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Protocol for the feasibility and acceptability of a brief routine weight management intervention for postnatal women embedded within the national child immunisation programme: randomised controlled cluster feasibility trial with nested qualitative study (PIMMS-WL)

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journal contribution
posted on 14.01.2020 by Helen M Parretti, Natalie Ives, Sarah Tearne, Alexandra Vince, Sheila M Greenfield, Kate Jolly, Susan A Jebb, Emma Frew, Lucy Yardley, Paul Little, Ruth V Pritchett, Amanda Daley
Introduction
On average women retain 5-9kg one year after giving birth which can increase the risk of later obesity and chronic diseases. Some previous trials in this population have been effective in reducing weight, but are too intensive and costly to deliver at scale. There is a need for low-cost interventions to facilitate weight loss in this population.
Methods and analysis
The primary aim is to assess the feasibility of delivering a weight management intervention for overweight/obese postnatal women within child immunisation appointments. We will conduct a randomised controlled cluster feasibility trial with a nested qualitative study to assess study recruitment and acceptability of the intervention. GP practice (cluster) will be the unit of randomisation, with practices randomised to offer usual care plus the intervention or usual care only. 80 women will be recruited.
The intervention group will be offered brief support that encourages self-management of weight when attending child immunisation appointments. Practice nurses will encourage women to weigh themselves weekly and record this, and to make healthy lifestyle choices through using an online weight management programme. Women will be advised to aim for 0.5-1kg/week weight loss. At each child immunisation the nurse will assess progress by weighing women. The comparator group will receive a healthy lifestyle leaflet.
Data on weight, body fat, depression, anxiety, body-image, eating behaviours and physical activity will be collected at baseline and follow-up. Women and nurses will be interviewed to ascertain their views about the intervention. The decision to proceed to the phase III trial will be based on pre-specified stop-go criteria.
Ethics and Dissemination
Data will be stored securely at the University of Birmingham. Results will be disseminated through academic publications and presentations and will inform a possible phase III trial. The National Research Ethics Committee approved the study protocol.
Trial Registration number: ISRCTN12209332

Funding

National Institute of Health Research (NIHR) Health Technology Assessment programme grant number 15/184/14

National Institute for Health Research Academic Clinical Lectureship

History

School

  • Sport, Exercise and Health Sciences

Published in

BMJ Open

Volume

10

Issue

2

Publisher

BMJ Publishing Group

Version

VoR (Version of Record)

Rights holder

© Author(s) (or their employer(s))

Publisher statement

This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

Acceptance date

07/01/2020

Publication date

2020-02-16

Copyright date

2020

eISSN

2044-6055

Language

en

Depositor

Prof Amanda Daley. Deposit date: 14 January 2020

Article number

e033027

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