Protocol to evaluate the effectiveness and cost-effectiveness of an environmental nutrition and physical activity intervention in nurseries (Nutrition and Physical Activity Self Assessment for Child Care - NAP SACC UK): a multicentre cluster randomised controlled trial

Ruth Kipping*, Miranda Pallan, Kim Hannam, Kate Willis, Alex Dobell, Chris Metcalfe, Russell Jago, Laura Johnson, Rebecca Langford, Corby K Martin, William Hollingworth, Madeleine Cochrane, James White, Pete Blair, Zoi Toumpakari, Jodi Taylor, Dianne Ward, Laurence Moore, Tom Reid, Megan PardoeLiping Wen, Marie Murphy, Anne Martin, Stephanie Chambers, Sharon Anne Simpson

*Corresponding author for this work

Research output: Contribution to journalArticle (Academic Journal)peer-review

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Abstract

BACKGROUND: One in seven UK children have obesity when starting school, with higher prevalence associated with deprivation. Most pre-school children do not meet UK recommendations for physical activity and nutrition. Formal childcare settings provide opportunities to deliver interventions to improve nutritional quality and physical activity to the majority of 3-4-year-olds. The nutrition and physical activity self-assessment for childcare (NAP SACC) intervention has demonstrated effectiveness in the USA with high acceptability in the UK. The study aims to evaluate the effectiveness and cost-effectiveness of the NAP SACC UK intervention to increase physical activity, reduce sedentary time and improve nutritional intake.

METHODS: Multi-centre cluster RCT with process and economic evaluation. Participants are children aged 2 years or over, attending UK early years settings (nurseries) for ≥ 12 h/week or ≥ 15 h/week during term time and their parents, and staff at participating nurseries. The 12-month intervention involves nursery managers working with a Partner (public health practitioner) to self-assess policies and practices relating to physical activity and nutrition; nursery staff attending one physical activity and one nutrition training workshop and setting goals to be achieved within 6 months. The Partner provides support and reviews progress. Nursery staff receive a further workshop and new goals are set, with Partner support for a further 6 months. The comparator is usual practice. Up to 56 nurseries will be stratified by area and randomly allocated to intervention or comparator arm with minimisation of differences in level of deprivation.

PRIMARY OUTCOMES: accelerometer-assessed mean total activity time on nursery days and average total energy (kcal) intake per eating occasion of lunch and morning/afternoon snacks consumed within nurseries.

SECONDARY OUTCOMES: accelerometer-assessed mean daily minutes of moderate-to-vigorous physical activity and sedentary time per nursery day, total physical activity on nursery days compared to non-nursery days, average serving size of lunch and morning/afternoon snacks in nursery per day, average percentage of core and non-core food in lunch and morning/afternoon snacks, zBMI, proportion of children who are overweight/obese and child quality-of-life. A process evaluation will examine fidelity, acceptability, sustainability and context. An economic evaluation will compare costs and consequences from the perspective of the local government, nursery and parents.

TRIAL REGISTRATION: ISRCTN33134697, 31/10/2019.

Original languageEnglish
Article number1475
JournalBMC Public Health
Volume23
Issue number1
DOIs
Publication statusPublished - 2 Aug 2023

Bibliographical note

Funding Information:
The sponsor of this study is the University of Bristol, Research and Enterprise Development, 2ndFloor, Augustine’s Courtyard, Orchard Lane, Bristol, BS1 5DS www.bristol.ac.uk/red/. The authors thank all the children, parents and childcare provider staff who took part in NAP SACC UK. We thank NAP SACC UK partners and trainers. We thank collaborators for their support of the study. We also thank the Chair and members of the Trial Steering Committee for their advice and support. The views expressed in this paper are those of the authors and not necessarily anyone in this acknowledgement list.

Funding Information:
The NAP SACC UK study is funded by the UK National Institute for Health and Care Research (NIHR) Public Health Research Programme (12/75/51). This study was designed and delivered in collaboration with the Bristol Trials Centre (BTC), a UKCRC Registered Clinical Trials Unit which is in receipt of NIHR CTU Support Funding. Pennington Biomedical’s Remote Food Photography Method© was utilised during the study, and Pennington Biomedical is supported by NORC Center Grant P30 DK072476 entitled “Nutrition and Metabolic Health Through the Lifespan” sponsored by the National Institute of Diabetes and Digestive and Kidney Disease and by grant U54 GM104940 from the National Institute of General Medical Sciences, which funds the Louisiana Clinical and Translational Science Center. None of the funders nor the study sponsor had involvement in the Trial Steering Committee, the collection, analysis, or interpretation of data or writing of the paper. Intervention costs have been funded by the Office for Health Improvement and Disparities (OHID), Sandwell Metropolitan Borough Council, Swindon Borough Council and Ayrshire and Arran Council. The views and opinions expressed in this publication are those of the authors and do not necessarily reflect those of the funding bodies listed here.

Publisher Copyright:
© 2023, The Author(s).

Keywords

  • Humans
  • Child, Preschool
  • Child
  • Infant
  • Child Care
  • Self-Assessment
  • Nurseries, Infant
  • Cost-Benefit Analysis
  • Health Promotion/methods
  • Exercise
  • Obesity
  • United Kingdom
  • Randomized Controlled Trials as Topic
  • Multicenter Studies as Topic

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