Trial from ANZCTR


Trial ID ACTRN12608000056392
Trial Status: Registered
Date Submitted: 15/01/2008
Date Registered: 29/01/2008
Prospectively registered

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Public title Positive feeding practices and food preferences in very early childhood: an innovative approach to obesity prevention
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Study title in 'Participant- Intervention- Comparator- Outcome (PICO)' format 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.
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Secondary ID [1] 510 0
None
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UTN
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Trial acronym
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Health condition(s) or problem(s) studied:
Childhood overweight and obesity 2720 0
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Condition category: Condition code:
Diet and nutrition Obesity
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2840 2840 0 0

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Descriptions 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.
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Intervention Code:
Prevention 2458 0
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Comparator / control treatment The intervention is compared with 'standard care'; self-directed access to universal services at child health clinics.
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Control group Active
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Primary Outcome: Infant food intake - 3 non-consecutive days using 2 x 24hr food records and 1 x 24hr recall (T1,T2, T3) 3726 0
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Timepoint: T1, T2, T3 3726 0
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Primary Outcome: Food preference - The Wardle Tool 3791 0
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Timepoint: T1, T2, T3 3791 0
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Primary Outcome: Feeding behaviour - Children's Eating Behaviour Questionnaire 3792 0
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Timepoint: T2, T3 3792 0
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Secondary Outcome: Weight and growth (WtHt z scores - length and weight using standard procedures) 6287 0
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Timepoint: T1, T2, T3 6287 0
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Secondary Outcome: Maternal feeding style and practices - the Infant Feeding Questionnaire and Child Feeding Questionnaire 6397 0
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Timepoint: T1, T2, T3 6397 0
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Secondary Outcome: Parenting skills and efficacy - Four brief scales from LSAC 6398 0
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Timepoint: T1, T2, T3 6398 0
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Secondary Outcome: Maternal BMI (height and weight standard procedures) 6399 0
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Timepoint: T1, T2, T3 6399 0
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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.
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Minimum age 18 Years
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Maximum age Not stated
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Gender Females
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Healthy volunteers? No
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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.
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Study type Interventional
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Purpose of the study Prevention
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Allocation to intervention Randomised controlled trial
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Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures) Allocation to the study arm is concealed by sealed opaque envelopes
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Describe the 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
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Masking / blinding Open (masking not used)
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Who is / are masked / blinded (choose all that apply)


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Assignment Parallel
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Other design features
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Type of endpoint(s) Efficacy
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Statistical Methods/Analysis
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Phase Not Applicable
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Anticipated date of first participant enrolment 1/01/2008
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Date of first participant enrolment 11/08/2008
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Anticipated date last participant recruited/enrolled
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Actual date last participant recruited/enrolled 19/08/2009
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Target sample size 830
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Recruitment status Closed: follow-up continuing
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Recruitment in Australia

Recruitment state(s)
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Recruitment outside Australia

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Funding Source: Government body 2967 0
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Name: National Health and Medical Research Council 2967 0
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Address: GPO Box 1421
Canberra ACT 2601
2967 0
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Country: Australia 2967 0
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Primary Sponsor University
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Name: Queensland University of Technology
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Address: Institute of Health and Biomedical Innovation
60 Musk Aveneue,
Kelvin Grove Qld 4059
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Country: Australia
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Secondary Sponsor: University 2678 0
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Name: Flinders University 2678 0
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Address: Department of Nutrition and Dietetics,
GPO Box 2100
Adelaide South Australia
2678 0
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Country: Australia 2678 0
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Other Collaborator: Hospital 149 0
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Name: Royal Children's Hospital and Southside Health Service Districts, Community Child Health Services 149 0
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Address: Contact:
Western suburbs: 1300 366 039
Eastern suburbs: 1300 366 039
Northern suburbs: 1300 366 039
149 0
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Country: Australia 149 0
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Other Collaborator: Hospital 150 0
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Name: Royal Brisbane and Women's Hospital and Health Service Distric 150 0
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Address: Cnr Butterfield St and Bowen Bridge Rd,
Herston Qld 4029
150 0
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Country: Australia 150 0
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Other Collaborator: Hospital 151 0
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Name: Mater Health Services 151 0
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Address: Raymond Terrace
South Brisbane Qld 4101
151 0
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Country: Australia 151 0
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Other Collaborator: Hospital 152 0
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Name: Children Youth and Women's Health Services 152 0
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Address: Regional Office
Level 2, 77 King William Road
North Adelaide S 5006
152 0
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Country: Australia 152 0
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Other Collaborator: Hospital 153 0
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Name: Lyell McEwin 153 0
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Address: Haydown Road
Elizabeth Vale SA 5112
153 0
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Country: Australia 153 0
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Other Collaborator: Hospital 154 0
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Name: Ashford Private Hosptial 154 0
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Address: 55 Anzac Highway
Ashford SA 5035
154 0
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Country: Australia 154 0
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Other Collaborator: Hospital 155 0
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Name: Logan Hospital 155 0
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Address: Cnr Armstrong and Loganlea Rds
Meadowbrook QLD 4133
155 0
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Country: Australia 155 0
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Has the study received approval from at least one Ethics Committee? Yes
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Ethics Committee name: Royal Children?s Hospital and Health Service District Ethics Committee 4919 0
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Address: Level 3, Foundation Building Department of Paediatrics and Child Health Royal Children's Hospital HERSTON QLD 4029 4919 0
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Country: Australia 4919 0
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Approval Date: 06/09/2007 4919 0
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Submitted Date: 4919 0
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HREC: EC00175 4919 0
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Ethics Committee name: Mater Health Services Human Research Ethics Committee 4920 0
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Address: Mater Health Services Research Secretariat Room 235, Level 2, Aubigny Place Raymond Terrace SOUTH BRISBANE QLD 4101 4920 0
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Country: Australia 4920 0
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Approval Date: 08/10/2007 4920 0
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Submitted Date: 4920 0
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HREC: EC00332 4920 0
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Ethics Committee name: Queensland University of Technology University Human Research Ethics Committee 4921 0
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Address: Research Ethics Officer Office of Research Queensland University of Technology GPO Box 2434 BRISBANE QLD 4001 4921 0
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Country: Australia 4921 0
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Approval Date: 28/09/2007 4921 0
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Submitted Date: 4921 0
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HREC: EC00171 4921 0
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Ethics Committee name: Central Northern Adelaide Health Services Ethics of Human Research Committtee (TQEH & LMH) 4922 0
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Address: The Queen Elizabeth Hospital DX: 456 101 28 Woodville Road WOODVILLE SOUTH SA 5011 4922 0
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Country: Australia 4922 0
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Approval Date: 18/12/2007 4922 0
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Submitted Date: 17/10/2007 4922 0
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HREC: EC00190 4922 0
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Ethics Committee name: Princess Alexandra Hospital Human Research Ethics Committee 4923 0
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Address: Level 2, Building 35 Princess Alexandra Hospital Ispwich Road WOOLLOONGABBA QLD 4102 4923 0
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Country: Australia 4923 0
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Approval Date: 17/08/2007 4923 0
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Submitted Date: 4923 0
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HREC: EC00167 4923 0
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Ethics Committee name: Royal Brisbane and Women's Hospital Human Research Ethics Committee 4924 0
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Address: Level 7 Sir Raphael Cilento Building (Block 7) Royal Brisbane and Women's Hospital Butterfield Street HERSTON QLD 4029 4924 0
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Country: Australia 4924 0
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Approval Date: 30/08/2007 4924 0
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Submitted Date: 4924 0
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HREC: EC00172 4924 0
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Ethics Committee name: Bayside Health Service District Human Research Ethics Committee 4925 0
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Address: Bayside Health Service District Redland Hospital PO Box 585 CLEVELAND QLD 4163 4925 0
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Country: Australia 4925 0
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Approval Date: 02/10/2007 4925 0
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Submitted Date: 4925 0
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HREC: EC00295 4925 0
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Ethics Committee name: Flinders Clinical Research Ethics Committee 4926 0
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Address: Flinders Medical Centre BEDFORD PARK SA 5042 4926 0
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Country: Australia 4926 0
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Approval Date: 08/02/2008 4926 0
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Submitted Date: 4926 0
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HREC: EC00188 4926 0
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Ethics Committee name: Children, Youth & Women's Health Service Research Ethics Committee 4927 0
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Address: Children, Youth and Women's Health Service 2nd Floor, Samuel Way Bldg 2 72 King William Road NORTH ADELAIDE SA 5006 4927 0
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Country: Australia 4927 0
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Approval Date: 19/12/2007 4927 0
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Submitted Date: 4927 0
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HREC: EC00197 4927 0
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Ethics Committee name: Bellberry Human Research Ethics Committee 4928 0
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Address: Level 1 81 Flinders Street 71 Anzac Highway ASHFORD SA 5035 4928 0
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Country: Australia 4928 0
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Approval Date: 19/12/2007 4928 0
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Submitted Date: 4928 0
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HREC: EC00372 4928 0
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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’.
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Trial website N/A
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Trial related presentations / publications
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Public Notes
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Principal Investigator
Title: Prof
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Name: Lynne Daniels
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Address: School of Exercise and Nutrition Sciences, Faculty of Health, Queensland University of Technology, Victoria Park Rd, Kelvin Grove, QLD, 4059
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Country: Australia
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Tel: +61 7 31386171
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Fax: +61 7 3138 6030
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Email: l2.daniels@qut.edu.au
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Contact person for public queries
Title: Prof
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Name: Lynne Daniels
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Address: School of Exercise and Nutrition Sciences, Faculty of Health, Queensland University of Technology, Victoria Park Rd, Kelvin Grove, QLD, 4059
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Country: Australia
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Tel: +61 7 3138 6139
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Fax: +61 7 3138 6030
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Email: l2.daniels@qut.edu.au
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Contact person for scientific queries
Title: Prof
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Name: Lynne Daniels
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Address: School of Exercise and Nutrition Sciences, Faculty of Health, Queensland University of Technology, Victoria Park Rd, Kelvin Grove, QLD, 4059
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Country: Australia
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Email: l2.daniels@qut.edu.au
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Contact person responsible for updating information
Title:
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Name: Professor Lynne Daniels
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Address: School of Exercise and Nutrition Sciences, Faculty of Health, Queensland University of Technology, Victoria Park Rd, Kelvin Grove, QLD, 4059
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Country: Australia
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Email: l2.daniels@qut.edu.au
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Addition Cancer fields
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