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
ACTRN12617000315314
Ethics application status
Approved
Date submitted
17/02/2017
Date registered
28/02/2017
Date last updated
28/02/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Parenting, Eating and Activity for Child Health (PEACH) Queensland: the trial of universal childhood obesity management program for families of primary school aged children
Scientific title
Queensland Health's Targeted Risk Modification Kids program: a trial of a statewide universal childhood obesity management program to lower BMI z score, improve diet, physical activity and parenting self efficacy,decrease sedentary behaviours and trial models for health service delivery
Secondary ID [1] 291040 0
nil known
Universal Trial Number (UTN)
Trial acronym
PEACH QLD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight 301832 0
Obesity 301833 0
diet 301842 0
physical activity 301843 0
parenting 301844 0
Condition category
Condition code
Public Health 301509 301509 0 0
Health service research
Diet and Nutrition 301520 301520 0 0
Obesity
Public Health 301771 301771 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The TRIM kids project trialled the universal availability of a childhood obesity management service in Queensland, Australia. It was the upscaled implemention of the Parenting, Eating and Activity for Child Health (PEACH) program. The aims of the project were to increase the capacity of families who participated to adopt healthy lifestyles (eating and physical activity and to promote healthy weight through sustainable behavior change.
Objectives of the project were to:
1: Successfully deliver the program to 1400 children state-wide.
2: Refine the PEACH model to ensure maximum retention of participants and further deploy the program to maximise participation state-wide (including regional and rural Queensland).
3: Document new models utilised to deliver the program.
4: Enhance the currently limited evidence-base on the effectiveness of paediatric treatment programs, in particular, in their use with culturally and linguistically diverse (CALD) and Aboriginal and Torres Strait Islander populations.
5: Contribute to the Department of Health’s vision through contributing to the early detection and appropriate treatment of childhood obesity and secondary prevention of obesity related conditions.
6: Leverage the funding opportunity to invest in the sustainability beyond the project lifecycle.
PEACH targeted families of children aged 5-11 years who were above the healthy weight range for age.
PROCEDURES AND MATERIALS
PEACH was a group-based, 6 month family-focussed lifestyle intervention. PEACH consisted of nine 90-minute face-to-face sessions (fortnightly or weekly), followed by a final tenth session at 6-months after session one. Between sessions nine and ten, facilitators made three individualised phone calls (duration varied according to family need). At each session, content was delivered by the facilitator to a group of parents, emphasising the role of peer-support in behaviour change. Sessions were held outside of school hours in a variety of tertiary and community based settings, predominantly school venues.
Topics included parenting styles, nutrition skills, and physical activity. Each of the ten parent sessions had defined objectives, take home messages and a small homework task. Parents were encouraged to set one or two family family-specific goals to work on between sessions, utilising the goal setting and action planning worksheet templates and the planning ahead template (PAT). Enrolled families received a Parent Handbook and provided additional one-on-one parent facilitator time support via three phone calls between sessions 9 and 10 at a time each parent had identified as convenient for them. Parents received appointment reminder SMS messages before each face-to-face session and twelve weekly motivational messages between sessions 9 and 10 e.g. "routines help children to move from one activity to th enext smoothly and calmly. why not use a PAT to set a healthy routine?
Concurrently with parent sessions, Children attended separate sessions with a child facilitator during which they participated in games and activities. Each child session included a brief healthy eating component based on the content corresponding parent session to facilitate family discussion at home. Children sessions were supported with a Child workbook which encouraged ‘at home’ activities. Siblings of enrolled children were encouraged to participate in the child sessions.
WORKFORCE
Facilitators were health professionals recruited from around Queensland via call for expressions of interest. Training workshops were conducted via a 2-day face-to-face workshop in Brisbane, Queensland or teleconference meeting in special circumstances. Workshops comprised program information including the background to PEACH and its key objectives, session content role-plays as well as information on the role of the facilitator in program delivery and collection of evaluation data from participants.
ADHERENCE AND MODIFICATIONS
Data regarding fidelity of the intervention was collected using session monitoring booklets. Facilitators recorded the duration of each session and their adherence to the session’s key content.
The project was implemented over five geographical time limited waves during which one program cycle (ie 6months) was delivered. The number of programs being run increased incrementally with each wave with services from previous waves expected to continue to offer the program in subsequent waves. Data was reviewed at the end of each wave and informed subsequent waves. Two key changes were made as a results: After wave 2, the QUT Project Implementation Team undertook a review of the program design and content, and as a consequence of this the intervention was adapted in order to improve retention and engagement. Some of this adaptations were: changed intervention frequency from fortnightly to weekly sessions, within a school term, reviewed program design and content to better align with families concerns and reasons for enrolment, Introduced SMS reminder messages before sessions, focused on using schools as ideal venues to reduce stigma, and sent motivational SMS messages to families between sessions 9 and 10. Following wave 4, eligibility criteria were changed to include healthy weight children.
Intervention code [1] 297022 0
Lifestyle
Intervention code [2] 297023 0
Behaviour
Intervention code [3] 297238 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 300909 0
Proportion of children with increased intake of fruit and vegetable and reduced intake of discretionary foods and/or non-milk sugar sweetened beverages via parent-reported dietary recall and Child Dietary Questionnaire (a validated tool which combines food frequency and dietary behaviours questions)
Timepoint [1] 300909 0
At six months after starting the program
Primary outcome [2] 300910 0
Proportion of parents reporting changes in their children's activity and sedentary behaviours using a parent reported physical activity survey.
Timepoint [2] 300910 0
At six months after starting the program
Primary outcome [3] 300911 0
Proportion of children who achieved a lower BMI z-score and/or a healthier weight status category. Height and weight measured by child facilitators at first and last sessions.
Timepoint [3] 300911 0
At six months after starting the program
Secondary outcome [1] 331176 0
Parenting self-efficacy and confidence as assessed by the parenting self-efficacy questionnaire.

Timepoint [1] 331176 0
At six months after starting the program

Eligibility
Key inclusion criteria
The eligibility criteria for enrolling in the program were modified for wave 5.

For waves 1 to 4:
>Child is above healthy BMI range
> Child is aged 5–11 years
> Child resides in Queensland

For wave 5:
> Child is aged 5–11 years
> Child resides in Queensland
Minimum age
5 Years
Maximum age
11 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
For waves 1 to 4:
> Child is within healthy BMI range
> Child is not aged 5–11 years
> Child does not reside in Queensland

For wave 5:
> Child is not aged 5–11 years
> Child does not reside in Queensland

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Completed
Date of first participant enrolment
Anticipated
Actual
18/09/2013
Date of last participant enrolment
Anticipated
Actual
5/06/2016
Date of last data collection
Anticipated
Actual
15/09/2016
Sample size
Target
1400
Accrual to date
Final
1513
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 295464 0
Government body
Name [1] 295464 0
Queensland Government Department of Health
Country [1] 295464 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
Victoria Park Rd
Kelvin Grove Queensland 4059
Country
Australia
Secondary sponsor category [1] 294289 0
University
Name [1] 294289 0
Flinders University
Address [1] 294289 0
Sturt Rd, Bedford Park SA 5042
Country [1] 294289 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296800 0
Queensland children’s Health Services Human Research Ethics Committee
Ethics committee address [1] 296800 0
Ethics committee country [1] 296800 0
Australia
Date submitted for ethics approval [1] 296800 0
Approval date [1] 296800 0
17/09/2013
Ethics approval number [1] 296800 0
HREC/13/QHC/25
Ethics committee name [2] 296805 0
Queensland University of Technology University Human Research Ethics Committee
Ethics committee address [2] 296805 0
Ethics committee country [2] 296805 0
Australia
Date submitted for ethics approval [2] 296805 0
Approval date [2] 296805 0
23/10/2013
Ethics approval number [2] 296805 0
1300000633
Ethics committee name [3] 296806 0
Flinders University Social and Behavioural Research Ethics Committee
Ethics committee address [3] 296806 0
Ethics committee country [3] 296806 0
Australia
Date submitted for ethics approval [3] 296806 0
Approval date [3] 296806 0
03/10/2013
Ethics approval number [3] 296806 0
H13/09-173

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

Contacts
Principal investigator
Name 72090 0
Prof Lynne Daniels
Address 72090 0
Emeritus Professor
School of Exercise and Nutrition Sciences,
Faculty of Health
Queensland University of Technology
Victoria Park Rd
Kelvin Grove Queensland 4069
Country 72090 0
Australia
Phone 72090 0
+61 7 3138 6139
Fax 72090 0
Email 72090 0
[email protected]
Contact person for public queries
Name 72091 0
Helen Vidgen
Address 72091 0
School of Exercise and Nutrition Sciences,
Faculty of Health
Queensland University of Technology
Victoria Park Rd
Kelvin Grove Queensland 4069
Country 72091 0
Australia
Phone 72091 0
+61 7 3138 0118
Fax 72091 0
Email 72091 0
[email protected]
Contact person for scientific queries
Name 72092 0
Helen Vidgen
Address 72092 0
School of Exercise and Nutrition Sciences,
Faculty of Health
Queensland University of Technology
Victoria Park Rd
Kelvin Grove
Queensland 4069
Country 72092 0
Australia
Phone 72092 0
+61 7 3138 0118
Fax 72092 0
Email 72092 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
SourceTitleYear of PublicationDOI
Dimensions AIPre–post evaluation of a weight management service for families with overweight and obese children, translated from the efficacious lifestyle intervention Parenting, Eating and Activity for Child Health (PEACH)2018https://doi.org/10.1017/s0007114518001083
N.B. These documents automatically identified may not have been verified by the study sponsor.