Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000264886
Ethics application status
Approved
Date submitted
13/01/2021
Date registered
10/03/2021
Date last updated
28/07/2024
Date data sharing statement initially provided
10/03/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Process evaluation of the 'Daughters and Dads Active And Empowered' program when delivered by trained facilitators in community settings.
Scientific title
Process evaluation of the 'Daughters and Dads Active And Empowered' program when delivered by trained facilitators in community settings: an investigation of recruitment, fidelity, compliance, attendance and satisfaction.
Secondary ID [1] 303153 0
N/A
Universal Trial Number (UTN)
Trial acronym
DADAE (Daughters And Dads Active and Empowered
Linked study record
This study is a follow-on from the RCT ACTRN12617001450303

Health condition
Health condition(s) or problem(s) studied:
Physical Inactivity 320268 0
Poor dietary behaviour 320269 0
Obesity 320270 0
Overweight 320271 0
Condition category
Condition code
Public Health 318198 318198 0 0
Health promotion/education
Diet and Nutrition 318511 318511 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Fathers will attend one 2-hour Dads-only education session covering all key content.

One week later, fathers and daughters will attend 8 weekly face-face sessions of the Daughters And Dads Active and Empowered program together, with the total duration of the study being 9-weeks.

* Each of the 8 weekly daughters and dads session will be broken up into 2 components:
(i) a 30-minute education session with fathers and daughters together
(ii) a 60-minute practical session where fathers and daughters participate together,

For Dads-only, education sessions focus on proven parenting key topic areas to improve their daughters’ social-emotional well-being, sports skills and physical activity levels.

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

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

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

*All fathers and daughters will be provided with program resources including a t-shirt, and a Home activity handbook containing tasks for fathers and daughters to complete together at home (e.g., activity and co-physical activity tracking, practicing social and emotional skills, rough and tumble play activities, fitness circuits, sports skills games). Brief instructions are provided for each task. Participants will be advised to complete activities from a variety of categories equating to a minimum approximate time investment of 12 minutes per week. The program resources/activity handbook is designed specifically for this study.

Adherence to the intervention will be monitored by:
- Attendance records at the sessions
- Activities completed on the Handbook
Intervention code [1] 319460 0
Lifestyle
Intervention code [2] 319461 0
Behaviour
Intervention code [3] 319694 0
Prevention
Comparator / control treatment
The program will be evaluated using a non-randomized, prospective design without a control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 326183 0
The primary trial outcome will be whether or not at least 4 of the following 5 process outcomes are achieved.
1. Fidelity of the program delivery - Fidelity will be defined as successful delivery of at least 80% of the session content by facilitators during the fathers-only workshops and the dads & daughter sessions (including physical activity tasks (e.g. rough and tumble play, sport skills and fitness)). This will be measured by weekly post session reflections completed by the facilitators and an independent observation of at least two sessions per program. This is guided by a set of questions/checklist designed specifically for this study.
Timepoint [1] 326183 0
Baseline, 10 weeks post baseline (primary endpoint) and 12 months post baseline.
Primary outcome [2] 326466 0
2. Attendance – assessed using workshop attendance checklists and measured by percentage of DADAE sessions attended . Defined as at least 70% attendance at the fathers-only workshops and the father-and-daughter sessions on average across the eight weeks.
Timepoint [2] 326466 0
Baseline, 10 weeks post baseline (primary endpoint) and 12 months post baseline.
Primary outcome [3] 326467 0
3. Compliance – as measured by the number of home tasks completed by Dads and their daughter. Successful compliance will be defined as Families completing at least 70% of the home-based tasks in the activity handbook. The activity handbooks will be collected after the final session by the University of Newcastle research team and the number of activities completed will be recorded.
Timepoint [3] 326467 0
Baseline, 10 weeks post baseline (primary endpoint) and 12 months post baseline.
Secondary outcome [1] 390413 0
*PRIMARY OUTCOME (#4)
4. Satisfaction – Success will be defined as a mean score of at least 4 out of 5 for satisfaction items measured via questionnaire using a 5-point Likert scale.
Timepoint [1] 390413 0
Baseline, 10 weeks post baseline (primary endpoint) and 12 months post baseline.
Secondary outcome [2] 390414 0
PRIMARY OUTCOME (#5)
5. Recruitment – achievement of recruitment targets for participants (at least 60 families per year), DADAE programs (at least 3 per year) and host community locations (at least 3 different locations).
Timepoint [2] 390414 0
Baseline, 10 weeks post baseline (primary endpoint) and 12 months post baseline.
Secondary outcome [3] 390415 0
Fathers Moderate-to-vigorous physical activity (MVPA) - Average weekly MVPA was measured with a modified version of the Godin Leisure Time Exercise Questionnaire.

Overall weekly minutes MVPA calculated by multiplying self-reported average weekly number of MVPA bouts by average bout length in minutes
Timepoint [3] 390415 0
Baseline, 10 weeks post baseline and 12 months post baseline.
Secondary outcome [4] 390417 0
Fathers Co-physical activity - Adapted item from the validated Youth Media Campaign Longitudinal Survey.

Fathers report on days per week they were physically active with their child one-on-one and with one or more family member.
Timepoint [4] 390417 0
Baseline, 10 weeks post baseline and 12 months post baseline.
Secondary outcome [5] 390418 0
Father Screen time - Screen-time measured using a modified version of the Adolescent Sedentary Activity Questionnaire.
Timepoint [5] 390418 0
Baseline, 10 weeks post baseline and 12 months post baseline.
Secondary outcome [6] 390419 0
Daughters screen time - measured using an adapted version of the Adolescent Sedentary Activity Questionnaire [father report]

Fathers report the total time in hours and minutes that they and their daughter spend sitting using screens (of any kind) for anything outside of work (for fathers) or homework (for daughters) on each day in the previous week.
Timepoint [6] 390419 0
Baseline, 10 weeks post baseline and 12 months post baseline.
Secondary outcome [7] 390420 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]

Each subscale scores created by asking fathers to report, on a 7-point Likert scale (1 = very poor, 7 = excellent), on “how good a job” they were doing on indicators of father involvement and taking the mean
Timepoint [7] 390420 0
Baseline, 10 weeks post baseline and 12 months post baseline.
Secondary outcome [8] 390421 0
Daughters’ self esteem - Measured with the self-esteem subscale from the Kindl [father-proxy]
Timepoint [8] 390421 0
Baseline, 10 weeks post baseline and 12 months post baseline.
Secondary outcome [9] 390422 0
Family functioning - measured with the family subscale from the Kindl [father-proxy]
Timepoint [9] 390422 0
Baseline, 10 weeks post baseline and 12 months post baseline..
Secondary outcome [10] 390423 0
Daughters’ social-emotional well-being - measured with the Devereux Students Strengths Assessment (DESSA)
[father-proxy]

The DESSA is a 72-item questionnaire organised into 8 social-emotional competency scales: self-awareness (7 items); social-awareness (9 items); Self-management (11 items); goal-directed behaviour (10 items); relationship skills (10 items); personal responsibility (10 items); decision making (8 items); optimistic thinking (7 items).
Timepoint [10] 390423 0
Baseline, 10 weeks post baseline and 12 months post baseline.
Secondary outcome [11] 390424 0
Father-daughter relationship measured with the disciplinary warmth and personal relationships subscales from the Parent Child Relationships Questionnaire [father-report]
Timepoint [11] 390424 0
Baseline, 10 weeks post baseline and 12 months post baseline.
Secondary outcome [12] 391590 0
Fathers MVPA (single item) - Self-reported days per week meeting physical activity recommendations measured with a single item from the Australian Bureau of Statistics 'Australian Health Survey'
Timepoint [12] 391590 0
Baseline, 10 weeks post baseline and 12 months post baseline.
Secondary outcome [13] 391591 0
Daughters MVPA (single item) - Self- reported days per week meeting physical activity recommendations measured with a single item from the Australian Bureau of Statistics 'Australian Health Survey'
Timepoint [13] 391591 0
Baseline, 10 weeks 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)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
In total, the DADAE Program will evaluate 3 programs per year for a period of 2 years, with approximately 60 families participating per year
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive analyses (percentage and frequency counts) will be conducted to assess fidelity, compliance, recruitment, attendance, retention, and program satisfaction. For secondary outcomes, Linear or Poisson mixed models will be conducted to establish change from baseline to post-intervention. Models will be adjusted for age, socioeconomic status and year of program. To deal with outliers, standardised values (z scores) will be created. Variables which had standardised scores above 3.29 will be truncated to a value 1 unit greater than the next lowest value for that variable. Effect sizes will be calculated using Cohen-d (d = M1-M2/s pooled). Only participants who consent to be involved in research and participate in the program will be included in analysis.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
2/10/2020
Date of last participant enrolment
Anticipated
9/10/2023
Actual
18/10/2023
Date of last data collection
Anticipated
31/01/2025
Actual
Sample size
Target
571
Accrual to date
Final
522
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 307559 0
Commercial sector/Industry
Name [1] 307559 0
Port Waratah Coal Services
Country [1] 307559 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] 308246 0
None
Name [1] 308246 0
Address [1] 308246 0
Country [1] 308246 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307621 0
University of Newcastle's Human Research Ethics Committee
Ethics committee address [1] 307621 0
Ethics committee country [1] 307621 0
Australia
Date submitted for ethics approval [1] 307621 0
Approval date [1] 307621 0
23/09/2020
Ethics approval number [1] 307621 0

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

Contacts
Principal investigator
Name 107890 0
Prof Philip Morgan
Address 107890 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 107890 0
Australia
Phone 107890 0
+61249217265
Fax 107890 0
Email 107890 0
[email protected]
Contact person for public queries
Name 107891 0
Philip Morgan
Address 107891 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 107891 0
Australia
Phone 107891 0
+61249217265
Fax 107891 0
Email 107891 0
[email protected]
Contact person for scientific queries
Name 107892 0
Philip Morgan
Address 107892 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 107892 0
Australia
Phone 107892 0
+61249217265
Fax 107892 0
Email 107892 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.