Trial Review

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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] 289573 0
Nil
Universal Trial Number (UTN)
Trial acronym
DADEE
Linked study record
ACTRN12615000022561

Health condition
Health condition(s) or problem(s) studied:
Physical inactivity 299302 0
Condition category
Condition code
Public Health 299298 299298 0 0
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] 295175 0
Lifestyle
Intervention code [2] 295176 0
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] 298790 0
Father physical activity (steps/day) measured with Yamax SW200 pedometers.
Timepoint [1] 298790 0
Baseline and 3 months post-baseline
Primary outcome [2] 298791 0
Daughter physical activity (steps/day) measured with Yamax SW200 pedometers.
Timepoint [2] 298791 0
Baseline and 3 months post-baseline
Secondary outcome [1] 325212 0
Weight for fathers and daughters (kg) using calibrated electronic scales
Timepoint [1] 325212 0
Baseline and 3 months post-baseline
Secondary outcome [2] 325213 0
Height of fathers and daughters (cm) (calibrated stadiometer)
Timepoint [2] 325213 0
Baseline and 3 months post-baseline
Secondary outcome [3] 325214 0
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] 325214 0
Baseline and 3 months post-baseline
Secondary outcome [4] 325215 0
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] 325215 0
Baseline and 3 months post-baseline
Secondary outcome [5] 325974 0
Daughters' Social Emotional Wellbeing; measured with the "Devereux Student Strengths Assessment" [Father + Mother reports]
Timepoint [5] 325974 0
Baseline and 3 months post-baseline
Secondary outcome [6] 325975 0
Father-Daughter Relationship; measured with personal relationships and disciplinary warmth subscales from the "Parent Child Relationships Questionnaire" [Father + Eldest Daughter Report]
Timepoint [6] 325975 0
Baseline and 3 months post-baseline
Secondary outcome [7] 325977 0
Role Modelling; measured with the explicit role modelling scale from the "Activity Support Scale" [Father Report]
Timepoint [7] 325977 0
Baseline and 3 months post-baseline
Secondary outcome [8] 325978 0
Parenting for Physical Activity; measured with scales from the "Parenting for Eating and Activity Scale" [Father Report]
Timepoint [8] 325978 0
Baseline and 3 months post-baseline
Secondary outcome [9] 325979 0
Father-Mother/Partner Relationship; measured with an item from the "Longitudinal Study of Australian Children Survey" [Father + Mother Report]
Timepoint [9] 325979 0
Baseline and 3 months post-baseline
Secondary outcome [10] 325980 0
Father and Daughter Screen Time Behaviour; measured with an adapted version of the Adolescent Sedentary Activity Questionnaire [Father Report]
Timepoint [10] 325980 0
Baseline and 3 months post-baseline
Secondary outcome [11] 325981 0
Daughters Perceived Sports Competence; measured with the sports competence scale of the "Physical Self-Description Questionnaire" [Daughter Report]
Timepoint [11] 325981 0
Baseline and 3 months post-baseline
Secondary outcome [12] 325984 0
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] 325984 0
Baseline and 3 months post-baseline
Secondary outcome [13] 325985 0
Coparenting: measured with Feinberg's Multi-Domain Self-Report Measure of Coparenting Short Form [Father + Mother report]
Timepoint [13] 325985 0
Baseline and 3 months post-baseline
Secondary outcome [14] 325986 0
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] 325986 0
Baseline and 3 months post-baseline
Secondary outcome [15] 327514 0
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] 327514 0
Baseline and 3 months post-baseline
Secondary outcome [16] 327515 0
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] 327515 0
Baseline and 3 months post-baseline.
Secondary outcome [17] 327516 0
Father Warmth and Authoratative Parenting - measured with scales from the Longitudinal Study of Australian Children (LSAC) [Father Report]
Timepoint [17] 327516 0
Baseline and 3 months post-baseline
Secondary outcome [18] 327517 0
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] 327517 0
Baseline and 3 months post-baseline
Secondary outcome [19] 327518 0
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] 327518 0
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] 293953 0
Other Collaborative groups
Name [1] 293953 0
Hunter Medical Research Institute
Country [1] 293953 0
Australia
Funding source category [2] 293954 0
Other Collaborative groups
Name [2] 293954 0
Port Waratah Coal Services
Country [2] 293954 0
Australia
Funding source category [3] 293955 0
Other Collaborative groups
Name [3] 293955 0
Hunter Children's Research Foundation (HCRF)
Country [3] 293955 0
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] 292773 0
None
Name [1] 292773 0
Address [1] 292773 0
Country [1] 292773 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295863 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 295863 0
Ethics committee country [1] 295863 0
Australia
Date submitted for ethics approval [1] 295863 0
12/08/2016
Approval date [1] 295863 0
18/08/2016
Ethics approval number [1] 295863 0
H-2014-0330

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

Contacts
Principal investigator
Name 67034 0
Prof Philip Morgan
Address 67034 0
ATC301
University of Newcastle
University Drive
Callaghan, 2308
NSW
Country 67034 0
Australia
Phone 67034 0
+61249217265
Fax 67034 0
Email 67034 0
[email protected]
Contact person for public queries
Name 67035 0
Philip Morgan
Address 67035 0
ATC301
University of Newcastle
University Drive
Callaghan, 2308
NSW
Country 67035 0
Australia
Phone 67035 0
+61249217265
Fax 67035 0
Email 67035 0
[email protected]
Contact person for scientific queries
Name 67036 0
Philip Morgan
Address 67036 0
ATC301
University of Newcastle
University Drive
Callaghan, 2308
NSW
Country 67036 0
Australia
Phone 67036 0
+61249217265
Fax 67036 0
Email 67036 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23436Statistical analysis plan  [email protected]
23437Informed consent form  [email protected]
23438Ethical approval  [email protected]
23439Analytic code  [email protected]
23440Analytic code  [email protected] Please contact chief investigator philip.morgan@ne... [More Details]

Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEffects 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.2023https://dx.doi.org/10.1037/dev0001609
N.B. These documents automatically identified may not have been verified by the study sponsor.