Preventing long-term conditions in people with high blood pressure through lifestyle changes
| ISRCTN | ISRCTN15193947 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15193947 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil Known |
| Integrated Research Application System (IRAS) | 350015 |
| Protocol serial number | Nil known |
| Sponsor | Chelsea and Westminster Hospital NHS Foundation Trust |
| Funder | NHS England |
- Submission date
- 09/12/2025
- Registration date
- 19/12/2025
- Last edited
- 15/12/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Multiple long-term conditions are associated with poorer health outcomes, higher death rates and greater use of health care services. While this has led to the development of guidelines for their treatment, their prevention has received less attention.
In 2016 the NHS in England established the Healthier You NHS Diabetes Prevention Programme (NHS DPP), a 9-month lifestyle intervention supporting behaviour change to achieve weight loss, increased physical activity, and better-quality nutrition for those at high risk of developing type 2 diabetes. Research has shown that completion of the NHS DPP may reduce incidence of other long-term conditions, resulting in this study for adults with hypertension (high blood pressure) to formally assess the effectiveness of this approach in reducing the risk of developing other long-term conditions over subsequent years.
Who can participate?
Individuals aged 18-79 years, or 80 years and over with written approval from their GP, with a diagnosis of hypertension who are registered with one of the General Practices that are taking part in the study.
What does the study involve?
Individuals will receive a text or letter from their General Practice which will invite them to attend the Healthier You Hypertension Pilot to prevent long-term conditions. The pilot involves a 9-month lifestyle behaviour change programme, with a choice of attending the intervention face-to-face or online. Face-to-face involves 13-group based sessions over 9 months, while online delivery is at the individual level over a similar time period. Individuals who attend the programme will be supported in setting appropriate goals to help loose weight if living with overweight or obesity, or the maintenance of a healthy weight, as a result of improved diet, increased levels of physical activity and improved quality of nutrition.
What are the possible benefits and risks of participating?
Those that attend the programme will have access to a lifestyle behaviour change programme, designed to reduce weight in those that are living with overweight or obesity by better quality nutrition and physical activity. The longer term benefits are expected to include a reduced risk of developing a number of long-term conditions. There are no risks associated with programme participation, and the lifestyle programme is consistent with current national guidelines for people living with hypertension.
Where is the study run from?
The study is being run by NHS England and takes places across 216 General Practices across England (UK)
When is the study starting and how long is it expected to run for?
This study starts in January 2026 and will finish in December 2028
Who is funding the study?
NHS England (UK)
Who is the main contact?
Prof. Jonathan Valabhji, j.valabhji@imperial.ac.uk
Contact information
Public, Scientific, Principal investigator
Department of Metabolism, Digestion and Reproduction
Faculty of Medicine
Chelsea and Westminster Hospital Campus
Imperial College London
London
SW10 9NH
United Kingdom
 ORCID ID |
0000-0001-9756-4061 |
|---|---|
| Phone | +44 (0)7563198129 |
| j.valabhji@imperial.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Stepped-wedge cluster randomized controlled trial |
| Secondary study design | Stepped-wedged cluster randomized controlled trial |
| Scientific title | Healthier You Hypertension pilot to prevent long-term conditions |
| Study acronym | Healthier You-BP |
| Study objectives | Multiple long-term conditions are associated with poorer health outcomes, higher mortality and greater use of health care services. While this has led to the development of guidelines for their treatment, their prevention has received less attention. In 2016 the NHS in England established the Healthier You NHS Diabetes Prevention Programme (NHS DPP), a 9-month lifestyle intervention supporting weight loss, increased physical activity, and better-quality nutrition for those at high risk of developing type 2 diabetes. Research has shown that completion of the NHS DPP may reduce incidence of other long-term conditions, resulting in this study to more formally assess whether or not this is the case. The primary objective of this study is to evaluate the effectiveness of access to a lifestyle intervention (a tailored version of the NHS DPP) in people living with hypertension in reducing incidence of long-term conditions when compared to ‘usual’ care. |
| Ethics approval(s) |
Approved 21/08/2025, North West - Greater Manchester South Research Ethics Committee (3 Piccadilly Place, London Road, Manchester, M1 3BN, United Kingdom; +44 (0)207 104 8014; gmsouth.rec@hra.nhs.uk), ref: 25/NW/0209 |
| Health condition(s) or problem(s) studied | Hypertension and subsequent development of other long-term conditions |
| Intervention | A stepped-wedge cluster randomised controlled trial in 216 GP practices (clusters) within eight Integrated Care Systems (ICSs) in England over 4 years. In year one, all GP practices will offer usual care. In year two, a third of GP practices will be randomly allocated to start to offer interventions while the remaining two-thirds will continue to offer usual care. In year three, a further third of GP practices will be randomly allocated to start to offer the interventions while the remaining third will continue to offer usual care. In year four, the final third of GP practices will start offering the interventions, so that interventions will then be offered by all 216 GP practices. All individuals living with hypertension within the intervention clusters will be eligible to be referred to the Healthier You Hypertension Pilot to Prevent Long-Term Conditions, a 9-month lifestyle intervention supporting weight loss, increased physical activity and better quality nutrition with a choice of face-to-face or digital delivery. Face-to-face delivery consists of 13 group-based intervention sessions over the 9-month period, while digital delivery is delivered at the individual level and consists of 9 engagement periods (including a digital registration), each lasting 30 days. All individuals within the control clusters will receive usual care. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
The incidence of associated long-term conditions in individuals with hypertension within participating GP practices measured through the Bridges to Health Segmentation dataset, an existing dataset held within NHS England, at the end of each year in the study (years 1, 2, 3 and 4). Associated conditions have been defined as atrial fibrillation, cerebrovascular disease, chronic kidney disease, chronic liver disease, chronic pain, coronary heart disease, depression, diabetes, heart failure, osteoarthritis, peripheral vascular disease and physical disability. |
| Key secondary outcome measure(s) |
1. The incidence of long-term conditions (associated and not associated conditions) in individuals with hypertension within participating GP practices measured through the Bridges to Health Segmentation dataset at the end of years 1, 2, 3 and 4. |
| Completion date | 31/12/2028 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 120 Years |
| Sex | All |
| Target sample size at registration | 130000 |
| Key inclusion criteria | 1. Diagnosed with hypertension and aged 18 years or over. 2. Individuals who are aged 80 years and older are eligible to access the programme if their clinician referrer provides written confirmation that the referrer perceives the benefits of the study outweigh any potential risks of participating in a weight loss programme for that individual. |
| Key exclusion criteria | 1. Individuals with diabetes or non-diabetic hyperglycaemia 2. Individuals with an eating disorder 3. Individuals with severe/moderate frailty 4. Individuals who have undergone bariatric surgery in the last 2 years 5. Individuals aged under 18 years 6. Pregnant women |
| Date of first enrolment | 01/01/2026 |
| Date of final enrolment | 31/03/2028 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centres
London
NW1 5JD
England
Manchester
M1 3BN
England
Worcester
WR3 7NS
England
Norwich
NR1 2DH
England
Luton
LU1 2LJ
England
Leicester
LE3 8TB
England
Sunderland
SR5 3XB
England
London
SE1 2TZ
England
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan |
Editorial Notes
09/12/2025: Study's existence confirmed by the North West - Greater Manchester South Research Ethics Committee.
