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Trial registered on ANZCTR


Registration number
ACTRN12615000354583
Ethics application status
Approved
Date submitted
29/10/2014
Date registered
20/04/2015
Date last updated
20/04/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Promoting healthy body image and eating patterns in young children: Helping parents create positive environments.
Scientific title
For parents of young children, will a new parenting resource, compared with standard nutrition information or delayed intervention, improve the family environment and reduce risk of child body dissatisfaction, disordered eating, and overweight.
Secondary ID [1] 284926 0
Nil known
Universal Trial Number (UTN)
U1111-1158-9096
Trial acronym
CBCC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
children's body image 292399 0
children's eating patterns 292400 0
child overweight 293382 0
Condition category
Condition code
Mental Health 292717 292717 0 0
Eating disorders
Mental Health 292718 292718 0 0
Other mental health disorders
Diet and Nutrition 292719 292719 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The evaluation will be conducted as a randomised controlled trial (RCT), whereby parents will be randomly allocated to one of four groups: Group A, B, C or D.
Arm 1:
For Group A, parents will receive a copy of the CBCC resource and attend a 2hr, manualised, group information session hosted by the research team and facilitated by trained personnel.
Arm 2:
For Group B, parents will be mailed a copy of the CBCC resource. They will not be required to attend an information session. The resource includes the A5 70 page Parent Booklet, The Extended Family Booklet, the CBCC website (confidentbody.net), a Do/Don'ts quick reference poster and a children's storybook called "Shapesville". The CBCC resources are evidence-based and design to promote parenting strategies that are protective against, and reduce parenting strategies that are risk factors for, the development of disordered eating, body dissatisfaction and overweight in children.
Arm 3:
For Group C, parents will be mailed a copy of a standard nutrition information resource 'Happy Healthy Kids for Life'. It is a 23-page A5 booklet for parents developed by dieticians at a community health centre in Melbourne, Australia, and is based on the Australian Dietary Guidelines. It contains information about the nutritional components of child healthy eating and some guidance on parental feeding practices, such as avoiding using food as a reward (instrumental feeding). It does not contain any information about child body image, or how teaching children about healthy eating may impact on the development of body satisfaction.
Arm 4:
For Group D, parents will only be asked to complete questionnaires.

All participants will complete questionnaires at baseline and at three follow-up time points (6 weeks, 6-months and 12-months)


To measure fidelity, at 6-week follow-up participants will be asked how much of the resource they read (0-100% sliding scale), whether they used any of the exercises or information in the resource, if they changed their behaviours or attitudes as a result of reading the resource, and what they have done with the resource now (i.e. kept it, thrown it away, lent it to a friend).
Intervention code [1] 289749 0
Prevention
Comparator / control treatment
Two control treatments will be included: (1) Group C will be an active control group, who will receive the standard nutrition resource 'Happy Healthy Kids for Life';

(2) Group D will be a delayed intervention group, who will only complete questionnaires throughout the trial and will receive all of the resources after completing the 12month follow-up questionnaire.
Control group
Active

Outcomes
Primary outcome [1] 292613 0
Positive parental behaviours in relation to promoting healthy body image and eating patterns for children, as assessed by the Parenting Strategies Scale derived for this study.
Timepoint [1] 292613 0
Baseline, and at 6 weeks, 6 months, and 12 months after baseline.
Secondary outcome [1] 309337 0
Stigmatising parenting behaviours that may increase the risk of body dissatisfaction and eating problems, as assessed by the Parenting Strategies Scale.
Timepoint [1] 309337 0
Baseline, and 6 weeks, 6 months, and 12 months after baseline.
Secondary outcome [2] 309338 0
Parental knowledge of parenting strategies to promote healthy body image and eating patterns in young children, measured by a Knowledge Test.
Timepoint [2] 309338 0
Baseline, and 6 weeks, 6 months, and 12 months after baseline.
Secondary outcome [3] 309339 0
Parental Feeding Practices, measured by a compilation of standardised child feeding questionnaires.
Timepoint [3] 309339 0
Baseline, and 6 weeks, 6 months, and 12 months after baseline.
Secondary outcome [4] 309340 0
Family meal environment, as assessed by an adaptation of the Family Eating Attitude and Behavior Scale.
Timepoint [4] 309340 0
Baseline, and 6 weeks, 6 months, and 12 months after baseline.
Secondary outcome [5] 309341 0
Children's media viewing, assessed for appearance focused content (children's top 3 favourite TV shows, Computer games and DVDs are listed by parents. These programs and media are then rated for body image/appearance focused content using adapted criteria from Herbozo et al, 2004).
Timepoint [5] 309341 0
Baseline, and 6 weeks, 6 months, and 12 months after baseline.
Secondary outcome [6] 309342 0
Parental body image, assessed by the Weight and Shape Concern scale of the Eating Disorder Examination Questionnaire and the Feeling Fat Scale of the Body Attitudes Questionnaire.
Timepoint [6] 309342 0
Baseline, and 6 weeks, 6 months, and 12 months after baseline.
Secondary outcome [7] 309343 0
Parental internalization of societal body ideals, assessed by the General and Athlete Internalization scales of the Socio-cultural Attitudes Towards Appearance Questionnaire.
Timepoint [7] 309343 0
Baseline, and 6 weeks, 6 months, and 12 months after baseline.
Secondary outcome [8] 309344 0
Parental dieting behaviour, assessed by the Restraint scale of the Dutch Eating Behaviors Questionnaire.
Timepoint [8] 309344 0
Baseline, and 6 weeks, 6 months, and 12 months after baseline.

Eligibility
Key inclusion criteria
Participants will include parents of children aged between 2 to 6 years, who live in Victoria, Australia, are 18 years or over, and have a good understanding of written and spoken English.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be excluded if they are not a parent of child between 2 and 6 years, live outside of Victoria, Australia, are under the age of 18 years, and do not have a good understanding of written and spoken English.

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)
The research study will be advertised through a range of public forums where parents of young children frequent. Upon expressing interest in participating, parents will be sent detailed information about the study and asked to complete an enrolment form, including personal contact information to ensure they meet the inclusion criteria. Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
As part of their enrolment, participants will be asked if they would be able to make themselves available for a face to face information session. Parents who respond 'yes' will be randomly assigned to one of four groups (A, B, C, or D). Parents who respond 'no' will be randomly assigned to one of three groups (B, C, or D). SPSS random sequence generator function will be used to create a random sequence of ABCD. As participants enrol in the study, they will be placed next to one letter in the sequence, indicating their allocation to group.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Given this is a four-arm RCT, it was determined that 80 participants would be required in each group (n = 320) to provide 80% power to detect a small-medium (d=.02) effect size.
ANCOVA and MMRM will be used to assess how groups change over time and whether they are significantly different from each other at each time point, taking into account differences at baseline and missing data at follow-up.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
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)
VIC

Funding & Sponsors
Funding source category [1] 290162 0
Charities/Societies/Foundations
Name [1] 290162 0
Cages Foundation
Address [1] 290162 0
PO Box 1334
North Sydney NSW 2059
Country [1] 290162 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
School of Psychology and Public Health
George Singer Building
Bundoora VIC 3086
Country
Australia
Secondary sponsor category [1] 288870 0
Charities/Societies/Foundations
Name [1] 288870 0
CAGES Foundation
Address [1] 288870 0
PO Box 1068
North Sydney NSW 2059
Country [1] 288870 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291318 0
La Trobe University Human Ethics Committee
Ethics committee address [1] 291318 0
Human Ethics
La Trobe University
Kingsbury Drive, Bundoora VIC 3086
Ethics committee country [1] 291318 0
Australia
Date submitted for ethics approval [1] 291318 0
23/04/2013
Approval date [1] 291318 0
20/06/2013
Ethics approval number [1] 291318 0
UHEC13-023

Summary
Brief summary
This project involves evaluating the effectiveness of a new parenting resource, Confident Body, Confident Child (CBCC). Parents who receive CBCC will be compared with parents who do not receive CBCC on attitudes, behaviours, and knowledge about body image and healthy eating patterns at pre-intervention, and at three post-intervention time points.
Trial website
http://www.latrobe.edu.au/psy/research/clinical-and-health-psychology/confident-body-study
Trial related presentations / publications
Hart LM, Cornell C, Damiano SR, Paxton SJ. (2015) Parents and prevention: A systematic review of interventions involving parents that aim to prevent body dissatisfaction or eating disorders. International Journal of Eating Disorders. doi: 10.1002/eat.22284

Hart LM, Damiano SR, Chittleborough P, Paxton SJ, Jorm AF. Parenting to prevent body dissatisfaction and unhealthy eating patterns in preschool children: A Delphi consensus study. Body Image. 2014, 11: 418-425.

Damiano SR, Hart LM, Paxton SJ. Development and validation of parenting measures for body image and eating patterns in childhood. Journal of Eating Disorders 2015;3:1-17.
Public notes
The Human Research Ethics Committee sent an email on 20/6/2013 stating that our application for this research had been approved, but due to staffing difficulties, formal notification via a letter would be delayed. We received the official letter of approval on 2 July 2013.

Contacts
Principal investigator
Name 49706 0
Prof Susan J Paxton
Address 49706 0
School of Psychology and Public Health
George Singer Building
La Trobe University
Kingsbury Drive, Bundoora VIC 3086
Country 49706 0
Australia
Phone 49706 0
+61 3 9479 1736
Fax 49706 0
Email 49706 0
susan.paxton@latrobe.edu.au
Contact person for public queries
Name 49707 0
Prof Susan J Paxton
Address 49707 0
School of Psychology and Public Health
George Singer Building
La Trobe University
Kingsbury Drive, Bundoora VIC 3086
Country 49707 0
Australia
Phone 49707 0
+61 3 9479 1736
Fax 49707 0
Email 49707 0
susan.paxton@latrobe.edu.au
Contact person for scientific queries
Name 49708 0
Prof Susan J Paxton
Address 49708 0
School of Psychology and Public Health
George Singer Building
La Trobe University
Kingsbury Drive, Bundoora VIC 3086
Country 49708 0
Australia
Phone 49708 0
+61 3 9479 1736
Fax 49708 0
Email 49708 0
susan.paxton@latrobe.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary