Condition category
Circulatory System
Date applied
29/05/2019
Date assigned
09/08/2019
Last edited
09/08/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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?
Horizon 2020

Who is the main contact?
Prof. Harm Van Marwijk
H.VanMarwijk@bsms.ac.uk

Trial website

https://www.uantwerpen.be/en/projects/spices/

Contact information

Type

Scientific

Primary contact

Prof Harm Van Marwijk

ORCID ID

Contact details

Bsms Teaching Building
University Of Sussex
Brighton
BN19PX
United Kingdom
+44 (0)1273644774
H.VanMarwijk@bsms.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

SPICESUK1

Study information

Scientific title

Scaling up Packages of Interventions for the prevention of Cardiovascular disease in selected European and sub-Saharan countries (an implementation research project)

Acronym

SPICES

Study hypothesis

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.

Ethics approval

Approved 15/03/2019, Research Office, Nottingham Trent University (Arkwright B113, 50 Shakespeare Street, Nottingham, NG1 4FQ; Tel: +44 (0)115 848 8117; Email: anton.muszansky@ntu.ac.uk), ref: 2018/286

Study design

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

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Community

Trial type

Prevention

Patient information sheet

http://j.mp/2XcRvEB

Condition

Cardiovascular disease

Intervention

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.

Intervention type

Behavioural

Phase

Drug names

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

01/03/2019

Overall trial end date

30/03/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

All eligible adults (over 18 years old)

Participant type

All

Age group

Adult

Gender

Both

Target number of participants

800

Participant exclusion criteria

1. Under 18 (non-adult)
2. Pregnant
3. Previously diagnosed with heart condition

Recruitment start date

01/04/2019

Recruitment end date

31/12/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Nottingham Trent University
50 Shakespeare Street
Nottingham
NG1 4FQ
United Kingdom

Trial participating centre

Brighton and Sussex Medical School
Bsms Teaching Building University Of Sussex
Brighton
BN1 9PX
United Kingdom

Sponsor information

Organisation

EU Horizon 2020

Sponsor details

EU HQ
Rue de la Loi 175
Brussels
1000
Belgium
+32 (0)2 281 59 20
erc-uk@bbsrc.ac.uk

Sponsor type

Other

Website

https://ec.europa.eu/programmes/horizon2020/en

Funders

Funder type

Government

Funder name

Horizon 2020

Alternative name(s)

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

government organisation

Funding Body Subtype

National government

Location

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 (swabra.nakato@uantwerpen.be/+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

01/04/2021

Participant level data

Stored in repository

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

04/06/2019: Trial's existence confirmed by research ethics committee.