Fresh Street Food and Health pilot study: A trial to evaluate the impact of a subsidy for fresh fruit and vegetables on a range of interconnected challenges for UK public health nutrition in areas of high deprivation and low fruit and vegetable consumption
| ISRCTN | ISRCTN14849428 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14849428 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 287024 |
| Protocol serial number | IRAS 287024 |
| Sponsor | Queen Mary University of London |
| Funder | National Institute for Health Research |
- Submission date
- 25/09/2020
- Registration date
- 06/10/2021
- Last edited
- 28/02/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Many communities in the UK are unable to afford, or access, all the food needed to make up a healthy diet. Despite national healthy eating information campaigns (e.g. 5-A-Day), and support for families on low incomes (Healthy Start), only one in five people eat the recommended 5 daily portions of fresh fruit and vegetables.
Researchers want to test a new approach (Fresh Street) to help improve diet and health. The Fresh Street scheme provides vouchers for fresh fruit and vegetables to households. Vouchers worth £5 are delivered to households every week, along with vegetable-based recipes, brief nutritional information, and healthy eating advice. Unique features of the scheme are that vouchers are offered to households (not individuals), all households are eligible (regardless of size or income), vouchers can only be used with local independent fresh fruit and vegetable sellers (not supermarkets), and households are encouraged to share vouchers if they wish.
This approach was developed with residents in Barnsley, an area of high deprivation in the north of England. The scheme was then tested in four streets (95 households) for a year to see if it was deliverable and acceptable. The scheme was popular with most (84%) of all eligible households joining the scheme. Most householders reported that the scheme helped them buy and eat more fruit and vegetables and most (89%) of all of the vouchers being used. Many described how it prompted them to think about eating healthily. People frequently talked about their health, and some reported that they had lost weight since joining the scheme. Local fruit and veg shops and stalls reported new customers and that existing customers were buying more.
The aim of this study is to test the effectiveness of this ‘place-based’ voucher approach on improving local food choices, diet, health and the wider environment.
Who can participate?
Areas of deprivation where diets are low in fresh fruit and veg
What does the study involve?
In the first year of the study the researchers will work closely with local residents, fruit and veg vendors, councillors, authorities and organisations to ensure that the scheme fits well with local priorities and resources (e.g. cook and grow schemes).
Before they start the scheme the researchers will test the methods they want to use to assess the scheme - short questionnaires and conversations (both online and door-step) in order to make sure that the methods they use are acceptable to householders. Throughout the study the researchers will carefully listen to householder’s stories and experiences of the scheme and ask them to help make sense of these experiences. They will also talk to local fruit and veg vendors and other local key people involved in health and food. They will also obtain anonymised level health data on GP and hospital visits for each area to see if the scheme has an effect on NHS healthcare use. They will test the scheme for two years in 34 streets (selected at random) and compare what happens in 34 similar streets without the scheme.
What are the possible benefits and risks of participating?
This study will help the researchers to understand the effect of the scheme on the diet and health of households (including families with children) and communities (streets). Throughout the study and after, they will share the knowledge gained with local people and the wider research community.
Where is the study run from?
The study is being run from Queen Mary University of London with the support of Grounded Research - the Community Research Hub in Doncaster.
When is the study starting and how long is it expected to run for?
October 2020 to October 2021
Who is funding the study
National Institute for Health Research (NIHR) (UK)
Who is the main contact
Dr Clare Relton
c.relton@qmul.ac.uk
Contact information
Scientific
58 Turner Street
London
E1 2AB
United Kingdom
 ORCID ID |
0000-0001-8530-5011 |
|---|---|
| Phone | +44 (0)207 882 6696 |
| c.relton@qmul.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Cluster randomized controlled trial with a parallel process evaluation |
| Secondary study design | Cluster randomised trial |
| Participant information sheet | 38807_PIS_Control Process Evaluation Interview_v2.0_23Aug2021.pdf |
| Scientific title | Fresh Street: a cluster randomised controlled trial of the benefits of a place-based, household-level subsidy for fresh fruit and vegetables on diet, health and the wider environment |
| Study acronym | Fresh Street |
| Study objectives | Different components of the Fresh Street intervention will provide the conditions required to increase fruit and vegetable consumption and improve diet quality. |
| Ethics approval(s) | Approved 03/09/2021, Queen Mary University of London Ethics of Research Committee (Research Ethics Facilitators, Room W117, Queen’s Building, Queen Mary University of London, Mile End Road, London E1 4NS; +44 (0)20 7882 7915 / 6947; research-ethics@qmul.ac.uk), ref: QMERC20.004 |
| Health condition(s) or problem(s) studied | Diet quality and health |
| Intervention | Eligible streets will be randomised to either the intervention or control arm. The allocation ratio will be 1:1. Stratified (by site) permuted blocked randomisation with block sizes of m=6 and 4 will be used to ensure a similar number of clusters within each arm. The randomisation will be carried out remotely by the PCTU. ‘Fresh Street’ is an innovative multi-component intervention, which combines supplier-specific vouchers for fresh fruit and vegetables (FV) with a range of diet and health information offered to all households in a geographical area regardless of type, size, or income. Households in the intervention arm will receive £5 worth of Fresh Street branded paper vouchers redeemable with local independent FV retailers (not supermarkets), a healthy and seasonal vegetable-based recipe, and nutrition and health/diet related information on a weekly basis over 6 months. In this intervention: 1. Vouchers are offered to households (not individuals) 2. All households are eligible, regardless of size, type, or income 3. Vouchers are redeemable only with local independent fruit and vegetable (FV) retailers (not supermarkets) 4. Households are encouraged to share vouchers Households in the control arm will continue to purchase and consume FV as usual over the 6 month period. In the first year of the study, the researchers will work closely with local residents, fruit and veg vendors, councillors, authorities and organisations to ensure that the scheme fits well with local priorities and resources (e.g. cook and grow schemes). Before they start the scheme the researchers will test the methods they want to use to assess the scheme - short questionnaires and conversations (both online and door-step) in order to make sure that the methods they use are acceptable to householders. Throughout the study, the researchers will carefully listen to householder’s stories and experiences of the scheme and ask them to help make sense of these experiences. They will also talk to local fruit and veg vendors and other local key people involved in health and food. They will also obtain anonymised level health data on GP and hospital visits for each area to see if the scheme has an effect on NHS healthcare use. They will test the scheme for two years in 34 streets (selected at random) and compare what happens in 34 similar streets without the scheme. Participating households will be followed up after 4-6 months for the pilot study, and if progression criteria are met and the study progresses to the main trial, participating households will be followed up again after 1 and 2 years |
| Intervention type | Other |
| Primary outcome measure(s) |
Portions of fruit and vegetables (FV) eaten in the previous day measured using Active Lives Survey questions at baseline and 4-6 months for the pilot study, and at 1 year and 2 years if progression criteria are met and the study progresses to the main trial |
| Key secondary outcome measure(s) |
The following will be measured at baseline and 4-6 months for the pilot study, and at further time points if progression criteria are met and the study progresses to the main trial: |
| Completion date | 31/12/2023 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | All |
| Sex | All |
| Target sample size at registration | 68 |
| Total final enrolment | 18 |
| Key inclusion criteria | Areas with a high deprivation index (IMD quintiles 4 or 5) |
| Key exclusion criteria | Areas with a low deprivation index (IMD quintiles 1 - 3) |
| Date of first enrolment | 15/09/2021 |
| Date of final enrolment | 01/10/2021 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centres
Almond Tree Court
Woodfield Park
Doncaster
DN4 8QP
United Kingdom
Beverley
East Riding of Yorkshire
HU17 9BA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 03/01/2025 | 27/02/2025 | Yes | No | |
| Participant information sheet | Process evaluation interview with control arm version 2.0 |
23/08/2021 | 21/09/2021 | No | Yes |
| Participant information sheet | Process evaluation interview with intervention arm version 2.0 |
23/08/2021 | 21/09/2021 | No | Yes |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Protocol file | version 4.0 | 12/08/2021 | 21/09/2021 | No | No |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
- 38807_PIS_Control Process Evaluation Interview_v2.0_23Aug2021.pdf
- Process evaluation interview with control arm
- 38807_PIS_Intervention Process Evaluation Interview_v2.0_23Aug2021.pdf
- Process evaluation interview with intervention arm
- 38807_Protocol_v4.0_12Aug21.pdf
- Protocol file
Editorial Notes
28/02/2025: Total final enrolment added.
27/02/2025: Publication reference added.
21/09/2021: Trial’s existence confirmed by Queen Mary University of London.
