Plain English Summary
Background and study aims
SPICES is an EU Horizon 2020 project working simultaneously in six settings across five countries (Limpopo, South Africa; Kampala, Uganda; Brest, France; Antwerp, Belgium; Brighton and Nottingham, United Kingdom). This two-year study is exploring the effectiveness of community-based heart disease prevention interventions against Primary Care based risk profiling, advice and support.
Who can participate?
All adults (over 18 years old)
What does the study involve?
Participants are randomly allocated to receive either:
1. In-person, community-based, Behaviour Change Support (individual and group work) delivered by trained volunteers using techniques of risk profiling, national guidelines on healthy behaviours, goal setting, action planning, problem solving, and motivational interviewing. Interventions are repeated up to 11 times over 24 months starting weekly and then less frequently.
2. Risk profiling and national guidelines on healthy behaviours.
What are the possible benefits and risks of participating?
Benefits are expected to include greater awareness of behavioural risks and remedies for a healthy heart; better informed decision making within participating families around diet, exercise and smoking; and intensive and academically informed support for participants in the intervention group through a series of intervention workshops sustained over 2 years. Risks include potential emotional distress and anxiety on being made aware of a high risk category score.
Where is the study run from?
1. Nottingham Trent University (UK)
2. Brighton and Sussex Medical School (UK)
When is the study starting and how long is it expected to run for?
March 2019 to March 2021
Who is funding the study?
Who is the main contact?
Prof. Harm Van Marwijk
Prof Harm Van Marwijk
Bsms Teaching Building
University Of Sussex
Scaling up Packages of Interventions for the prevention of Cardiovascular disease in selected European and sub-Saharan countries (an implementation research project)
Engaging with target populations outside of formal healthcare facilities will be more effective in increasing knowledge of CVD risk factors, scaling up CVD risk-profiling, and supporting personal and community behaviour change than Primary Care situated interventions.
Approved 15/03/2019, Research Office, Nottingham Trent University (Arkwright B113, 50 Shakespeare Street, Nottingham, NG1 4FQ; Tel: +44 (0)115 848 8117; Email: email@example.com), ref: 2018/286
Mixed methods incorporating stepped wedge, cluster-randomised, controlled intervention trial with qualitative investigation of barriers and facilitators to individual and organisational change
Primary study design
Secondary study design
Cluster randomised trial
Patient information sheet
Participants are randomised according to postcode and partner community organisations from which participants have been recruited:
1. In-person, community-based, Behaviour Change Support (individual and group work) delivered by trained volunteers using techniques of Risk Profiling, National Guidelines on Healthy Behaviours, Goal Setting, Action Planning, Problem Solving, and Motivational Interviewing. Interventions will be repeated up to 11 times over 24 months starting weekly and then less frequently.
2. Control group provided only with Risk Profiling and National Guidelines on Healthy Behaviours.
Primary outcome measure
1. Predicted cardiovascular risk profile score measured using survey incorporating the non-clinical INTERHEART risk profiling instrument at baseline, 6, 12, 18 and 24 months
2. Perception of CVD risk score measured using survey (ABCD questionnaire) incorporated into baseline survey at baseline, 6, 12, 18 and 24 months
3. Adherence to Dietary Approaches to Stop Hypertension (DASH) dietary advice measured through administration of adapted ‘DASH-Q’ survey instrument with Intervention Group 9 times during 18-24 month period
4. Adherence to national (UK) guidelines on recommended levels of Physical Activity measured through administration of International Physical Activity Questionnaire (IPAQ) with Intervention Group 9 times during 18-24 month period
Secondary outcome measures
1. Qualitative data on barriers and facilitators to healthy behaviour change collected through individual interviews with Intervention Group 9 times during 18-24 month period
2. Qualitative data on impact of social determinants on behaviour change intentions gathered through focus groups and individual case studies with selected Intervention Group participants
Overall trial start date
Overall trial end date
Reason abandoned (if study stopped)
Participant inclusion criteria
All eligible adults (over 18 years old)
Target number of participants
Participant exclusion criteria
1. Under 18 (non-adult)
3. Previously diagnosed with heart condition
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Nottingham Trent University
50 Shakespeare Street
Trial participating centre
Brighton and Sussex Medical School
Bsms Teaching Building University Of Sussex
European Union Framework Programme for Research and Innovation, EU Framework Programme for Research and Innovation, Horizon 2020 - Research and Innovation Framework Programme
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
1. A joint protocol for publication by Nottingham Trent University and Brighton and Sussex Medical School is being drafted. A copy can be provided as soon as this has been approved by partners.
2. Implementation Science paper
3. Public Health & Community Engagement paper
IPD sharing statement
All survey data (baseline survey and intervention survey) are uploaded to the secure research data server at the University of Antwerp using the ‘RedCap’ application. RedCap has extensive security measures (see https://projectredcap.org/about/faq/). If you require assistance or have any questions about REDCap, please contactREDCap Administrator (firstname.lastname@example.org/+3232658862). Participant data will only be available to third parties in aggregate and anonymised form as and when results are published in due course.
Intention to publish date
Participant level data
Stored in repository
Basic results (scientific)