Objective 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.
Results Retention was 93% (622) at 6 months, 88% (586) at 12 months and 94% attended ≥4/5 sessions. The intervention strengthened maternal attitudes to following infant feeding recommendations, reduced reported milk intakes at ages 3 (−14%; intervention vs control infants), 4 (−12%), 5 (−9%) and 6 (−7%) months, slowed initial infant weight gain from baseline to 6 months (mean change 0.32 vs 0.42 SDS, baseline-adjusted difference (intervention vs control) −0.08 (95% CI −0.17 to −0.004) SDS), but had no effect on the primary outcome of weight gain to 12 months (baseline-adjusted difference −0.04 (−0.17, 0.10) SDS). By 12 months, 40.3% of infants in the intervention group and 45.9% in the control group showed rapid weight gain (OR 0.84, 95% CI 0.59 to 1.17).
Conclusions Despite reducing milk intakes and initial weight gain, the intervention did not alter the high prevalence of rapid weight gain to age 12 months suggesting the need for sustained intervention.
Trial registration number ISRCTN20814693.
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Contributors RL, WH, EW, SJG and KKO are grant holders. They conceptualised the study, designed the protocol and contributed to the interpretation of data. SJS conducted the statistical analyses. LI conducted the economic analysis. FW and AS are trial managers. RL wrote the first draft of the manuscript. All authors approved the final manuscript as submitted and agree to be accountable for all aspects of the work.
Funding The Baby Milk trial is funded by the National Prevention Research Initiative (http://www.npri.org.uk 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 which is funded by the British Heart Foundation, Cancer Research UK, Economic and Social Research Council, Medical Research Council, the National Institute for Health Research, and the Wellcome Trust. The funding partners relevant to this award are (in alphabetical order): Alzheimer’s Research Trust; Alzheimer’s Society; Biotechnology and Biological Sciences Research Council; British Heart Foundation; Cancer Research UK; Chief Scientist Office, Scottish Government Health Directorate; Department of Health; Diabetes UK; Economic and Social Research Council; Health and Social Care Research and Development Division of the Public Health Agency (HSC R&D Division); Medical Research Council; The Stroke Association; Wellcome Trust; Welsh Assembly Government; and World Cancer Research Fund. RL was supported by an MRC Population Health Fellowship (Grant No G070165) and SJG, KKO and SJS are also supported by the MRC (Unit Programmes: MC_UU_12015/2 and MC_UU_12015/4).
Competing interests None declared.
Patient consent Parental/guardian consent obtained.
Ethics approval Cambridge South Research Ethics Committee (Ref: 10/H0305/9)
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement All raw data are available for researchers upon request.
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