Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000901606
Ethics application status
Approved
Date submitted
4/08/2023
Date registered
22/08/2023
Date last updated
23/02/2024
Date data sharing statement initially provided
22/08/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility study of Healthy Dads, Healthy Mob: biya yadha gudjagang yadha for Aboriginal father/father figures and their children living on Darkinjung Country to optimise cardiovascular health.
Scientific title
Feasibility study of Healthy Dads, Healthy Mob: biya yadha gudjagang yadha for Aboriginal father/father figures and their children living on Darkinjung Country: an investigation of recruitment, retention and satisfaction.
Secondary ID [1] 310287 0
Nil known
Universal Trial Number (UTN)
Trial acronym
HDHM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical Inactivity 330981 0
Childhood Obesity 330982 0
Condition category
Condition code
Diet and Nutrition 327801 327801 0 0
Obesity
Public Health 327802 327802 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The 'Healthy Dads, Healthy Mob: biya yadha gudjagang yadha' intervention duration will be one session per week, for 9 weeks, and will include:
• 1 x ‘dads-only’ information session (90 minutes: face-to-face)
• 8 x sessions that Dads and their child/ren attend together (90 minutes: face-to-face).

Each father and child program session will be broken up into 2 components:
- A 30-minute welcome and education session conducted for fathers and children together. This education session will be delivered verbally and with the use of a visual presentation (using powerpoint which includes interactive activities, short videos, gifs, imagery and text.).
- A 60-minute practical session where fathers and children participate together.

The sessions will focus on:
• Positive parenting strategies.
• Fundamental movement skills (e.g. throwing, kicking, striking and catching);
• Rough and tumble play;
• Health-related fitness;
• Healthy eating for families;
• Social-emotional well-being
• Culture and health;
• Positive Aboriginal and Torres Strait Islander role models;
• Pressures e.g. drugs, alcohol, risk-taking;
• Fun and active household and backyard games.

The sessions will be run by a lead facilitator (Mr. Jake MacDonald), whose main role will be to deliver all learning experiences, and potentially a co-facilitator (depending on participant numbers), who will provide a supporting role during all sessions (e.g., equipment organisation, management of group-based activities), administrative support prior to sessions (attendance sheets and home program compliance [which will be assessed by review of completed activity handbooks]) and following sessions (participant feedback questionnaires in the final program session). Mr MacDonald is a proud Ngarabal man, previous Physical Education teacher and PhD student at the University of Newcastle (UON).

In addition to these sessions, participants will receive the following program resources:
• A t-shirt each, water bottle and bag.
• An activity handbook developed for this study with a range of activities for fathers and children to complete at home between sessions. The activities include fundamental movement skill practice and home activities that match each session theme (e.g. nutrition, culture, physical activity) (approx. 30-minute time commitment per week).
Intervention code [1] 326669 0
Lifestyle
Intervention code [2] 326670 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 335646 0
Satisfaction - 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 [father-report].
Timepoint [1] 335646 0
3 months post-baseline.
Primary outcome [2] 335647 0
Recruitment and retention - Measured by achieving target of participants (approximately 20 families) and retaining 70% of participants. Assessed by audit of study enrolment logs.
Timepoint [2] 335647 0
3 months post-baseline.
Secondary outcome [1] 425042 0
Fidelity of the program delivery - Fidelity will be defined as the delivery of at least 80% of the session content by facilitators during the fathers-only workshop and the dads & children 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] 425042 0
3 months post-baseline.
Secondary outcome [2] 425044 0
Attendance - Assessed using attendance records and measured by percentage of sessions attended. Defined as at least 70% attendance at the dads-only workshops and the father-and-child sessions on average across the eight weeks.
Timepoint [2] 425044 0
3 months post-baseline.
Secondary outcome [3] 425045 0
Compliance - Measured by the number of home tasks completed by Dads and their children. Compliance will be defined as families completing at least 60% 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] 425045 0
3 months post-baseline.
Secondary outcome [4] 425046 0
Father-child co-physical activity - Validated items adapted from the Youth Media Campaign Longitudinal Survey regarding days in past week that fathers were physically active with child [father report].
Timepoint [4] 425046 0
Baseline and 3 months post-baseline.
Secondary outcome [5] 425047 0
Body Mass Index (BMI) (fathers): calculated using the standard formula (i.e., weight in kilograms divided by the square of height in metres).

As mentioned below, height will be measured using a calibrated stadiometer, and weight will be measured using calibrated electronic scales.
Timepoint [5] 425047 0
Baseline and 3 months post-baseline.
Secondary outcome [6] 425048 0
Body Mass Index z-score (BMI-z) (children): calculated using age- and sex-adjusted standardised scores.
Timepoint [6] 425048 0
Baseline and 3 months post-baseline.
Secondary outcome [7] 425049 0
Weight (fathers and children) - measured using calibrated electronic scales.
Timepoint [7] 425049 0
Baseline and 3 months post-baseline.
Secondary outcome [8] 425050 0
Height (fathers and children) - measured using calibrated stadiometer.
Timepoint [8] 425050 0
Baseline and 3 months post-baseline.
Secondary outcome [9] 425051 0
Fathers Moderate-to-vigorous physical activity (MVPA)- Average weekly MVPA measured with a modified version of the Godin-Shephard Leisure-Time Physical Activity Questionnaire. Overall weekly minutes MVPA calculated by multiplying self-reported average weekly number of MVPA bouts by average bout length in minutes [father-report].
Timepoint [9] 425051 0
Baseline and 3 months post-baseline.
Secondary outcome [10] 425052 0
Physical Activity (fathers) - Self-reported days per week meeting physical activity recommendations measured with a single item from the Australian Bureau of Statistics ‘National Health Survey’ [father-report].
Timepoint [10] 425052 0
Baseline and 3 months post-baseline.
Secondary outcome [11] 425053 0
Physical Activity (children) - Self-reported days per week meeting physical activity recommendations measured with a single item from the Australian Bureau of Statistics ‘National Health Survey’ [father report].
Timepoint [11] 425053 0
Baseline and 3 months post-baseline.
Secondary outcome [12] 425054 0
Dietary intake (fathers) - Measured using an adapted version of the Many Rivers Short Food Frequency Questionnaire (MRSFFQ) [Validated in Aboriginal and Torres Strait Islander children] with the recommendations from the Go4Fun program [father-report].
Timepoint [12] 425054 0
Baseline and 3 months post-baseline.
Secondary outcome [13] 425055 0
Dietary intake (children) - Measured using an adapted version of the Many Rivers Short Food Frequency Questionnaire (MRSFFQ) [Validated in Aboriginal and Torres Strait Islander children] with the recommendations from the Go4Fun program [father-report].
Timepoint [13] 425055 0
Baseline and 3 months post-baseline.
Secondary outcome [14] 425056 0
Father-child relationship - measured with the disciplinary warmth and personal relationships subscales from the Parent Child Relationships Questionnaire [father-report].
Timepoint [14] 425056 0
Baseline and 3 months post-baseline.
Secondary outcome [15] 425057 0
Culture and Identity - Measured using the 3-item cultural engagement scale (Shepherd, Delgado, Sherwood, Paradies, 2018) [father-report].
Timepoint [15] 425057 0
Baseline and 3 months post-baseline.
Secondary outcome [16] 425058 0
Positive aspects of the program for fathers/father-figures and their child/ren [father-report]. This will be measured by a qualitative assessment specifically designed for this study, using an audio-recorded, group yarning session with a member of the research team with participants who opt-in to participate. We will only conduct this yarning session if 50% or more of participants opt-in.
Timepoint [16] 425058 0
3 months post-baseline.
Secondary outcome [17] 425059 0
Aspects of the program that could be improved for fathers/father-figures and their child/ren [father-report]. This will be measured by a qualitative assessment specifically designed for this study, using an audio-recorded, group yarning session with a member of the research team with participants who opt-in to participate. We will only conduct this yarning session if 50% or more of participants opt-in.
Timepoint [17] 425059 0
3 months post-baseline.
Secondary outcome [18] 425060 0
Overall impact of the program on fathers/father-figures and their child/ren [father-report]. This will be measured by a qualitative assessment specifically designed for this study, using an audio-recorded, group yarning session with a member of the research team with participants who opt-in to participate. We will only conduct this yarning session if 50% or more of participants opt-in.
Timepoint [18] 425060 0
3 months post-baseline.

Eligibility
Key inclusion criteria
Men can participate if they:
• Identify as Aboriginal and/or Torres Strait Islander.
• Are living on Darkinjung Country.
• Are a father, step-father or father-figure to a child who attends primary school in the year of the trial (aged 5-12 years).
• Pass a pre-exercise health screening questionnaire and /or provide GP clearance to participate.

Children can participate if they attend primary school in the year of the trial (aged 5-12 years).
Minimum age
5 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Men will require a doctor’s clearance to participate if they report any concerns on a pre-exercise screening questionnaire (e.g., history of heart pains during exercise).

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



Intervention assignment
Single group
Other design features
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, Paired t-test will be used to compare mean scores at pre-intervention and post-intervention, and effect sizes calculated using Cohen d. Only participants who consent to be involved in research will be included in analysis. A Thematic Network Analysis will be used to analyse the qualitative data from the post-program yarning session.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2023
Actual
7/09/2023
Date of last participant enrolment
Anticipated
9/10/2023
Actual
29/09/2023
Date of last data collection
Anticipated
1/03/2024
Actual
14/12/2023
Sample size
Target
20
Accrual to date
Final
15
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 314499 0
Other
Name [1] 314499 0
National Heart Foundation of Australia
Country [1] 314499 0
Australia
Primary sponsor type
Individual
Name
Professor Philip Morgan
Address
School of Education,
Research Centre for Active Living & Learning,
College of Human and Social Futures.
University Drive,
University of Newcastle,
Callaghan NSW 2308.
Country
Australia
Secondary sponsor category [1] 316444 0
None
Name [1] 316444 0
Not applicable.
Address [1] 316444 0
Not applicable.
Country [1] 316444 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313544 0
Aboriginal Health and Medical Research Council (AH&MRC)
Ethics committee address [1] 313544 0
Ethics committee country [1] 313544 0
Australia
Date submitted for ethics approval [1] 313544 0
26/06/2023
Approval date [1] 313544 0
28/08/2023
Ethics approval number [1] 313544 0
41241564

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

Contacts
Principal investigator
Name 128494 0
Prof Philip Morgan
Address 128494 0
School of Education,
Research Centre for Active Living & Learning,
College of Human and Social Futures.
University Drive,
University of Newcastle,
Callaghan NSW 2308.
Country 128494 0
Australia
Phone 128494 0
+61 2 4921 7265
Fax 128494 0
Email 128494 0
[email protected]
Contact person for public queries
Name 128495 0
Philip Morgan
Address 128495 0
School of Education,
Research Centre for Active Living & Learning,
College of Human and Social Futures.
University Drive,
University of Newcastle,
Callaghan NSW 2308.
Country 128495 0
Australia
Phone 128495 0
+61 2 4921 7265
Fax 128495 0
Email 128495 0
[email protected]
Contact person for scientific queries
Name 128496 0
Philip Morgan
Address 128496 0
School of Education,
Research Centre for Active Living & Learning,
College of Human and Social Futures.
University Drive,
University of Newcastle,
Callaghan NSW 2308.
Country 128496 0
Australia
Phone 128496 0
+61 2 4921 7265
Fax 128496 0
Email 128496 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. We will provide participants with the initial report findings for consultation and to ensure that any changes are amended before dissemination/ publication.
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.