ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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Trial registered on ANZCTR

Registration number

ACTRN12621001291875

Ethics application status

Approved

Date submitted

24/08/2021

Date registered

24/09/2021

Date last updated

24/09/2021

Date data sharing statement initially provided

24/09/2021

Type of registration

Prospectively registered

Titles & IDs

Public title

Healthy Habits Triple P: A parent-focused online program to support healthy eating in early childhood

Scientific title

Healthy habits Triple P: Effect of a parent-focused evidence-based intervention on the dietary practices of young children

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

U1111-1268-9997

Trial acronym

Linked study record

Health condition

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

Poor diet

Condition category

Condition code

Public Health

Health promotion/education

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The Healthy Habits For Life Triple P online program is designed to improve parenting practices and confidence related to children’s dietary habits. It is based on a social learning model to promote self-regulation in children, which forms the theoretical basis of Triple P. This program is easy to use and engaging and includes interactive features like video/audio clips, goal-setting activities, reminders, and progress trackers. The program could be completed in 3-4 hours but parents are encouraged to complete at their own pace within four weeks of allocation. It is compatible for use on a smartphone, tablet or computer and has two modules: 1. Getting Started with Healthy Habits focuses on the five core principles of positive parenting in the context of promoting healthy lifestyle practices in families. 2. Healthy Eating to Promote Children’s Wellbeing introduces parents to nutrition strategies from both a content perspective (in line with the updated Australian Dietary Guidelines 2013) and regarding managing child eating behaviours (e.g., fussy eating, food choices, mealtime behaviours). Information about parents’ access, time online, and module completion will be collected remotely.

Intervention code [1]

Lifestyle

Comparator / control treatment

The control group will be kept on the waitlist, they will have access to the online intervention after the six-week followup. They will receive educational materials and access to the Queensland Health website for children’s health and parenting.

Control group

Active

Outcomes

Primary outcome [1]

Child Diet using Children's Dietary questionnaire

Timepoint [1]

6-weeks after randomisation

Secondary outcome [1]

Lifestyle-Specific Parenting Behaviours will be assessed using the Lifestyle Parenting Questionnaire

Timepoint [1]

6-weeks after randomisation

Secondary outcome [2]

Child Lifestyle Behaviour and Parent Efficacy assessed using a composite measure, Lifestyle Behaviour Checklist

Timepoint [2]

6-weeks after randomisation

Secondary outcome [3]

Frequency of consumption of sugar-rich foods and drinks among children assessed using a study-specific questionnaire

Timepoint [3]

6-weeks after randomisation

Secondary outcome [4]

Parents’ confidence in dealing with children’s demands for sugar-rich foods using The Comprehensive Snack Parenting Questionnaire

Timepoint [4]

6-weeks after randomisation

Eligibility

Key inclusion criteria

Having a child aged 2-6 years,
Able to read and understand English,
Provide written informed consent
Having access to a device (e.g. smartphone, tablet, computer) with internet access.

Minimum age

2 Years

Maximum age

60 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Family members of a parent already participating in the study will be excluded

Study design

Purpose of the study

Educational / counselling / training

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Who is / are masked / blinded?

Intervention assignment

Other design features

Phase

Not Applicable

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

30/09/2021

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors

Funding source category [1]

University

Name [1]

Griffith University School of Medicine and Dentistry

Address [1]

Griffith Health Building (G40)
Cnr Olsen Ave and Parklands Dr
Southport QLD 4222

Country [1]

Australia

Primary sponsor type

Individual

Name

Dr Santosh Kumar Tadakamadla

Address

Room: 7.63, Level 7
School of Medicine and Dentistry
Griffith Health Building (G40)
Cnr Olsen Ave and
Parklands Dr
Southport QLD 4222

Country

Australia

Secondary sponsor category [1]

Individual

Name [1]

Dr Amy Mitchell

Address [1]

Health Sciences (N48) Room 2.20,
School of Nursing and Midwifery,
170 Kessels road,
Griffith University,
Nathan,
QLD 4111.

Country [1]

Australia

Secondary sponsor category [2]

Individual

Name [2]

A/Prof Alina Morawska

Address [2]

13 Upland Rd,
Parenting and Family Support Centre,
School of Psychology,
The University of Queensland,
Brisbane QLD 4072

Country [2]

Australia

Secondary sponsor category [3]

Individual

Name [3]

Dr Vatsna Rathore

Address [3]

Room: 5.51, Level 5
School of Medicine and Dentistry
Griffith Health Building (G40)
Cnr Olsen Ave and
Parklands Dr
Southport QLD 4222

Country [3]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Griffith University Human Research Ethics Committee

Ethics committee address [1]

Griffith University
170 Kessels Rd
Nathan
QLD 4111

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

18/08/2021

Approval date [1]

27/08/2021

Ethics approval number [1]

2021/636

Summary

Brief summary

The prevalence of childhood obesity and overweight is a critical health issue in Queensland. A recent report indicated that 26% of children in Queensland are overweight (19%) or obese (7%). Although the causes of childhood obesity are complex, the intake of energy-dense, nutrient-poor food is a key contributor to obesity in Australian schoolchildren. Parental influence, role modeling, and the home environment are the strongest determinants of healthy eating in children, particularly for the younger age groups. As key role models and decision-makers regarding their child’s food intake, parents have a critical role to play in childhood dietary practices. This is especially true of parents of children aged 2-6 years as this is a formative period for the development of a child’s lifestyle habits and behaviour and a critical period for parental support seeking.
Low-intensity programs that are embedded within the principles of positive parenting have shown promising results in improving health behaviours in children. Therefore, it is essential to develop interventions that target specific parenting contexts, such as parenting practices related to dietary intake. Here, we intend to evaluate the efficacy of a novel web-based program, ‘Healthy Habits for Life Triple P’, which is based on the Triple P-Positive parenting Program system of family behavioural intervention.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Santosh Kumar Tadakamadla

Address

Room: 7.63, Level 7
School of Medicine and Dentistry
Griffith Health Building (G40)
Cnr Olsen Ave and
Parklands Dr
Southport QLD 4222

Country

Australia

Phone

+61 756780153

Fax

s.tadakamadla@griffith.edu.au

Contact person for public queries

Name

Santosh Kumar Tadakamadla

Address

Room: 7.63, Level 7
School of Medicine and Dentistry
Griffith Health Building (G40)
Cnr Olsen Ave and
Parklands Dr
Southport QLD 4222

Country

Australia

Phone

+61 756780153

Fax

s.tadakamadla@griffith.edu.au

Contact person for scientific queries

Name

Santosh Kumar Tadakamadla

Address

Room: 7.63, Level 7
School of Medicine and Dentistry
Griffith Health Building (G40)
Cnr Olsen Ave and
Parklands Dr
Southport QLD 4222

Country

Australia

Phone

+61 756780153

Fax

s.tadakamadla@griffith.edu.au

Data sharing statement

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

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
12975	Informed consent form			santoshkumar.tadakamadla@griffithuni.edu.au

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.

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