Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001010684
Ethics application status
Approved
Date submitted
11/09/2014
Date registered
19/09/2014
Date last updated
18/05/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy of the Baby Healthy Living (Triple P) parenting intervention for parents of 4-18 month old babies at risk for infant obesity.
Scientific title
Efficacy of the Baby Healthy Living (Triple P) parenting intervention for parents with babies at risk for infant obesity, comparing the intervention against the care as usual condition in improving parenting skills and confidence and reducing risk factors associated with infant obesity.
Secondary ID [1] 285300 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psychological risk factors associated with infant obesity 292974 0
Parenting practices/behaviour 292975 0
Parental beliefs and knowledge 292978 0
Infant self-regulation of energy intake 292979 0
Parenting efficacy 292980 0
Infant weight status 292981 0
Condition category
Condition code
Mental Health 293271 293271 0 0
Studies of normal psychology, cognitive function and behaviour
Diet and Nutrition 293272 293272 0 0
Obesity
Public Health 293273 293273 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention consists of one, 2-hour group discussion session, Positive Parenting for Baby Healthy Living, designed to target the direct and indirect pathways of parenting impact on infant obesity outcomes i.e. feeding practices, parenting practices, parents’ beliefs and knowledge, and parenting confidence and stress. The content draws on the theoretical principles that form the basis of Triple P, and is designed to be interactive and provide opportunities for discussion.

The Baby Healthy Living session focuses on providing parents with strategies that empower them to promote effectively good habits in their baby by having realistic expectations of their child and themselves, encouraging their baby’s self-regulation, setting early age appropriate limits and reducing stress. The session begins by exploring the challenges of being a parent in our society and discussing strategies to raise a healthy baby. The principles of positive parenting are then introduced as a way to promote babies’ healthy development (e.g. eating, sleeping, getting active) and manage infants’ behaviour and emotions in a constructive way. Finally, parents learn about coping strategies to manage stress.

Parents in the intervention receive a workbook and view a set of slides including short video segments. Detailed resources including a presentation guide and a session checklist are followed by the practitioner to guide them in delivering the session.
Intervention code [1] 290209 0
Behaviour
Comparator / control treatment
Families in the control group (Care As Usual) will be assessed on entry to the trial, 6 weeks later, and then again at 6 months. During this time, families will be free to access any resources they might need per usual. After the 6-month follow-up assessment families will be offered participation in the intervention.
Control group
Active

Outcomes
Primary outcome [1] 293116 0
Parental feeding practices as measured by the Infant Feeding Styles Questionnaire (Thompson, Mendez, Borja, Adair, Zimmer & Bentley, 2009) and the the Family Lifestyle Scale (Gelmini & Morawska, 2014)
Timepoint [1] 293116 0
Baseline, 4 weeks post-intervention, 6 months after intervention
Primary outcome [2] 293117 0
Parental feeding responsiveness as measured by the Mealtime Scenarios (Gelmini & Morawska, 2014)
Timepoint [2] 293117 0
Baseline, 4 weeks post-intervention, 6 months after intervention
Primary outcome [3] 293118 0
Parental self-efficacy in responsive feeding as measured by the Self-Efficacy in Responsive Feeding Scale (Gelmini & Morawska, 2013)
Timepoint [3] 293118 0
Baseline, 4 weeks post-intervention, 6 months after intervention
Secondary outcome [1] 310392 0
Parental beliefs and knowledge about feeding as measured by the Infant Feeding Styles Questionnaire (Thompson, Mendez, Borja, Adair, Zimmer & Bentley, 2009) and the Family Lifestyle Scale (Gelmini & Morawska, 2014)
Timepoint [1] 310392 0
Baseline, 4 weeks post-intervention, 6 months after intervention
Secondary outcome [2] 310396 0
Parenting self-efficacy as assessed by the Maternal Self-Efficacy Scale (Teti & Gelfand, 1991)
Timepoint [2] 310396 0
Baseline, 4 weeks post-intervention, 6 months after intervention
Secondary outcome [3] 310398 0
Child's self-regulatory skills as measured by the Short Temperament Scale for Infants (Sanson, Prior, Garino, Oberklaid & Sewell, 1987) or the Short Temperament Scale for Toddlers (Sewell, Oberklaid, Prior, Sanson & Kyrios, 1988)
Timepoint [3] 310398 0
Baseline, 4 weeks post-intervention, 6 months after intervention
Secondary outcome [4] 310399 0
Child's weight status as assessed by the body measurements (weight, length and head circumference) through the home visits.
Timepoint [4] 310399 0
Baseline, 4 weeks post-intervention, 6 months after intervention
Secondary outcome [5] 310400 0
Parental eating behaviours as measured by 2 items from the Revised Three-Factor Eating Questionnaire (Karlsson, Persson, Sjostrom & Sullivan, 2000)
Timepoint [5] 310400 0
Baseline, 4 weeks post-intervention, 6 months after intervention
Secondary outcome [6] 310401 0
Parent's satisfaction with the program assessed through Client Satisfaction Questionnaire (Turner, Markie-Dadds, & Sanders, 1998)
Timepoint [6] 310401 0
4 weeks post-intervention

Eligibility
Key inclusion criteria
To be eligible to participate in the study, parents have to meet two (2) or more of the following inclusion criteria, which are all risk factors associated with infant obesity:

(i) Single parent;

(ii) Parent is concerned about feeding their baby or their child’s behaviour at mealtimes;

(iii) Parent introduced solid food before their baby was 4 months of age;

(iv) Parent usually has the TV on during mealtimes and/or when feeding their baby;

(v) Parent whose highest level of education is high school or less;

(vi) Parent whose occupation is labourer, sales worker or machinery operator/driver;

(vii) Parent whose Body Mass Index (BMI) is greater than or equal to 25 (overweight or obese);

(viii) Child whose weight for length (WFL) ratio is greater than or equal to the 85th percentile (overweight or obese).
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
The exclusion criteria include:

(i) Child is below 4 months or over 18 months of age;

(ii) Child was born preterm;

(iii) Parents are currently seeing a professional for the child’s behaviours difficulties;

(iv) Parents are currently receiving psychological help or counselling;

(v) Child has developmental disorder or delay; or

(vi) Parent (or partner) has difficulties reading newspaper

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A pre-prepared series of sealed opaque envelopes, each labelled with a participant ID number and containing a Randomisation Notification Letter, will be used to conceal the group allocation from both researchers and participants until after completion of the time 1 assessment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation of participants to either the intervention group or the care as usual control group will be done using a random allocation sequence generated using a computer-based random number generator.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A power analysis was conducted to determine the required sample size. To detect a medium effect size of .30 with alpha set at .05, and power at .80, a minimum sample size of 55 participants per group is needed (i.e., N=110 for this two group study). Allowing for potential attrition of 20% the proposed sample size will provide sufficient power to
conduct the proposed analyses.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
26/07/2014
Actual
27/07/2014
Date of last participant enrolment
Anticipated
Actual
21/04/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
82
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 289926 0
Self funded/Unfunded
Name [1] 289926 0
Country [1] 289926 0
Primary sponsor type
Individual
Name
Agnes Gelmini
Address
Parenting and Family Support Centre
School of Psychology
Rm s327, Social Sciences Building (Blg 24),
The University of Queensland
ST LUCIA
QLD 4072
Country
Australia
Secondary sponsor category [1] 288619 0
Individual
Name [1] 288619 0
Alina Morawska
Address [1] 288619 0
Parenting and Family Support Centre
School of Psychology
Social Sciences Building (Blg 24)
The University of Queensland
St Lucia
QLD 4072
Country [1] 288619 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291643 0
UQ Behavioural & Social Sciences Ethical Review Committee (BSSERC)
Ethics committee address [1] 291643 0
Ethics committee country [1] 291643 0
Australia
Date submitted for ethics approval [1] 291643 0
08/05/2014
Approval date [1] 291643 0
19/06/2014
Ethics approval number [1] 291643 0
2014000654

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

Contacts
Principal investigator
Name 51286 0
Ms Agnes Gelmini
Address 51286 0
Parenting and Family Support Centre School of Psychology Rm s327, Social Sciences Building (Blg 24), The University of Queensland
ST LUCIA QLD 4072
Country 51286 0
Australia
Phone 51286 0
+61 7 3346 7689
Fax 51286 0
Email 51286 0
[email protected]
Contact person for public queries
Name 51287 0
Agnes Gelmini
Address 51287 0
Parenting and Family Support Centre School of Psychology Rm s327, Social Sciences Building (Blg 24), The University of Queensland
ST LUCIA QLD 4072
Country 51287 0
Australia
Phone 51287 0
+61 7 3346 7689
Fax 51287 0
Email 51287 0
[email protected]
Contact person for scientific queries
Name 51288 0
Agnes Gelmini
Address 51288 0
Parenting and Family Support Centre School of Psychology Rm s327, Social Sciences Building (Blg 24), The University of Queensland
ST LUCIA QLD 4072
Country 51288 0
Australia
Phone 51288 0
+61 7 3346 7689
Fax 51288 0
Email 51288 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.