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.
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.
