• Aims of the study
• Design
• Chief/Principal investigators
• Co-investigators
• Status
• Unit role
• Funding
• Data sharing
• Trial Registration Number
• Acknowledgement to use when citing study

Aims of the study

To assess the efficacy of a theory-based behavioural intervention to prevent rapid weight gain in formula milk-fed infants.

Design

In this single (assessor) blind, randomised controlled trial, 669 healthy full-term infants receiving formula milk within 14 weeks of birth were individually randomised to intervention (n=340) or attention-matched control (n=329) groups. The intervention aimed to reduce formula milk intakes, and promote responsive feeding and growth monitoring to prevent rapid weight gain (≥+0.67 SD scores (SDS)). It was delivered to mothers by trained facilitators up to infant age 6 months through three face-to-face contacts, two telephone contacts and written materials.

Chief/Principal investigator

Dr Raj Lakshman – University of Cambridge

Co-Investigators

Professor Ken Ong – University of Cambridge

Prof Simon Griffin – University of Cambridge

Dr Ed Wilson – University of Cambridge

Dr Wendy Hardeman – University of East Anglia

Professor Marc Suhrcke – University of York

Dr Simon Cohn – London School of Hygiene and Tropical Medicine

Status

Completed.

Unit role

Unit led study with responsibility for data.

Funding

This work was supported by MRC National Prevention Research Initiative Grant Reference MR/J000361/.

Data sharing

Data and Intervention materials available on request. Please see our Data Sharing pages for more information.

• Data Request Form

Trial Registration Number

Trial registration number ISRCTN20814693.

Acknowledgement to use when citing study

The Baby Milk trial was funded by the National Prevention Research Initiative (Grant no. MR/J000361/1). The work was undertaken under the auspices of the Centre for Diet and Activity Research (CEDAR), a UKCRC Public Health Research Centre of Excellence and the MRC Epidemiology Unit.