Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12617001450303
Ethics application status
Approved
Date submitted
4/10/2017
Date registered
12/10/2017
Date last updated
12/10/2023
Date data sharing statement initially provided
21/10/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The 'Dads And Daughters Exercising and Empowered' (DADEE) Community Rollout: Effectiveness of a father-daughter physical activity program delivered by trained facilitators in community settings
Scientific title
The 'Dads And Daughters Exercising and Empowered' (DADEE) Community Rollout: Effectiveness of a father-daughter physical activity program delivered by trained facilitators on meeting physical activity recommendations.
Secondary ID [1] 293049 0
Nil
Universal Trial Number (UTN)
Trial acronym
DADEE (Dads And Daughters Exercising and Empowered)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical inactivity 304959 0
Condition category
Condition code
Public Health 304291 304291 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
* Fathers and daughters will attend 9 weekly face-face sessions of the DADEE program together.

* Each session will be broken up into 3 components:

(i) a 15-minute education session with fathers and daughters together;
(ii) a 30-minute education session for fathers and daughters conducted separately;
(ii) a 45-minute practical session where fathers and daughters participate together.

Mothers and siblings will also be invited to attend session 4 of the program, where all family members participate in the activities together..

* The sessions will be group-based (~20 families), delivered by university-trained facilitators (qualified and pre-service teachers) at local school halls.

For fathers, the education sessions focus on proven parenting strategies to improve their daughters’ social-emotional well-being, sports skills and physical activity levels.

The daughters’ education sessions focus on developing key social and emotional skills including self-control, persistence, critical thinking, resilience, and self-reliance.

The 45-minute DADEE practical sessions focus on 3 key areas - Rough and Tumble Play, Fitness and Fundamental Movement Skills.

* All fathers will be provided with program resources including a t-shirt, a folder containing session summaries, a sports skills booklet and a log book to document brief tasks (e.g., step count monitoring).

* All daughters will receive a t-shirt and a booklet with session summaries. As in the sessions, the daughters material will cover similar themes to the dads material, but will be tailored for the age group.

*All participants will have access to the 'DADEE' App for the duration of the program (and beyond the study period). This app includes physical activity tasks for fathers to complete with their daughter/s at home (e.g., rough and tumble play activities, fitness circuits, sports skills games). Brief instructions are provided for each task on the app. Participants will be advised to complete activities from a variety of categories equating to an approximate time investment of 30 minutes per week.

Adherence to the intervention will be monitored by:
- Attendance records at the sessions
- Activities completed in the Dads Log Book
- Activities completed on the DADEE app
Intervention code [1] 299282 0
Lifestyle
Intervention code [2] 299283 0
Behaviour
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 303574 0
Days Meeting Physical Activity Recommendations (Fathers), measured with a single item from the Australian Bureau of Statistics 'Australian Health Survey' [father-report]
Timepoint [1] 303574 0
Baseline, 3 months post-baseline (primary time-point) and 12 months post-baseline
Primary outcome [2] 303575 0
Days Meeting Physical Activity Recommendations (Daughters), measured with a single item from the Australian Bureau of Statistics 'Australian Health Survey' [father-proxy]
Timepoint [2] 303575 0
Baseline, 3 months post-baseline (primary time-point) and 12 months post-baseline
Secondary outcome [1] 339439 0
Days Meeting Screen Time Recommendations (Daughters), measured with a single item from the Australian Bureau of Statistics, Australian Health Survey [father-proxy]
Timepoint [1] 339439 0
Baseline, 3 months post-baseline and 12 months post-baseline
Secondary outcome [2] 339441 0
Moderate-to-Vigorous Physical Activity (Fathers), measured with an adapted version of the 'Godin Leisure Time Exercise Questionnaire' [father-report']
Timepoint [2] 339441 0
Baseline, 3 months post-baseline and 12 months post-baseline
Secondary outcome [3] 339443 0
Father-Daughter Co-Physical Activity, measured with an adapted item from the Youth Media Campaign Longitudinal Survey [father-report]
Timepoint [3] 339443 0
Baseline, 3 months post-baseline and 12 months post-baseline
Secondary outcome [4] 339445 0
Screen-Time (Fathers), measured with an adapted version of the Adolescent Sedentary Activity Questionnaire [father-report]
Timepoint [4] 339445 0
Baseline, 3 months post-baseline and 12 months post-baseline
Secondary outcome [5] 339446 0
Screen-Time (Daughters), measured with an adapted version of the Adolescent Sedentary Activity Questionnaire [father-proxy]
Timepoint [5] 339446 0
Baseline, 3 months post-baseline and 12 months post-baseline
Secondary outcome [6] 339447 0
Father Involvement, measured with selected subscales from the Inventory of Father Involvement (mother support, praise and affection, time and talking together, attentiveness) [father-report]
Timepoint [6] 339447 0
Baseline, 3 months post-baseline and 12 months post-baseline
Secondary outcome [7] 339448 0
Self-esteem (Daughters), measured with the self-esteem subscale from the Kindl (7 years +) or Kiddy-Kindl (4-6 years) [father-proxy]
Timepoint [7] 339448 0
Baseline, 3 months post-baseline and 12 months post-baseline
Secondary outcome [8] 339449 0
Social-Emotional Well-Being (Daughters), measured with the Devereux Students Strengths Assessment [father-proxy]
Timepoint [8] 339449 0
Baseline, 3 months post-baseline and 12 months post-baseline
Secondary outcome [9] 339450 0
Father-Daughter Relationship, measured with the disciplinary warmth and personal relationships subscales from the Parent Child Relationships Questionnaire [father-report]
Timepoint [9] 339450 0
Baseline, 3 months post-baseline and 12 months post-baseline
Secondary outcome [10] 339656 0
Family Functioning (Daughters), measured with the family subscale from the Kindl (7 years +) or Kiddy-Kindl (4-6 years) [father-proxy]
Timepoint [10] 339656 0
Baseline, 3 months post-baseline and 12 months post-baseline

Eligibility
Key inclusion criteria
Men can participate if they:

- Are a father or father-figure of a daughter currently attending primary school (K - 6)
- Are able to pass a health-screening questionnaire.
- Are able to attend the program sessions
- Are able to attend program assessments

Aside from attending primary school (K-6), there are no additional eligibility criteria for daughters.
Minimum age
4 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Men with notable pre-existing health conditions (e.g., history of cardiovascular disease, recent chest pains while exercising) will require a doctor's clearance prior to enrollment.

There are no additional exclusion criteria for daughters.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not applicable.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
In total, the DADEE Program will be evaluated on 12 occasions over 3 years (4 programs per year), with approximately 20 families participating in each program.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Mixed effects regression models will be used to investigate the outcomes at all time points and adjusted for SES (SEIFA decile), cohort year, previous involvement in the program, number of daughters enrolled in program, age of father (father outcomes only) and age of eldest daughter. Random individual-level intercepts will be included in all models to adjust for correlation of outcomes due to the same individual being measured at multiple timepoints. Model estimates (Incidence rate ratio [IRR], or average difference) with 95% confidence intervals (CIs) and p-values will be presented. For all models, statistical significance will be assessed at the 5% level. Missing data will be handled using the mixed modelling framework. Effect sizes will be calculated using Cohen-d (d = M1-M2/s pooled).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
23/10/2017
Actual
16/10/2017
Date of last participant enrolment
Anticipated
1/11/2019
Actual
21/10/2019
Date of last data collection
Anticipated
20/12/2020
Actual
21/12/2020
Sample size
Target
560
Accrual to date
Final
542
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 297664 0
Charities/Societies/Foundations
Name [1] 297664 0
Hunter Medical Research Institute
Country [1] 297664 0
Australia
Funding source category [2] 297665 0
Commercial sector/Industry
Name [2] 297665 0
Port Waratah Coal Services
Country [2] 297665 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] 296691 0
None
Name [1] 296691 0
Address [1] 296691 0
Country [1] 296691 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298746 0
University of Newcastle's Human Research Ethics Committee
Ethics committee address [1] 298746 0
Ethics committee country [1] 298746 0
Australia
Date submitted for ethics approval [1] 298746 0
Approval date [1] 298746 0
22/09/2017
Ethics approval number [1] 298746 0

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

Contacts
Principal investigator
Name 78094 0
Prof Philip Morgan
Address 78094 0
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 78094 0
Australia
Phone 78094 0
+61249217265
Fax 78094 0
Email 78094 0
[email protected]
Contact person for public queries
Name 78095 0
Philip Morgan
Address 78095 0
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 78095 0
Australia
Phone 78095 0
+61249217265
Fax 78095 0
Email 78095 0
[email protected]
Contact person for scientific queries
Name 78096 0
Philip Morgan
Address 78096 0
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 78096 0
Australia
Phone 78096 0
+61249217265
Fax 78096 0
Email 78096 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
When will data be available (start and end dates)?
Beginning 6 months and ending 5 years following article publication
Available to whom?
Data will be available on a case-by-case basis at the discretion of the chief investigator to researchers who provide a methodologically sound proposal.
Available for what types of analyses?
Data will be available only to achieve the aims in the approved proposal
How or where can data be obtained?
Access to data will be subject to approvals by Principal Investigator Please contact chief investigator [email protected] to discuss any 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
No additional documents have been identified.