GLOWING Pilot Cluster RCT

• Research type

  Research Study

• Full title

  GestationaL Obesity Weight management: Implementation of National Guidelines (GLOWING): A pilot cluster randomised controlled trial of a guideline implementation intervention for the management of maternal obesity by midwives

• IRAS ID

  185182

• Contact name

  Nicola Heslehurst

• Contact email

  nicola.heslehurst@ncl.ac.uk

• Sponsor organisation

  Newcastle upon Tyne Hospitals NHS Foundation Trust

• Duration of Study in the UK

  1 years, 11 months, 30 days

• Research summary

  This is a pilot cluster randomised controlled trial of a midwifery training intervention to support the implementation of guidelines for weight management in pregnancy.

  Study intervention: Intensive theory-based one day training for community midwives on weight communication and weight management in pregnancy

  The aims and outcomes of the intervention are:
  Primary aim: The implementation of guidelines into clinical practice through community midwives behaviour change
  Secondary aim: To identify if community midwives’ practice mediates pregnant/postnatal women’s weight, or weight-related behaviours
  Primary outcome: Community midwives’ behaviours in routine practice
  Secondary outcome: Pregnant/postnatal women's weight and weight-related behaviours

  The specific pilot study objectives are to:
  1) Pilot the intervention delivery, data collection and analysis methods to ascertain feasibility and acceptability thereof
  2) Identify the intervention’s active ingredients (in success or failure) through process evaluation
  3) Collect data required to inform sample size estimations and scope data collection procedures for economic evaluation within the definitive trial
  
  The intervention has been developed using behaviour change theory relevant for changing health professionals’ clinical practice (Social Cognitive Theory). The clusters in the pilot study are NHS Trusts which will be randomly allocated to receive the intervention, or to act as control sites. Community midwives in the intervention clusters will receive a one day intensive training course, and will be provided with information resources to share with pregnant women during routine consultations. The development of the intervention was systematic and tailored, using the best available existing evidence on health professionals’ determinants of maternal obesity and weight management practice, and on the most effective behaviour change techniques and modes of delivery to overcome barriers to practice. Midwives will be followed up for 6 months after the delivery of the training intervention. Women will be recruited in the 3rd trimester of pregnancy, and followed up for 12 months postnatal.

• REC name

  Yorkshire & The Humber - South Yorkshire Research Ethics Committee

• REC reference

  15/YH/0565

• Date of REC Opinion

  16 Dec 2015

• REC opinion

  Favourable Opinion