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Trial registered on ANZCTR

Registration number

ACTRN12616001270404

Ethics application status

Approved

Date submitted

7/09/2016

Date registered

9/09/2016

Date last updated

14/12/2017

Type of registration

Prospectively registered

Titles & IDs

Public title

Engaging Fathers to Increase Physical Activity and Well-being in Girls: The Dads and Daughters Exercising and Empowered (DADEE) Community Trial

Scientific title

Engaging Fathers to Increase Physical Activity and Well-being in Girls: The DADEE Community Randomised Controlled Trial

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

DADEE

Linked study record

ACTRN12615000022561

Health condition

Health condition(s) or problem(s) studied:

Physical inactivity

Condition category

Condition code

Public Health

Health promotion/education

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

* Fathers and daughters will attend 9 weekly face-face sessions of the DADEE program together.

* Each session will be broken up into 3 components:

(i) a 15-minute education session with fathers and daughters together;
(ii) a 30-minute education session for fathers and daughters conducted separately;
(ii) a 45-minute practical session where fathers and daughters participate together.

Mothers and siblings are also invited to attend session 5 of the program, where all family members participate in the activities together..

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

For fathers, the education sessions focus on proven parenting strategies to improve their daughters’ social-emotional well-being, sports skills and physical activity levels.

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

The 45-minute DADEE practical sessions focus on 3 key areas - Rough and Tumble Play, Fitness and Fundamental Movement Skills.

* All fathers will be provided with program resources including a t-shirt, a folder containing session summaries, a, sport skills booklet and a log book to document brief tasks (e.g., step count monitoring).

* All daughters will receive a t-shirt and a booklet with session summaries. As in the sessions, the daughters material will cover similar themes to the dads material, but will be tailored for the age group.

*All participants will have access to the 'DADEE' App for the duration of the program (and beyond the study period). This app includes physical activity tasks for fathers to complete with their daughter/s at home (e.g., rough and tumble play activities, fitness circuits, sports skills games). Brief instructions are provided for each task on the app. Participants will be advised to complete activities from a variety of categories equating to an approximate time investment of 30 minutes per week.

Adherence to the intervention will be monitored by:
- Attendance records at the sessions
- Activities completed in the Dads Log Book
- Activities completed on the DADEE app

Intervention code [1]

Lifestyle

Intervention code [2]

Behaviour

Comparator / control treatment

Wait-list control group. The wait-list control group will be offered the intervention after the 3-month assessment.

Control group

Active

Outcomes

Primary outcome [1]

Father physical activity (steps/day) measured with Yamax SW200 pedometers.

Timepoint [1]

Baseline and 3 months post-baseline

Primary outcome [2]

Daughter physical activity (steps/day) measured with Yamax SW200 pedometers.

Timepoint [2]

Baseline and 3 months post-baseline

Secondary outcome [1]

Weight for fathers and daughters (kg) using calibrated electronic scales

Timepoint [1]

Baseline and 3 months post-baseline

Secondary outcome [2]

Height of fathers and daughters (cm) (calibrated stadiometer)

Timepoint [2]

Baseline and 3 months post-baseline

Secondary outcome [3]

Body Mass Index (BMI) for fathers using the formula: weight in kilograms divided by the square of height in meters. For daughters, age adjusted standardised scores (z-scores) will be calculated.

Timepoint [3]

Baseline and 3 months post-baseline

Secondary outcome [4]

Object Control Fundamental Movement Skill competency for daughters; measured using the Test of Gross Motor Development II:
- Striking a stationary ball (two handed)
- Catch
- Kick
- Overhand throw
- Stationary dribble

Test of Gross Motor Development III
- Underhand throw

Timepoint [4]

Baseline and 3 months post-baseline

Secondary outcome [5]

Daughters' Social Emotional Wellbeing; measured with the "Devereux Student Strengths Assessment" [Father + Mother reports]

Timepoint [5]

Baseline and 3 months post-baseline

Secondary outcome [6]

Father-Daughter Relationship; measured with personal relationships and disciplinary warmth subscales from the "Parent Child Relationships Questionnaire" [Father + Eldest Daughter Report]

Timepoint [6]

Baseline and 3 months post-baseline

Secondary outcome [7]

Role Modelling; measured with the explicit role modelling scale from the "Activity Support Scale" [Father Report]

Timepoint [7]

Baseline and 3 months post-baseline

Secondary outcome [8]

Parenting for Physical Activity; measured with scales from the "Parenting for Eating and Activity Scale" [Father Report]

Timepoint [8]

Baseline and 3 months post-baseline

Secondary outcome [9]

Father-Mother/Partner Relationship; measured with an item from the "Longitudinal Study of Australian Children Survey" [Father + Mother Report]

Timepoint [9]

Baseline and 3 months post-baseline

Secondary outcome [10]

Father and Daughter Screen Time Behaviour; measured with an adapted version of the Adolescent Sedentary Activity Questionnaire [Father Report]

Timepoint [10]

Baseline and 3 months post-baseline

Secondary outcome [11]

Daughters Perceived Sports Competence; measured with the sports competence scale of the "Physical Self-Description Questionnaire" [Daughter Report]

Timepoint [11]

Baseline and 3 months post-baseline

Secondary outcome [12]

Father and Mother Moderate-to-Vigorous Physical Activity; measured with an adapted version of the "Godin Leisure Time Exercise Questionnaire" [Mother + Father report]

Timepoint [12]

Baseline and 3 months post-baseline

Secondary outcome [13]

Coparenting: measured with Feinberg's Multi-Domain Self-Report Measure of Coparenting Short Form [Father + Mother report]

Timepoint [13]

Baseline and 3 months post-baseline

Secondary outcome [14]

Daughters working memory, shifting and inhibition: measured with the Early Years Toolbox apps: Mr Ant (visuo-spatial working memory), Go/No-Go (inhibition), Card Sorting (Shifting).

**4-5 year old daughters only (subsample)

Timepoint [14]

Baseline and 3 months post-baseline

Secondary outcome [15]

Daughter self esteem - measured with the self-esteem subscale from the Kindl (7 years +) or Kiddy-Kindl (4-6 years) (Father, Mother + Eldest Daughter Report).

Timepoint [15]

Baseline and 3 months post-baseline

Secondary outcome [16]

Family functioning - measured with the family subscale from the Kindl (7 years +) or Kiddy-Kindl (4-6 years) (Father, Mother + Eldest Daughter Report).

Timepoint [16]

Baseline and 3 months post-baseline.

Secondary outcome [17]

Father Warmth and Authoratative Parenting - measured with scales from the Longitudinal Study of Australian Children (LSAC) [Father Report]

Timepoint [17]

Baseline and 3 months post-baseline

Secondary outcome [18]

Father involvement - measured with subscales from the Inventory of Father Involvement (mother support, praise and affection, time and taking, attentiveness) [Father + Mother Report]

Timepoint [18]

Baseline and 3 months post-baseline

Secondary outcome [19]

Co-physical activity - measured with an item from the Youth Media Campaign Longitudinal Survey plus additional items developed for this study. [Father Report]

Timepoint [19]

Baseline and 3 months post-baseline.

Eligibility

Key inclusion criteria

Men can participate if they:

- Are a father, step father or male guardian (who lives with their daughter at least 50% of the week)
- Have a daughter who attends primary school (K-6)
- Are able to pass a health-screening questionnaire

Daughters can participate if they currently attend primary school (K-6).

Minimum age

4 Years

Maximum age

65 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Men will require a doctors certificate to participate if they report:

- A history of major medical problems such as heart disease or diabetes

- Orthopedic or joint problems that would be a barrier to completing
physical activity such as walking

There are no additional key exclusion criteria for the daughters.

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 (DADEE program group and wait-list control) will be pre-packed into identical, sealed opaque envelopes and consecutively numbered and ordered according to the randomisation schedule.

The packing and sequencing of these envelopes will be completed by a research assistant who will not be involved in enrolment, assessment or allocation of participants.

Study participants will complete all baseline assessments before proceeding to a separate room to meet with a research assistant who will not be involved with assessments. The allocation sequence will be concealed during this process.

Families will be stratified by father's BMI category and their name will be written down in the next available position on the relevant randomisation schedule. At this point the corresponding envelope for that position will be opened by the research assistant and details of the group assignment will be provided to the family using a standardised protocol.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

The randomisation allocation sequence will be generated by a statistician who will not have any contact with participants during the trial. Allocation will be stratified by father's BMI category and the allocation sequence within strata will be generated by a computer based random number producing algorithm.

Randomisation codes will be stored in a restricted computer folder, which will not be accessible by those assessing participants, those involved in group allocating participants or those participating in data entry for the study.

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 DADEE program will be adjusted for age, ses, and the interactions of these covariates with time and treatment, where significant.

A sample size of 74 fathers will provide 90% power to detect a 1200 step/day difference in physical activity between the intervention and control groups at 3 months with 20% attrition (p<0.05). This calculation is based on a pre-post correlation of 0.76 and a change score standard deviation of 2020 steps/day (values derived from fathers in the DADEE pilot study).

A sample size of 191 daughters will provide 90% power to detect a 1200 step/day difference in physical activity between the intervention and control groups at 3 months with 20% attrition (p<0.05). This calculation is based on a pre-post correlation of 0.61 and a change score standard deviation of 2298 steps/day (values derived from daughters in the DADEE pilot study).

As multiple daughters per family will be eligible to participate, this calculation also adjusts for clustering at the family level using a correction factor of [1+ (m-1) x ICC], where m = average daughters per family and ICC = the intracluster correlation coefficient. Assuming an average number of 1.33 daughters per family and an ICC of 0.73 for physical activity, the correction factor is 1.24 (estimates based on DADEE pilot data).

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

26/09/2016

Actual

26/09/2016

Date of last participant enrolment

Anticipated

Actual

10/10/2016

Date of last data collection

Anticipated

Actual

16/12/2016

Sample size

Target

265

Accrual to date

Final

351

Recruitment in Australia

Recruitment state(s)

NSW

Funding & Sponsors

Funding source category [1]

Other Collaborative groups

Name [1]

Hunter Medical Research Institute

Address [1]

Hunter Medical Research Institute (HMRI) Clinical Research Centre John Hunter Hospital Lookout Road,
New Lambton
Postal address: Locked Bag 1 Hunter Region Mail Centre NSW 2310

Country [1]

Australia

Funding source category [2]

Other Collaborative groups

Name [2]

Port Waratah Coal Services

Address [2]

Port Waratah Coal Services
Curlew St
Kooragang
NSW 2304

Country [2]

Australia

Funding source category [3]

Other Collaborative groups

Name [3]

Hunter Children's Research Foundation (HCRF)

Address [3]

PO Box 235
New Lambton
NSW 2305

Country [3]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Newcastle Human Research Ethics Committee

Ethics committee address [1]

University of Newcastle Human Research Ethics Committee
University of Newcastle,
University Drive, Callaghan
NSW, 2308

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

12/08/2016

Approval date [1]

18/08/2016

Ethics approval number [1]

H-2014-0330

Summary

Brief summary

It is well established that physical activity is associated with many physical and psychological health benefits. Participating in regular physical activity during childhood is also vital for optimal growth and development and kids who are active show greater resilience and increased social-emotional wellbeing. However, more than 80% of adolescent girls do not meet government physical activity recommendations and there is a striking difference in activity levels between boys and girls at all ages.  

Current strategies to engage girls in physical activity and sports programs have had minimal impact and innovative approaches that address the underlying socio-cultural barriers that girls face are needed. Targeting fathers to take an active role in increasing their daughters’ physical activity levels may be one such innovation.

The DADEE Program is an intervention which engages fathers in positive lifestyle role modelling and effective parenting strategies to improve the physical activity behaviours, physical confidence, sport skills and social-emotional wellbeing of their daughters. Importantly, DADEE also targets girls to improve the fitness and physical activity levels, and parenting skills of their fathers.

The program has been successfully tested in an efficacy RCT at the University of Newcastle. The aim of this trial is to test the effectiveness of the DADEE Program when delivered by local trained facilitators in community settings (i.e., schools).

As in the DADEE pilot study, the two major purposes of this community effectiveness trial are:

(i) to help fathers improve their own physical activity levels and learn parenting skills to promote and role model positive behaviours relating to physical activity for their daughters

(ii) to improve the physical activity behaviours, fundamental movement skill proficiency and social-emotional well-being of their daughters.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Philip Morgan

Address

ATC301
University of Newcastle
University Drive
Callaghan, 2308
NSW

Country

Australia

Phone

+61249217265

Fax

philip.morgan@newcastle.edu.au

Contact person for public queries

Name

Philip Morgan

Address

ATC301
University of Newcastle
University Drive
Callaghan, 2308
NSW

Country

Australia

Phone

+61249217265

Fax

philip.morgan@newcastle.edu.au

Contact person for scientific queries

Name

Philip Morgan

Address

ATC301
University of Newcastle
University Drive
Callaghan, 2308
NSW

Country

Australia

Phone

+61249217265

Fax

philip.morgan@newcastle.edu.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

Current supporting documents:

Updated to:

Doc. No.	Type	Email	Other Details
23436	Statistical analysis plan	philip.morgan@newcastle.edu.au
23437	Informed consent form	philip.morgan@newcastle.edu.au
23438	Ethical approval	philip.morgan@newcastle.edu.au
23439	Analytic code	philip.morgan@newcastle.edu.au
23440	Analytic code	philip.morgan@newcastle.edu.au	Please contact chief investigator philip.morgan@ne... [More Details]

Results publications and other study-related documents

Documents added manually

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Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Effects of a father-daughter physical activity intervention delivered by trained facilitators in the community setting on girls' social-emotional well-being: A randomized controlled trial.	2023	https://dx.doi.org/10.1037/dev0001609

N.B. These documents automatically identified may not have been verified by the study sponsor.

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