Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000105145
Ethics application status
Approved
Date submitted
11/01/2019
Date registered
24/01/2019
Date last updated
24/01/2020
Date data sharing statement initially provided
24/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The Healthy Youngsters, Healthy Dads Program: A healthy lifestyle program for fathers and their preschool-aged children.
Scientific title
The Healthy Youngsters, Healthy Dads Randomised Controlled Trial: Evaluation of a healthy lifestyle program for fathers and their preschool-aged children.
Secondary ID [1] 296025 0
N/A
Universal Trial Number (UTN)
Trial acronym
HYHD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical inactivity 309554 0
Overweight 309555 0
Poor dietary behaviour 310628 0
Obesity 311059 0
Condition category
Condition code
Diet and Nutrition 308376 308376 0 0
Obesity
Public Health 308377 308377 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The ‘Healthy Youngsters Healthy Dads’ intervention will include:

- 2 x ‘dads-only’ information workshops (2 x 2 hours: face-to-face)
- 8 x ‘dads-and-youngsters’ education and practical sessions (1.5 hours/week: face-to-face)

During each dads-only workshop, fathers will 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 will be 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).

There are eight weekly themes for the dads-and-youngsters sessions, including:
1. Rough and tumble play
2. Vegetables
3. Physical activity
4. Fruit
5. Screens
6. Water
7. Sport skills (i.e., fundamental movement skills)
8. Summary of program

In addition to these sessions, participants will receive the following program resources:
- A t-shirt and water bottle
- An activity book 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 at the University of Newcastle by local trained facilitators (qualified teachers and student teachers). 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).

Participants will be randomly allocated into either an intervention or control group. The intervention group will first participate in the 8-week HYHD program in term 1 2019 (2nd February - 23rd March, 2019), with the control group to follow thereafter in term 4 2019.

Intervention adherence will be assessed via:
- Attendance records at the session
- Completed activity book (e.g. recorded steps, reviewed goals and completed sport skills activities)
Intervention code [1] 312360 0
Lifestyle
Intervention code [2] 312361 0
Behaviour
Comparator / control treatment
Wait-list control group for 9 months. The wait-list control group will be offered the intervention after the 9-month follow-up assessment.
Control group
Active

Outcomes
Primary outcome [1] 307355 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)
Timepoint [1] 307355 0
Baseline, 10 weeks post-baseline (primary endpoint) and 9 months post-enrollment.
Secondary outcome [1] 351572 0
Body Mass Index (BMI) (fathers): calculated using the standard formula (i.e., weight in kilograms divided by the square of height in metres). Weight will be measured using digital scales and height will be measured using a stadiometer.
Timepoint [1] 351572 0
Baseline, 10 weeks post-baseline and 9 months post-enrollment.
Secondary outcome [2] 351573 0
Body Mass Index z-score (BMI-z) (children): calculated using age- and sex-adjusted standardised scores. Weight will be measured using digital scales and height will be measured using a stadiometer.
Timepoint [2] 351573 0
Baseline, 10 weeks post-baseline and 9 months post-enrollment.
Secondary outcome [3] 351574 0
Weight (fathers and children) - measured using calibrated electronic scales.
Timepoint [3] 351574 0
Baseline, 10 weeks post-baseline and 9 months post-enrollment.
Secondary outcome [4] 351576 0
Body fat percentage (fathers) measured using the InBody720 bioelectrical impendence analyser.
Timepoint [4] 351576 0
Baseline, 10 weeks post-baseline and 9 months post-enrollment.
Secondary outcome [5] 351579 0
Object Control Fundamental Movement Skill Competency (children), measured using the Test of Gross Motor Development 3
Timepoint [5] 351579 0
Baseline, 10 weeks post-baseline and 9 months post-enrollment.
Secondary outcome [6] 351580 0
Self-reported physical activity (fathers) measured using an adapted version of the Godin Leisure Time Exercise Questionnaire [father report]
Timepoint [6] 351580 0
Baseline, 10 weeks post-baseline and 9 months post-enrollment.
Secondary outcome [7] 351581 0
Father-child co-physical activity (days/week) - measured using an adapted item from the Youth Media Campaign Longitudinal Survey [father report]
Timepoint [7] 351581 0
Baseline, 10 weeks post-baseline and 9 months post-enrollment.
Secondary outcome [8] 351582 0
Physical Activity Role Modelling (fathers) - measured using the explicit role modelling scale from the Activity Support Scale [father report]
Timepoint [8] 351582 0
Baseline, 10 weeks post-baseline and 9 months post-enrollment.
Secondary outcome [9] 351583 0
Physical activity and dietary parenting practices (fathers), measured with scales from the Parenting for Eating and Activity Scale [father report]
Timepoint [9] 351583 0
Baseline, 10 weeks post-baseline and 9 months post-enrollment.
Secondary outcome [10] 351584 0
Screen time parenting practices (fathers) - measured with scales developed for this study [father report]
Timepoint [10] 351584 0
Baseline, 10 weeks post-baseline and 9 months post-enrollment.
Secondary outcome [11] 351585 0
Screen time (fathers) measured using an adapted version of the Adolescent Sedentary Activity Questionnaire [father report]
Timepoint [11] 351585 0
Baseline, 10 weeks post-baseline and 9 months post-enrollment.
Secondary outcome [12] 351586 0
Screen time (children) measured using an adapted version of the Adolescent Sedentary Activity Questionnaire [mother report]
Timepoint [12] 351586 0
Baseline, 10 weeks post-baseline and 9 months post-enrollment.
Secondary outcome [13] 351587 0
Father self-efficacy - measured using the positive engagement and direct care subscales of the Fathering Self Efficacy scale [father-report]
Timepoint [13] 351587 0
Baseline, 10 weeks post-baseline and 9 months post-enrollment.
Secondary outcome [14] 351589 0
Social-emotional well-being (children) - measured using the Self-Control and Emotional Control problems scales from the Devereux Early Childhood Assessment Clinical Form [father report].
Timepoint [14] 351589 0
Baseline, 10 weeks post-baseline and 9 months post-enrollment.
Secondary outcome [15] 351590 0
Co-parenting (mothers and fathers) measured using Feinberg's co-parenting scale [mother and father report]
Timepoint [15] 351590 0
Baseline, 10 weeks post-baseline and 9 months post-enrollment.
Secondary outcome [16] 351591 0
Dietary intake (fathers) - measured using the adult Australian Eating Survey food frequency questionnaire [father report]
Timepoint [16] 351591 0
Baseline, 10 weeks post-baseline and 9 months post-enrollment.
Secondary outcome [17] 353577 0
Dietary intake (children) - measured using the Child and Adolescent Australian Eating Survey [mother-report]
Timepoint [17] 353577 0
Baseline, 10 weeks post-baseline and 9 months post-enrollment.
Secondary outcome [18] 354572 0
Executive function (children) measured using the Heads, Toes, Knees and Shoulders test.
Timepoint [18] 354572 0
Baseline, 10 weeks post-baseline and 9 months post-enrollment.
Secondary outcome [19] 355114 0
Physical activity (sub-group of 50 randomly allocated children) - measured with one week of wrist-worn accelerometry using wGT3X-BT ActiGraph accelerometers (measure varying intensities of activities i.e. light, moderate, vigorous plus counts per minute)

For every sequential block of 12 families that complete assessments, 5 will be randomly allocated at baseline assessments to complete this measure. The randomisation schedule for this study component will be completed by an independent statistician, packed into sealed opaque envelopes by a research assistant not involved in study assessments, and revealed to participants by a research assistant not involved in sequence generation or allocation concealment.
Timepoint [19] 355114 0
Baseline, 10 weeks post-baseline and 9 months post-enrollment.
Secondary outcome [20] 355115 0
Physical activity (sub-group of 50 randomly allocated dads) - measured with one week of wrist-worn accelerometry using wGT3X-BT ActiGraph accelerometers (measure varying intensities of activities i.e. light, moderate, vigorous plus counts per minute)

For every sequential block of 12 families that complete assessments, 5 will be randomly allocated at baseline assessments to complete this measure. The randomisation schedule for this study component will be completed by an independent statistician, packed into sealed opaque envelopes by a research assistant not involved in study assessments, and revealed to participants by a research assistant not involved in sequence generation or allocation concealment.
Timepoint [20] 355115 0
Baseline, 10 weeks post-baseline and 9 months post-enrollment.
Secondary outcome [21] 365926 0
Body fat percentage (children) measured using the InBody720 bioelectrical impendence analyser
Timepoint [21] 365926 0
Baseline, 10 weeks post-baseline and 9 months post-enrollment.
Secondary outcome [22] 365927 0
Physical activity and dietary parenting practices (mothers), measured with scales from the Parenting for Eating and Activity Scale [mother report]
Timepoint [22] 365927 0
Baseline, 10 weeks post-baseline and 9 months post-enrollment.
Secondary outcome [23] 365928 0
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)
Timepoint [23] 365928 0
Baseline, 10 weeks post-baseline and 9 months post-enrollment.
Secondary outcome [24] 366000 0
Screen time parenting practices (mothers) - measured with scales developed for this study [mother report]
Timepoint [24] 366000 0
Baseline, 10 weeks post-baseline and 9 months post-enrollment.

Eligibility
Key inclusion criteria
Men can participate if they:

- Are a father, step father or male guardian of a child aged 3-5 years
- Live with their child at least 50% of the week
- Are able to attend all assessments
- Are able to attend all program sessions
- 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 baseline assessments;
- Older than 5 years at baseline assessments; or
- Attending primary school in 2019

Study design
Purpose of the study
Treatment
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 (intervention group and wait-list control) will be pre-packed into identical, sealed opaque envelopes and consecutively numbered and ordered according to the randomisation sequences within strata. The packing and sequencing of these envelopes will be completed by a research assistant who will not be involved in enrollment, assessment or allocation of participants or intervention delivery..
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation allocation sequences will be generated by a statistician (who will not have any contact with participants during the trial) using a computer-based random number producing algorithm. Randomisation will be stratified by i) child physical activity level (above or below median) and ii) physical activity measurement condition (pedometer only, or pedometer plus accelerometer). After all pre-program assessments have been completed and the data required for stratification are available, all families will be randomised in the order they completed the baseline measurement sessions by a research assistant with no involvement in assessment, sequence generation, or allocation concealment.

After each family's name has been written in the next available position on the relevant randomisation schedule, the corresponding envelope for that position will be opened by the research assistant and details of the group assignment will be emailed to the family using a standardised template.

Randomisation codes will be stored in a restricted computer folder, which will not be accessible by those research staff assessing participants, allocating participants or entering data.
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 HYHD program will be adjusted for age, SES and sex (child participants only) and the interactions of these covariates with time and treatment, where significant.

A sample size of 120 children will provide 80% power to detect a 1500 step/day difference in physical activity between the intervention and control groups at 10 weeks (p<0.05). This calculation is based on a predicted change score standard deviation of 2700 steps/day (derived from children in the HYHD pilot study) and accounts for 15% attrition from baseline.
A completers analysis will also be conducted for participants who attend all three assessment time points.

Finally, per-protocol analysis will be conducted for participants that attended at least 75% of the sessions and completed at least 75% of the activity folder (measured by completing 4.5 or more of the 6 home tasks on average each week).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
25/01/2019
Actual
25/01/2019
Date of last participant enrolment
Anticipated
31/01/2019
Actual
31/01/2019
Date of last data collection
Anticipated
26/10/2019
Actual
4/11/2019
Sample size
Target
240
Accrual to date
Final
250
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 300614 0
Other Collaborative groups
Name [1] 300614 0
Hunter Medical Research Institute
Country [1] 300614 0
Australia
Funding source category [2] 300615 0
Commercial sector/Industry
Name [2] 300615 0
Greater Charitable Foundation
Country [2] 300615 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] 300120 0
None
Name [1] 300120 0
n/a
Address [1] 300120 0
n/a
Country [1] 300120 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301403 0
University of Newcastle's Human Research Ethics Committee
Ethics committee address [1] 301403 0
Ethics committee country [1] 301403 0
Australia
Date submitted for ethics approval [1] 301403 0
07/09/2018
Approval date [1] 301403 0
06/11/2018
Ethics approval number [1] 301403 0
H-2017-0381

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

Contacts
Principal investigator
Name 86882 0
Prof Philip Morgan
Address 86882 0
ATC301
University of Newcastle
University Drive
Callaghan, 2308
NSW
Country 86882 0
Australia
Phone 86882 0
+61 249217265
Fax 86882 0
Email 86882 0
[email protected]
Contact person for public queries
Name 86883 0
Philip Morgan
Address 86883 0
ATC301
University of Newcastle
University Drive
Callaghan, 2308
NSW
Country 86883 0
Australia
Phone 86883 0
+61 249217265
Fax 86883 0
Email 86883 0
[email protected]
Contact person for scientific queries
Name 86884 0
Philip Morgan
Address 86884 0
ATC301
University of Newcastle
University Drive
Callaghan, 2308
NSW
Country 86884 0
Australia
Phone 86884 0
+61 249217265
Fax 86884 0
Email 86884 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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
EmbaseDietary outcomes of the 'healthy youngsters, healthy dads' randomised controlled trial.2021https://dx.doi.org/10.3390/nu13103306
N.B. These documents automatically identified may not have been verified by the study sponsor.