Evaluation of community level interventions to address social and structural determinants of health

ISRCTN	ISRCTN68175121
DOI	https://doi.org/10.1186/ISRCTN68175121
Secondary identifying numbers	WT083679AIA

Submission date: 08/04/2008
Registration date: 10/04/2008
Last edited: 13/04/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
The aim of this study is to measure the effect and cost effectiveness of Well London, a complex 3.5-year intervention to promote healthy physical activity, healthy eating and mental health/wellbeing in 20 of London’s most deprived communities.

Who can participate?
Residents in the participating areas of London

What does the study involve?
The 20 boroughs each select two deprived communities as candidates, and one community is selected at random to receive the Well London intervention, while the other community receives no intervention (the comparison or ‘control’ community). The intervention communities participate in designing, delivering and evaluating interventions to meet their needs. Interventions are drawn from a set of possible projects. The exact mix is decided upon in each area depending on what local people identify as priorities and what facilities and services are already provided. Possible projects include improving public spaces to encourage physical activity, supporting local cultural projects, improving access to healthy food choices in the local area, and raising awareness of mental health. We compare physical activity, healthy eating and mental health/wellbeing between the intervention and control communities by carrying out surveys before the health promotion activities start and again after four years.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
Massey University (New Zealand)

When is the study starting and how long is it expected to run for?
March 2008 to December 2012

Who is funding the study?
1. Big Lottery Fund (UK)
2. The Wellcome Trust (UK) (grant ref: 083679)

Who is the main contact?
Dr Martin Wall

Study website

Contact information

Dr Martin Wall
Scientific

Centre for Social & Health Outcomes Research and Evaluation
Massey University
PO Box 6137
Wellesley St
Auckland
1010
New Zealand

Study information

Study design	Randomised cluster controlled trial
Primary study design	Interventional
Secondary study design	Cluster randomised trial
Study setting(s)	Community
Study type	Quality of life
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	A randomised cluster controlled trial of community level interventions to address social and structural determinants of physical activity, diet and mental wellbeing
Study acronym	WLRCCT
Study objectives	Are community designed interventions at Lower Super Output Area (LSOA) level effective in securing improvements in levels of healthy eating, healthy physical activity and mental health?
Ethics approval(s)	University of East London Research Ethics Committee, 15/10/2007, ref: ETH/07/96/0 UEL
Health condition(s) or problem(s) studied	Healthy behaviours related to diet, exercise and positive mental wellbeing
Intervention	Target number of participants: In each wave of the adult survey (at the start and end of the project) there will be 4000 participants (100 in each of the 20 intervention and 20 control areas). In the adolescent survey there will be 60 children in each of the 40 areas in each wave. Interventions: Well London (WL) is the Greater London Authority's flagship project on health supported by NHS London and 20 primary care trusts (PCTs) and boroughs. The project commenced in March 2008 in 20 of the most deprived communities in London with £9.42 million funding from Big Lottery "Wellbeing" Fund (BLF) delivering complex interventions over 3.5 years to address poor diet, insufficient physical activity and poor mental wellbeing. Interventions are based on existing best practice, designed and implemented with community participation. Initially two areas (LSOAs) in each of 20 London boroughs were chosen as being in the most deprived 10% of all London LSOAs using the Index of Multiple Deprivation. One of the two was then randomly chosen for interventions and the remaining area was left as control with no spending. The two areas do not adjoin each other to avoid any 'spill-over' of the intervention. The control cluster is therefore 'matched' to the intervention area in that it is in the same borough and that it is similarly deprived. Health indicators in matched clusters will be compared at start and end of WL. Quantitative surveys will take place in both intervention and control clusters to evaluate interventions and the approach taken to participatory design and provide evidence on appropriateness of extending this model to other deprived areas. Interventions are drawn from a set of possible projects. The exact mix will be decided upon in each area depending on what local people identify as priorities and what facilities and services are already provided. The set of possible projects include: 1. Healthy Spaces a project to improve the quality of public space in the area to encourage physical activity 2. Active Living, residents will be provided with maps informing them of local resources for making healthy choices e.g. farmer's markets, open space 3. Be Creative Be Well, supporting and facilitating local cultural projects to foster social networks and social capital 4. Buywell, a set of interventions to improve access to healthy food choices in the local area 5. Changing Minds, people with experience of mental ill-health will be recruited to raise awareness of mental health and promote understanding of its impact 6. DIY Happiness, using humour and creativity and based on positive psychology theories activities will aim to reduce impact of stress and increase psychological resources 7. Eatwell aims to improve diet and nutrition by raising awareness of importance of diet to physical and mental health and making healthy eating easier and more attractive Full details of the projects are on the Well London website at http://www.londonshealth.gov.uk/well_london.htm. The interventions are due to start in all intervention areas in 2008 and continue throughout the four year period with roughly equal spend on project activity in each year. The follow-up is a repeat of the adult and adolescent surveys at the end of the interventions in 2012. The surveys will be of a randomly selected sample of addresses within the intervention and control areas. We are not attempting in 2012 to re-contact those who took part in the survey in 2008.
Intervention type	Behavioural
Primary outcome measure	Adult survey: Changes in levels of mental health (MH), physical activity, healthy eating between baseline and follow up. MH is measured using the 12-item General Health Questionnaire (GHQ-12) and positive psychology scale. Also questions on social networks and social capital are drawn from the UK Government Harmonised question set on social capital. Physical activity is measured using the International Physical Activity Questionnaire. Diet is measured using questions from the Health Survey for England on items consumed in the previous 24-hour period. Other questions on healthy quality of life and demographic and social characteristics are also collected. Child survey: Adolescent questionnaire measures emotional behavioural status using 2001 Child Behaviour checklist, self -esteem will be measured using Rosenberg self-esteem scale, the Child Health and Illness Profile - adolescent edition will be used to measure overall health status and the Child's Attitudes to Physical Activity Scale will assess attitudes to PA. Again the measures will be taken at baseline and follow-up in control and intervention areas.
Secondary outcome measures	Questionnaires will not only measure levels of healthy behaviour around diet, physical activities and mental well being but perceived barriers or constraints to identify areas where resources can be targeted.
Overall study start date	01/03/2008
Completion date	01/12/2012

Eligibility

Participant type(s)	Other
Age group	Mixed
Sex	Both
Target number of participants	4000
Key inclusion criteria	1. Adult survey, resident in a sampled address within intervention or control areas over age of 16, either sex 2. Child survey, resident of the area and at school participating in survey, between 13 and 16 years old, either sex
Key exclusion criteria	1. No participants under 13 2. No one who lives outside of the area 3. No residents whose addresses have not been randomly chosen
Date of first enrolment	01/03/2008
Date of final enrolment	01/12/2012

Locations

Countries of recruitment

New Zealand
United Kingdom

Study participating centre

Massey University

Auckland
1010
New Zealand

Sponsor information

University of East London (UK)
University/education

c/o Tim Brooks
The Graduate School
Docklands Campus
4 - 6 University Way
London
E16 2RD
England
United Kingdom

Phone	+44 (0)20 8223 2421
Email	t.brooks@uel.ac.uk
Website	http://www.uel.ac.uk/
"ROR"	https://ror.org/057jrqr44

Funders

Funder type

Charity

Big Lottery Fund - funding interventions
Private sector organisation / Other non-profit organizations

Alternative name(s): BIG
Location: United Kingdom

Wellcome Trust (grant ref: 083679) - funding evaluations and full randomised cluster trial
Private sector organisation / International organizations

Location: United Kingdom

University of East London
Private sector organisation / Universities (academic only)

Alternative name(s): UEL
Location: United Kingdom

University of Westminster (UK)
Private sector organisation / Universities (academic only)

Location: United Kingdom

London School of Hygiene and Tropical Medicine (LSHTM) (UK)

No information available

Loughborough University (UK)
Private sector organisation / Universities (academic only)

Alternative name(s): Lboro
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Protocol article	protocol	28/06/2009	Yes	No
Results article	results	06/07/2012	Yes	No
Results article	results	02/12/2013	Yes	No

Editorial Notes

13/04/2016: Plain English summary added.