Trial Review

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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] 281319 0
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 287534 0
Condition category
Condition code
Public Health 287857 287857 0 0
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] 285781 0
Lifestyle
Intervention code [2] 285782 0
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] 288079 0
Fathers' body weight (kg) as measured on a set of electonic scales which are regularly checked and calibrated as necessary.
Timepoint [1] 288079 0
At baseline and at 3, 6 and 12 month follow-up.
Secondary outcome [1] 299383 0
Waist circumference for fathers and children (cm) using non-extensible steel tapes.
Timepoint [1] 299383 0
At baseline and at 3, 6 and 12 month follow-up.
Secondary outcome [2] 299384 0
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] 299384 0
At baseline and at 3, 6 and 12 month follow-up
Secondary outcome [3] 299385 0
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] 299385 0
At baseline and at 3, 6 and 12 month follow-up.
Secondary outcome [4] 299386 0
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] 299386 0
At baseline and at 3, 6 and 12 month follow-up.
Secondary outcome [5] 299387 0
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] 299387 0
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] 299388 0
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] 299388 0
At baseline and at 3, 6 and 12 month follow-up.
Secondary outcome [7] 299389 0
Dietary portion size is reported by fathers using photographs from the Dietary Questionnaire for Epidemiological Studies Version 2
Timepoint [7] 299389 0
At baseline and at 3, 6 and 12 month follow-up.
Secondary outcome [8] 299390 0
Alcohol Consumption is self reported by fathers using a Modified Alcohol Use Disorders Identification Test 2009
Timepoint [8] 299390 0
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] 5807 0
2320
Recruitment postcode(s) [2] 5808 0
2333
Recruitment postcode(s) [3] 5809 0
2337
Recruitment postcode(s) [4] 5810 0
2336
Recruitment postcode(s) [5] 5811 0
2330
Recruitment postcode(s) [6] 5812 0
2325

Funding & Sponsors
Funding source category [1] 286078 0
Other Collaborative groups
Name [1] 286078 0
Hunter Medical Research Institute
Country [1] 286078 0
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] 284893 0
None
Name [1] 284893 0
Address [1] 284893 0
Country [1] 284893 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288128 0
University of Newcastle, Human Research Ethics Committee
Ethics committee address [1] 288128 0
Ethics committee country [1] 288128 0
Australia
Date submitted for ethics approval [1] 288128 0
12/02/2010
Approval date [1] 288128 0
17/04/2010
Ethics approval number [1] 288128 0
H-2010-0045

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

Contacts
Principal investigator
Name 34771 0
Prof Philip Morgan
Address 34771 0
Priority Research Centre in Physical Activity and Nutrition
School of Education
University of Newcastle
University Drive
Callaghan NSW 2308
Country 34771 0
Australia
Phone 34771 0
+61 2 29217265
Fax 34771 0
+61 2 4921 7407
Email 34771 0
[email protected]
Contact person for public queries
Name 18018 0
Philip Morgan
Address 18018 0
Priority Research Centre in Physical Activity and Nutrition
School of Education
University of Newcastle
University Drive
Callaghan NSW 2308
Country 18018 0
Australia
Phone 18018 0
+61 2 29217265
Fax 18018 0
+61 2 4921 7407
Email 18018 0
[email protected]
Contact person for scientific queries
Name 8946 0
Philip Morgan
Address 8946 0
Priority Research Centre in Physical Activity and Nutrition
School of Education
University of Newcastle
University Drive
Callaghan NSW 2308
Country 8946 0
Australia
Phone 8946 0
+61 2 29217265
Fax 8946 0
+61 2 4921 7407
Email 8946 0
[email protected]

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 [email protected] 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
SourceTitleYear of PublicationDOI
EmbaseTwelve-month outcomes of a father-child lifestyle intervention delivered by trained local facilitators in underserved communities: The Healthy Dads Healthy Kids dissemination trial.2019https://dx.doi.org/10.1093/tbm/ibz031
N.B. These documents automatically identified may not have been verified by the study sponsor.