Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001463167
Ethics application status
Approved
Date submitted
11/10/2019
Date registered
22/10/2019
Date last updated
20/11/2023
Date data sharing statement initially provided
22/10/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Process evaluation of the Healthy Youngsters, Healthy Dads Community program: a healthy lifestyle program for fathers and their preschool-aged children delivered by trained facilitators in community settings
Scientific title
Process evaluation of the Healthy Youngsters, Healthy Dads Community program: a healthy lifestyle program for fathers and their preschool-aged children delivered by trained facilitators in community settings
Secondary ID [1] 299517 0
N/A
Universal Trial Number (UTN)
Trial acronym
HYHD
Linked study record
This study is a follow-on from the pilot trial ACTRN12618000135213 and RCT ACTRN12619000105145.

Health condition
Health condition(s) or problem(s) studied:
Physical inactivity 314766 0
Poor dietary behaviour 314767 0
Obesity 314768 0
Overweight 314769 0
Condition category
Condition code
Diet and Nutrition 313098 313098 0 0
Obesity
Public Health 313099 313099 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Healthy Youngsters Healthy Dads (HYHD) intervention is the same as that described in the RCT (ACTRN12619000105145).

In summary, the program is implemented face-to-face over 8 weeks with two ‘dads-only’ information workshops and eight weekly ‘dads-and-youngsters’ education and practical sessions. The two 'dads-only' workshops occur before week 1 and week 2 of the 'dads-and-youngsters' sessions. During each dads-only workshop, fathers learn evidenced-based strategies to improve their own lifestyle behaviours and parenting practices to improve their children’s physical activity, dietary habits, social-emotional well-being and sports skills.

Each dads-and-youngsters practical session is broken up into 2 components:
(i) A 20-minute educational session based on weekly theme, conducted for fathers and children together
(ii) A 55-minute practical session where fathers and children participate together in rough and tumble play (e.g. sock wrestles), health-related fitness (e.g. fitness circuits, shuttle carries) and fundamental movement skills (e.g. catching, kicking, throwing).
Mothers/partners and siblings will also be invited to attend session 5 of the program, where all family members participate in all activities together.

In addition to these sessions, participants will receive the following program resources:
- A t-shirt, 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 goal setting, fundamental movement skill practice, physical activity tracking and home challenges that match each session theme (e.g. nutrition, screen time, physical activity) (approx. 30-minute time commitment per week).

Both components will be delivered by local trained facilitators (qualified teachers and student teachers) at either the University of Newcastle or at local primary schools in the Newcastle region. All facilitators will attend a training course delivered by Professor Philip Morgan at the University of Newcastle where they will learn how to deliver the HYHD program and will receive resources to support their facilitation (e.g. facilitator manual).

When translating evidence-based programs into real-world settings ongoing modifications are required based on the unique characteristics of the settings and populations. Modifications will be made to the program based on both outcome and process evaluation of each subsequent program implementation in 2019 and 2020. The goal will be to develop a comprehensive model of a real-world intervention for application in communities through updating materials, developing standardized train-the-trainer education and resources and ongoing evaluation of the intervention implementation with a final evaluation conducted in 2020.
Intervention code [1] 315773 0
Lifestyle
Intervention code [2] 315774 0
Behaviour
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] 321639 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 & youngster 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.
2. Attendance – as measured by percentage of HYHD sessions attended. Defined as at least 70% attendance at the fathers-only workshops and the father-and-child sessions on average across the eight weeks.
3. Compliance – as measured by the number of home tasks completed by Dads and their Youngsters. 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.
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.
5. Recruitment – achievement of recruitment targets for participants (at least 12 families per program), HYHD programs (at least 4 per year) and host community locations (at least 2 different locations).
Timepoint [1] 321639 0
10 weeks post-baseline (primary endpoint)
Secondary outcome [1] 375709 0
Self-reported physical activity (fathers) measured using an adapted version of the Godin Leisure Time Exercise Questionnaire [father report]
Timepoint [1] 375709 0
At baseline and 10 weeks post-baseline and 12-months post-baseline
Secondary outcome [2] 375710 0
Father-child co-physical activity (days/week) - measured using an adapted item from the Youth Media Campaign Longitudinal Survey [father report]
Timepoint [2] 375710 0
At baseline and 10 weeks post-baseline and 12-months post-baseline
Secondary outcome [3] 375714 0
Screen time (fathers) measured using an adapted version of the Adolescent Sedentary Activity Questionnaire [father report]
Timepoint [3] 375714 0
At baseline and 10 weeks post-baseline and 12-months post-baseline
Secondary outcome [4] 375780 0
Screen time (child) measured using an adapted version of the Adolescent Sedentary Activity Questionnaire [father report]
Timepoint [4] 375780 0
At baseline and 10 weeks post-baseline and 12-months post-baseline
Secondary outcome [5] 375782 0
Father self-efficacy - measured using the positive engagement and direct care subscales of the Fathering Self Efficacy scale [father-report]
Timepoint [5] 375782 0
At baseline and 10 weeks post-baseline and 12-months post-baseline
Secondary outcome [6] 375783 0
Co-parenting (mothers and fathers) measured using Feinberg's co-parenting scale [father report]
Timepoint [6] 375783 0
At baseline and 10 weeks post-baseline and 12-months post-baseline
Secondary outcome [7] 375784 0
Dietary intake (fathers) - measured using an adapted version of the Many Rivers Short Food Frequency Questionnaire (MRSFFQ) with the recommendations from the Go4Fun program [father report]
Timepoint [7] 375784 0
At baseline and 10 weeks post-baseline and 12-months post-baseline
Secondary outcome [8] 375786 0
Dietary intake (child) - measured using an adapted version of the Many Rivers Short Food Frequency Questionnaire (MRSFFQ) with the recommendations from the Go4Fun program [father report]
Timepoint [8] 375786 0
At baseline and 10 weeks post-baseline and 12-months post-baseline
Secondary outcome [9] 375787 0
Average steps/day (children) - measured with one week of pedometry using YAMAX SW200 pedometers (average steps/day used for analysis where at least 4 days are recorded, including at least 1 weekend day). This outcome was only collected in 2020 cohort group.
Timepoint [9] 375787 0
At baseline and 10 weeks post-baseline
Secondary outcome [10] 375788 0
Average steps/day (fathers) - measured with one week of pedometry using YAMAX SW200 pedometers (average steps/day used for analysis where at least 4 days are recorded, including at least one weekend day). This outcome was only collected in 2020 cohort group
Timepoint [10] 375788 0
At baseline and 10 weeks post-baseline

Eligibility
Key inclusion criteria
Men can participate if they:

- Are a father, step father, grandfather or male guardian of a child aged 3-5 years
- Are able to pass a pre-exercise screening questionnaire for physical activity

Children can participate if they are 3-5 years old, but not attending primary school in the year of the trial.
Minimum age
3 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Men will require a doctors clearance to participate if they report any concerns on a pre-exercise screening questionnaire (e.g., history of heart pains during exercise).

Children cannot participate if they are:
- Younger than 3 years at the start of the program;
- Older than 5 years at the start of the program; or
- Attending primary school at the start of the program

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)
Subjects will complete an online eligibility survey which includes a pre-exercise screening questionnaire. If a participant meets the eligibility criteria they will be enrolled in the study.
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
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Mixed effects regression models will be used to investigate the outcomes. Mixed effects linear regression, adjusted for cohort year and previous involvement in the RCT (note: 71% of 2019 cohort we involved as a control group in related RCT), will be used to compare Father Self-efficacy score, Co-parenting score, and all three dietary intake variables (Dad and Child) at each of the applicable follow-up times. Mixed effects negative binomial regression, adjusted for cohort year and involvement in the RCT, will be used to compare MVPA and Weekly Average Screen time (Dad and Child) at each of the applicable follow-up times. Mixed effects gamma regression, with no adjustment, will be used to compare Average Steps/Day (Dad and Child) at each of the applicable follow-up times. 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. Correlation between individuals who undertook the program in the same session will also investigated through nested random intercept models. Correlation will be retained only in models for dad outcomes of Average Screen time and the Dietary Intake variables. In all other instances the correlation was found to be negligible and removed from the model. Model estimates (rate ratio [RR], or average difference) with 95% confidence intervals (CIs) and p-values will be presented. For all models, statistical significance is assessed at the 5% level.

Mixed effects hurdle gamma regression models, with random individual-level intercepts, will be used to investigate outcomes of Father-child co-physical activity (solo and family) and number of nights dinner consumed in front of TV (dad and child). These models separate the outcome into a binary and gamma component. For the binary component, a 1 is given when the outcome has a value of zero and a 0 given for non-zero values of the outcome. The binary component is then modelled via a mixed effects logistic regression with an odds ratio (OR) with 95% confidence interval (CIs) and p-value presented. Non-zero outcome values are then modelled via a mixed effects gamma regression with a rate ratio (RR) with 95% confidence interval (CI) and p-value presented.
Missing data will be handled using the mixed modelling framework.

For all outcomes, with the exception of dad and child Average Steps/Day, all models described above were repeated with the fixed effect for previous involvement in the RCT (previous involvement in program) removed. Model estimates were then compared to those from the main analysis.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
24/10/2019
Actual
24/10/2019
Date of last participant enrolment
Anticipated
9/05/2020
Actual
15/10/2020
Date of last data collection
Anticipated
31/10/2021
Actual
31/10/2021
Sample size
Target
250
Accrual to date
Final
281
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 304010 0
Other Collaborative groups
Name [1] 304010 0
Hunter Medical Research Institute
Country [1] 304010 0
Australia
Funding source category [2] 304012 0
Commercial sector/Industry
Name [2] 304012 0
Greater Charitable Foundation
Country [2] 304012 0
Australia
Primary sponsor type
Individual
Name
Prof. 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] 304184 0
None
Name [1] 304184 0
n/a
Address [1] 304184 0
n/a
Country [1] 304184 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304504 0
University of Newcastle's Human Research Ethics Committee
Ethics committee address [1] 304504 0
Ethics committee country [1] 304504 0
Australia
Date submitted for ethics approval [1] 304504 0
03/09/2019
Approval date [1] 304504 0
20/09/2019
Ethics approval number [1] 304504 0
H-2017-0381

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

Contacts
Principal investigator
Name 97178 0
Prof Philip Morgan
Address 97178 0
ATC301
University of Newcastle
University Drive
Callaghan, 2308
NSW
Country 97178 0
Australia
Phone 97178 0
+61 249217265
Fax 97178 0
Email 97178 0
[email protected]
Contact person for public queries
Name 97179 0
Philip Morgan
Address 97179 0
ATC301
University of Newcastle
University Drive
Callaghan, 2308
NSW
Country 97179 0
Australia
Phone 97179 0
+61 249217265
Fax 97179 0
Email 97179 0
[email protected]
Contact person for scientific queries
Name 97180 0
Philip Morgan
Address 97180 0
ATC301
University of Newcastle
University Drive
Callaghan, 2308
NSW
Country 97180 0
Australia
Phone 97180 0
+61 249217265
Fax 97180 0
Email 97180 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

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