Randomised controlled trial of a theory-based behavioural intervention to reduce formula milk intake

Rajalakshmi Lakshman, Stephen J Sharp, Fiona Whittle, Annie Schiff, Wendy Hardeman, Lisa Irvine, Ed Wilson, Simon J Griffin, Ken K Ong

Research output: Contribution to journalArticlepeer-review

11 Citations (Scopus)
53 Downloads (Pure)


Objective: To assess the efficacy of a theory-based behavioural intervention to prevent rapidweight gain in formula-milk fed infants. Design: In this single (assessor) blind, randomised controlled trial, 669 healthy full-terminfants receiving formula-milk within 14 weeks of birth were individually-randomised tointervention (n=340) or attention-matched control (n=329) groups. The intervention aimed toreduce formula-milk intakes, and promote responsive feeding and growth monitoring toprevent rapid weight gain (>+ 0.67 standard deviation scores [SDS]). It was delivered tomothers by trained facilitators up to infant age 6 months through 3 face-to-face contacts, 2telephone 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 feedingrecommendations, reduced reported milk intakes at ages 3 (-14%; intervention vs controlinfants), 4 (-12%), 5 (-9%), and 6 (-7%) months, slowed initial infant weight gain frombaseline to 6 months (mean change 0.32 vs 0.42 SDS, baseline-adjusted difference(intervention vs control) -0.08 [95% CI; -0.17, -0.004] SDS), but had no effect on the primaryoutcome 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 groupshowed rapid weight gain (OR: 0.84 [95% CI; 0.59, 1.17]). Conclusions: Despite reducing milk intakes and initial weight gain, the intervention did notalter the high prevalence of rapid weight gain to age 12 months suggesting the need forsustained intervention.
Original languageEnglish
Pages (from-to)1054-1060
Number of pages7
JournalArchives of Disease in Childhood
Issue number11
Early online date14 May 2018
Publication statusPublished - 1 Nov 2018


  • Infant feeding
  • formula-milk
  • growth
  • obesity prevention
  • rapid weight gain
  • behavioural intervention


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