Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000022561
Ethics application status
Approved
Date submitted
11/12/2014
Date registered
15/01/2015
Date last updated
7/12/2018
Date data sharing statement initially provided
7/12/2018
Date results provided
7/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Engaging dads and daughters to increase physical activity and social and emotional well-being in pre-adolescent girls: The DADEE (Dads And Daughters Exercising and Empowered) program
Scientific title
Engaging dads and daughters to increase physical activity and social and emotional well-being in pre-adolescent girls: The DADEE (Dads And Daughters Exercising and Empowered) randomised controlled trial
Secondary ID [1] 285794 0
Nil
Universal Trial Number (UTN)
Trial acronym
DADEE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical inactivity 293686 0
Condition category
Condition code
Public Health 293985 293985 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The program will be delivered in two phases:

Phase 1 (face-to-face)

* Fathers and daughters will attend 8 weekly sessions of the DADEE program together.

* Each session will be broken up into 2 components:

(i) a 25-minute education session conducted separately for fathers and girls;

(ii) a 60-minute practical session where fathers and daughter(s) participate together.

* The sessions will be group-based (20-25 families), delivered by qualified physical education teachers and will focus on:
- parenting and behavioural strategies to improve physical activity & social-emotional well-being;
- fundamental movement skills (e.g. throwing, kicking, striking and catching);
- rough and tumble play;
- physical challenges to develop social-emotional well-being

* All participants will be provided with program resources including handbook, logbooks and sports equipment pack.

Phase 2 (home-based)

* The second phase of the intervention is home-based. The primary interface will be a 'DADEE' App which will include physical activity tasks for fathers to complete with their daughter/s between weeks 8 and 36. Both fathers and daughters will have access to the app. Participants will be advised to complete activities from a variety of categories equating to a minimum time investment of 30-60 minutes per week.

Adherence to the intervention will be monitored by:
- Attendance records at the sessions
- Compliance to home tasks by dads and daughters
- Activities completed on the DADEE app
Intervention code [1] 290759 0
Lifestyle
Intervention code [2] 290760 0
Behaviour
Comparator / control treatment
Wait-list control group for 36 weeks. The wait-list control group will be offered the intervention after the 36 week assessment.
Control group
Active

Outcomes
Primary outcome [1] 293760 0
Father physical activity (steps/day) measured with Yamax SW200 pedometers.
Timepoint [1] 293760 0
Baseline, 8- & 36-weeks post-baseline
Primary outcome [2] 293761 0
Daughter physical activity (steps/day) measured with Yamax SW200 pedometers.
Timepoint [2] 293761 0
Baseline, 8- & 36-weeks post-baseline
Secondary outcome [1] 311901 0
Weight for fathers and daughters (kg) using calibrated electronic scales
Timepoint [1] 311901 0
Baseline, 8- & 36-weeks post-baseline
Secondary outcome [2] 311902 0
Height of fathers and daughters (cm) (calibrated stadiometer)
Timepoint [2] 311902 0
Baseline, 8- & 36-weeks post-baseline
Secondary outcome [3] 311903 0
Body Mass Index (BMI) for fathers using the formula: weight in kilograms divided by the square of height in meters.

BMI for daughters (BMI-z) will be calculated similarly using standard deviation for children's scores related to age and gender
Timepoint [3] 311903 0
Baseline, 8- & 36-weeks post-baseline
Secondary outcome [4] 311942 0
Object Control Fundamental Movement Skill competency for daughters; measured using the Test of Gross Motor Development II:

- Striking a stationary ball
- Catch
- Kick
- Overhand throw
- Stationary dribble

Test of Gross Motor Development III

- Underhand throw
Timepoint [4] 311942 0
Baseline, 8- & 36-weeks post-baseline
Secondary outcome [5] 311943 0
Perceptions of the Father Role; measured with a scale from the "Early Childhood Longitudinal Study Father Survey" [Father report]
Timepoint [5] 311943 0
Baseline, 8- & 36-weeks post-baseline
Secondary outcome [6] 311944 0
Father Engagement; measured with the "Inventory of Father Involvement" plus validated scales from the "Longitudinal Study of Australian Children Survey", the "Early Childhood Longitudinal Study Father Survey", and the "Child Development Supplement of the Panel Study of Income Dynamics" [Father Report]
Timepoint [6] 311944 0
Baseline, 8- & 36-weeks post-baseline
Secondary outcome [7] 311945 0
Daughters' Social Emotional Wellbeing; measured with the "Strengths and Difficulties Questionnaire" (Emotional symptoms, Prosocial Behaviour subscales) [Father, Mother + eldest daughter reports] plus the "Devereux Student Strengths Assessment" [Father + Mother reports]
Timepoint [7] 311945 0
Baseline, 8- & 36-weeks post-baseline
Secondary outcome [8] 312310 0
Father-Daughter Relationship; measured with the "Parent Child Relationships Questionnaire" [Father + Eldest Daughter Report]
Timepoint [8] 312310 0
Baseline, 8- & 36-weeks post-baseline
Secondary outcome [9] 312311 0
Co-Physical Activity; measured with an adapted item from the "Youth Media Campaign Longitudinal Survey" [Father Report]
Timepoint [9] 312311 0
Baseline, 8- & 36-weeks post-baseline
Secondary outcome [10] 312312 0
Role Modelling; measured with the explicit role modelling scale from the "Activity Support Scale" [Father Report]
Timepoint [10] 312312 0
Baseline, 8- & 36-weeks post-baseline
Secondary outcome [11] 312313 0
Parenting for Physical Activity; measured with scales from the "Parenting for Eating and Activity Scale" [Father Report]
Timepoint [11] 312313 0
Baseline, 8- & 36-weeks post-baseline
Secondary outcome [12] 312314 0
Father-Mother/Partner Relationship; measured with items from the "Longitufinal Study of Australian Children Survey" [Father + Mother Report]
Timepoint [12] 312314 0
Baseline, 8- & 36-weeks post-baseline
Secondary outcome [13] 312315 0
Daughter's Screen Time Behaviour; measured with items from the "Children's Lesiure Acitivites Study Survey" [Father + Mother Report]
Timepoint [13] 312315 0
Baseline, 8- & 36-weeks post-baseline
Secondary outcome [14] 312316 0
Daughters Perceived Sports Competence; measured with the sports competence scale of the "Physical Self-Description Questionnaire" [Daughter Report]
Timepoint [14] 312316 0
Baseline, 8- & 36-weeks post-baseline
Secondary outcome [15] 312317 0
Daughters Global Self-Perception; measured with the global self-perception scale from "Harters Physical Self-perception Profile" [Daughter Report]
Timepoint [15] 312317 0
Baseline, 8- & 36-weeks post-baseline
Secondary outcome [16] 312318 0
Daughters Perceived Sports Skills Competence; measured with the object control items from the "Pictorial Scale of Perceived Movement Skill Competence for Young Children" [Daughter Report]
Timepoint [16] 312318 0
Baseline, 8- & 36-weeks post-baseline
Secondary outcome [17] 312319 0
Father Moderate-to-Vigorous Physical Activity; measured with an adapted version of the "Godin Leisure Time Exercise Questionnaire" [Father report]
Timepoint [17] 312319 0
Baseline, 8- & 36-weeks post-baseline
Secondary outcome [18] 312320 0
Fathers Resting Heart Rate; measured with Polar Heart Rate Monitors (Polar H7 Heart rate sensor) which display heart rate through the ‘Polar Team’ App.
Timepoint [18] 312320 0
Baseline, 8- & 36-weeks post-baseline

Eligibility
Key inclusion criteria
Men can participate in this project if they:

- Are a father, step father or male guardian (who lives with their daughter at least three days of the week)

- Have a daughter who attends primary school (K-6)

- Are able to pass a health-screening questionnaire

Daughters can participate in this project if they currently attend primary school (K-6).
Minimum age
5 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Men will not be eligible to participate if they have:

- A history of major medical problems such as heart disease or diabetes

- Orthopedic or joint problems that would be a barrier to completing physical activity such as walking

There are no additional key exclusion criteria for the daughters.

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)
Study information for the two different groups (DADEE program group and wait-list control) will be pre-packed into identical, sealed opaque envelopes and consecutively numbered and ordered according to the randomisation schedule.

The packing and sequencing of these envelopes will be completed by a research assistant who will not be involved in enrolment, assessment or allocation of participants.

Study participants will complete all baseline assessments before proceeding to a separate room to meet with a research assistant who will not be involved with assessments. The allocation sequence will be concealed during this process.

Families will be stratified by father's BMI and their name will be written down in the next available position on the relevant randomisation schedule. At this point the corresponding envelope for that position will be opened by the research assistant and details of the group assignment will be provided to the family using a standardised protocol.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation allocation sequence will be generated by a statistician who will not have any contact with participants during the trial. Allocation will be stratified by father's BMI and the allocation sequence within strata will be generated by a computer based random number producing algorithm.

Randomisation codes will be stored in a restricted computer folder, which will not be accessible by those assessing participants, those involved in group allocating participants or those participating in data entry for the study.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Analyses investigating the efficacy of the DADEE program will be adjusted for age, ses, and the interactions of these covariates with time and treatment, where significant.

A sample size of 86 fathers will provide 80% power to detect a 1500 step/day difference in physical activity between the intervention and control groups at 8 weeks with 15% attrition (p<0.05). This calculation is based on a correlation between pre and post scores of 0.64 and a baseline standard deviation of 2643 steps/day (values derived from fathers in the Healthy Dads Healthy Kids pilot study, which tested a healthy lifestyle program for fathers and their primary school aged children).

Similarly, a sample size of 134 daughters will provide 80% power to detect a 1500 step/day difference in physical activity between the intervention and control groups at 8 weeks with 15% attrition (p<0.05). This calculation is based on a correlation between pre and post scores of 0.58 and a baseline standard deviation of 3082 steps/day (values derived from daughters in the Healthy Dads Healthy Kids pilot study).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
19/01/2015
Actual
19/01/2015
Date of last participant enrolment
Anticipated
Actual
2/02/2015
Date of last data collection
Anticipated
Actual
17/10/2015
Sample size
Target
220
Accrual to date
Final
268
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 290373 0
Other Collaborative groups
Name [1] 290373 0
Hunter Medical Research Institute
Country [1] 290373 0
Australia
Funding source category [2] 290374 0
Other Collaborative groups
Name [2] 290374 0
Port Waratah Coal Services
Country [2] 290374 0
Australia
Funding source category [3] 290403 0
Other Collaborative groups
Name [3] 290403 0
Hunter Children's Research Foundation (HCRF)
Country [3] 290403 0
Australia
Primary sponsor type
Individual
Name
Professor Philip Morgan
Address
Priority Research Centre for Physical Activity and Nutrition
School of Education
Faculty of Education and Arts
University Drive
University of Newcastle
Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 289100 0
None
Name [1] 289100 0
Address [1] 289100 0
Country [1] 289100 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292076 0
The University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 292076 0
Ethics committee country [1] 292076 0
Australia
Date submitted for ethics approval [1] 292076 0
Approval date [1] 292076 0
06/11/2014
Ethics approval number [1] 292076 0
H-2014-0330

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

Contacts
Principal investigator
Name 53298 0
Prof Philip Morgan
Address 53298 0
Priority Research Centre in Physical Activity and Nutrition University Drive University of Newcaslte Callaghan NSW 2308
Country 53298 0
Australia
Phone 53298 0
+61 2 4921 7265
Fax 53298 0
Email 53298 0
[email protected]
Contact person for public queries
Name 53299 0
Alyce Barnes
Address 53299 0
School of Education Faculty of Education and Arts University of Newcastle University Drive Callaghan NSW 2308
Country 53299 0
Australia
Phone 53299 0
+61 2 49216566
Fax 53299 0
Email 53299 0
[email protected]
Contact person for scientific queries
Name 53300 0
Philip Morgan
Address 53300 0
School of Education Faculty of Education and Arts University of Newcastle University Drive Callaghan NSW 2308
Country 53300 0
Australia
Phone 53300 0
+61 2 4921 7265
Fax 53300 0
Email 53300 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
Please contact [email protected] for data sharing requests.


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
EmbaseFundamental movement skills: Where do girls fall short? A novel investigation of object-control skill execution in primary-school aged girls.2018https://dx.doi.org/10.1016/j.pmedr.2018.06.005
N.B. These documents automatically identified may not have been verified by the study sponsor.