Protocol for the feasibility and acceptability of a brief routine weight management intervention for post natal women embedded within the national child immunisation programme: randomised controlled cluster feasibility trial with nested qualitative study (PIMMS-WL)
Protocol for the feasibility and acceptability of a brief routine weight management intervention for post natal women embedded within the national child immunisation programme: randomised controlled cluster feasibility trial with nested qualitative study (PIMMS-WL)
Introduction On average women retain 5 to 9 kg 1 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. General practitioner practice (cluster) will be the unit of randomisation, with practices randomised to offer usual care plus the intervention or usual care only. Eighty 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 to 1 kg/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 prespecified 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
postnatal, randomised cluster feasibility trial, obesity, weight, qualitative
Parretti, Helen
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Ives, Natalie
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Tearne, Sarah
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Vince, Alexandra
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Greenfield, Sheila M
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Jolly, Kate
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Jebb, Susan A.
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Frew, emma
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Yardley, Lucy
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Little, Paul
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Pritchett, Ruth V.
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Daley, Amanda
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16 February 2020
Parretti, Helen
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Ives, Natalie
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Tearne, Sarah
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Vince, Alexandra
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Greenfield, Sheila M
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Jolly, Kate
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Jebb, Susan A.
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Frew, emma
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Yardley, Lucy
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Little, Paul
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Pritchett, Ruth V.
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Daley, Amanda
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Parretti, Helen, Ives, Natalie, Tearne, Sarah, Vince, Alexandra, Greenfield, Sheila M, Jolly, Kate, Jebb, Susan A., Frew, emma, Yardley, Lucy, Little, Paul, Pritchett, Ruth V. and Daley, Amanda
(2020)
Protocol for the feasibility and acceptability of a brief routine weight management intervention for post natal women embedded within the national child immunisation programme: randomised controlled cluster feasibility trial with nested qualitative study (PIMMS-WL).
BMJ Open, 10 (2), [e033027].
(doi:10.1136/bmjopen-2019-033027).
Abstract
Introduction On average women retain 5 to 9 kg 1 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. General practitioner practice (cluster) will be the unit of randomisation, with practices randomised to offer usual care plus the intervention or usual care only. Eighty 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 to 1 kg/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 prespecified 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
Text
PIMMSWL_Protocol
- Accepted Manuscript
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e033027.full
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More information
Accepted/In Press date: 7 January 2020
e-pub ahead of print date: 16 February 2020
Published date: 16 February 2020
Additional Information:
Funding Information:
Funding This work is supported by the National Institute of Health Research (NIHR) Health Technology Assessment programme grant number 15/184/14. HMP was funded by a National Institute for Health Research Academic Clinical Lectureship. Competing interests None declared. Patient consent for publication Not required.
Publisher Copyright:
© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ.
Keywords:
postnatal, randomised cluster feasibility trial, obesity, weight, qualitative
Identifiers
Local EPrints ID: 438316
URI: http://eprints.soton.ac.uk/id/eprint/438316
ISSN: 2044-6055
PURE UUID: 298f8e43-24e0-4ab0-823e-e5d1eb863dc5
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Date deposited: 04 Mar 2020 17:34
Last modified: 17 Mar 2024 02:47
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Contributors
Author:
Helen Parretti
Author:
Natalie Ives
Author:
Sarah Tearne
Author:
Alexandra Vince
Author:
Sheila M Greenfield
Author:
Kate Jolly
Author:
Susan A. Jebb
Author:
emma Frew
Author:
Ruth V. Pritchett
Author:
Amanda Daley
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