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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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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). / Parretti, H M; Ives, Natalie J; Tearne, Sarah; Vince, A T; Greenfield, S M; Jolly, Kate; Jebb, Susan; Frew, Emma; Yardley, Lucy; Little, Paul; Pritchett, Ruth ; Daley, Amanda.

In: BMJ Open, 05.12.2019.

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Parretti, H M ; Ives, Natalie J ; Tearne, Sarah ; Vince, A T ; Greenfield, S M ; Jolly, Kate ; Jebb, Susan ; Frew, Emma ; Yardley, Lucy ; Little, Paul ; Pritchett, Ruth ; Daley, Amanda. / 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). In: BMJ Open. 2019.

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@article{412764c5a9044412a54752ac0a0b5f22,
title = "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)",
abstract = "IntroductionOn 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 analysisThe 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 prespecified stop-go criteria.Ethics and DisseminationData 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.",
author = "Parretti, {H M} and Ives, {Natalie J} and Sarah Tearne and Vince, {A T} and Greenfield, {S M} and Kate Jolly and Susan Jebb and Emma Frew and Lucy Yardley and Paul Little and Ruth Pritchett and Amanda Daley",
year = "2019",
month = "12",
day = "5",
language = "English",
journal = "BMJ Open",
issn = "2044-6055",
publisher = "BMJ Publishing Group",

}

RIS - suitable for import to EndNote

TY - JOUR

T1 - Protocol for the feasibility and acceptability of a brief routine weight management intervention for postnatal women embedded within the national child immunisation programme

T2 - randomised controlled cluster feasibility trial with nested qualitative study (PIMMS-WL)

AU - Parretti, H M

AU - Ives, Natalie J

AU - Tearne, Sarah

AU - Vince, A T

AU - Greenfield, S M

AU - Jolly, Kate

AU - Jebb, Susan

AU - Frew, Emma

AU - Yardley, Lucy

AU - Little, Paul

AU - Pritchett, Ruth

AU - Daley, Amanda

PY - 2019/12/5

Y1 - 2019/12/5

N2 - IntroductionOn 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 analysisThe 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 prespecified stop-go criteria.Ethics and DisseminationData 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.

AB - IntroductionOn 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 analysisThe 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 prespecified stop-go criteria.Ethics and DisseminationData 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.

M3 - Article

JO - BMJ Open

JF - BMJ Open

SN - 2044-6055

ER -