title: The HAPPY (Healthy and Active Parenting Programmme for early Years) feasibility randomised control trial: acceptability and feasibility of an intervention to reduce infant obesity.
abstract: BACKGROUND
  The prevalence of infant obesity is increasing, but there is a lack of evidence-based approaches to prevent obesity at this age. This study tested the acceptability and feasibility of evaluating a theory-based intervention aimed at reducing risk of obesity in infants of overweight/obese women during and after pregnancy: the Healthy and Active Parenting Programme for Early Years (HAPPY).
  
  
  METHODS
  A feasibility randomised controlled trial was conducted in Bradford, England. One hundred twenty overweight/obese pregnant women (Body Mass Index [BMI] ≥25 kg/m(2)) were recruited between 10-26 weeks gestation. Consenting women were randomly allocated to HAPPY (6 antenatal, 6 postnatal sessions: N = 59) or usual care (N = 61). Appropriate outcome measures for a full trial were explored, including: infant's length and weight, woman's BMI, physical activity and dietary intake of the women and infants. Health economic data were collected. Measurement occurred before randomisation and when the infant was aged 6 months and 12 months. Feasibility outcomes were: recruitment/attrition rates, and acceptability of: randomisation, measurement, and intervention. Intra-class correlations for infant weight were calculated. Fidelity was assessed through observations and facilitator feedback. Focus groups and semi-structured interviews explored acceptability of methods, implementation, and intervention content.
  
  
  RESULTS
  Recruitment targets were met (~20 women/month) with a recruitment rate of 30 % of eligible women (120/396). There was 30 % attrition at 12 months; 66 % of recruited women failed to attend intervention sessions, but those who attended the first session were likely to continue to attend (mean 9.4/12 sessions, range 1-12). Reaction to intervention content was positive, and fidelity was high. Group clustering was minimal; an adjusted effect size of -0.25 standard deviation scores for infant weight at 12 months (95 % CI: -0.16-0.65) favouring the intervention was observed using intention to treat analyses. No adverse events were reported.
  
  
  CONCLUSIONS
  The HAPPY intervention appeared feasible and acceptable to participants who attended and those delivering it, however attendance was low; adaptations to increase initial attendance are recommended. Whilst the study was not powered to detect a definitive effect, our results suggest a potential to reduce risk of infant obesity. The evidence reported provides valuable lessons to inform progression to a definitive trial.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN56735429.
authors.affiliation: Bradford Institute for Health Research, Bradford Teaching Hospital NHS Foundation Trust, Bradford Royal Infirmary, Duckworth Lane, Bradford, BD9 6RJ, UK. Rosie.mceachan@bthft.nhs.uk.
authors.forename: Rosemary R C
authors.initials: RRC
authors.lastname: McEachan
authors.affiliation: Bradford Institute for Health Research, Bradford Teaching Hospital NHS Foundation Trust, Bradford Royal Infirmary, Duckworth Lane, Bradford, BD9 6RJ, UK.|Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9JT, UK.
authors.forename: Gillian
authors.initials: G
authors.lastname: Santorelli
authors.affiliation: Bradford Institute for Health Research, Bradford Teaching Hospital NHS Foundation Trust, Bradford Royal Infirmary, Duckworth Lane, Bradford, BD9 6RJ, UK.|Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9JT, UK.
authors.forename: Maria
authors.initials: M
authors.lastname: Bryant
authors.affiliation: Institute for Health and Wellbeing, Leeds Beckett University, Leeds, LS1 3HE, UK.
authors.forename: Pinki
authors.initials: P
authors.lastname: Sahota
authors.affiliation: Bradford Institute for Health Research, Bradford Teaching Hospital NHS Foundation Trust, Bradford Royal Infirmary, Duckworth Lane, Bradford, BD9 6RJ, UK.|Department of Health Sciences, University of York, York, YO10 5DD, UK.
authors.forename: Diane
authors.initials: D
authors.lastname: Farrar
authors.affiliation: Faculty of Health Studies, University of Bradford, Bradford, BD7 1DP, UK.
authors.forename: Neil
authors.initials: N
authors.lastname: Small
authors.affiliation: Bradford Institute for Health Research, Bradford Teaching Hospital NHS Foundation Trust, Bradford Royal Infirmary, Duckworth Lane, Bradford, BD9 6RJ, UK.
authors.forename: Shaheen
authors.initials: S
authors.lastname: Akhtar
authors.affiliation: Barnardo's, Bradford, BD8 7BS, UK.
authors.forename: Judith
authors.initials: J
authors.lastname: Sargent
authors.affiliation: Bradford Institute for Health Research, Bradford Teaching Hospital NHS Foundation Trust, Bradford Royal Infirmary, Duckworth Lane, Bradford, BD9 6RJ, UK.
authors.forename: Sally E
authors.initials: SE
authors.lastname: Barber
authors.affiliation: Australian Institute of Health Innovation, Macquarie University, Sydney, NSW 2109, Australia.
authors.forename: Natalie
authors.initials: N
authors.lastname: Taylor
authors.affiliation: Centre for Health Economics, University of York, York, YO10 5DD, UK.
authors.forename: Gerry
authors.initials: G
authors.lastname: Richardson
authors.affiliation: Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9JT, UK.
authors.forename: Amanda J
authors.initials: AJ
authors.lastname: Farrin
authors.affiliation: Edinburgh Migration, Ethnicity and Health Research Group, Centre for Population Health Sciences, Institute of Population Health Sciences and Informatics, University of Edinburgh, Edinburgh, EH8 9AG, UK.
authors.forename: Raj S
authors.initials: RS
authors.lastname: Bhopal
authors.affiliation: Bradford Institute for Health Research, Bradford Teaching Hospital NHS Foundation Trust, Bradford Royal Infirmary, Duckworth Lane, Bradford, BD9 6RJ, UK.|School of Sport, Health and Exercise Science, Loughborough University, Leicestershire, LE11 3TT, UK.
authors.forename: Daniel D
authors.initials: DD
authors.lastname: Bingham
authors.affiliation: Bradford Institute for Health Research, Bradford Teaching Hospital NHS Foundation Trust, Bradford Royal Infirmary, Duckworth Lane, Bradford, BD9 6RJ, UK.
authors.forename: Sara M
authors.initials: SM
authors.lastname: Ahern
authors.affiliation: Bradford Institute for Health Research, Bradford Teaching Hospital NHS Foundation Trust, Bradford Royal Infirmary, Duckworth Lane, Bradford, BD9 6RJ, UK.
authors.forename: John
authors.initials: J
authors.lastname: Wright
mesh_terms: D000328:Adult; D004739:England / Q000453:epidemiology; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D015438:Health Behavior; D006293:Health Promotion / Q000379:methods*; D006801:Humans; D007223:Infant; D009035:Mothers / Q000523:psychology* / Q000706:statistics & numerical data; D009765:Obesity / Q000453:epidemiology; D050177:Overweight / Q000453:epidemiology; D016487:Parenting / Q000523:psychology*; D063766:Pediatric Obesity / Q000453:epidemiology / Q000517:prevention & control*; D011247:Pregnancy