Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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] 305125 0
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 323358 0
Condition category
Condition code
Public Health 320929 320929 0 0
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] 321533 0
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] 328713 0
Child Diet using Children's Dietary questionnaire
Timepoint [1] 328713 0
6-weeks after randomisation
Secondary outcome [1] 400093 0
Lifestyle-Specific Parenting Behaviours will be assessed using the Lifestyle Parenting Questionnaire
Timepoint [1] 400093 0
6-weeks after randomisation
Secondary outcome [2] 400094 0
Child Lifestyle Behaviour and Parent Efficacy assessed using a composite measure, Lifestyle Behaviour Checklist
Timepoint [2] 400094 0
6-weeks after randomisation
Secondary outcome [3] 400095 0
Frequency of consumption of sugar-rich foods and drinks among children assessed using a study-specific questionnaire
Timepoint [3] 400095 0
6-weeks after randomisation
Secondary outcome [4] 400096 0
Parents’ confidence in dealing with children’s demands for sugar-rich foods using The Comprehensive Snack Parenting Questionnaire
Timepoint [4] 400096 0
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
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 309514 0
University
Name [1] 309514 0
Griffith University School of Medicine and Dentistry
Country [1] 309514 0
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] 310494 0
Individual
Name [1] 310494 0
Dr Amy Mitchell
Address [1] 310494 0
Health Sciences (N48) Room 2.20,
School of Nursing and Midwifery,
170 Kessels road,
Griffith University,
Nathan,
QLD 4111.
Country [1] 310494 0
Australia
Secondary sponsor category [2] 310495 0
Individual
Name [2] 310495 0
A/Prof Alina Morawska
Address [2] 310495 0
13 Upland Rd,
Parenting and Family Support Centre,
School of Psychology,
The University of Queensland,
Brisbane QLD 4072
Country [2] 310495 0
Australia
Secondary sponsor category [3] 310496 0
Individual
Name [3] 310496 0
Dr Vatsna Rathore
Address [3] 310496 0
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] 310496 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309298 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 309298 0
Ethics committee country [1] 309298 0
Australia
Date submitted for ethics approval [1] 309298 0
18/08/2021
Approval date [1] 309298 0
27/08/2021
Ethics approval number [1] 309298 0
2021/636

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

Contacts
Principal investigator
Name 113678 0
Dr Santosh Kumar Tadakamadla
Address 113678 0
Room: 7.63, Level 7
School of Medicine and Dentistry
Griffith Health Building (G40)
Cnr Olsen Ave and
Parklands Dr
Southport QLD 4222
Country 113678 0
Australia
Phone 113678 0
+61 756780153
Fax 113678 0
Email 113678 0
[email protected]
Contact person for public queries
Name 113679 0
Santosh Kumar Tadakamadla
Address 113679 0
Room: 7.63, Level 7
School of Medicine and Dentistry
Griffith Health Building (G40)
Cnr Olsen Ave and
Parklands Dr
Southport QLD 4222
Country 113679 0
Australia
Phone 113679 0
+61 756780153
Fax 113679 0
Email 113679 0
[email protected]
Contact person for scientific queries
Name 113680 0
Santosh Kumar Tadakamadla
Address 113680 0
Room: 7.63, Level 7
School of Medicine and Dentistry
Griffith Health Building (G40)
Cnr Olsen Ave and
Parklands Dr
Southport QLD 4222
Country 113680 0
Australia
Phone 113680 0
+61 756780153
Fax 113680 0
Email 113680 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
12975Informed consent form  [email protected]



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.