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
7/02/2023
Date data sharing statement initially provided
7/02/2023
Date results information initially provided
7/02/2023
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
Sex
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
Country [1] 286189 0
New Zealand
Funding source category [2] 292321 0
Commercial sector/Industry
Name [2] 292321 0
Meat and Livestock Australia
Country [2] 292321 0
Australia
Funding source category [3] 292322 0
Charities/Societies/Foundations
Name [3] 292322 0
KPS and Perpetual Trustees Limited
Country [3] 292322 0
New Zealand
Funding source category [4] 292323 0
University
Name [4] 292323 0
University of Otago
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
[email protected]
Contact person for public queries
Name 18108 0
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
[email protected]
Contact person for scientific queries
Name 9036 0
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
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Unfortunately data sharing was not part of our ethics application obtained in 2011.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIBaby-Led Introduction to SolidS (BLISS) study: a randomised controlled trial of a baby-led approach to complementary feeding2015https://doi.org/10.1186/s12887-015-0491-8
Dimensions AIA Baby-Led Approach to Eating Solids and Risk of Choking2016https://doi.org/10.1542/peds.2016-0772
EmbaseEffect of a baby-led approach to complementary feeding on infant growth and overweight: A randomized clinical trial.2017https://dx.doi.org/10.1001/jamapediatrics.2017.1284
EmbaseImpact of a modified version of baby-led weaning on infant food and nutrient intakes: The BLISS randomized controlled trial.2018https://dx.doi.org/10.3390/nu10060740
EmbaseImpact of a modified version of baby-led weaning on iron intake and status: A randomised controlled trial.2018https://dx.doi.org/10.1136/bmjopen-2017-019036
EmbaseModified Version of Baby-Led Weaning Does Not Result in Lower Zinc Intake or Status in Infants: A Randomized Controlled Trial.2018https://dx.doi.org/10.1016/j.jand.2018.02.005
Dimensions AIMediation Analysis as a Means of Identifying Dietary Components That Differentially Affect the Fecal Microbiota of Infants Weaned by Modified Baby-Led and Traditional Approaches2018https://doi.org/10.1128/aem.00914-18
EmbaseAssociation between the faecal short-chain fatty acid propionate and infant sleep.2020https://dx.doi.org/10.1038/s41430-019-0556-0
N.B. These documents automatically identified may not have been verified by the study sponsor.