WELLBASED: Improving health, wellbeing and equality by evidenced-based urban policies for tackling energy poverty
| ISRCTN | ISRCTN14905838 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14905838 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 945097 |
| Sponsor | European Commission |
| Funder | European Union’s Horizon 2020 research and innovation programme under grant agreement No 945097. |
- Submission date
- 15/02/2022
- Registration date
- 21/02/2022
- Last edited
- 25/04/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and aim
Nearly 11% of the European population lives in energy poverty. They struggle to afford their basic energy needs. They often live in poorly maintained building stocks and cannot adequately keep their home warm in winter and cool in summer. Energy poverty is a multidimensional problem caused by rising energy prices, low incomes, and poor energy efficiency of housing. People living in energy poverty maintain poorer health and wellbeing than non-energy poor citizens. In the WELLBASED project, six pilot sites (Valencia (Spain), Heerlen (Netherlands), Leeds (UK), Edirne (Turkey), Obuda (Hungary), and Jelgava (Latvia)) will implement and evaluate the WELLBASED urban program. The program is based on the socio-ecological model and adopted to each pilot site, the aim is to support people living in energy poverty and improve health and well-being. The study aims to recruit 1750 participants across the different pilot cities. The study’s findings should help to propose EU-wide solutions to policy-makers and city practitioners with regard to energy poverty and its impact on health.
Who can participate?
Vulnerable adults aged 18 or older who live in energy poverty conditions at one of the pilot sites.
What does the study involve?
Participants are invited to participate in the study at a communal center, a public space or when visited at home. Participants are allocated to one of two groups. The intervention group participates in the WELLBASED Urban Program. The other group is the control group. The WELLBASED Urban Program is a comprehensive urban programme based on the four layers of the social-ecological model. It includes actions related to the individual citizen (e.g. energy-audits, energy-behavior), the social and community networks (e.g. training of professionals), the living and working conditions (e.g. building improvements) and the socio-economic, cultural and environmental dimension (e.g. policy recommendations) to improve citizens’ health and well-being. Actions are implemented for a period of 12 months. At baseline, 6 months, 12 months and 18 months participants in both groups complete self-report questionnaires assessing socio-demographic characteristics, energy poverty and health and well-being outcomes. In the intervention group, peak flow, blood pressure, SpO2, and heart rate are monitored monthly, and sleep quality every three months. Sensors installed inside homes of the participants measure CO2, humidity, and temperature. In addition, in the intervention group twenty participants of each site are asked to participate in two interviews, at the beginning and towards the end of the study. During the interviews, people’s experiences of challenges associated with energy poverty and health and with the WELLBASED program are discussed.
What are the possible benefits and risks of participating?
Participants in the intervention group will receive the benefits of the WELLBASED urban program and contribute to better health and wellbeing for people living in energy poverty. As this is a non-invasive study, no significant risks for participants are foreseen.
Where is the study run from?
Erasmus Univesity Medical Center (the Netherlands).
The WELLBASED project coordinator is Las Naves (Spain).
When is the study starting and how long is it expected to run for?
November 2021 to September 2024
Who is funding the study?
European Union’s Horizon 2020 research and innovation programme under grant agreement No 945097.
Who is the main contact?
Dr. Amy van Grieken, a.vangrieken@erasmusmc.nl
Merel Stevens (researcher), m.stevens@erasmusmc.nl
Noemi Garcia (project coördinator), noemi.garcia@lasnaves.com
Contact information
Scientific
Molenwaterplein 40
Rotterdam
3015 GD
Netherlands
 ORCID ID |
0000-0001-6767-9159 |
|---|---|
| Phone | +31 107043498 |
| a.vangrieken@erasmusmc.nl |
Public
Wytemaweg 80
Rotterdam
3000 CA
Netherlands
| m.stevens@erasmusmc.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multisite pre-post controlled study design |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| Scientific title | A comprehensive urban programme to reduce energy poverty and its effects on health and wellbeing of citizens in six European cities unable to afford their basic energy needs |
| Study acronym | WELLBASED |
| Study objectives | The hypothesis of this study is that vulnerable people living in energy poverty who participate in the WELLBASED programme have more favourable results with regard to indicators of health, wellbeing and quality of life in comparison to the participants in the control condition. |
| Ethics approval(s) | 1. Approved 03/11/2021, Ethics committee for research with medicines of the university clinical hospital of Valencia (Avenida Blasco Ibáñez 17, 46010 Valencia, Spain; +34 96 197 39 76; ceic_hcv@gva.es), ref: 2021/316 2. Approved 04/07/2022, Ethics committee University of Leeds - AREA (Faculties of Business, Environment and Social Sciences, Leeds, UK; no telephone provided; ResearchEthics@leeds.ac.uk), ref: AREA 21-070 3. Approved 19/04/2022, Central Medical Ethics committee (Brīvības iela 72 k-1, LV 1011, Rīga, Latvia; +371 67876000; vm@vm.gov.lv), ref: Nr. 01-29.1.2/2267 4. Approved 21/03/2022, Medical Ethical Committee of Erasmus Medical Center (P.O. Box 2040, 3000 CA Rotterdam, Room Ae-337, the Netherlands), ref: MEC-2022-0150 5. Approved 06/04/2022, Trakya University Edirne Clinical Studies Ethical Committee (Turkey; no telephone provided; no email address provided), ref: 07/01 6. Approved 11/07/2022, Committee Name Egészségügyi Tudományos Tanács Tudományos és Kutatásetikai Bizottsága, ETT TUKEB (Scientific and Research Ethics Committee of the Medical Research Council, Ministry of Health, Medical Research Council Arany János u. 6-8 Budapest, H-1051 Hungary; +36 13119651; szolanka.jozsefne@eum.hu), ref. 332/2022 |
| Health condition(s) or problem(s) studied | Energy poverty |
| Intervention | In the intervention group the WELLBASED Urban Programme is implemented. In the control group no intervention activities are implemented. The WELLBASED Urban Program is a comprehensive urban programme based on the four layers of the social ecological model. It includes actions related to the individual citizen (e.g. energy-audits, energy-behavior), the social and community networks (e.g. training of professionals), the living and working conditions (e.g. building improvements) and the socio-economic, cultural and environmental dimension (e.g. policy recommendations) to improve citizens’ health and well-being. Actions are implemented for a period of 12 months. Data using self-report questionnaires will be collected at baseline (start of the implementation of the intervention in the intervention group), 6 months, 12 months and 18 months in both intervention and control group. Additional data is collected in the intervention group using mixed methods research. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
Current primary outcome measure as of 28/03/2023: |
| Key secondary outcome measure(s) |
Current secondary outcome measures as of 28/03/2023: |
| Completion date | 01/09/2024 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 1750 |
| Total final enrolment | 1340 |
| Key inclusion criteria | 1. Aged ≥18 years old 2. In a vulnerable situation (unemployed, low income, single parents, parents with dependent children, seniors (65+) with dependency conditions, seniors (65+) living along, people with disabilities attended by social services, belonging to a minority, migrant situation, etc.), 3. Living in energy poverty conditions 4. Belonging to the recruitment sites identified by the pilot partners for the study |
| Key exclusion criteria | 1. Cannot adequately participate in the intervention actions proposed in the pilot (e.g. intellectual disabilities, severe language limitations) or 2. Illegally connected to the electricity grid. |
| Date of first enrolment | 01/09/2022 |
| Date of final enrolment | 30/06/2023 |
Locations
Countries of recruitment
- United Kingdom
- England
- Hungary
- Latvia
- Netherlands
- Spain
- Türkiye
Study participating centres
Heerlen
6400 AA
Netherlands
Edirne
22000
Türkiye
València
46024
Spain
Valencia
46010
Spain
Calverley Street
Leeds
LS1 1UR
United Kingdom
Budapest
-
Hungary
Jelgava
LV-3001
Latvia
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? |
|---|---|---|---|---|---|
| Protocol article | 19/08/2022 | 22/08/2022 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
25/04/2024: The following changes were made to the study record:
1. Total final enrolment added.
2. The overall study end date was changed from 01/03/2024 to 01/09/2024.
3. The intention to publish date was changed from 01/03/2025 to 01/08/2025.
22/05/2023: The recruitment end date has been changed from 31/05/2023 to 30/06/2023.
28/03/2023: The following changes have been made and the plain English summary updated accordingly:
1. Ethics approval added.
2. The primary outcome measure has been changed.
3. The secondary outcome measures have been changed.
4. The recruitment end date has been changed from 01/03/2023 to 31/05/2023.
5. Project coordinator contact was replaced in the plain English summary.
22/08/2022: Publication reference added.
04/04/2022: The sponsor email address was updated.
18/02/2022: Trial's existence confirmed by European commission
