Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000135213
Ethics application status
Approved
Date submitted
22/01/2018
Date registered
30/01/2018
Date last updated
12/03/2019
Date data sharing statement initially provided
12/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The Healthy Youngsters, Healthy Dads Pilot Study: A family-based healthy lifestyles program for fathers and their preschool-aged children.
Scientific title
The Healthy Youngsters, Healthy Dads Pilot Study: Preliminary evaluation of a family-based healthy lifestyles program for fathers and their preschool-aged children.
Secondary ID [1] 293841 0
N/A
Universal Trial Number (UTN)
Trial acronym
HYHD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical inactivity 306289 0
Childhood obesity 306290 0
Condition category
Condition code
Diet and Nutrition 305376 305376 0 0
Obesity
Public Health 305377 305377 0 0
Health promotion/education

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

- 1 x 'dads-only' information workshop (5 hours; face-to-face)
- 8 x 'dads-and-kids' practical sessions (1.5 hours/week; face-to-face)

Both components will be delivered at the University of Newcastle by chief investigators Professor Philip Morgan and Doctor Alyce Barnes, who are researchers with health and physical education qualifications and over 10 years experience each in delivered healthy lifestyle interventions.

At the dads-only workshop, fathers will be taught evidence-based parenting strategies to improve their children's physical activity, eating habits, social-emotional well-being and sports skills.

For each dads-and-kids practical, the session will be broken up into 2 components:

(i) a 20-minute welcome session conducted for fathers and children together;
(ii) a 55-minute practical session where fathers and children participate together

The dads-and-kids sessions will focus on:
o healthy eating for families
o fundamental movement skills (e.g. throwing, kicking, striking and catching);
o rough and tumble play;
o health-related fitness and
o fun and active household and backyard games

In addition to these sessions, participants will receive the following program resources:
- A t-shirt and water bottle
- A sports skill book developed for this study with a range of activities fathers and children can do to improve children's fundamental movement skills at home
- A log book to complete home activities (e.g., step count monitoring)
- A series of short informational videos for fathers and mothers to review at home, which will align with the information presented at each session

Intervention adherence will be assessed via:

- Attendance records at the session
- Activities completed in the log book and sports skill book
Intervention code [1] 300101 0
Lifestyle
Intervention code [2] 300103 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 304523 0
The primary outcomes of this feasibility trial will relate to participant attendance and perceived acceptability. The trial will be deemed successful if:

- The attendance of fathers at the father-only workshop is at least 80%
- The average attendance at the father-and-child sessions is at least 80%
- Fathers' mean overall program satisfaction is at least 4 out of 5 on the following scale

1 - Poor
2 - Fair
3 - Average
4 - Good
5 - Excellent
Timepoint [1] 304523 0
3 months post-randomisation
Secondary outcome [1] 342224 0
Physical activity (fathers and children) - measured with one week of pedometry using YAMAX SW200 pedometer (average steps/day used for analysis where at least 4 days are recorded)
Timepoint [1] 342224 0
Baseline and 3 months post-baseline
Secondary outcome [2] 342226 0
Weight (fathers and children) - measured using calibrated electronic scales.
Timepoint [2] 342226 0
Baseline and 3 months post-baseline
Secondary outcome [3] 342228 0
Height (fathers and children) - measured using a calibrated stadiometer
Timepoint [3] 342228 0
Baseline and 3 months post-baseline (children only)
Secondary outcome [4] 342229 0
Body Mass Index (BMI) (fathers): calculated using the standard formula (i.e., weight in kilograms divided by the square of height in metres).
Timepoint [4] 342229 0
Baseline and 3 months post-baseline
Secondary outcome [5] 342230 0
Body Mass Index z-score (BMI-z) (children): calculated using age- and sex-adjusted standardised scores.
Timepoint [5] 342230 0
Baseline and 3 months post-baseline
Secondary outcome [6] 342231 0
Body composition (fathers and children) measured using the InBody720 bioelectrical impendence analyser.
Timepoint [6] 342231 0
Baseline and 3 months post-baseline
Secondary outcome [7] 342232 0
Object Control Fundamental Movement Skill Competency (children), measured using the Test of Gross Motor Development 3
Timepoint [7] 342232 0
Baseline and 3 months post-baseline
Secondary outcome [8] 342233 0
Executive function (children) measured using the Heads, Toes, Knees and Shoulders test.
Timepoint [8] 342233 0
Baseline and 3 months post-baseline
Secondary outcome [9] 342234 0
Self-reported physical activity (fathers) measured using an adapted version of the Godin Leisure Time Exercise Questionnaire [father report]
Timepoint [9] 342234 0
Baseline and 3 months post-baseline
Secondary outcome [10] 342235 0
Father-child co-physical activity - measured using an adapted item from the Youth Media Campaign Longitudinal Survey [father report]
Timepoint [10] 342235 0
Baseline and 3 months post-baseline
Secondary outcome [11] 342236 0
Physical Activity Role Modelling (fathers) - measured using the explicit role modelling scale from the Activity Support Scale [father report]
Timepoint [11] 342236 0
Baseline and 3 months post-baseline
Secondary outcome [12] 342238 0
Physical activity and dietary parenting practices (fathers and mothers), measured with scales from the Parenting for Eating and Activity Scale [father and mother report]
Timepoint [12] 342238 0
Baseline and 3 months post-baseline
Secondary outcome [13] 342239 0
Screen time parenting practices (fathers and mothers) - measured with scales developed for this study [father and mother report]
Timepoint [13] 342239 0
Baseline and 3 months post-baseline
Secondary outcome [14] 342240 0
Screen time (fathers) measured using an adapted version of the Adolescent Sedentary Activity Questionnaire [father report]
Timepoint [14] 342240 0
Baseline and 3 months post-baseline
Secondary outcome [15] 342241 0
Screen time (children) measured using an adapted version of the Adolescent Sedentary Activity Questionnaire [mother report]
Timepoint [15] 342241 0
Baseline and 3 months post-baseline
Secondary outcome [16] 342242 0
Father-child relationship - measured using the Personal Relationships and Disciplinary Warmth subscales of the Parent-Child Relationships Questionnaire [father-report]
Timepoint [16] 342242 0
Baseline and 3 months post-baseline
Secondary outcome [17] 342243 0
Parenting responsibility (fathers) - measured using a single item from the Inventory of Father Involvement [father report]
Timepoint [17] 342243 0
Baseline and 3 months post-baseline
Secondary outcome [18] 342244 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 [18] 342244 0
Baseline and 3 months post-baseline
Secondary outcome [19] 342245 0
Co-parenting (mothers and fathers) measured using Feinberg's co-parenting scale [mother and father report]
Timepoint [19] 342245 0
Baseline and 3 months post-baseline
Secondary outcome [20] 342385 0
Dietary intake (fathers) - measured using the adult Australian Eating Survey food frequency questionnaire [father report]
Timepoint [20] 342385 0
Baseline and 3 months post-baseline
Secondary outcome [21] 342386 0
Dietary intake (children) - measured using the Child and Adolescent Australian Eating Survey [mother-report]
Timepoint [21] 342386 0
Baseline and 3 months post-baseline

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 both assessments
- Are able to attend all program sessions
- Are able to pass a health-screening questionnaire for physical activity

Children can participate if they are 3-5 years old, but not yet attending school
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).

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)
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
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/02/2018
Actual
10/02/2018
Date of last participant enrolment
Anticipated
17/02/2018
Actual
17/02/2018
Date of last data collection
Anticipated
10/05/2018
Actual
10/05/2018
Sample size
Target
25
Accrual to date
Final
25
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 298460 0
Other
Name [1] 298460 0
Hunter Medical Research Institute
Country [1] 298460 0
Australia
Funding source category [2] 298464 0
Commercial sector/Industry
Name [2] 298464 0
Greater Charitable Foundation
Country [2] 298464 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] 297601 0
None
Name [1] 297601 0
n/a
Address [1] 297601 0
n/a
Country [1] 297601 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299451 0
University of Newcastle's Human Research Ethics Committee
Ethics committee address [1] 299451 0
Ethics committee country [1] 299451 0
Australia
Date submitted for ethics approval [1] 299451 0
Approval date [1] 299451 0
08/12/2017
Ethics approval number [1] 299451 0

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

Contacts
Principal investigator
Name 80446 0
Prof Philip Morgan
Address 80446 0
ATC301
University of Newcastle
University Drive
Callaghan, 2308
NSW
Country 80446 0
Australia
Phone 80446 0
+61249217265
Fax 80446 0
Email 80446 0
[email protected]
Contact person for public queries
Name 80447 0
Philip Morgan
Address 80447 0
ATC301
University of Newcastle
University Drive
Callaghan, 2308
NSW
Country 80447 0
Australia
Phone 80447 0
+61249216096
Fax 80447 0
Email 80447 0
[email protected]
Contact person for scientific queries
Name 80448 0
Philip Morgan
Address 80448 0
ATC301
University of Newcastle
University Drive
Callaghan, 2308
NSW
Country 80448 0
Australia
Phone 80448 0
+61249216096
Fax 80448 0
Email 80448 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
No additional documents have been identified.