Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000608066
Ethics application status
Approved
Date submitted
18/07/2010
Date registered
27/07/2010
Date last updated
6/05/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
The Healthy Dads, Healthy Kids Community Program: A community effectiveness trial evaluating a community-based healthy lifestyle program for overweight fathers and their children
Scientific title
The Healthy Dads, Healthy Kids Community Program Randomised Controlled Trial: Evaluation of a community based healthy lifestyles program for overweight fathers and their children.
Secondary ID [1] 252239 0
N/A
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity in fathers and their children 257156 0
Condition category
Condition code
Diet and Nutrition 257307 257307 0 0
Obesity
Public Health 257308 257308 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is the first phase of a two phase project. During phase 1, the intervention was delivered at the school sites of Singleton and Maitland and evaluated using a RCT design. The duration of the intervention is 7 weeks. The intervention involves fathers attending seven 90 minute face to face information sessions (including 3 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) the importance of fathers for children's physical activity levels; strategies for encouraging physical activity in children; 3) father and child engagement in a variety of physical activities to develop child's confidence and ability in performing various fundamental movement skills; 4) nutritional information to encourage healthy eating for fathers and children; 5) another session for father and child engagement in a variety of physical activities; 6) sustaining healthy eating patterns for the family; 7) 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).
Phase 2, a larger scale community roll out of the program evaluated using a non-randomized, prospective design - will be described in more detail elsewhere.
Intervention code [1] 256316 0
Lifestyle
Intervention code [2] 256317 0
Behaviour
Comparator / control treatment
A wait-list control group was utilised for 3 months in the Phase 1 trial at Singleton and 6 months at Maitland.
Control group
Active

Outcomes
Primary outcome [1] 258223 0
Fathers' body weight (kg) as measured on a set of electonic scales which are regularly checked and calibrated as necessary.
Timepoint [1] 258223 0
Phase 1 (Singleton): At baseline and 3 month follow up.
Phase 1 (Maitland): At baseline and at 3, 6 and 12 month follow-up.
Secondary outcome [1] 263880 0
Waist circumference for fathers and children (cm) using non-extensible steel tapes.
Timepoint [1] 263880 0
Phase 1 (Singleton): At baseline and 3 month follow up.
Phase 1 (Maitland): At baseline and at 3, 6 and 12 month follow-up.
Secondary outcome [2] 263881 0
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] 263881 0
Phase 1 (Singleton): At baseline and 3 month follow up.
Phase 1 (Maitland): At baseline and at 3, 6 and 12 month follow-up.
Secondary outcome [3] 263882 0
Systolic and diastolic blood pressure for fathers and children using an automated blood pressure monitor.
Timepoint [3] 263882 0
Phase 1 (Singleton): At baseline and 3 month follow up.
Phase 1 (Maitland): At baseline and at 3 and 6 month follow-up.
Secondary outcome [4] 263883 0
Physical activity using pedometers for fathers and children
Timepoint [4] 263883 0
Phase 1 (Singleton): At baseline and 3 month follow up.
Phase 1 (Maitland): At baseline and at 3, 6 and 12 month follow-up.
Secondary outcome [5] 263884 0
Dietary intake (kilojoules and macronutrient profile) for fathers. Fathers will complete the Australian Eating Survey 2010. Dietary intake for children, completed by mothers using the Australian Child and Adolescent Eating Survey - Version 1.2 and the Child Feeding.
Timepoint [5] 263884 0
Phase 1 (Singleton): At baseline and 3 month follow up.
Phase 1 (Maitland): At baseline and at 3, 6 and 12 month follow-up.
Secondary outcome [6] 263886 0
Resting heart rate for fathers and children using an automated blood pressure monitor.
Timepoint [6] 263886 0
Phase 1 (Singleton): At baseline and at 3 month follow-up.
Phase 1 (Maitland): At baseline and at 3 and 6 month follow-up.
Secondary outcome [7] 263887 0
Parenting strategies: Parental engagement is measured using a specifically designed Parental Engagement survey in Phase 1. Parenting strategies for physical activity and nutrition are measured during phase 1 (Maitland only) using a validated questionnaire.
Timepoint [7] 263887 0
For the questionnaires:
Phase 1 (Singleton): At baseline and at 3 month follow-up.
Phase 1 (Maitland): At baseline and at 3, 6 and 12 month follow-up.
Secondary outcome [8] 263888 0
Child feeding behaviours: using a survey completed by mothers to assess behaviours associated with child feeding.
Timepoint [8] 263888 0
Phase 1 (Singleton): At baseline and at 3 month follow-up.
Phase 1 (Maitland): At baseline and at 3, 6 and 12 month follow-up.
Secondary outcome [9] 263889 0
Parenting behaviours related to child's eating and physical activity using the Parental Eating and Behavioural Activitiy Survey (PEAS).
Timepoint [9] 263889 0
Phase 1 (Singleton): At baseline and at 3 month follow-up.
Phase 1 (Maitland): At baseline and at 3, 6 and 12 month follow-up.
Secondary outcome [10] 264176 0
Sedentary behaviour as indicated by self-reported for fathers and proxy report for children (completed by mothers during Phase 1).
Timepoint [10] 264176 0
Phase 1 (Singleton): At baseline and 3 month follow up.
Phase 1 (Maitland): At baseline and at 3, 6 and 12 month follow-up.

Eligibility
Key inclusion criteria
Overweight or obese (Body Mass Index (BMI) 25 and 40 kg/m2) fathers from the Hunter Valley region who have a 5-12 year old child. In addition participants will be required to not participate in other weight loss programs during the study; pass a health-screening questionnaire; and have access to a computer with Internet facilities.
Minimum age
18 Years
Maximum age
65 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
History of major medical problems such as heart disease in the last 5 years, diabetes or orthopaedic or joint problems that would be a barrier to physical activity, taking medications that might interfere with weight loss and children with extreme obesity (BMI z-score >= 4).

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)
Subjects will complete a phone eligibility screen with a research assistant and also a pre-exercise screening questionnaire. Participants over 40 years will be required to receive doctor's clearance prior to commencement of the study. To ensure concealment, the random allocation sequence will be generated by a statistician and given to the project manager. Allocation will be concealed as (1) person who determines subject eligibility is unaware of group allocation (2) the use of sealed opaque envelopes (3) randomization will be completed by a research assistant who is not involved in the assessment of participants and the allocation sequence will be concealed when enrolling/randomising participants in Phase 1 and Phase 2.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The random allocation sequence will be generated by a computer-based random number-producing algorithm in equal block lengths to ensure an equal chance of allocation to each group.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Participants will be blinded at baseline assessment only during Phase 1.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/07/2010
Actual
27/08/2010
Date of last participant enrolment
Anticipated
Actual
24/05/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256845 0
Other Collaborative groups
Name [1] 256845 0
Hunter Medical Research Institute
Country [1] 256845 0
Australia
Funding source category [2] 256846 0
Other Collaborative groups
Name [2] 256846 0
Coal & Allied Community Development Fund
Country [2] 256846 0
Australia
Primary sponsor type
Individual
Name
Professor Philip Morgan
Address
School of Education
Faculty of Education and Arts
University Dve
University of Newcastle
Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 256120 0
None
Name [1] 256120 0
Address [1] 256120 0
Country [1] 256120 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258862 0
University of Newcastle, Human Research Ethics Committee
Ethics committee address [1] 258862 0
Ethics committee country [1] 258862 0
Australia
Date submitted for ethics approval [1] 258862 0
12/02/2010
Approval date [1] 258862 0
17/04/2010
Ethics approval number [1] 258862 0
H-2010-0045

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

Contacts
Principal investigator
Name 31047 0
Prof Philip Morgan
Address 31047 0
School of Education
Faculty of Education and Arts
University of Newcastle
University Dve
Callaghan NSW
2308
Country 31047 0
Australia
Phone 31047 0
+61 2 4921 7265
Fax 31047 0
+61 2 4921 7407
Email 31047 0
[email protected]
Contact person for public queries
Name 14294 0
Philip Morgan
Address 14294 0
School of Education Faculty of Education and Arts University of Newcastle University Dve Callaghan NSW 2308
Country 14294 0
Australia
Phone 14294 0
+61 2 29217265
Fax 14294 0
+61 2 4921 7407
Email 14294 0
[email protected]
Contact person for scientific queries
Name 5222 0
Professor Philip Morgan
Address 5222 0
School of Education Faculty of Education and Arts University of Newcastle University Dve Callaghan NSW 2308
Country 5222 0
Australia
Phone 5222 0
+61 2 49217265
Fax 5222 0
Email 5222 0
[email protected]

No information has been provided regarding IPD availability


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
EmbaseThe 'Healthy Dads, Healthy Kids' community effectiveness trial: study protocol of a community-based healthy lifestyle program for fathers and their children.2011https://dx.doi.org/10.1186/1471-2458-11-876
EmbasePaternal Lifestyle-Related Parenting Practices Mediate Changes in Children's Dietary and Physical Activity Behaviors: Findings From the Healthy Dads, Healthy Kids Community Randomized Controlled Trial.2015https://dx.doi.org/10.1123/jpah.2014-0367
EmbaseDietary outcomes of overweight fathers and their children in the Healthy Dads, Healthy Kids community randomised controlled trial.2018https://dx.doi.org/10.1111/jhn.12543
N.B. These documents automatically identified may not have been verified by the study sponsor.