ANZCTR - Registration

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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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Obesity

Condition category

Condition code

Diet and Nutrition

Obesity

Public Health

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]

Lifestyle

Intervention code [2]

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]

Fathers' body weight (kg)

Timepoint [1]

At baseline and at 3 and 6 months follow-up

Secondary outcome [1]

Waist circumference for fathers and children (cm)

Timepoint [1]

At baseline and at 3 and 6 months follow-up

Secondary outcome [2]

Body Mass Index for fathers and children (BMI-z)

Timepoint [2]

At baseline and at 3 and 6 months follow-up

Secondary outcome [3]

Systolic and Diastolic Blood pressure for fathers and children

Timepoint [3]

At baseline and at 3 and 6 months follow-up

Secondary outcome [4]

Physical Activity using pedometers for fathers and children

Timepoint [4]

At baseline and at 3 and 6 months follow-up

Secondary outcome [5]

Dietary Intake (kilojoules and macronutrient profile) for fathers and children

Timepoint [5]

At baseline and at 3 and 6 months follow-up

Secondary outcome [6]

Resting Heart Rate for fathers and children

Timepoint [6]

At baseline and at 3 and 6 months follow-up

Secondary outcome [7]

Parental Engagement

Timepoint [7]

At baseline and at 3 and 6 months follow-up

Secondary outcome [8]

Child Feeding Behaviours

Timepoint [8]

At baseline and at 3 and 6 months follow-up

Secondary outcome [9]

% body fat by Bioimpedance Analysis (BIA) for fathers and children

Timepoint [9]

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]

Other Collaborative groups

Name [1]

Hunter Medical Research Institute (HMRI)

Address [1]

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

Prof Philip Morgan

Address

School of Education
Faculty of Education and Arts
University of Newcastle Callaghan NSW 2308

Country

Australia

Secondary sponsor category [1]

Individual

Name [1]

Prof David Lubans

Address [1]

School of Education
Faculty of Education and Arts
University of Newcastle Callaghan NSW 2308

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The University of Newcastle Human Research Ethics Committee

Ethics committee address [1]

Research Services 
Research Office 
The University of Newcastle 
Callaghan NSW 2308

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

29/07/2008

Ethics approval number [1]

H-2008-0251

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) program was designed to engage overweight fathers to role model and promote positive behaviours relating to physical activity and healthy eating. Major aims of HDHK 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).

Trial website

Trial related presentations / publications

Morgan, P.J., Lubans, D.R., Callister, R., Okely, A.D., Burrows, T., Fletcher, R., & Collins, C.E. (2011). The ‘Healthy Dads, Healthy Kids’ randomized controlled trial: Efficacy of a healthy lifestyle program for overweight fathers and their children. International Journal of Obesity, 35(3), 436-447. 

Hall, L., Collins, C.E., Morgan, P.J., Burrows, T.L., Lubans, D.R. & Callister, R. (2011). Children’s intake of fruit and selected energy-dense nutrient-poor foods is associated with fathers’ intake. Journal of the American Dietetic Association. 111(7), 1039-1044. 

Lubans, D.R., Morgan, P.J., Collins, C.E., Okely, A.D., Burrows, T., & Callister, R. (2012). Mediators of weight loss in the ‘Healthy Dads, Healthy Kids’ pilot study for overweight fathers. International Journal of Behavioural Nutrition and Physical Activity, 9:45. 

Burrows, T., Morgan, P.J., Lubans, D.R., Callister, R., Okely, T., Bray, J. & Collins, C.E. (2012). Dietary outcomes of the Healthy Dads Healthy Kids randomised controlled trial. Journal of Pediatric Gastroenterology and Nutrition, 55(4), 408-411.

Public notes

Contacts

Principal investigator

Name

Prof Philip Morgan

Address

School of Education Faculty of Education and Arts University of Newcastle University Dve Callaghan NSW 2308

Country

Australia

Phone

+61 2 4921 7265

Fax

Email

[email protected]

Contact person for public queries

Name

Philip Morgan

Address

School of Education
Faculty of Education and Arts
University of Newcastle
University Dve
Callaghan NSW 2308

Country

Australia

Phone

+61 2 4921 7265

Fax

+61 2 4921 7407

Email

[email protected]

Contact person for scientific queries

Name

Philip Morgan

Address

School of Education
Faculty of Education and Arts
University of Newcastle
University Dve
Callaghan NSW 2308

Country

Australia

Phone

+61 2 4921 7265

Fax

+61 2 4921 7407

Email

[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.