Trial registered on ANZCTR


Trial ID
ACTRN12608000056392
Ethics application status
Approved
Date submitted
15/01/2008
Date registered
29/01/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
Positive feeding practices and food preferences in very early childhood: an innovative approach to obesity prevention
Scientific title
Primary prevention of childhood overweight : An RCT to evaluate the efficacy of a parent education and peer support program for first time mothers of infants 4-7 months at enrolment that provides anticipatory guideance designed to promote early feeding practices that improve early maternal and child feeding behaviours and child food preferences and intakes to support healthy growth at 2 years of age.
Secondary ID [1] 510 0
None
Universal Trial Number (UTN)
Trial acronym

Health condition
Health condition(s) or problem(s) studied:
Childhood overweight and obesity 2720 0
Condition category
Condition code
Diet and nutrition 2840 2840 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will consist of two consecutive 9-month modules each comprising of (i) 6 x fortnightly group sessions then (ii) 5 x monthly maintenance contacts (choice sms/email). The intervention will be delivered through existing child health clinics in Brisbane and Adelaide, co-led by a dietician and a psychologist. The modules will focus on feeding relationships, processes and skills appropriate to the developmental stage. Module one will focus on establishing solid feeding and positive exposure and Module two will focus on managing the growing need for autonomy and independence. Both Modules have a shared content of enhancing attachment and encouraging recognition of and positive responses to the child's feeding cues appropriate to developmental stage.
Intervention code [1] 2458 0
Prevention
Comparator / control treatment
The intervention is compared with 'standard care'; self-directed access to universal services at child health clinics.
Control group
Active

Outcomes
Primary outcome [1] 3726 0
Infant food intake - 3 non-consecutive days using 2 x 24hr food records and 1 x 24hr recall (T1,T2, T3)
Timepoint [1] 3726 0
T1, T2, T3
Primary outcome [2] 3791 0
Food preference - The Wardle Tool
Timepoint [2] 3791 0
T1, T2, T3
Primary outcome [3] 3792 0
Feeding behaviour - Children's Eating Behaviour Questionnaire
Timepoint [3] 3792 0
T2, T3
Secondary outcome [1] 6287 0
Weight and growth (WtHt z scores - length and weight using standard procedures)
Timepoint [1] 6287 0
T1, T2, T3
Secondary outcome [2] 6397 0
Maternal feeding style and practices - the Infant Feeding Questionnaire and Child Feeding Questionnaire
Timepoint [2] 6397 0
T1, T2, T3
Secondary outcome [3] 6398 0
Parenting skills and efficacy - Four brief scales from LSAC
Timepoint [3] 6398 0
T1, T2, T3
Secondary outcome [4] 6399 0
Maternal BMI (height and weight standard procedures)
Timepoint [4] 6399 0
T1, T2, T3

Eligibility
Key inclusion criteria
Infants: born healthy, >37 weeks, <2500g
Mothers: first time (primiparous), >18years, willing and able to attend sessions at designated metropolitan child health clinics and facility with English.
Minimum age
18 Years
Maximum age
Not stated
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Infant: any diagnosed congenital abnormality or chronic condition likely to influence normal development, including feeding behaviour. Mothers: eligible/enrolled in an intensive home-visiting program; maternal self-reported eating or psychiatric disorders/mental health problems. In addition, the Kessler Psychological Distress Scale (K10) will be used to screen for psychiatric morbidity.

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)
Allocation to the study arm is concealed by sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer-generated randomisation schedule will be provided by a statistician, independent of the study, at the Institute of Health and Biomedical Innovation, QUT. This will be stratified by clinic (which consenting mothers nominate their preference for) and prepared as clinic specific, sequentially numbered, sealed envelopes
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

Recruitment
Anticipated date of first participant enrolment
1/01/2008
Actual date of first participant enrolment
11/08/2008
Anticipated date last participant enrolled
Actual date last participant enrolled
19/08/2009
Target sample size
830
Actual sample size
698
Recruitment status
Completed
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2967 0
Government body
Name [1] 2967 0
National Health and Medical Research Council
Address [1] 2967 0
GPO Box 1421
Canberra ACT 2601
Country [1] 2967 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
Institute of Health and Biomedical Innovation
60 Musk Aveneue,
Kelvin Grove Qld 4059
Country
Australia
Secondary sponsor category [1] 2678 0
University
Name [1] 2678 0
Flinders University
Address [1] 2678 0
Department of Nutrition and Dietetics,
GPO Box 2100
Adelaide South Australia
Country [1] 2678 0
Australia
Other collaborator category [1] 149 0
Hospital
Name [1] 149 0
Royal Children's Hospital and Southside Health Service Districts, Community Child Health Services
Address [1] 149 0
Contact:
Western suburbs: 1300 366 039
Eastern suburbs: 1300 366 039
Northern suburbs: 1300 366 039
Country [1] 149 0
Australia
Other collaborator category [2] 150 0
Hospital
Name [2] 150 0
Royal Brisbane and Women's Hospital and Health Service Distric
Address [2] 150 0
Cnr Butterfield St and Bowen Bridge Rd,
Herston Qld 4029
Country [2] 150 0
Australia
Other collaborator category [3] 151 0
Hospital
Name [3] 151 0
Mater Health Services
Address [3] 151 0
Raymond Terrace
South Brisbane Qld 4101
Country [3] 151 0
Australia
Other collaborator category [4] 152 0
Hospital
Name [4] 152 0
Children Youth and Women's Health Services
Address [4] 152 0
Regional Office
Level 2, 77 King William Road
North Adelaide S 5006
Country [4] 152 0
Australia
Other collaborator category [5] 153 0
Hospital
Name [5] 153 0
Lyell McEwin
Address [5] 153 0
Haydown Road
Elizabeth Vale SA 5112
Country [5] 153 0
Australia
Other collaborator category [6] 154 0
Hospital
Name [6] 154 0
Ashford Private Hosptial
Address [6] 154 0
55 Anzac Highway
Ashford SA 5035
Country [6] 154 0
Australia
Other collaborator category [7] 155 0
Hospital
Name [7] 155 0
Logan Hospital
Address [7] 155 0
Cnr Armstrong and Loganlea Rds
Meadowbrook QLD 4133
Country [7] 155 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4919 0
Royal Children?s Hospital and Health Service District Ethics Committee
Ethics committee address [1] 4919 0
Level 3, Foundation Building Department of Paediatrics and Child Health Royal Children's Hospital HERSTON QLD 4029
Ethics committee country [1] 4919 0
Australia
Date submitted for ethics approval [1] 4919 0
Approval date [1] 4919 0
06/09/2007
Ethics approval number [1] 4919 0
EC00175
Ethics committee name [2] 4920 0
Mater Health Services Human Research Ethics Committee
Ethics committee address [2] 4920 0
Mater Health Services Research Secretariat Room 235, Level 2, Aubigny Place Raymond Terrace SOUTH BRISBANE QLD 4101
Ethics committee country [2] 4920 0
Australia
Date submitted for ethics approval [2] 4920 0
Approval date [2] 4920 0
08/10/2007
Ethics approval number [2] 4920 0
EC00332
Ethics committee name [3] 4921 0
Queensland University of Technology University Human Research Ethics Committee
Ethics committee address [3] 4921 0
Research Ethics Officer Office of Research Queensland University of Technology GPO Box 2434 BRISBANE QLD 4001
Ethics committee country [3] 4921 0
Australia
Date submitted for ethics approval [3] 4921 0
Approval date [3] 4921 0
28/09/2007
Ethics approval number [3] 4921 0
EC00171
Ethics committee name [4] 4922 0
Central Northern Adelaide Health Services Ethics of Human Research Committtee (TQEH & LMH)
Ethics committee address [4] 4922 0
The Queen Elizabeth Hospital DX: 456 101 28 Woodville Road WOODVILLE SOUTH SA 5011
Ethics committee country [4] 4922 0
Australia
Date submitted for ethics approval [4] 4922 0
17/10/2007
Approval date [4] 4922 0
18/12/2007
Ethics approval number [4] 4922 0
EC00190
Ethics committee name [5] 4923 0
Princess Alexandra Hospital Human Research Ethics Committee
Ethics committee address [5] 4923 0
Level 2, Building 35 Princess Alexandra Hospital Ispwich Road WOOLLOONGABBA QLD 4102
Ethics committee country [5] 4923 0
Australia
Date submitted for ethics approval [5] 4923 0
Approval date [5] 4923 0
17/08/2007
Ethics approval number [5] 4923 0
EC00167
Ethics committee name [6] 4924 0
Royal Brisbane and Women's Hospital Human Research Ethics Committee
Ethics committee address [6] 4924 0
Level 7 Sir Raphael Cilento Building (Block 7) Royal Brisbane and Women's Hospital Butterfield Street HERSTON QLD 4029
Ethics committee country [6] 4924 0
Australia
Date submitted for ethics approval [6] 4924 0
Approval date [6] 4924 0
30/08/2007
Ethics approval number [6] 4924 0
EC00172
Ethics committee name [7] 4925 0
Bayside Health Service District Human Research Ethics Committee
Ethics committee address [7] 4925 0
Bayside Health Service District Redland Hospital PO Box 585 CLEVELAND QLD 4163
Ethics committee country [7] 4925 0
Australia
Date submitted for ethics approval [7] 4925 0
Approval date [7] 4925 0
02/10/2007
Ethics approval number [7] 4925 0
EC00295
Ethics committee name [8] 4926 0
Flinders Clinical Research Ethics Committee
Ethics committee address [8] 4926 0
Flinders Medical Centre BEDFORD PARK SA 5042
Ethics committee country [8] 4926 0
Australia
Date submitted for ethics approval [8] 4926 0
Approval date [8] 4926 0
08/02/2008
Ethics approval number [8] 4926 0
EC00188
Ethics committee name [9] 4927 0
Children, Youth & Women's Health Service Research Ethics Committee
Ethics committee address [9] 4927 0
Children, Youth and Women's Health Service 2nd Floor, Samuel Way Bldg 2 72 King William Road NORTH ADELAIDE SA 5006
Ethics committee country [9] 4927 0
Australia
Date submitted for ethics approval [9] 4927 0
Approval date [9] 4927 0
19/12/2007
Ethics approval number [9] 4927 0
EC00197
Ethics committee name [10] 4928 0
Bellberry Human Research Ethics Committee
Ethics committee address [10] 4928 0
Level 1 81 Flinders Street 71 Anzac Highway ASHFORD SA 5035
Ethics committee country [10] 4928 0
Australia
Date submitted for ethics approval [10] 4928 0
Approval date [10] 4928 0
19/12/2007
Ethics approval number [10] 4928 0
EC00372

Summary
Brief summary
One-fifth of Australian children are overweight and at increased risk of becoming overweight adults. This study will evaluate if an intervention to equip parents with the confdence and skills to intitiate and maintain positive early feeding practices can foster healthy food preferences, dietary intakes and eating patterns in young children.
The 18-month study will use a randomised controlled design and aims to enrol 830 first time mothers with healthy term infants in Brisbane and Adelaide. The intervention will provide anticipatory guidance via 2x12 week parent education and peer support modules (6 x 1.5hr group sessions), each followed by 6xmonthly maintenance contacts (choice sms/email). The modules will commence at ages 4-7 and 13-16 months to coicide with establishment of solid feeding and development of autonomy and independence. The intervention will be delivered in established community child health clinics in Brisbane and Adelaide. The control group will have self-directed access to usual services provided by local Child Health Clinics. Outcome measures will be assessed at baseline (age 4-7m), 9 m (age 13-16m) and 18 m (final, age 2y) and will include infant food intake and preferences, feeding behaviour and growth and maternal feeding style/practices, parenting efficacy and BMI. Additional co-variate measures include: demographics, maternal mental health, dietary restraint and weight concern, and infant temperament.
This study will provide the first Level II evidence for efficacy of a comprehensive, structured intervention to promote positive feeding practices on early childhood intake and food preferences. It is consistent with current community interest in early childhood as the foundation for health and well being and addresses National Research Priority 2: Promoting and maintaining heath – ‘A healthy start to life’ and ‘Preventive health care’.
Trial website
N/A
Trial related presentations / publications
http://eprints.qut.edu.au/view/person/Daniels,_Lynne.html
Public notes

Contacts
Principal investigator
Name 28302 0
Prof Lynne Daniels
Address 28302 0
School of Exercise and Nutrition Sciences, Faculty of Health, Queensland University of Technology, Victoria Park Rd, Kelvin Grove, QLD, 4059
Country 28302 0
Australia
Phone 28302 0
+61 7 31386171
Fax 28302 0
+61 7 3138 6030
Email 28302 0
l2.daniels@qut.edu.au
Contact person for public queries
Name 11459 0
Prof Lynne Daniels
Address 11459 0
School of Exercise and Nutrition Sciences, Faculty of Health, Queensland University of Technology, Victoria Park Rd, Kelvin Grove, QLD, 4059
Country 11459 0
Australia
Phone 11459 0
+61 7 3138 6139
Fax 11459 0
+61 7 3138 6030
Email 11459 0
l2.daniels@qut.edu.au
Contact person for scientific queries
Name 2387 0
Prof Lynne Daniels
Address 2387 0
School of Exercise and Nutrition Sciences, Faculty of Health, Queensland University of Technology, Victoria Park Rd, Kelvin Grove, QLD, 4059
Country 2387 0
Australia
Phone 2387 0
+61 7 3138 6139
Fax 2387 0
+61 7 3138 6030
Email 2387 0
l2.daniels@qut.edu.au