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Evaluation of Health Intervention Research

Find out about the projects in our Evaluation of Interventions workstream.

A randomised controlled trial of colorectal polyp and cancer prevention using aspirin and resistant starch in carriers of Hereditary Non-Polyposis Colon Cancer (Lynch syndrome) – The CAPP2 Study

Investigators

  • Professor John Mathers
  • Professor Sir John Burn (Lead Investigator)
  • Professor Tim Bishop (University of Leeds)

Overview

Observational and epidemiological data indicate use of aspirin reduces risk of colorectal neoplasia.

However, when the CAPP2 Study started, the effects of aspirin in people with Lynch syndrome (hereditary nonpolyposis colon cancer) were not known.

The results suggest that higher intakes of dietary fibre may equate to lower colorectal cancer risk. There was also evidence that resistant starch (RS; a form of dietary fibre) had an antineoplastic effect on the colon. However, the effects in people with Lynch syndrome were unknown.

Methods

The CAPP2 Study began on 1 May 1998.

In a randomised, placebo-controlled trial, we used a two-by-two design to investigate the effects of aspirin (600 mg per day) and resistant starch (Novelose; 30 g per day) on cancer risk in people with Lynch syndrome.

The protocol specified intervention for 24 months, but participants could opt to remain on study for a further two years. The average duration of participation in the study was 29 months.

Outcomes

Analyses took place on the outcome data at the end of the intervention, and again when the first participants reached 10 years from the start of the intervention.

Currently, we are undertaking further analysis when all participants have reached 10 years. Some have reached 20 years, post-intervention.

Publications

Burn J, Bishop DT, Mecklin JP, Macrae F, Möslein G, Olschwang S, Bisgaard ML, Ramesar R, Eccles D, Maher ER, Bertario L, Jarvinen HJ, Lindblom A, Evans DG, Lubinski J, Morrison PJ, Ho JW, Vasen HF, Side L, Thomas HJ, Scott RJ, Dunlop M, Barker G, Elliott F, Jass JR, Fodde R, Lynch HT, Mathers JC; CAPP2 Investigators. (2008) N Engl J Med. 359(24):2567-78. “Effect of aspirin or resistant starch on colorectal neoplasia in the Lynch syndrome.”

Burn J, Gerdes AM, Macrae F, Mecklin JP, Moeslein G, Olschwang S, Eccles D, Evans DG, Maher ER, Bertario L, Bisgaard ML, Dunlop MG, Ho JW, Hodgson SV, Lindblom A, Lubinski J, Morrison PJ, Murday V, Ramesar R, Side L, Scott RJ, Thomas HJ, Vasen HF, Barker G, Crawford G, Elliott F, Movahedi M, Pylvanainen K, Wijnen JT, Fodde R, Lynch HT, Mathers JC, Bishop DT; CAPP2 Investigators. (2011) Lancet. 378(9809):2081-7. “Long-term effect of aspirin on cancer risk in carriers of hereditary colorectal cancer: an analysis from the CAPP2 randomised controlled trial.”

Movahedi M, Bishop DT, Macrae F, Mecklin JP, Moeslein G, Olschwang S, Eccles D, Evans DG, Maher ER, Bertario L, Bisgaard ML, Dunlop MG, Ho JW, Hodgson SV, Lindblom A, Lubinski J, Morrison PJ, Murday V, Ramesar RS, Side L, Scott RJ, Thomas HJ, Vasen HF, Burn J, Mathers JC. (2015) J Clin Oncol. 33(31):3591-7. “Obesity, Aspirin, and Risk of Colorectal Cancer in Carriers of Hereditary Colorectal Cancer: A Prospective Investigation in the CAPP2 Study.”

Burn J, Sheth H, Elliott F, Reed L, Macrae F, Mecklin JP, Möslein G, McRonald FE, Bertario L, Evans DG, Gerdes AM, Ho JWC, Lindblom A, Morrison PJ, Rashbass J, Ramesar R, Seppälä T, Thomas HJW, Pylvänäinen K, Borthwick GM, Mathers JC, Bishop DT; CAPP2 Investigators. (2020) Lancet. 395(10240):1855-1863. “Cancer prevention with aspirin in hereditary colorectal cancer (Lynch syndrome), 10-year follow-up and registry-based 20-year data in the CAPP2 study: a double-blind, randomised, placebo-controlled trial.”

Funding

The CAPP2 Study received funding from:

  • the European Union
  • UK MRC
  • Cancer Research UK
  • NIHR
  • The Newcastle upon Tyne Hospitals NHS Charity
  • National Starch and Chemical Co (now part of Ingredion)
  • Cancer Council of Victoria and NSW, Australia
  • Cancer Australia
  • THRIPP South Africa
  • The Finnish Cancer Foundation
  • Barbour Foundation
The MapMe intervention

Aims

This intervention aims to help tackle childhood overweight and obesity.

MapMe

The web-based tool consists of body image scales of 4-5 and 10-11-year-old children of known weight status. It also provides information on:

  • the consequences of being overweight in childhood
  • healthy eating
  • physical activity
  • links to further support

Outcomes

Results from small scale testing of MapMe suggested positive weight outcomes in children who were overweight or obese, one year post-intervention.

Testing will now take place in a large, randomised, controlled trial across nine local authorities.

The National Child Measurement Programme

The National Child Measurement Programme (NCMP) aims to adopt MapMe.

It will support parents to act upon the NCMP letters they receive about their child’s weight status. It helps improve their understanding and recognition of childhood weight concerns.

We will assess the impact of the intervention on child weight outcomes at 1 year. We will also complete a process and economic evaluation. If our results find to be effective, NCMP will incorporate MapMe into its routine delivery.

Funding

This project received funding from the National Institute for Health Research (NIHR) – Public Health Research Programme

Start/end date

01/03/2020 – 28/02/2024.

Due to the Covid-19 pandemic, the planned trial experienced a 12-month delay. It will now take place during the 2021/22 academic year.

Applicants

Prof Ashley Adamson (PI) 1, Dr Angela Jones 1, Dr Bronia Arnott 1, Dr Elizabeth Evans 2, Dr Yemi Oluboyede 1, Dr Laura Basterfield 1, Prof John Matthews 3, Prof Vera Araujo-Soares 4, Prof Louisa Ells 5, Prof Martin Tovée 6, Loretta Sollars 7, Alison Gahagan 7, Rosie Taylor 7

1 Population Health Sciences Institute, Newcastle University

2 School of Psychology, Newcastle University

3 School of Mathematics, Statistics and Physics, Newcastle University

4 Faculty of Behavioural, Management and Social Sciences, University of Twente

5 School of Clinical and Applied Sciences, Leeds Beckett University

6 Faculty of Health and Life Sciences, Northumbria University

7 Health Intelligence Division, Public Health England

An evaluation of the implementation of national school food standards in secondary schools and their impact on the school food environment and pupil intake of free sugars: a mixed-methods study

Funder

NIHR

Dates

01/03/19 - 01/05/21

Funding

£815,889

Find out more

Collaborators

Miranda Pallan and Professor Peymane Adab at Birmingham University lead the project.

Professor A Adamson and Dr S Spence are collaborators.

Aims

We aim to evaluate how secondary schools implement:

  • School Food Standards
  • wider healthy eating recommendations (from the national School Food Plan)

It also considers how they influence pupils’ diets and dental health.

Investigating the impact of social prescribing in the North East of England

Dates

July 2018 – April 2021

Funder

NIHR

Research

We investigate the impact of a social prescribing scheme in the West End of Newcastle.

John Wildman is leading work packages that use quantitative quasi-experimental methods. These estimate the impact of the scheme on a range of health outcomes.

Publications:

Wildman J, Wildman JM. Combining Health and Outcomes Beyond Health in Complex Evaluations of Complex Interventions: Suggestions for Economic Evaluation. Value in Health 2019, 22(5), 511-517.

Moffatt S, Wildman J, Pollard TM, Penn L, O'Brien N, Pearce MS, Wildman JM. Evaluating the impact of a community-based social prescribing intervention on people with type 2 diabetes in North East England: mixed-methods study protocol. BMJ Open 2019, 9(1).

Public perceptions of the health risks of climate change and priorities for action

Funder

PH-PRU (NIHR Public Health Policy Research Unit)

Start/end date

April 2020 – March 2022

Aims

This project aims to:

  • provide evidence on people’s perceptions of the health risks of climate change and their priorities for action
  • help inform national policies and local action plans to reduce climate change related risks to health

Collaborators

  • Primary Investigator - Hilary Graham, University of York
  • Co-Investigators - Susan Chilton and Jytte Nielsen
A scoping study on the valuation of risks to life and health: the monetary value of a life year (VOLY)

Dates

This project ran between 2018- 2019

Funding

This project received funding from:

  • Department for Environment, Food and Rural Affairs
  • Department of Health and Social Care
  • Department for Transport
  • the Food Standards Agency
  • Food Standards Scotland
  • the Health and Safety Executive
  • the Home Office

Collaborators

  • Primary Investigator: Susan Chilton
  • Co-Investigators: Jytte Nielsen and others

This was a collaboration between:

  • Newcastle University
  • Glasgow Caledonian University
  • Birmingham University

Aims

We assessed the need for and feasibility of new large-scale primary research to update:

  • the Value of a Life Year (VOLY)
  • Willingness-To-Pay for a Quality Adjusted Life-Year (WTP-QALY)

UK Government Departments and Agencies use these figures.

For further information on this project, please visit.

Prof Eileen Kaner - projects

Investigators:

Prof Eileen F. S. Kaner, Prof Public Health & Primary Care (Res), Population Health Sciences

Aim:

To conduct cross-disciplinary, applied health research across the life-course to improve physical, mental health and social outcomes in individuals and communities.

Objectives:

  • To understand the impact of structural, social and behavioural risk factors on individuals, communities and wider society.
  • To explore the impact of multiple (social) disadvantage on physical and mental health outcomes.
  • To develop and evaluate complex interventions aimed at promoting health and well-being across the life-course.
  • To accelerate the uptake and use of evidence-based preventive care by health and social care practitioners.
  • To promote evidence-based policy and practice to improve physical and mental health and wider well-being in society.

Research Grants:

Bambra C, Kaner E, Pickett K, Whitty P. on behalf of 12 Applied Research Collaboration (ARCs), NIHR ARC North East and North Cumbria, National Priority Area: Health and Care Inequalities, 2020-23. Award Value: £1,875,000

Adamson A, Sniehotta F, Kaner E, Haining S. on behalf of 12 Applied Research Collaboration (ARCs), NIHR ARC North East and North Cumbria, National Priority Area: Prevention, including behavioural risk factors, 2020-23. Award Value: £1,875, 000

Kaner E. NIHR Senior Investigator award. Ref NIHR201348, 2020-2024. Award Value: £80,000

Kaner E, Lhussier M, Redgate S, Wildman J, Hackett S, Gray J, Rowlands G, McKean C, Heslop J, Mancini M, Hartley J. "Supporting access to books and reading to promote health and well-being in disadvantaged groups: realist evaluation of Community Reading Coach provision in five Local Authority areas [The ‘Read-well’ project]". NIHR Applied Research Collaboration, North East and North Cumbria 2020-23. Award Value: £96,000

McGovern, R. Firth, J. Adams, E. Alderson, H. Barron, C. Frost, H. McGovern, W. Redgate, S. Renwick, T. Smart, D. Xeros, P. Kaner, E. "Working with Children and Families at the Edge of Care – A realist evaluation of North Tyneside Council’s Keeping Families Connected Provision". NIHR Applied Research Collaboration, North East and North Cumbria, 2020-22. Award Value: £55,162

McGovern, R, Bate A, Gilvarry E, Araujo Soares V, Hay J, Robinson C, Kaner E. "SAFEguarding children in Substance exPosed fAmilies by supporting the non-using CaregivEr: Safe Space", MRC PHIND 2020-22, Grant reference: MR/V004034/1, Award Value: £141,261

Ramsay S, Kaner E, Watt R, Bambra C, Sniehotta F, Craig D, Beyer F, Landes D, Mann C, Moffatt S, Paisi M. "Identifying effective and sustainable interventions to improve the oral health and related behaviours of adults with severe and multiple disadvantage: evidence synthesis and qualitative stakeholder research". NIHR PRP (22-02-02): Health Inequalities Research Initiative. 2020-22 (30 months). Award Value: £629,492