Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000855224
Ethics application status
Approved
Date submitted
29/09/2009
Date registered
1/10/2009
Date last updated
5/01/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
The 'Healthy Dads Healthy Kids' program: Evaluation of a healthy lifestyles program for overweight dads and their children
Scientific title
The 'Healthy Dads Healthy Kids' Randomised Controlled Trial: Feasibility and efficacy of an obesity treatment and healthy lifestyles program for overweight fathers and their children
Secondary ID [1] 288240 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 243830 0
Condition category
Condition code
Diet and Nutrition 240005 240005 0 0
Obesity
Public Health 252123 252123 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The duration of the intervention is 3 months. The intervention involves fathers attending eight 90 minute face to face information sessions (including 3 interactive sessions with their children). Sessions focus on i) activity and eating behaviours to support and achieve weight loss goals ii) identification of healthy and unhealthy lifestyle behaviours and explanation of the use of role modelling and positive reinforcement iii) Father and child engagement in a variety of physical activities to develop child's confidence and ability in performing various fundamental movement skills. iv) problem solving and post program goal setting v) Revision and consolidation of new knowledge and skills.
Fathers will also receive behavioural procedures over the course of the program via use of the online website www.calorieking.com.au to support the key strategies of self monitoring and social support relating to weight loss. Instruction and orientation to the website will be provided. The website allows submission of self-monitored energy expenditure and intake, weight and online group support.
Intervention code [1] 241268 0
Lifestyle
Intervention code [2] 241269 0
Behaviour
Comparator / control treatment
Wait-list control group for 6 months. The wait-list control group will be offered the intervention immediately following the 6-month follow-up assessment.
Control group
Active

Outcomes
Primary outcome [1] 240906 0
Fathers' body weight (kg)
Timepoint [1] 240906 0
At baseline and at 3 and 6 months follow-up
Secondary outcome [1] 257611 0
Waist circumference for fathers and children (cm)
Timepoint [1] 257611 0
At baseline and at 3 and 6 months follow-up
Secondary outcome [2] 257612 0
Body Mass Index for fathers and children (BMI-z)
Timepoint [2] 257612 0
At baseline and at 3 and 6 months follow-up
Secondary outcome [3] 257613 0
Systolic and Diastolic Blood pressure for fathers and children
Timepoint [3] 257613 0
At baseline and at 3 and 6 months follow-up
Secondary outcome [4] 257614 0
Physical Activity using pedometers for fathers and children
Timepoint [4] 257614 0
At baseline and at 3 and 6 months follow-up
Secondary outcome [5] 257773 0
Dietary Intake (kilojoules and macronutrient profile) for fathers and children
Timepoint [5] 257773 0
At baseline and at 3 and 6 months follow-up
Secondary outcome [6] 257775 0
Resting Heart Rate for fathers and children
Timepoint [6] 257775 0
At baseline and at 3 and 6 months follow-up
Secondary outcome [7] 257811 0
Parental Engagement
Timepoint [7] 257811 0
At baseline and at 3 and 6 months follow-up
Secondary outcome [8] 257812 0
Child Feeding Behaviours
Timepoint [8] 257812 0
At baseline and at 3 and 6 months follow-up
Secondary outcome [9] 257813 0
% body fat by Bioimpedance Analysis (BIA) for fathers and children
Timepoint [9] 257813 0
At baseline and at 3 and 6 months follow-up

Eligibility
Key inclusion criteria
Overweight or obese (BMI 25 and 40kg/m2) fathers from the Hunter region who have a 5-12 year old child.
Minimum age
21 Years
Maximum age
60 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, recent weight loss of 4.5kg or more or who are taking medications that might interfere with weight loss and children with extreme obesity (BMI z-score >=4). Participants particpating in other weight loss programs were also excluded.

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 completed a phone eligibility screen with a research assistant and also a pre-exercise screening questionnaire. Participants over 40 years were required to receive doctor's clearance prior to commencement of the study.

To ensure concealment, the random allocation sequence was generated by a statistician and given to the project manager. Randomization was completed by a research assistant who was not involved in the assessment of participants and the allocation sequence was concealed when enrolling participants.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The random allocation sequence was generated by a computer-based random number-producing algorithm in block lengths of six 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
Assessors and participants were blinded at baseline assessment
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2008
Actual
1/10/2008
Date of last participant enrolment
Anticipated
Actual
15/10/2008
Date of last data collection
Anticipated
Actual
Sample size
Target
44
Accrual to date
Final
53
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 243811 0
Other Collaborative groups
Name [1] 243811 0
Hunter Medical Research Institute (HMRI)
Country [1] 243811 0
Australia
Primary sponsor type
Individual
Name
Prof Philip Morgan
Address
School of Education
Faculty of Education and Arts
University of Newcastle Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 237168 0
Individual
Name [1] 237168 0
Prof David Lubans
Address [1] 237168 0
School of Education
Faculty of Education and Arts
University of Newcastle Callaghan NSW 2308
Country [1] 237168 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243943 0
The University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 243943 0
Ethics committee country [1] 243943 0
Australia
Date submitted for ethics approval [1] 243943 0
Approval date [1] 243943 0
29/07/2008
Ethics approval number [1] 243943 0
H-2008-0251

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

Contacts
Principal investigator
Name 30273 0
Prof Philip Morgan
Address 30273 0
School of Education Faculty of Education and Arts University of Newcastle University Dve Callaghan NSW 2308
Country 30273 0
Australia
Phone 30273 0
+61 2 4921 7265
Fax 30273 0
Email 30273 0
[email protected]
Contact person for public queries
Name 13520 0
Philip Morgan
Address 13520 0
School of Education
Faculty of Education and Arts
University of Newcastle
University Dve
Callaghan NSW 2308
Country 13520 0
Australia
Phone 13520 0
+61 2 4921 7265
Fax 13520 0
+61 2 4921 7407
Email 13520 0
[email protected]
Contact person for scientific queries
Name 4448 0
Philip Morgan
Address 4448 0
School of Education
Faculty of Education and Arts
University of Newcastle
University Dve
Callaghan NSW 2308
Country 4448 0
Australia
Phone 4448 0
+61 2 4921 7265
Fax 4448 0
+61 2 4921 7407
Email 4448 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
No additional documents have been identified.