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Trial registered on ANZCTR

Registration number

ACTRN12613000067774

Ethics application status

Approved

Date submitted

30/11/2012

Date registered

17/01/2013

Date last updated

4/12/2018

Date data sharing statement initially provided

4/12/2018

Date results provided

4/12/2018

Type of registration

Retrospectively registered

Titles & IDs

Public title

The 'Healthy Dads, Healthy Kids' community effectiveness trial: Evaluation of a community-based healthy lifestyle program for overweight fathers and their children

Scientific title

The 'Healthy Dads, Healthy Kids' community effectiveness trial for overweight fathers and their children in four local government areas of the Hunter Valley Region, NSW, Australia with the primary outcome of reducing body weight in fathers.

Secondary ID [1]

N/A

Universal Trial Number (UTN)

U1111-1135-2156

Trial acronym

Linked study record

Health condition

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

Obesity treatment/prevention

Condition category

Condition code

Public Health

Health promotion/education

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The intervention is the second phase of a two phase project. Phase 1 (a community RCT) is described in ACTRN12610000608066 http://www.anzctr.org.au/trial_view.aspx?ID=335368

Phase 2 will follow the same methodology as Phase 1 and will be conducted in 5 Local Government Areas of the Hunter Valley Region, NSW, Australia (Maitland, Singleton, Muswellbrook, Scone, Cessnock). In short, the duration of the intervention is 8 sessions over 12 weeks. The intervention involves fathers attending eight 90 minute face to face information sessions (including 4 interactive sessions with their children). The program includes: physical activity components; dietary and nutritional information; a self-monitoring component. More specifically program sessions focus on: 1) sustainable weight loss for men; identification of healthy and unhealthy lifestyle behaviours and explanation of the use of role modelling and positive reinforcement; 2) father and child engagement in a variety of physical activities to develop child's confidence and ability in performing various fundamental movement skills; 3) the importance of fathers for children's physical activity levels; strategies for encouraging physical activity in children; 4) another session for father and child engagement in a variety of physical activities; 5) nutritional information to encourage healthy eating for fathers and children; 6) Father and child games and fun physical activities as well as a focus on positive family traditions and rituals 7) sustaining healthy eating patterns for the family; 8) father and child engagement activities and closure.

Fathers will also receive behavioural procedures over the course of the program via the use of the online website www.calorieking.com.au. The key constructs of social cognitive theory will be operationalised in the sessions (self efficacy, self monitoring, goal setting and social support).

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 from the community RCT (phase 1) and each subsequent program implementation in 2011 and 2012 and these will be documented. 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 implementation of the intervention with a final evaluation conducted in 2012/13.

Intervention code [1]

Lifestyle

Intervention code [2]

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]

Fathers' body weight (kg) as measured on a set of electonic scales which are regularly checked and calibrated as necessary.

Timepoint [1]

At baseline and at 3, 6 and 12 month follow-up.

Secondary outcome [1]

Waist circumference for fathers and children (cm) using non-extensible steel tapes.

Timepoint [1]

At baseline and at 3, 6 and 12 month follow-up.

Secondary outcome [2]

Body Mass Index (BMI) for fathers calculated using the formula: weight in kilograms divided by the square of height in meters. Children's Body Mass Index z-score (BMI-z) will be calculated similarly using standard deviation for children's scores related to age and gender. Children's body weight (kg) will be measured using the same protocol as for the fathers and height of fathers and children will be calculated using a portable stadiometer.

Timepoint [2]

At baseline and at 3, 6 and 12 month follow-up

Secondary outcome [3]

Physical activity of fathers is measured using a modified version of the Godin Leisure-Time Exercise Questionnaire (GLTEQ) and the Children's Leisure Activities Study Survey (CLASS) questionnaire is completed by the father with the eldest child as the reference.

Timepoint [3]

At baseline and at 3, 6 and 12 month follow-up.

Secondary outcome [4]

Dietary intake for fathers. A modified version of the Australian Eating Survey relating to 8 key nutritional messages is completed by fathers. This questionnaire is also completed by fathers as proxy for their eldest child.

Timepoint [4]

At baseline and at 3, 6 and 12 month follow-up.

Secondary outcome [5]

Parenting strategies: Parental engagement is measured using a modified version of the Parental Engagement survey used in Phase 1. Fathers will complete the questionnaire in reference to their eldest child. Parenting strategies for physical activity and nutrition are measured using a validated questionnaire. Attitudes to rough and tumble play are assessed via a semi-structured interview with a limited number of participants.

Timepoint [5]

For the questionnaires: At baseline and at 3, 6 and 12 month follow-up. The semi-structured interview is to occur prior to the baseline assessment in a select number of participants.

Secondary outcome [6]

Sedentary behaviour measured in fathers using the Modified sitting questionnaire and proxy-report for children (completed by fathers) using the Indoor based activites section of the CLASS questionnaire.

Timepoint [6]

At baseline and at 3, 6 and 12 month follow-up.

Secondary outcome [7]

Dietary portion size is reported by fathers using photographs from the Dietary Questionnaire for Epidemiological Studies Version 2

Timepoint [7]

At baseline and at 3, 6 and 12 month follow-up.

Secondary outcome [8]

Alcohol Consumption is self reported by fathers using a Modified Alcohol Use Disorders Identification Test 2009

Timepoint [8]

At baseline and at 3, 6 and 12 month follow-up.

Eligibility

Key inclusion criteria

Overweight or obese fathers (BMI over 25kg/m2) of children aged 5-12 years (primary school age). Medical approval to participate must be obtained when indicated by health screening.

Minimum age

18 Years

Maximum age

65 Years

Sex

Males

Can healthy volunteers participate?

Yes

Key exclusion criteria

Lack of a medical clearance from treating doctor if the Exercise and Sports Science Australia Adult Pre-Exercise Screening Tool identifies the participant requires a medical clearance prior to undertaking exercise.

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 a phone eligibility screen with a research assistant and also 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

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

7/03/2011

Actual

7/03/2011

Date of last participant enrolment

Anticipated

Actual

1/10/2012

Date of last data collection

Anticipated

Actual

1/10/2013

Sample size

Target

200

Accrual to date

Final

189

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment postcode(s) [1]

2320

Recruitment postcode(s) [2]

2333

Recruitment postcode(s) [3]

2337

Recruitment postcode(s) [4]

2336

Recruitment postcode(s) [5]

2330

Recruitment postcode(s) [6]

2325

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

Primary sponsor type

Individual

Name

Professor Philip Morgan

Address

Priority Research Centre in Physical Activity and Nutrition
School of Education
University of Newcastle
University Drive
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]

Research Services/Research Office

University of Newcastle
University Drive
Callaghan New South Wales 2308

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

12/02/2010

Approval date [1]

17/04/2010

Ethics approval number [1]

H-2010-0045

Summary

Brief summary

It is well established that parents of primary school aged children substantially influence the food and physical activity home environment through behaviours, attitudes, feeding styles and role modelling. However, the contribution of fathers’ influence on children’s physical activity and eating behaviour is often overlooked.The Healthy Dads Healthy Kids (HDHK) project is based on research that shows the eating habits and exercise routine of fathers and father figures influence the ways in which the whole family approaches their health. The program was developed and successfully trialled at the University of Newcastle, with trial results showing that the major aims of HDHK were achieved. These were (i) to help overweight/obese fathers achieve a healthy weight, and (ii) to improve the activity and eating behaviours of their children (using fathers as the key agents of behaviour change). Phase 1 of the HDHK community effectiveness trial (http://www.anzctr.org.au/trial_view.aspx?ID=335368 
) was to evaluate the impact of the program in a community setting  with trained local facilitators, employing a RCT design. The intention of this current project (Phase 2) is to research the effectivenss of the HDHK program on a larger scale community roll-out using a non-randomized, prospective design.

Trial website

http://healthydadshealthykids.com.au/

Trial related presentations / publications

Morgan, P.J., Lubans, D.R., Plotnikoff, R.C., Callister, R., Burrows, T., Fletcher, R., Okely, A.D. Young, M., Miller, A., Clay, V. Lloyd, A. & Collins, C.E. (2011). The ‘Healthy Dads, Healthy Kids’ community effectiveness trial: study protocol of a community-based healthy lifestyle program for fathers and their children, BMC Public Health, 11: 876.

Public notes

Contacts

Principal investigator

Name

Prof Philip Morgan

Address

Priority Research Centre in Physical Activity and Nutrition
School of Education
University of Newcastle
University Drive
Callaghan NSW 2308

Country

Australia

Phone

+61 2 29217265

Fax

+61 2 4921 7407

philip.morgan@newcastle.edu.au

Contact person for public queries

Name

Philip Morgan

Address

Priority Research Centre in Physical Activity and Nutrition
School of Education
University of Newcastle
University Drive
Callaghan NSW 2308

Country

Australia

Phone

+61 2 29217265

Fax

+61 2 4921 7407

philip.morgan@newcastle.edu.au

Contact person for scientific queries

Name

Philip Morgan

Address

Priority Research Centre in Physical Activity and Nutrition
School of Education
University of Newcastle
University Drive
Callaghan NSW 2308

Country

Australia

Phone

+61 2 29217265

Fax

+61 2 4921 7407

philip.morgan@newcastle.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Undecided

No/undecided IPD sharing reason/comment

Please contact chief investigator philip.morgan@newcastle.edu.au with requests for data sharing.

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

Source	Title	Year of Publication	DOI
Embase	Twelve-month outcomes of a father-child lifestyle intervention delivered by trained local facilitators in underserved communities: The Healthy Dads Healthy Kids dissemination trial.	2019	https://dx.doi.org/10.1093/tbm/ibz031

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

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Documents added manually

Documents added automatically