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Trial registered on ANZCTR
Registration number
ACTRN12612001133820
Ethics application status
Approved
Date submitted
23/10/2012
Date registered
24/10/2012
Date last updated
11/10/2016
Type of registration
Prospectively registered
Titles & IDs
Public title
Baby-led introduction to solids (BLISS)
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Scientific title
The effect of a baby-led approach to complementary feeding on growth, nutrition and iron status from birth to two years of age
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Secondary ID [1]
281426
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Nil
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Universal Trial Number (UTN)
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Trial acronym
BLISS
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Growth patterns and obesity
287677
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Iron and zinc deficiency
287678
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Condition category
Condition code
Public Health
288017
288017
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0
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Health promotion/education
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Diet and Nutrition
288018
288018
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0
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Other diet and nutrition disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
7 home visits, approximately 1 hour in length, when the child is 1 week, and 1, 3, 5 (all by lactation consultant), and 5.5, 7 and 9 (by trained nurse or other health professional) months of age providing anticipatory guidance to assist mothers to exclusively breastfeed to 6 months, then introduce complementary foods from 6 months following a modified baby-led weaning approach (BLW). This uses the concepts of BLW (infant self-feeds rather than parent spoon feeds, families eating together) but using resources that address concerns with BLW that have been raised by health professionals - including the potential for growth faltering, poor iron status, and choking.
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Intervention code [1]
285925
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Lifestyle
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Intervention code [2]
285935
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Behaviour
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Intervention code [3]
285936
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Prevention
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Comparator / control treatment
Both control and intervention groups will receive their usual "Well Child" care from their chosen provider. This usually consists of 6-7 home or clinic visits (from 6 weeks to 2 years of age) from trained health professional, targeting various issues including breastfeeding, eating, sleep, parenting, and physical activity. The intervention group will receive the additional 7 home visits detailed above.
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Control group
Active
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Outcomes
Primary outcome [1]
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Body mass index
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Timepoint [1]
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12 months (follow-up at 24 months)
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Secondary outcome [1]
299651
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Iron status (Haemoglobin, serum ferritin, and soluble transferrin receptor concentrations)
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Timepoint [1]
299651
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12 months
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Secondary outcome [2]
299652
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Growth faltering (defined by WHO as a current weight or rate of weight gain that is significantly lower (<-1 SD score) than that of other children of similar age and sex)
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Timepoint [2]
299652
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6-11 months
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Secondary outcome [3]
299653
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Self-regulation of energy intake (assessed using the questionnaire of Tan et al (J Pediatr Psychol 2011;36:340) and by compensation experiment where children are exposed to a first course of known energy content (one low energy, one high energy) then allowed to eat ad libitum from a buffet. The difference in energy consumed at the second course following the low and high energy preloads is then calculated.
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Timepoint [3]
299653
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12 and 24 months
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Secondary outcome [4]
299654
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Zinc status (serum zinc concentration)
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Timepoint [4]
299654
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12 months
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Secondary outcome [5]
299655
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Dietary intake (3 day weighed diet records)
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Timepoint [5]
299655
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7, 12 and 24 months
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Eligibility
Key inclusion criteria
Before birth criteria:
1) booking before 34 weeks gestation
2) able to communicate in English or Te Reo Maori
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Minimum age
16
Years
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Maximum age
No limit
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Gender
Females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Before birth criteria:
1) home address outside study area (metropolitan Dunedin)
2) expecting to shift out of metropolitan Dunedin in the next two years
After birth criteria
3) identified congenital abnormality likely to affect feeding or growth
4) birth before 37 weeks gestation
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Once consent has been obtained, an online randomisation programme will be used to randomise participants into BLISS or control groups. After allocation, participant blinding will not be possible. However, all outcome assessment data will be collected by research personnel blind to group allocation.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
As parity and SES may significantly affect the primary outcome, a stratified block allocation will be used (parity 1 vs. >1, and NZDep low, medium, high) with a random block length that will ensure that participants are allocated to groups in the desired ratio so that there are final group numbers of approximately 150 in the BLISS and control groups.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint(s)
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/11/2012
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Actual
7/02/2013
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Date of last participant enrolment
Anticipated
1/12/2013
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Actual
18/11/2013
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Date of last data collection
Anticipated
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Actual
13/04/2016
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Sample size
Target
200
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Accrual to date
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Final
206
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Recruitment outside Australia
Country [1]
4619
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New Zealand
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State/province [1]
4619
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Otago
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Funding & Sponsors
Funding source category [1]
286189
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Government body
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Name [1]
286189
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Lotteries Health Research
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Address [1]
286189
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The Department of Internal Affairs
46 Waring Taylor Street
WELLINGTON 6011
PO Box 805
WELLINGTON 6140
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Country [1]
286189
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New Zealand
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Funding source category [2]
292321
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Commercial sector/Industry
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Name [2]
292321
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Meat and Livestock Australia
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Address [2]
292321
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Level 1, 40 Mount Street, North Sydney NSW 2060
Postal address: PO Box 1961, North Sydney NSW 2059
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Country [2]
292321
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Australia
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Funding source category [3]
292322
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Charities/Societies/Foundations
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Name [3]
292322
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KPS and Perpetual Trustees Limited
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Address [3]
292322
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28 Antico Street, Melrose, Wellington
Otago House 83 Princes St, Dunedin 9016
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Country [3]
292322
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New Zealand
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Funding source category [4]
292323
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University
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Name [4]
292323
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University of Otago
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Address [4]
292323
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PO Box 56
Dunedin
NZ
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Country [4]
292323
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New Zealand
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Primary sponsor type
University
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Name
University of Otago
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Address
PO Box 56
Dunedin 9054
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Country
New Zealand
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Secondary sponsor category [1]
285000
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None
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Name [1]
285000
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Address [1]
285000
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Country [1]
285000
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
288262
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Lower South Regional Ethics Committee
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Ethics committee address [1]
288262
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Ministry of Health
229 Moray Place
PO Box 5849
Dunedin 9054
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Ethics committee country [1]
288262
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New Zealand
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Date submitted for ethics approval [1]
288262
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Approval date [1]
288262
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03/11/2011
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Ethics approval number [1]
288262
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LRS-11-09-037
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Summary
Brief summary
The Baby-Led Introduction to SolidS (BLISS) study will determine whether a novel approach to infant feeding using foods that infants can feed themselves encourages self-regulation of energy intake and prevents the development of overweight without detrimental effects on iron status and growth. 300 families will be randomised to Control (standard advice from birth-12 months), or BLISS (additional guidance and support to delay introduction of solids to 6 months, followed by infant self-feeding from 6-12 months). Growth, energy self-regulation, diet quality and iron and zinc status will be measured at 12 and/or 24 months. A baby-led approach that encourages children to eat in response to internal hunger cues rather than external cues from their environment should encourage better energy self-regulation and improved weight outcomes at 12 months that are maintained at two years of age.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
34861
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A/Prof Rachael Taylor
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Address
34861
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University of Otago
PO Box 56
Dunedin 9054
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Country
34861
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New Zealand
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Phone
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+64 3 470 9180
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Fax
34861
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Email
34861
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rachael.taylor@otago.ac.nz
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Contact person for public queries
Name
18108
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Dr Dr Anne-Louise Heath
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Address
18108
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Department of Human Nutrition
University of Otago
PO Box 56
Dunedin 9054
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Country
18108
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New Zealand
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Phone
18108
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+64 3 479 8379
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Fax
18108
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+64 3 479 7958
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Email
18108
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anne-louise.heath@otago.ac.nz
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Contact person for scientific queries
Name
9036
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A/Prof Associate Professor Rachael Taylor
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Address
9036
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Department of Medicine
University of Otago
PO Box 56
Dunedin 9054
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Country
9036
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New Zealand
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Phone
9036
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+64 3 470 9180
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Fax
9036
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+64 3 479 7958
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Email
9036
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rachael.taylor@otago.ac.nz
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No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
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Other publications
Have study results been made publicly available in another format?
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Results – basic reporting
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Results – plain English summary
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