ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12620000529943

Ethics application status

Approved

Date submitted

13/03/2020

Date registered

30/04/2020

Date last updated

19/10/2022

Date data sharing statement initially provided

30/04/2020

Date results information initially provided

19/10/2022

Type of registration

Retrospectively registered

Titles & IDs

Public title

MILQ: Mother Infant Lactation Questionnaire

Scientific title

Mother Infant Lactation Questionnaire

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

MILQ

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Infant feeding

Breast feeding

Condition category

Condition code

Diet and Nutrition

Other diet and nutrition disorders

Reproductive Health and Childbirth

Breast feeding

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

No intervention.
Infant feeding practices (such as breastfeeding, use of infant formula, introduction of complimentary feeding, variety and type of complimentary foods) will be regularly assessed from as soon after birth (as possible) until the infant is 12 months of age.
Participants will be asked to answer a series of questions about how they feed their infant, either via an online survey or via phone interview with study staff. Participants will be asked to answer these questions at enrollment, and when the infant is 3 weeks, 5 weeks, 7 weeks, 3 months, 4 months, 5 months, 6 months, 9 months and 12 months of age.

Intervention code [1]

Not applicable

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

The primary objective of MILQ is to understand and document the current feeding practices of South Australian mothers with full-term infants.
The primary outcome is the prevalence of exclusive breastfeeding by mothers of full term infants up to 2 months old. This will be assessed with a study specific questionnaire to be completed by parents via an online survey.

Timepoint [1]

Participants complete questions about feeding via an online survey or phone interview with study staff at enrollment and when the infant is 7 weeks of age (window 7 weeks-60 days).

Secondary outcome [1]

Prevalence of breastfeeding and proportion of infants ever breastfed.
Participants complete questions about breastfeeding via an online survey or phone interview with study staff. The questionnaire has been designed specifically for the study and has not been validated.

Timepoint [1]

Participants complete questions at enrollment and when the infant is 3 weeks, 5 weeks, 7 weeks, 3 months, 4 months, 5 months, 6 months, 9 months, and 12 months of age. The survey has been designed specifically for the study and has not been validated.

Secondary outcome [2]

Duration of breastfeeding (mean and median) as indicated through questions about breastfeeding via an online survey or phone interview with study staff. The questionnaire has been designed specifically for the study and has not been validated.

Timepoint [2]

Participants complete questions at enrollment and when the infant is 3 weeks, 5 weeks, 7 weeks, 3 months, 4 months, 5 months, 6 months, 9 months, and 12 months of age.

Secondary outcome [3]

Maternal and infant characteristics associated with initiation and continuation of breastfeeding will be measured with a questionnaire that asks about demographic and other characteristics (such as whether the mother was born in Australia, whether the baby was born by caesarean section, did the mother smoke during pregnancy).
This information will be collected through a parent-completed questionnaire that has been designed specifically for the study and has not been validated.

Timepoint [3]

baseline/enrollment-shortly after birth.

Secondary outcome [4]

Breastfeeding support and resources wanted by mothers will be measured through a questionnaire that asks whether the mother is breastfeeding, and whether they have wanted more support, and what their preferred source of support is (with a list of options to select from-such as lactation consultant, pamphlet, family/friends). The questionnaire has been designed specifically for the study and has not been validated.

Timepoint [4]

Participants complete questions at enrollment and when the infant is 3 weeks, 5 weeks, 7 weeks, 3 months, 4 months, 5 months, 6 months, 9 months, and 12 months of age.

Secondary outcome [5]

Breastfeeding preferences and intentions of mothers will be assessed by a questionnaire where mothers will be asked how they planned to feed their infant before it was born.The questionnaire has been designed specifically for the study and has not been validated.

Timepoint [5]

Participants completed question at enrollment

Secondary outcome [6]

Type of first feed will be measured through a questionnaire where parents can select the type of milk (i.e. breastmilk/formula) that the infant was provided for their first feed. The questionnaire has been designed specifically for the study and has not been validated.

Timepoint [6]

shortly after birth-at enrollment questionnaire.

Secondary outcome [7]

Barriers for breastfeeding continuation will be assessed through a questionnaire where women can select from a list things that been difficult or that have discouraged them from breastfeeding. The questionnaire has been designed specifically for the study and has not been validated.

Timepoint [7]

Participants complete questions at enrollment and when the infant is 3 weeks, 5 weeks, 7 weeks, 3 months, 4 months, 5 months, 6 months, 9 months, and 12 months of age. Participants who have previously indicated they are no longer breastfeeding will not be questioned in subsequent surveys about barriers and enablers.

Secondary outcome [8]

Types of foods introduced as first complementary foods will be measured through a questionnaire where parents can select the food group that the infant was provided for their first complimentary feed. The questionnaire has been designed specifically for the study and has not been validated.

Timepoint [8]

Participants complete questions when the infant is 3 months, 4 months, 5 months, 6 months, 9 months, and 12 months of age.

Secondary outcome [9]

Variety of complimentary foods will be measured through a questionnaire where parents can select all food groups that the infant has been provided. The questionnaire has been designed specifically for the study and has not been validated.

Timepoint [9]

Participants complete questions when the infant is 3 months, 4 months, 5 months, 6 months, 9 months, and 12 months of age.

Secondary outcome [10]

Proportion of infants aged 0 to 5 months that were predominantly breastfed will be measured through a repeat questionnaire asking how the infant is fed. The questionnaire has been designed specifically for the study and has not been validated.

Timepoint [10]

birth-enrolment, 3 weeks, 5 weeks, 7 weeks, 3 months, 4 months and 5 months

Secondary outcome [11]

Proportion of infants introduced solid, semi-solid or soft foods by 6 months of age will be measured through a repeat questionnaire. The questionnaire has been designed specifically for the study and has not been validated.

Timepoint [11]

3 months, 4 months, 5 months and 6 months

Secondary outcome [12]

Rationale for breastfeeding preferences and intentions of mothers will be assessed by a questionnaire where mothers will be asked to select from a drop down list why they had planned/preferred to feed their baby as they indicated (i.e. why planned to feed formula/breast milk/both). The questionnaire has been designed specifically for the study and has not been validated.

Timepoint [12]

at enrollment

Secondary outcome [13]

enablers for breastfeeding continuation will be assessed through a questionnaire where women can select from a list things that have helped them breastfeed. The questionnaire has been designed specifically for the study and has not been validated.

Timepoint [13]

Secondary outcome [14]

reasons for ceasing breastfeeding will be assessed through a questionnaire where women can select from a list things that were difficult or discouraged them from breastfeeding. The questionnaire has been designed specifically for the study and has not been validated.

Timepoint [14]

Eligibility

Key inclusion criteria

• Term-born (37+0 to 41+6 weeks)
• Singleton birth
• Appropriate birth weight for gestational age (weight >5th and <95th percentile: boys 2,604-4,215 grams, girls 2,532-4,041 grams)
• Caregiver or legally authorised representative is over the age of 16 years
• Caregiver or legally authorised representative is able to provide informed consent

Minimum age

0 Days

Maximum age

65 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

preterm birth
Multiple pregnancy

Study design

Purpose

Natural history

Duration

Longitudinal

Selection

Defined population

Timing

Prospective

Statistical methods / analysis

The data collected will be a mixture of categorical, continuous, dichotomous and free text responses. A detailed statistical analysis plan for each individual research objective will be carried out in consultation with an experienced biostatistician, and appropriate controls/confounders included in the statistical model.

Recruitment

Recruitment status

Active, not recruiting

Date of first participant enrolment

Anticipated

Actual

27/02/2020

Date of last participant enrolment

Anticipated

31/12/2021

Actual

11/07/2022

Date of last data collection

Anticipated

31/01/2023

Actual

Sample size

Target

1000

Accrual to date

Final

1281

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

FONTERRA CO-OPERATIVE GROUP LIMITED

Address [1]

Fonterra Co-operative Group Limited
Dairy Farm Road,
Fitzherbert, Palmerston North
New Zealand, 4442

Country [1]

New Zealand

Primary sponsor type

Other

Name

South Australian Health and Medical Research Institute

Address

72 King William Road
North Adelaide, South Australia
Australia, 5006

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Women's and Children's Health Network (WCHN) Human Research Ethics Committee's (HREC)

Ethics committee address [1]

72 King William Road
North Adelaide 5006
South Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

29/08/2019

Approval date [1]

22/11/2019

Ethics approval number [1]

Summary

Brief summary

SAHMRI Women and Kids are conducting a new survey (MILQ), that will follow mother-infant pairs across the first 12 months of life to find out how South Australian babies are being fed. We would like to find out what is helpful in initiating and continuing breastfeeding, as well as anything that could make breastfeeding difficult. We are also interested in the timing of complementary foods (such as solids and semi-solids) and the types of foods given to babies in their first year of life.
The aim of the MILQ study is to understand how families are feeding their full term infants over the first 12 months of life, and what challenges they experience. We hope to use this information to inform the support services at South Australian hospitals and postnatal care providers. The information collected will also help us understand the current practices for the introduction of complementary feeding.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Maria Makrides

Address

Theme Leader SAHMRI Women and Kids South Australian Health and Medical Research Institute (SAHMRI)
72 King William Road
North Adelaide, South Australia
Australia, 5006

Country

Australia

Phone

+61 8 8128 4416

Fax

maria.makrides@sahmri.com

Contact person for public queries

Name

Dr Jacqueline Gould

Address

SAHMRI Women and Kids South Australian Health and Medical Research Institute (SAHMRI)
72 King William Road
North Adelaide, South Australia
Australia, 5006

Country

Australia

Phone

+61 8 8128 4423

Fax

jacqueline.gould@sahmri.com

Contact person for scientific queries

Name

Dr Jacqueline Gould

Address

SAHMRI Women and Kids South Australian Health and Medical Research Institute (SAHMRI)
72 King William Road
North Adelaide, South Australia
Australia, 5006

Country

Australia

Phone

+61 8 8128 4423

Fax

jacqueline.gould@sahmri.com

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

Only de-identified data may be shared, with the written approval of the study steering committee and the WCHN HREC. Data will not be made publicly available in a data repository.

When will data be available (start and end dates)?

Requests for data sharing may be made after 2023, with no applicable end date.

Available to whom?

Data may be shared with researchers, government or health professionals who provide a methodologically sound proposal that is approved by the study steering committee and the WCHN HREC.

Available for what types of analyses?

Analyses to achieve the aims of the proposal that is approved by the study steering committee and the WCHN HREC.

How or where can data be obtained?

Data can be requested from the study steering committee (via. Dr Jacqueline Gould through email: jacqueline.gould@sahmri.com).

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Dimensions AI	New Methodologies for Conducting Maternal, Infant, and Child Nutrition Research in the Era of COVID-19	2021	https://doi.org/10.3390/nu13030941

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically