A cluster RCT and process evaluation of an implementation optimisation intervention to promote parental engagement enrolment and attendance in a childhood obesity prevention programme: results of the Optimising Family Engagement in HENRY (OFTEN) trial

Maria Bryant; Wendy Burton; Michelle Collinson; Amanda Farrin; Jane Nixon; June Stevens; Kim Roberts; Robbie Foy; Harry Rutter; Bethan Copsey; Suzanne Hartley; Sandy Tubeuf; Julia Brown

doi:10.1186/s13063-021-05757-w

A cluster RCT and process evaluation of an implementation optimisation intervention to promote parental engagement enrolment and attendance in a childhood obesity prevention programme: results of the Optimising Family Engagement in HENRY (OFTEN) trial

Maria Bryant, Wendy Burton, Michelle Collinson, Amanda Farrin, Jane Nixon, June Stevens, Kim Roberts, Robbie Foy, Harry Rutter, Bethan Copsey, Suzanne Hartley, Sandy Tubeuf, Julia Brown

Research output: Contribution to journal › Article › peer-review

3 Citations (SciVal)

Abstract

Background: Poor and variable implementation of childhood obesity prevention programmes reduces their population impact and sustainability. We drew upon ethnographic work to develop a multi-level, theory-based implementation optimisation intervention. This intervention aimed to promote parental enrolment and attendance at HENRY (Health Exercise Nutrition for the Really Young), a UK community obesity prevention programme, by changing behaviours of children’s centre and local authority stakeholders. Methods: We evaluated the effectiveness of the implementation optimisation intervention on HENRY programme enrolment and attendance over a 12-month implementation period in a cluster randomised controlled trial. We randomised 20 local government authorities (with 126 children’s centres) to HENRY plus the implementation optimisation intervention or to HENRY alone. Primary outcomes were (1) the proportion of centres enrolling at least eight parents per programme and (2) the proportion of centres with a minimum of 75% of parents attending at least five of eight sessions per programme. Trial analyses adjusted for stratification factors (pre-randomisation implementation of HENRY, local authority size, deprivation) and allowed for cluster design. A parallel mixed-methods process evaluation used qualitative interviews and routine monitoring to explain trial results. Results: Neither primary outcome differed significantly between groups; 17.8% of intervention centres and 18.0% of control centres achieved the parent enrolment target (adjusted difference − 1.2%; 95% CI − 19.5%, 17.1%); 17.1% of intervention centres and 13.9% of control centres achieved the attendance target (adjusted difference 1.2%; 95% CI − 15.7%, 18.1%). Unexpectedly, the trial coincided with substantial national service restructuring, including centre closures and reduced funds. Some commissioning and management teams stopped or reduced delivery of both HENRY and the implementation optimisation intervention due to competing demands. Thus, at follow-up, HENRY programmes were delivered to approximately half the number of parents compared to baseline (n = 433 vs. 881). Conclusions: During a period in which services were reduced by external policies, this first definitive trial found no evidence of effectiveness for an implementation optimisation intervention promoting parent enrolment to and attendance at an obesity prevention programme. Trial registration: ClinicalTrials.govNCT02675699. Registered on 4 February 2016.

Original language	English
Article number	773
Journal	Trials
Volume	22
Issue number	1
DOIs	https://doi.org/10.1186/s13063-021-05757-w
Publication status	Published - 5 Nov 2021

Bibliographical note

Funding Information:
The trial was funded by the NIHR Trainees Coordinating Programme awarded to the chief investigator (MB) (CDF-2014-07-052). The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health.

Funding Information:
KR is the chief executive of HENRY, which may receive increased publicity and consequent commissioning as a result of this research. KR was blinded to treatment allocation and was excluded from steering committee meetings. Involvement of KR was essential for the development of the optimisation intervention under investigation (ensuring feasible approaches were recommended and agreeing on related incurred costs). At the time of the study, HR was supported by the NIHR Collaboration for Leadership in Applied Health Research and Care (CLAHRC) North Thames at Barts Health NHS Trust. The other authors declare that they have no competing interests.

Funding Information:
We acknowledge our parent advisory team for their support in developing the intervention and ongoing advice in study design and recruitment (Amal Najlat, Chloe Anderson, Kelly Milner, Claire Donkin, Sarah Young, Terri Francis and Rachael Baptista). We thank members of the trial steering committee (TSC), including Professor Peymane Adab (TSC Chair, University of Birmingham), Professor Alicia O?Cathain (mixed methods expert, University of Sheffield), Professor Kelvin Jordan (statistical expertise, Keele University), Dr Thomas Willis (behaviour change expertise, University of Leeds) and Amal Najlat (parent representative). We are also grateful to the children?s centres that permitted observations which support the intervention development (anonymous). We acknowledge the optimisation intervention development team for their significant contributions (Professor Pinki Sahota, Dr Maureen Twiddy, Jackie Moores and Chloe Anderson). We thank the HENRY team for their support in developing and delivering the intervention, providing data and liaising with centres (Rebecca Nourse, Sian Livsey and Kim Roberts)

Publisher Copyright:
© 2021, The Author(s).

Keywords

Attendance
Community
Engagement
Enrolment
Obesity
Parent

ASJC Scopus subject areas

Medicine (miscellaneous)
Pharmacology (medical)

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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Bryant, M., Burton, W., Collinson, M., Farrin, A., Nixon, J., Stevens, J., Roberts, K., Foy, R., Rutter, H., Copsey, B., Hartley, S., Tubeuf, S., & Brown, J. (2021). A cluster RCT and process evaluation of an implementation optimisation intervention to promote parental engagement enrolment and attendance in a childhood obesity prevention programme: results of the Optimising Family Engagement in HENRY (OFTEN) trial. Trials, 22(1), Article 773. https://doi.org/10.1186/s13063-021-05757-w

A cluster RCT and process evaluation of an implementation optimisation intervention to promote parental engagement enrolment and attendance in a childhood obesity prevention programme: results of the Optimising Family Engagement in HENRY (OFTEN) trial. / Bryant, Maria; Burton, Wendy; Collinson, Michelle et al.
In: Trials, Vol. 22, No. 1, 773, 05.11.2021.

Research output: Contribution to journal › Article › peer-review

Bryant, M, Burton, W, Collinson, M, Farrin, A, Nixon, J, Stevens, J, Roberts, K, Foy, R, Rutter, H, Copsey, B, Hartley, S, Tubeuf, S & Brown, J 2021, 'A cluster RCT and process evaluation of an implementation optimisation intervention to promote parental engagement enrolment and attendance in a childhood obesity prevention programme: results of the Optimising Family Engagement in HENRY (OFTEN) trial', Trials, vol. 22, no. 1, 773. https://doi.org/10.1186/s13063-021-05757-w

Bryant M, Burton W, Collinson M, Farrin A, Nixon J, Stevens J et al. A cluster RCT and process evaluation of an implementation optimisation intervention to promote parental engagement enrolment and attendance in a childhood obesity prevention programme: results of the Optimising Family Engagement in HENRY (OFTEN) trial. Trials. 2021 Nov 5;22(1):773. doi: 10.1186/s13063-021-05757-w

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abstract = "Background: Poor and variable implementation of childhood obesity prevention programmes reduces their population impact and sustainability. We drew upon ethnographic work to develop a multi-level, theory-based implementation optimisation intervention. This intervention aimed to promote parental enrolment and attendance at HENRY (Health Exercise Nutrition for the Really Young), a UK community obesity prevention programme, by changing behaviours of children{\textquoteright}s centre and local authority stakeholders. Methods: We evaluated the effectiveness of the implementation optimisation intervention on HENRY programme enrolment and attendance over a 12-month implementation period in a cluster randomised controlled trial. We randomised 20 local government authorities (with 126 children{\textquoteright}s centres) to HENRY plus the implementation optimisation intervention or to HENRY alone. Primary outcomes were (1) the proportion of centres enrolling at least eight parents per programme and (2) the proportion of centres with a minimum of 75% of parents attending at least five of eight sessions per programme. Trial analyses adjusted for stratification factors (pre-randomisation implementation of HENRY, local authority size, deprivation) and allowed for cluster design. A parallel mixed-methods process evaluation used qualitative interviews and routine monitoring to explain trial results. Results: Neither primary outcome differed significantly between groups; 17.8% of intervention centres and 18.0% of control centres achieved the parent enrolment target (adjusted difference − 1.2%; 95% CI − 19.5%, 17.1%); 17.1% of intervention centres and 13.9% of control centres achieved the attendance target (adjusted difference 1.2%; 95% CI − 15.7%, 18.1%). Unexpectedly, the trial coincided with substantial national service restructuring, including centre closures and reduced funds. Some commissioning and management teams stopped or reduced delivery of both HENRY and the implementation optimisation intervention due to competing demands. Thus, at follow-up, HENRY programmes were delivered to approximately half the number of parents compared to baseline (n = 433 vs. 881). Conclusions: During a period in which services were reduced by external policies, this first definitive trial found no evidence of effectiveness for an implementation optimisation intervention promoting parent enrolment to and attendance at an obesity prevention programme. Trial registration: ClinicalTrials.govNCT02675699. Registered on 4 February 2016.",

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author = "Maria Bryant and Wendy Burton and Michelle Collinson and Amanda Farrin and Jane Nixon and June Stevens and Kim Roberts and Robbie Foy and Harry Rutter and Bethan Copsey and Suzanne Hartley and Sandy Tubeuf and Julia Brown",

note = "Funding Information: The trial was funded by the NIHR Trainees Coordinating Programme awarded to the chief investigator (MB) (CDF-2014-07-052). The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health. Funding Information: KR is the chief executive of HENRY, which may receive increased publicity and consequent commissioning as a result of this research. KR was blinded to treatment allocation and was excluded from steering committee meetings. Involvement of KR was essential for the development of the optimisation intervention under investigation (ensuring feasible approaches were recommended and agreeing on related incurred costs). At the time of the study, HR was supported by the NIHR Collaboration for Leadership in Applied Health Research and Care (CLAHRC) North Thames at Barts Health NHS Trust. The other authors declare that they have no competing interests. Funding Information: We acknowledge our parent advisory team for their support in developing the intervention and ongoing advice in study design and recruitment (Amal Najlat, Chloe Anderson, Kelly Milner, Claire Donkin, Sarah Young, Terri Francis and Rachael Baptista). We thank members of the trial steering committee (TSC), including Professor Peymane Adab (TSC Chair, University of Birmingham), Professor Alicia O?Cathain (mixed methods expert, University of Sheffield), Professor Kelvin Jordan (statistical expertise, Keele University), Dr Thomas Willis (behaviour change expertise, University of Leeds) and Amal Najlat (parent representative). We are also grateful to the children?s centres that permitted observations which support the intervention development (anonymous). We acknowledge the optimisation intervention development team for their significant contributions (Professor Pinki Sahota, Dr Maureen Twiddy, Jackie Moores and Chloe Anderson). We thank the HENRY team for their support in developing and delivering the intervention, providing data and liaising with centres (Rebecca Nourse, Sian Livsey and Kim Roberts) Publisher Copyright: {\textcopyright} 2021, The Author(s).",

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T1 - A cluster RCT and process evaluation of an implementation optimisation intervention to promote parental engagement enrolment and attendance in a childhood obesity prevention programme: results of the Optimising Family Engagement in HENRY (OFTEN) trial

AU - Bryant, Maria

AU - Burton, Wendy

AU - Collinson, Michelle

AU - Farrin, Amanda

AU - Nixon, Jane

AU - Stevens, June

AU - Roberts, Kim

AU - Foy, Robbie

AU - Rutter, Harry

AU - Copsey, Bethan

AU - Hartley, Suzanne

AU - Tubeuf, Sandy

AU - Brown, Julia

N1 - Funding Information: The trial was funded by the NIHR Trainees Coordinating Programme awarded to the chief investigator (MB) (CDF-2014-07-052). The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health. Funding Information: KR is the chief executive of HENRY, which may receive increased publicity and consequent commissioning as a result of this research. KR was blinded to treatment allocation and was excluded from steering committee meetings. Involvement of KR was essential for the development of the optimisation intervention under investigation (ensuring feasible approaches were recommended and agreeing on related incurred costs). At the time of the study, HR was supported by the NIHR Collaboration for Leadership in Applied Health Research and Care (CLAHRC) North Thames at Barts Health NHS Trust. The other authors declare that they have no competing interests. Funding Information: We acknowledge our parent advisory team for their support in developing the intervention and ongoing advice in study design and recruitment (Amal Najlat, Chloe Anderson, Kelly Milner, Claire Donkin, Sarah Young, Terri Francis and Rachael Baptista). We thank members of the trial steering committee (TSC), including Professor Peymane Adab (TSC Chair, University of Birmingham), Professor Alicia O?Cathain (mixed methods expert, University of Sheffield), Professor Kelvin Jordan (statistical expertise, Keele University), Dr Thomas Willis (behaviour change expertise, University of Leeds) and Amal Najlat (parent representative). We are also grateful to the children?s centres that permitted observations which support the intervention development (anonymous). We acknowledge the optimisation intervention development team for their significant contributions (Professor Pinki Sahota, Dr Maureen Twiddy, Jackie Moores and Chloe Anderson). We thank the HENRY team for their support in developing and delivering the intervention, providing data and liaising with centres (Rebecca Nourse, Sian Livsey and Kim Roberts) Publisher Copyright: © 2021, The Author(s).

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N2 - Background: Poor and variable implementation of childhood obesity prevention programmes reduces their population impact and sustainability. We drew upon ethnographic work to develop a multi-level, theory-based implementation optimisation intervention. This intervention aimed to promote parental enrolment and attendance at HENRY (Health Exercise Nutrition for the Really Young), a UK community obesity prevention programme, by changing behaviours of children’s centre and local authority stakeholders. Methods: We evaluated the effectiveness of the implementation optimisation intervention on HENRY programme enrolment and attendance over a 12-month implementation period in a cluster randomised controlled trial. We randomised 20 local government authorities (with 126 children’s centres) to HENRY plus the implementation optimisation intervention or to HENRY alone. Primary outcomes were (1) the proportion of centres enrolling at least eight parents per programme and (2) the proportion of centres with a minimum of 75% of parents attending at least five of eight sessions per programme. Trial analyses adjusted for stratification factors (pre-randomisation implementation of HENRY, local authority size, deprivation) and allowed for cluster design. A parallel mixed-methods process evaluation used qualitative interviews and routine monitoring to explain trial results. Results: Neither primary outcome differed significantly between groups; 17.8% of intervention centres and 18.0% of control centres achieved the parent enrolment target (adjusted difference − 1.2%; 95% CI − 19.5%, 17.1%); 17.1% of intervention centres and 13.9% of control centres achieved the attendance target (adjusted difference 1.2%; 95% CI − 15.7%, 18.1%). Unexpectedly, the trial coincided with substantial national service restructuring, including centre closures and reduced funds. Some commissioning and management teams stopped or reduced delivery of both HENRY and the implementation optimisation intervention due to competing demands. Thus, at follow-up, HENRY programmes were delivered to approximately half the number of parents compared to baseline (n = 433 vs. 881). Conclusions: During a period in which services were reduced by external policies, this first definitive trial found no evidence of effectiveness for an implementation optimisation intervention promoting parent enrolment to and attendance at an obesity prevention programme. Trial registration: ClinicalTrials.govNCT02675699. Registered on 4 February 2016.

AB - Background: Poor and variable implementation of childhood obesity prevention programmes reduces their population impact and sustainability. We drew upon ethnographic work to develop a multi-level, theory-based implementation optimisation intervention. This intervention aimed to promote parental enrolment and attendance at HENRY (Health Exercise Nutrition for the Really Young), a UK community obesity prevention programme, by changing behaviours of children’s centre and local authority stakeholders. Methods: We evaluated the effectiveness of the implementation optimisation intervention on HENRY programme enrolment and attendance over a 12-month implementation period in a cluster randomised controlled trial. We randomised 20 local government authorities (with 126 children’s centres) to HENRY plus the implementation optimisation intervention or to HENRY alone. Primary outcomes were (1) the proportion of centres enrolling at least eight parents per programme and (2) the proportion of centres with a minimum of 75% of parents attending at least five of eight sessions per programme. Trial analyses adjusted for stratification factors (pre-randomisation implementation of HENRY, local authority size, deprivation) and allowed for cluster design. A parallel mixed-methods process evaluation used qualitative interviews and routine monitoring to explain trial results. Results: Neither primary outcome differed significantly between groups; 17.8% of intervention centres and 18.0% of control centres achieved the parent enrolment target (adjusted difference − 1.2%; 95% CI − 19.5%, 17.1%); 17.1% of intervention centres and 13.9% of control centres achieved the attendance target (adjusted difference 1.2%; 95% CI − 15.7%, 18.1%). Unexpectedly, the trial coincided with substantial national service restructuring, including centre closures and reduced funds. Some commissioning and management teams stopped or reduced delivery of both HENRY and the implementation optimisation intervention due to competing demands. Thus, at follow-up, HENRY programmes were delivered to approximately half the number of parents compared to baseline (n = 433 vs. 881). Conclusions: During a period in which services were reduced by external policies, this first definitive trial found no evidence of effectiveness for an implementation optimisation intervention promoting parent enrolment to and attendance at an obesity prevention programme. Trial registration: ClinicalTrials.govNCT02675699. Registered on 4 February 2016.

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A cluster RCT and process evaluation of an implementation optimisation intervention to promote parental engagement enrolment and attendance in a childhood obesity prevention programme: results of the Optimising Family Engagement in HENRY (OFTEN) trial

Abstract

Bibliographical note

Keywords

ASJC Scopus subject areas

UN SDGs

Access to Document

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