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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)
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 5-9kg 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
postnatal, randomised cluster feasibility trial, obesity, weight, qualitative
2044-6055
Parretti, Helen
6ec7e2d4-63bd-4b95-9af4-ab7b23959472
Ives, Natalie
1ea83439-1f54-4948-a754-1fc62f4665b3
Tearne, Sarah
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Vince, Alexandra
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Greenfield, Sheila M
6d7b4a15-9ab9-410c-b9b3-4827fae85a25
Jolly, Kate
1f61bd9e-bac6-4b1f-a54d-a3081f747c32
Jebb, Susan A.
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Frew, emma
5c2273ab-3ca2-410f-b0e5-be7dc77b836a
Yardley, Lucy
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Little, Paul
1bf2d1f7-200c-47a5-ab16-fe5a8756a777
Pritchett, Ruth V.
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Daley, Amanda
b4db8784-bff5-45d7-8c28-67503a40389a
Parretti, Helen
6ec7e2d4-63bd-4b95-9af4-ab7b23959472
Ives, Natalie
1ea83439-1f54-4948-a754-1fc62f4665b3
Tearne, Sarah
02c849e5-387c-4e3c-ba4a-5d8e4fcacb61
Vince, Alexandra
266ade26-4eaf-4e41-80b4-86eae5444c63
Greenfield, Sheila M
6d7b4a15-9ab9-410c-b9b3-4827fae85a25
Jolly, Kate
1f61bd9e-bac6-4b1f-a54d-a3081f747c32
Jebb, Susan A.
11904a4d-1abb-43ba-9d4b-d5da37ae1ebd
Frew, emma
5c2273ab-3ca2-410f-b0e5-be7dc77b836a
Yardley, Lucy
64be42c4-511d-484d-abaa-f8813452a22e
Little, Paul
1bf2d1f7-200c-47a5-ab16-fe5a8756a777
Pritchett, Ruth V.
26c7cdaf-65ad-4c09-ae54-384e7e199d16
Daley, Amanda
b4db8784-bff5-45d7-8c28-67503a40389a

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. (doi:10.1136/bmjopen-2019-033027).

Record type: Article

Abstract

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

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More information

Accepted/In Press date: 7 January 2020
e-pub ahead of print date: 16 February 2020
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
ORCID for Lucy Yardley: ORCID iD orcid.org/0000-0002-3853-883X

Catalogue record

Date deposited: 04 Mar 2020 17:34
Last modified: 19 May 2020 00:31

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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: Lucy Yardley ORCID iD
Author: Paul Little
Author: Ruth V. Pritchett
Author: Amanda Daley

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