnett, Ha, & Sum, 2015).
Timepoint [7] 349999 0
Measurements will be taken at baseline, at the end of the intervention period (i.e., over the tenth intervention session), and post-intervention follow-up (i.e., one year after the baseline measurement).
Secondary outcome [8] 351678 0
The time parents and children spend doing activity together (co-physical activity) will be measured as secondary outcomes. Using proximity sensors in the ActiGraph devices (Kuzik & Carson, 2018), the duration of co-physical activity periods per day will also be measured.
Timepoint [8] 351678 0
Accelerometry measurements will be taken at baseline, at the end of the intervention period (i.e., over the tenth intervention session), and post-intervention follow-up (i.e., one year after the baseline measurement).
Secondary outcome [9] 351679 0
Parents' fundamental movement skills competency selected from the Test of Gross Motor Development-3) will be assessed using the protocol by Chan, Ha, Ng, and Lubans (in press). Specifically, the composite scores from the tests for kick, catch, overhand throw, and one-hand forehand strike will be measured.
Timepoint [9] 351679 0
Measurements will be taken at baseline, at the end of the intervention period (i.e., over the tenth intervention session), and post-intervention follow-up (i.e., one year after the baseline measurement).
Secondary outcome [10] 351680 0
Parents' basic psychological needs satisfaction and thwarting will be measured using the scale used in the study of Ng, Ntoumanis, Thøgersen-Ntoumani, Stott, and Hindle (2013).
Timepoint [10] 351680 0
Measurements will be taken at baseline, at the end of the intervention period (i.e., over the tenth intervention session), and post-intervention follow-up (i.e., one year after the baseline measurement).
Secondary outcome [11] 351681 0
Parents' well-being will be measured by the Chinese version of the Flourishing Scale (Diener et al., 2010).
Timepoint [11] 351681 0
Measurements will be taken at baseline, at the end of the intervention period (i.e., over the tenth intervention session), and post-intervention follow-up (i.e., one year after the baseline measurement).

Eligibility
Key inclusion criteria
Students (around 8 to 11 years old) who are in their Primary 3 to 5 studies in Hong Kong schools and their parents will be recruited to take part in this study. A pool of gender-balanced participants will be recruited via schools in Hong Kong that meet our eligibility criteria. Specifically, schools will be eligible if (i) they are co-educational (i.e. mixed-sex); (ii) located in the regions of Hong Kong Island (except the Islands district), Kowloon and New Territories; (iii) either government primary schools or aided primary schools.
Minimum age
8 Years
Maximum age
11 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
All participants will need to complete the Physical Activity Readiness Questionnaire (PAR-Q) before the study. Participants will be excluded from the study if they were deemed to be unfit for taking part in physical activity.

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)
After completing baseline measures, participants will draw a sealed envelope to decide whether they will be allocated to the experimental group or the wait-list control group. Therefore allocation is concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using the procedure of drawing a sealed envelope by the participants within each school, half of the recruited families will be allocated to the experimental group, and the other half will be allocated in the wait-list control group (i.e., 1:1 ratio).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
In each school, half of the recruited families will be allocated to the experimental group, and the other half will be allocated in the wait-list control group (i.e., 1:1 ratio). Participants allocated to the experimental group will receive ten bi-weekly intervention sessions over approximately 6 months immediately after baseline measures are taken. Participants allocated to the control group will be asked to attend all measurement sessions, but they will only receive the intervention 12 months later (i.e., after the final follow-up time point).
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size determination
A power calculation was conducted to estimate the required sample size. Power calculation was based on the primary outcome of children’s MVPA, at the primary time point of 6-months. Calculations were conducted using G*Power 3.1.7. Based on the Healthy Dads, Healthy Kids study (Morgan et al., 2014) and the estimated effect size of d = 0.5. With a Type I error probability of 0.05 and power of 0.8, the required sample size was calculated to be N = 128. To account for an estimated non-compliance (cases with insufficient wear time) rate of 30%, a minimum of N = 204 children will be recruited.

Data analyses will be conducted using linear mixed models using an intention-to-treat approach. Group differences concerning all primary and secondary outcomes will be examined. Specifically, a two-level (i.e., level 1 = time, level 2 = individual) model will be examined for each outcome, using the equation: Outcome = B0 + B1*Time + B2*Group + B3*Time*Group. The B1 coefficient will be parameterized as a variable with random slope and random intercept at all levels. Additional analyses will be conducted by adding the potential covariates and mediators to the models. An intervention effect will be deemed to be present if the B3 coefficient was statistically significant from zero.

Structural equation modelling will also be used to test the structural model of children’s perceived need support/control predicting need satisfaction/thwarting, and in turn physical activity behaviors and well-being. In the same model, we will examine the relationship between parents’ self-reported need supportive/controlling behaviors and children’s perception of the same constructs. Based on the work of Radel, Sarrazin, Legrain, and Wild (2010), we will also examine the link between parents’ need satisfaction, motivation and their parenting styles in the model. To account for the relatively small sample size, a Bayesian approach will be used for structural equation modelling analyses (e.g., Ng, Ntoumanis, Thøgersen-Ntoumani, Stott, & Hindle, 2013).

Semi-structured in-depth qualitative interviews in the format of focus group or individual interview will be conducted by a trained research assistant at different time points, namely, pre-intervention (information provided above), mid-intervention, post-intervention, and at follow-up (i.e., one year from start of intervention). Interview guides based on the SDT will be developed. Field notes will be written during and immediately after the interviews. All interviews will be audio recorded and transcribed verbatim. After the interviews are transcribed, they will be sent to the participants to review, to check for accuracy (member checking) and establish credibility. Any necessary changes will be made. The transcribed raw contents will be set out in lists, and similar items will be grouped under representative themes. Initial codes will be created openly using NVivo version 10 (QSR International) to categorize transcripts into components that are of potential significance to the research objectives.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/09/2018
Actual
15/09/2018
Date of last participant enrolment
Anticipated
28/09/2019
Actual
30/09/2019
Date of last data collection
Anticipated
26/09/2020
Actual
31/10/2019
Sample size
Target
204
Accrual to date
Final
170
Recruitment outside Australia
Country [1] 10679 0
Hong Kong
State/province [1] 10679 0

Funding & Sponsors
Funding source category [1] 300224 0
Government body
Name [1] 300224 0
Research Grants Committee - General Research Fund
Country [1] 300224 0
Hong Kong
Primary sponsor type
Individual
Name
Amy S Ha
Address
Department of Sports Science and Physical Education
Kwok Sports Building
The Chinese University of Hong Kong
Shatin, Hong Kong
Country
Hong Kong
Secondary sponsor category [1] 299649 0
None
Name [1] 299649 0
Address [1] 299649 0
Country [1] 299649 0
Other collaborator category [1] 280265 0
Individual
Name [1] 280265 0
Johan Ng
Address [1] 280265 0
Department of Sports Science and Physical Education
Kwok Sports Building
The Chinese University of Hong Kong
Shatin, Hong Kong
Country [1] 280265 0
Hong Kong
Other collaborator category [2] 280266 0
Individual
Name [2] 280266 0
Chris Lonsdale
Address [2] 280266 0
Institute for Positive Psychology and Education
25A Barker Road, Strathfield NSW 2135
Australian Catholic University
Country [2] 280266 0
Australia
Other collaborator category [3] 280267 0
Individual
Name [3] 280267 0
David Lubans
Address [3] 280267 0
Priority Research Centre for Physical Activity and Nutrition
School of Education
University of Newcastle
Callaghan
NSW 2308
Australia.
Country [3] 280267 0
Australia
Other collaborator category [4] 280268 0
Individual
Name [4] 280268 0
Florrie Ng
Address [4] 280268 0
Department of Educational Psychology
Ho Tim Building
The Chinese University of Hong Kong
Shatin, Hong Kong
Country [4] 280268 0
Hong Kong

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301047 0
Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee
Ethics committee address [1] 301047 0
8/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin
Ethics committee country [1] 301047 0
Hong Kong
Date submitted for ethics approval [1] 301047 0
16/01/2017
Approval date [1] 301047 0
01/03/2017
Ethics approval number [1] 301047 0
2017.018

Summary
Brief summary
The “Active 1+FUN” intervention program was designed to enhance physical activity behaviors of families. Intervention components include free activity classes and free exercise equipment. Effectiveness of the intervention will be evaluated using a randomized controlled trial. We hypothesized that children and parents who took part in the intervention program will show higher increases, relative to those in the wait-list control group, in moderate-to-vigorous physical activity behaviors.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2913 2913 0 0
/AnzctrAttachments/375660-Ethics Approval.pdf (Ethics approval)

Contacts
Principal investigator
Name 85698 0
Prof Amy Ha
Address 85698 0
Department of Sports Science and Physical Education
Kwok Sports Building
The Chinese University of Hong Kong
Shatin
Country 85698 0
Hong Kong
Phone 85698 0
+852 39436083
Fax 85698 0
Email 85698 0
sauchingha@cuhk.edu.hk
Contact person for public queries
Name 85699 0
Dr Johan Ng
Address 85699 0
Department of Sports Science and Physical Education
Kwok Sports Building
The Chinese University of Hong Kong
Shatin
Country 85699 0
Hong Kong
Phone 85699 0
+852 39436098
Fax 85699 0
Email 85699 0
yyng@cuhk.edu.hk
Contact person for scientific queries
Name 85700 0
Dr Johan Ng
Address 85700 0
Department of Sports Science and Physical Education
Kwok Sports Building
The Chinese University of Hong Kong
Shatin
Country 85700 0
Hong Kong
Phone 85700 0
+852 39436098
Fax 85700 0
Email 85700 0
yyng@cuhk.edu.hk

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Participant consent was not sought


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
3990Study protocolHa, A. S., Ng, J. Y., Lonsdale, C., Lubans, D. R., & Ng, F. F. (2019). Promoting physical activity in children through family-based intervention: protocol of the “Active 1+ FUN” randomized controlled trial. BMC public health, 19(1), 218.https://bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-019-6537-3  375660-(Uploaded-12-08-2019-11-37-24)-Study-related document.pdf



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbasePromoting physical activity in children through family-based intervention: protocol of the "Active 1+FUN" randomized controlled trial.2019https://dx.doi.org/10.1186/s12889-019-6537-3
EmbaseImproving children's fundamental movement skills through a family-based physical activity program: results from the "Active 1 + FUN" randomized controlled trial.2021https://dx.doi.org/10.1186/s12966-021-01160-5
N.B. These documents automatically identified may not have been verified by the study sponsor.