Trial Review

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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)
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
Secondary ID [1] 281426 0
Nil
Universal Trial Number (UTN)
Trial acronym
BLISS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Growth patterns and obesity 287677 0
Iron and zinc deficiency 287678 0
Condition category
Condition code
Public Health 288017 288017 0 0
Health promotion/education
Diet and Nutrition 288018 288018 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 285925 0
Lifestyle
Intervention code [2] 285935 0
Behaviour
Intervention code [3] 285936 0
Prevention
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.
Control group
Active

Outcomes
Primary outcome [1] 288225 0
Body mass index
Timepoint [1] 288225 0
12 months (follow-up at 24 months)
Secondary outcome [1] 299651 0
Iron status (Haemoglobin, serum ferritin, and soluble transferrin receptor concentrations)
Timepoint [1] 299651 0
12 months
Secondary outcome [2] 299652 0
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)
Timepoint [2] 299652 0
6-11 months
Secondary outcome [3] 299653 0
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.
Timepoint [3] 299653 0
12 and 24 months
Secondary outcome [4] 299654 0
Zinc status (serum zinc concentration)
Timepoint [4] 299654 0
12 months
Secondary outcome [5] 299655 0
Dietary intake (3 day weighed diet records)
Timepoint [5] 299655 0
7, 12 and 24 months

Eligibility
Key inclusion criteria
Before birth criteria:
1) booking before 34 weeks gestation
2) able to communicate in English or Te Reo Maori
Minimum age
16 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
Yes
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

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)
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.
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.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/11/2012
Actual
7/02/2013
Date of last participant enrolment
Anticipated
1/12/2013
Actual
18/11/2013
Date of last data collection
Anticipated
Actual
13/04/2016
Sample size
Target
200
Accrual to date
Final
206
Recruitment outside Australia
Country [1] 4619 0
New Zealand
State/province [1] 4619 0
Otago

Funding & Sponsors
Funding source category [1] 286189 0
Government body
Name [1] 286189 0
Lotteries Health Research
Address [1] 286189 0
The Department of Internal Affairs
46 Waring Taylor Street
WELLINGTON 6011
PO Box 805
WELLINGTON 6140
Country [1] 286189 0
New Zealand
Funding source category [2] 292321 0
Commercial sector/Industry
Name [2] 292321 0
Meat and Livestock Australia
Address [2] 292321 0
Level 1, 40 Mount Street, North Sydney NSW 2060
Postal address: PO Box 1961, North Sydney NSW 2059
Country [2] 292321 0
Australia
Funding source category [3] 292322 0
Charities/Societies/Foundations
Name [3] 292322 0
KPS and Perpetual Trustees Limited
Address [3] 292322 0
28 Antico Street, Melrose, Wellington
Otago House 83 Princes St, Dunedin 9016
Country [3] 292322 0
New Zealand
Funding source category [4] 292323 0
University
Name [4] 292323 0
University of Otago
Address [4] 292323 0
PO Box 56
Dunedin
NZ
Country [4] 292323 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
PO Box 56
Dunedin 9054
Country
New Zealand
Secondary sponsor category [1] 285000 0
None
Name [1] 285000 0
Address [1] 285000 0
Country [1] 285000 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288262 0
Lower South Regional Ethics Committee
Ethics committee address [1] 288262 0
Ministry of Health
229 Moray Place
PO Box 5849
Dunedin 9054
Ethics committee country [1] 288262 0
New Zealand
Date submitted for ethics approval [1] 288262 0
Approval date [1] 288262 0
03/11/2011
Ethics approval number [1] 288262 0
LRS-11-09-037

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34861 0
A/Prof Rachael Taylor
Address 34861 0
University of Otago
PO Box 56
Dunedin 9054
Country 34861 0
New Zealand
Phone 34861 0
+64 3 470 9180
Fax 34861 0
Email 34861 0
rachael.taylor@otago.ac.nz
Contact person for public queries
Name 18108 0
Dr Dr Anne-Louise Heath
Address 18108 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin 9054
Country 18108 0
New Zealand
Phone 18108 0
+64 3 479 8379
Fax 18108 0
+64 3 479 7958
Email 18108 0
anne-louise.heath@otago.ac.nz
Contact person for scientific queries
Name 9036 0
A/Prof Associate Professor Rachael Taylor
Address 9036 0
Department of Medicine
University of Otago
PO Box 56
Dunedin 9054
Country 9036 0
New Zealand
Phone 9036 0
+64 3 470 9180
Fax 9036 0
+64 3 479 7958
Email 9036 0
rachael.taylor@otago.ac.nz

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