Evidence map›Paper›PMID 29760009›Full record

Trial reportArchives of disease in childhood2018

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

Open access · hybridAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Archives of disease in childhood, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 7 pooled it
2.4field-weighted citation impact, top 11% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 7 syntheses or guidelines pooled it, 27 citations in OpenAlex.

  1. Pooled it
  2. Identifying behavior change techniques (BCTs) in responsive feeding interventions to prevent childhood obesity-A systematic review.Obesity reviews : an official journal of the International Association for the Study of Obesity · 2025
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  10. A Scoping Review of Instruments Used to Measure Weight and Body Composition in Infants Under 1 Year.Obesity reviews : an official journal of the International Association for the Study of Obesity · 2026
    Article
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  13. The care of infants with rapid weight gain: Should we be doing more?Journal of paediatrics and child health · 2022
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 2 institutions in 1 country.

Rajalakshmi LakshmanMRC Epidemiology Unit and UKCRC Centre of Excellence in Diet and Activity Research (CEDAR), University of Cambridge, Cambridge, UK.ORCID 0000-0001-6748-5960
Stephen J SharpMRC Epidemiology Unit and UKCRC Centre of Excellence in Diet and Activity Research (CEDAR), University of Cambridge, Cambridge, UK.
Fiona WhittleMRC Epidemiology Unit and UKCRC Centre of Excellence in Diet and Activity Research (CEDAR), University of Cambridge, Cambridge, UK.
Annie SchiffMRC Epidemiology Unit and UKCRC Centre of Excellence in Diet and Activity Research (CEDAR), University of Cambridge, Cambridge, UK.
Wendy HardemanHealth Promotion Research Group, School of Health Sciences, University of East Anglia, Norwich, UK.
Lisa IrvineNorwich Medical School, University of East Anglia, Norwich, UK.
Ed WilsonCambridge Centre for Health Services Research, Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK.
Simon J GriffinDepartment of Paediatrics, University of Cambridge, Cambridge, UK.
Ken K OngMRC Epidemiology Unit and UKCRC Centre of Excellence in Diet and Activity Research (CEDAR), University of Cambridge, Cambridge, UK.ORCID 0000-0003-4689-7530
University of Cambridge · GBUniversity of East Anglia · GB

Funding

Biotechnology and Biological Sciences Research CouncilBritish Heart FoundationCancer Research UKChief Scientist OfficeDepartment of HealthMedical Research Council G070165Medical Research Council MC_EX_UU_MR/J000361/1Medical Research Council MC_UU_12015/2Medical Research Council MC_UU_12015/4Medical Research Council MR/J000361/1Medical Research Council MR/K023187/1Wellcome Trust
6 · The paper itself

Abstract

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

designIn 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.

resultsRetention 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).

conclusionsDespite 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.

Indexed as

Bottle FeedingBreast FeedingInfant FormulaInfant Nutritional Physiological PhenomenaEnergy IntakeFeeding BehaviorFemaleHealth Knowledge, Attitudes, PracticeHealth PromotionHumansInfantInfant, NewbornMaleMothersObservational Studies as TopicPediatric Obesitynutritionobesity

Identifiers

PMID29760009
PMCPMC6225804
OpenAlexW2803876623

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.