Improving brestfeeding rates with a online support tool in Sunderland, UK

Last registered on March 02, 2021

Pre-Trial

Trial Information

General Information

Title
Improving brestfeeding rates with a online support tool in Sunderland, UK
RCT ID
AEARCTR-0007261
Initial registration date
March 01, 2021

Initial registration date is when the trial was registered.

It corresponds to when the registration was submitted to the Registry to be reviewed for publication.

First published
March 02, 2021, 6:39 AM EST

First published corresponds to when the trial was first made public on the Registry after being reviewed.

Locations

Primary Investigator

Affiliation
The Behaviouralist

Other Primary Investigator(s)

Additional Trial Information

Status
In development
Start date
2021-03-01
End date
2021-11-01
Secondary IDs
Abstract
Breastfeeding initiation and continuation rates in Sunderland are significantly lower than the national percentage. In this trial, we investigate the effectiveness of encouraging the use of an online breastfeeding tool (the breastfeeding friend) on breastfeeding initiation and continuation rates among mothers in Sunderland.
External Link(s)

Registration Citation

Citation
Monti, Manuel. 2021. "Improving brestfeeding rates with a online support tool in Sunderland, UK." AEA RCT Registry. March 02. https://doi.org/10.1257/rct.7261
Experimental Details

Interventions

Intervention(s)
The intervention is an encouragement to use the Breastfeeding Friend (BFF) tool during the postnatal period to access information and support related to breastfeeding. The encouragement is done by health visitors who provide a brief explanation about the tool and a leaflet that contains information on how to access the tool.
Intervention Start Date
2021-03-01
Intervention End Date
2021-11-01

Primary Outcomes

Primary Outcomes (end points)
Breastfeeding initiation rate, breastfeeding continuation rates
Primary Outcomes (explanation)
Breastfeeding initiation rate (measured at new birth visit), breastfeeding continuation rates (measured at 6-8 week visit and 3-4 month visit)

Secondary Outcomes

Secondary Outcomes (end points)
Secondary Outcomes (explanation)

Experimental Design

Experimental Design
The trial is conducted as a clustered randomised controlled trial where randomisation of the encouragement to use the BFF tool occurs at the electoral ward level. Recruitment will occur over 8 months (10 in the case that not enough mothers have been recruited) and mothers will be followed up for four months after giving birth.
Experimental Design Details
This trial will be conducted as a clustered randomised controlled trial where we will randomise the delivery of the treatment (i.e., the encouragement to take the treatment) at the ward level. This trial design reduces the risk of cross-contamination across treatment groups and thus the risk of a violation of SUTVA. Additionally, as the inclusion of participants in the trial will be done on a rolling basis, this trial design simplifies the randomisation process (i.e., it will only be conducted once) and reduces the risk of errors in the assignment and delivery of treatments. Wards will be randomly assigned to treatment (i.e., receiving the encouragement) and control groups with an even split (i.e., participants from 50% of wards will be assigned to the treatment group and participants from 50% of wards to the control group).

The trial will take place over the course of eight to ten months. All expectant mothers that are registered to receive an antenatal visit by the Sunderland Health Visiting Service will be included in the trial on a rolling basis for the duration of the trial. Mothers and babies will be followed up for four months after birth and outcomes of interest will be collected in predetermined health visits.
Randomization Method
Randomisation at the electoral ward level is done by a computer.
Randomization Unit
Electoral Ward
Was the treatment clustered?
Yes

Experiment Characteristics

Sample size: planned number of clusters
25 electoral wards
Sample size: planned number of observations
1,724 mothers
Sample size (or number of clusters) by treatment arms
13 electoral wards in the treatment group, 12 in the control group
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
5 percentage point increase in the breastfeeding continuation at 6-8 weeks
Supporting Documents and Materials

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IRB

Institutional Review Boards (IRBs)

IRB Name
NHS Wales REC 7
IRB Approval Date
2020-12-30
IRB Approval Number
286853

Post-Trial

Post Trial Information

Study Withdrawal

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Intervention

Is the intervention completed?
No
Data Collection Complete
Data Publication

Data Publication

Is public data available?
No

Program Files

Program Files
Reports, Papers & Other Materials

Relevant Paper(s)

Reports & Other Materials