Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001066976
Ethics application status
Approved
Date submitted
10/10/2011
Date registered
12/10/2011
Date last updated
15/04/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
The FamilyFIT study: Promoting family health through an innovative community program.
Scientific title
FamilyFIT: A pilot randomised controlled trial to assess the feasibility and preliminary efficacy of a family focused, community-based program conducted out of school hours compared to no intervention to increase physical activity levels among primary school-aged children (5-12years).
Secondary ID [1] 273141 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical activity levels of primary school- aged children (5-12 years) 278895 0
Condition category
Condition code
Public Health 279070 279070 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The FamilyFIT Program will be conducted as a pilot randomised controlled trial (RCT). Families (parents and children) attend eight, approximately ninety minute face-to-face sessions once a week, for eight weeks. The sessions will be conducted out of school hours, at a local venue and delivered by a qualified health promotion practitioner and physical education teachers. Each session parents will receive a thirty minute information component to receive information, skills and tailored resources to support parenting strategies which influence activity behaviour and establish a family-home environment conducive to physical activity. Each session, will also involve a sixty minute practical component involving parents and children participating in interactive fun and skill-based physical activity together; to develop children’s self confidence and ability in performing various fundamental movement skills (e.g. run, hop, skip and throw a ball), increasing incidental physical activity (e.g taking stairs instead of lifts) and health-related physical activities.
Intervention code [1] 269482 0
Lifestyle
Intervention code [2] 269483 0
Behaviour
Comparator / control treatment
No Treatment. The control group will receive a copy of the written intervention resource materials at the conclusion of the study.
Control group
Active

Outcomes
Primary outcome [1] 279720 0
Childrens physical activity levels (defined as mean steps per day) objectively measured using the Yamax Digiwalker pedometer over a seven day period.

In families with more than one child aged 5-12 years, one child will be randomly selected for the primary outcome measure.
Timepoint [1] 279720 0
Baseline (1-2 weeks prior to intervention commencement) and 10 week follow up (immediately following completion of intervention program).
Secondary outcome [1] 294291 0
Parental physical activity levels (defined as mean steps per day) objectively measured using the Yamax Digiwalker pedometer over a seven day period.
Timepoint [1] 294291 0
Baseline (1-2 weeks prior to intervention commencement) and 10 week follow up (immediately following completion of intervention program).
Secondary outcome [2] 294292 0
Self-reported child and adult physical activity levels using items from the International Physical Activity Questionnaire (IPAQ)-short form for parents and a parent proxy measure for children using items from the Children's Leisure Activities Study Survey (CLASS) Parent Questionnaire.
Timepoint [2] 294292 0
Baseline (1-2 weeks prior to intervention commencement) and 10 week follow up (immediately following completion of intervention program).
Secondary outcome [3] 294293 0
Self-reported child and adult sedentary behaviour using items from the Children's Leisure Activities Study Survey (CLASS) Parent Questionnaire (parent proxy for children) and a short version total and domain-specific sitting questionnaire for parents.
Timepoint [3] 294293 0
Baseline (1-2 weeks prior to intervention commencement) and 10 week follow up (immediately following completion of intervention program).
Secondary outcome [4] 294294 0
Self reported parental support for child physical activity using items from The Activity Support Scale for Multiple Groups (ACTS-MG).
Timepoint [4] 294294 0
Baseline (1-2 weeks prior to intervention commencement) and 10 week follow up (immediately following completion of intervention program).
Secondary outcome [5] 294295 0
Self report aspects of the home social environment and physical environment that influence children's physical activity using items from the Home Environment Survey (HES).
Timepoint [5] 294295 0
Baseline (1-2 weeks prior to intervention commencement) and 10 week follow up (immediately following completion of intervention program).
Secondary outcome [6] 294296 0
Self reported parenting styles of mothers and fathers using items adapted from The Longitudinal Study of Australian Children.
Timepoint [6] 294296 0
Baseline (1-2 weeks prior to intervention commencement) and 10 week follow up (immediately following completion of intervention program).
Secondary outcome [7] 294297 0
Weight of parents and children (kg) using a calibrated electronic scale
Timepoint [7] 294297 0
Baseline (1-2 weeks prior to intervention commencement) and 10 week follow up (immediately following completion of intervention program).
Secondary outcome [8] 294298 0
Waist circumference of parents and children (cm) using non-extensible steel tape.
Timepoint [8] 294298 0
Baseline (1-2 weeks prior to intervention commencement) and 10 week follow up (immediately following completion of intervention program).
Secondary outcome [9] 294299 0
Systolic and diastolic blood pressure of parents using an automated blood pressure cuffs.
Timepoint [9] 294299 0
Baseline (1-2 weeks prior to intervention commencement) and 10 week follow up (immediately following completion of intervention program).
Secondary outcome [10] 294300 0
Resting Heart Rate of parents and children using an automated blood pressure cuffs.
Timepoint [10] 294300 0
Baseline (1-2 weeks prior to intervention commencement) and 10 week follow up (immediately following completion of intervention program).
Secondary outcome [11] 294301 0
Height of parents and children (cm) using a portable stadiometer.
Timepoint [11] 294301 0
Baseline (1-2 weeks prior to intervention commencement) and 10 week follow up (immediately following completion of intervention program).

Eligibility
Key inclusion criteria
Families with at least one child currently enrolled in primary school (aged 5-12years).
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants (children and adults) deemed to be at risk of an exercise-related complication as assessed by a questionnaire developed from the Sports Medicine Australia Pre-exercise Screening System will require a doctor’s clearance to enrol in the study.

Parents or children identified with extreme obesity (BMI z-score > 4) based on measurements taken, by trained assessors at baseline assessment, will require a doctor’s clearance to enrol in the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Parents interested in participating in the study will contact the researchers. Family eligibility, based on the study’s inclusion/exclusion criteria will be screened over the telephone. All participants (parents and children) will be required to pass a Pre exercise Screening Questionnaire. Participants deemed to be at a potential risk of an exercise related complication will be required to obtain a doctor's clearance prior to enrolling in the study.

Once written consent is obtained and baseline assessments conducted for all participating family members (parents and children), families will be randomised to one of the two study groups.

To ensure concealment, the random allocation sequence will be generated by a statisticain and given to the project manager. Randomisation will be completed by a research assistant who is not involved in the assessment of participants.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The random allocation sequence will be generated by a computer-based random number algorithm in equal block lengths to ensure an equal chance of allcoation to each group.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Participants will be blinded at baseline assessments only.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
11/10/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 269960 0
Other Collaborative groups
Name [1] 269960 0
Hunter Medical Research Institute/Hunter Children's Research Foundation
Country [1] 269960 0
Australia
Funding source category [2] 269961 0
University
Name [2] 269961 0
University of Newcastle
Country [2] 269961 0
Australia
Funding source category [3] 269962 0
University
Name [3] 269962 0
The Priority Research Centre for Health Behaviour (PRCHB) University of Newcastle
Country [3] 269962 0
Australia
Funding source category [4] 269963 0
Charities/Societies/Foundations
Name [4] 269963 0
Cancer Council NSW
Country [4] 269963 0
Australia
Primary sponsor type
Individual
Name
Ms Lorraine Paras
Address
Priority Research Centre for Health Behaviour (PRCHB)
University of Newcastle
Room 230A, Level 2,
David Maddison Building
Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 268957 0
Individual
Name [1] 268957 0
Associate Professor Erica James
Address [1] 268957 0
School of Medicine and Public Health
University of Newcastle
Level 3, David Maddison Building
Callaghan NSW 2308
Country [1] 268957 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271931 0
The University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 271931 0
Ethics committee country [1] 271931 0
Australia
Date submitted for ethics approval [1] 271931 0
Approval date [1] 271931 0
07/06/2011
Ethics approval number [1] 271931 0
H-2011-0129

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

Contacts
Principal investigator
Name 33223 0
Address 33223 0
Country 33223 0
Phone 33223 0
Fax 33223 0
Email 33223 0
Contact person for public queries
Name 16470 0
Lorraine Paras
Address 16470 0
Priority Research Centre for Health Behaviour (PRCHB)
University of Newcastle
Room 230A, Level 2,
David Maddison Building
Callaghan NSW 2308
Country 16470 0
Australia
Phone 16470 0
+61 2 49138613
Fax 16470 0
+61 2 49138601
Email 16470 0
[email protected]
Contact person for scientific queries
Name 7398 0
Associate Professor Erica James
Address 7398 0
School of Medicine and Public Health
University of Newcastle
Level 3, David Maddison Building
Callaghan NSW 2308
Country 7398 0
Australia
Phone 7398 0
+61 2 49138466
Fax 7398 0
+61 2 491 38148
Email 7398 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.