Physical ActivityNCT03153098
An Evaluation of the Active Herts Physical Activity Programme
An observational study of Physical Activity, run by University of East Anglia at 1 site in United Kingdom.
Trial summary
There is a high prevalence of inactive adults in the United Kingdom (UK), many of whom suffer from conditions such as diabetes, cardiovascular disease, and poor mental health. These problems often co-exist more frequently in areas of higher socio-economic deprivation. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- What is being tested?
- Active Herts
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 739 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 Jan 2016to 7 Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Participants will live in one of four Hertfordshire districts (Broxbourne, Stevenage, Hertsmere, and Watford), United Kingdom. The four districts contain the highest number of deprived Lower Super Output Areas (LSOA) in Hertfordshire and are in the five highest rates of under 75 mortality rate from CVD (2-3%), adult obesity (8-10%), and diabetes (4-6%). A life expectancy gap of 6-9.6 years exists between the most and least deprived areas across these districts. Less than 50% of this population participate in 30 minutes of physical activity once per week.
Who may be able to join
- inactive adults and do less than 30mins of physical activity per week
- aged 16 or over
- resident of Hertfordshire boroughs, including Broxbourne, Hertsmere, Stevenage or Watford
- Referred patients and clients may also have:
- a long term medical condition such as type 2 diabetes, hypertension, high cholesterol etc.
- a mild to moderate mental health condition such as anxiety, depression or stress
- a history or family history of heart disease
Who cannot join
- participants not able to give informed consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University of East Anglia
Norwich, NR4 7TJ
Andy Jones, Prof, 0044 1603 593127, A.P.Jones@uea.ac.uk
About this study
Official title: Physical Activity Promotion in Areas of Deprivation for Inactive Adults With Cardiovascular Disease (CVD) Risk: An Evaluation of Active Herts
There is a high prevalence of inactive adults in the United Kingdom (UK), many of whom suffer from conditions such as diabetes, cardiovascular disease, and poor mental health. These problems often co-exist more frequently in areas of higher socio-economic deprivation. There is an ongoing need to test the effectiveness, acceptability, and sustainability of community physical activity interventions. The Active Herts programme is a community physical activity programme aimed at inactive adults aged 16 and over who have one or more risk factors for cardiovascular disease (CVD) and/or a mild to moderate mental health condition. The programme uses the latest evidence-based behaviour change techniques to target physical activity, wellbeing, and key drivers of behaviour from the COM-B ('Capability', 'Opportunity', 'Motivation' and 'Behaviour') model of behaviour change.
This evaluation will follow a mixed-methods longitudinal (baseline, and 3, 6 and 12 month follow-ups) pragmatic observational design. Two types of programme are being delivered, each in a different area. In one, group participants will receive a behaviour change technique booklet, consultations (baseline, and optional at 3, 6, and 12 months), a booster phone call (week 2), motivational text messages (weeks 3, 6, and 12), and signposting to 12 weeks of exercise classes. In the other 'enhanced delivery' group, participants will receive the same but the 12 weeks of exercise will be free and tailored to their needs, and there will be optional exercise 'buddies' available. An outcome evaluation will assess changes in physical activity as the primary outcome, and sporting participation, sitting, wellbeing, psychological capability, and reflective motivation as secondary outcomes. A process evaluation will use both one-to-one interviews and focus groups to explore the views of stakeholders, delivery staff, and participants over three phases (set-up, deviations in the delivery of the intervention, and looking back over the intervention). Economic evaluation will examine the costs of the Active Herts programme against the benefits gained in terms of reduced risk of morbidity from a range of chronic conditions.
This study will measure key drivers of physical activity using up to date behaviour change theory, allowing evaluation of not only whether physical activity has increased but also why. The research will inform the future development of a scalable intervention that can be more robustly tested in a randomised controlled trial.
- Conditions
- Physical Activity
- Being tested
- Active Herts
- Keywords
- physical activity, intervention, behaviour change, inactive adults, behaviour change techniques, well-being
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active HertsBehavioural
Also called Healthy and Active In Herts
Active Herts is a community physical activity intervention aimed at inactive adults aged 16 and over who have one or more risk factors for CVD and/or a mild to moderate mental health condition. The programme uses the latest evidence-based behaviour change techniques to target physical activity, wellbeing, and key drivers of behaviour from the COM-B model of behaviour change.
| Study group | Role | What they receive |
|---|---|---|
| Standard delivery | Participants will receive a behaviour change technique booklet, consultations (baseline, and optional at 3, 6, and 12 months), a booster phone call (week 2), motivational text messages (weeks 3, 6, and 12), and signposting to 12 weeks of exercise classes. Receives: Behavioral: Active Herts | |
| Enhanced delivery | Participants will receive the same as intervention but the 12 weeks of exercise will be free and tailored to their needs, and there will be optional exercise 'buddies' available. Receives: Behavioral: Active Herts |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Physical activity from baseline
Assessed using the International Physical Activity Questionnaire (IPAQ)
Measured: 12 months
Secondary outcomes (3)
Change in mental well-being from baseline
Assessed using Warwick Edinburgh well-being scale
Measured: Short term (3 months), longer term (6 and 12 months)
Change in perceptions of health from baseline
EuroQOL five dimensions questionnaire (EQ-5D)
Measured: Short term (3 months), longer term (6 and 12 months)
Readiness to change behaviour
Key determinants of behaviour - measured using COM-B Capability, Opportunity, and Motivation
Measured: Short term (3 months), longer term (6 and 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2017
- Study start7 Jan 2016
- Primary completion7 Jan 2019 (estimated)
- Study completion7 Jan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 739 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of East Anglia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Hertfordshire, Hertfordshire Sports Partnership, Sport England, Broxbourne Borough Council, East and North Hertfordshire Clinical Commisioning Group, Hertfordshire Valley Clinical Commisioning Group, Hertfordshire Public Health
- Responsible party
- Sponsor
- Investigators
- Andy Jones, Prof, Principal investigator, University of East Anglia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03153098
- Sponsor's protocol ID
- ActiveHerts
- Status last verified
- Apr 2017
- First submitted
- 5 May 2017
- Last updated
- 15 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chater AM, Schulz J, Jones A, Burke A, Carr S, Kukucska D, Troop N, Trivedi D, Howlett N. Outcome evaluation of Active Herts: A community-based physical activity programme for inactive adults at risk of cardiovascular disease and/or low mental wellbeing. Front Public Health. 2022 Sep 9;10:903109. doi: 10.3389/fpubh.2022.903109. eCollection 2022.
PubMed 36159253Howlett N, Jones A, Bain L, Chater A. How effective is community physical activity promotion in areas of deprivation for inactive adults with cardiovascular disease risk and/or mental health concerns? Study protocol for a pragmatic observational evaluation of the 'Active Herts' physical activity programme. BMJ Open. 2017 Nov 25;7(11):e017783. doi: 10.1136/bmjopen-2017-017783.
PubMed 29175885
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity Promotion in Areas of Deprivation for Inactive Adults With Cardiovascular Disease (CVD) Risk: An Evaluation of Active Herts
- ClinicalTrials.gov ID
- NCT03153098
- Acronym / sponsor ID
- ActiveHerts
- Conditions
- Physical Activity
- Keywords
- physical activity, intervention, behaviour change, inactive adults, behaviour change techniques, well-being
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 739 participants (estimated)
- Lead sponsor
- University of East AngliaUniversity, hospital or other
- Collaborators
- University of Hertfordshire, Hertfordshire Sports Partnership, Sport England, Broxbourne Borough Council, East and North Hertfordshire Clinical Commisioning Group, Hertfordshire Valley Clinical Commisioning Group, Hertfordshire Public Health
- Study start
- 7 Jan 2016 (actual)
- Primary completion
- 7 Jan 2019 (estimated)
- Study completion
- 7 Jan 2019 (estimated)
- First posted
- 15 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There is a high prevalence of inactive adults in the United Kingdom (UK), many of whom suffer from conditions such as diabetes, cardiovascular disease, and poor mental health. These problems often co-exist more frequently in areas of higher socio-economic deprivation. There is an ongoing need to test the effectiveness, acceptability, and sustainability of community physical activity interventions. The Active Herts programme is a community physical activity programme aimed at inactive adults aged 16 and over who have one or more risk factors for cardiovascular disease (CVD) and/or a mild to moderate mental health condition. The programme uses the latest evidence-based behaviour change techniques to target physical activity, wellbeing, and key drivers of behaviour from the COM-B ('Capability', 'Opportunity', 'Motivation' and 'Behaviour') model of behaviour change.
This evaluation will follow a mixed-methods longitudinal (baseline, and 3, 6 and 12 month follow-ups) pragmatic observational design. Two types of programme are being delivered, each in a different area. In one, group participants will receive a behaviour change technique booklet, consultations (baseline, and optional at 3, 6, and 12 months), a booster phone call (week 2), motivational text messages (weeks 3, 6, and 12), and signposting to 12 weeks of exercise classes. In the other 'enhanced delivery' group, participants will receive the same but the 12 weeks of exercise will be free and tailored to their needs, and there will be optional exercise 'buddies' available. An outcome evaluation will assess changes in physical activity as the primary outcome, and sporting participation, sitting, wellbeing, psychological capability, and reflective motivation as secondary outcomes. A process evaluation will use both one-to-one interviews and focus groups to explore the views of stakeholders, delivery staff, and participants over three phases (set-up, deviations in the delivery of the intervention, and looking back over the intervention). Economic evaluation will examine the costs of the Active Herts programme against the benefits gained in terms of reduced risk of morbidity from a range of chronic conditions.
This study will measure key drivers of physical activity using up to date behaviour change theory, allowing evaluation of not only whether physical activity has increased but also why. The research will inform the future development of a scalable intervention that can be more robustly tested in a randomised controlled trial.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard delivery | – | Behavioral: Active HertsParticipants will receive a behaviour change technique booklet, consultations (baseline, and optional at 3, 6, and 12 months), a booster phone call (week 2), motivational text messages (weeks 3, 6, and 12), and signposting to 12 weeks of exercise classes. |
| Enhanced delivery | – | Behavioral: Active HertsParticipants will receive the same as intervention but the 12 weeks of exercise will be free and tailored to their needs, and there will be optional exercise 'buddies' available. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants will live in one of four Hertfordshire districts (Broxbourne, Stevenage, Hertsmere, and Watford), United Kingdom. The four districts contain the highest number of deprived Lower Super Output Areas (LSOA) in Hertfordshire and are in the five highest rates of under 75 mortality rate from CVD (2-3%), adult obesity (8-10%), and diabetes (4-6%). A life expectancy gap of 6-9.6 years exists between the most and least deprived areas across these districts. Less than 50% of this population participate in 30 minutes of physical activity once per week.
Key inclusion criteria (7 listed)
- inactive adults and do less than 30mins of physical activity per week
- aged 16 or over
- resident of Hertfordshire boroughs, including Broxbourne, Hertsmere, Stevenage or Watford
- a long term medical condition such as type 2 diabetes, hypertension, high cholesterol etc.
- a mild to moderate mental health condition such as anxiety, depression or stress
Key exclusion criteria (1 listed)
- participants not able to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active HertsAlso: Healthy and Active In HertsActive Herts is a community physical activity intervention aimed at inactive adults aged 16 and over who have one or more risk factors for CVD and/or a mild to moderate mental health condition. The programme uses the latest evidence-based behaviour change techniques to target physical activity, wellbeing, and key drivers of behaviour from the COM-B model of behaviour change. | Behavioural | Enhanced delivery, Standard delivery |
Primary outcome
Change in Physical activity from baseline
Time frame: 12 months
Assessed using the International Physical Activity Questionnaire (IPAQ)
3 secondary outcomes
Change in mental well-being from baseline
Time frame: Short term (3 months), longer term (6 and 12 months)
Change in perceptions of health from baseline
Time frame: Short term (3 months), longer term (6 and 12 months)
Readiness to change behaviour
Time frame: Short term (3 months), longer term (6 and 12 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2017.
- Derived from this study: PubMed 36159253Chater AM, Schulz J, Jones A, Burke A, Carr S, Kukucska D, Troop N, Trivedi D, Howlett N. Outcome evaluation of Active Herts: A community-based physical activity programme for inactive adults at risk of cardiovascular disease and/or low mental wellbeing. Front Public Health. 2022 Sep 9;10:903109. doi: 10.3389/fpubh.2022.903109. eCollection 2022.
- Derived from this study: PubMed 29175885Howlett N, Jones A, Bain L, Chater A. How effective is community physical activity promotion in areas of deprivation for inactive adults with cardiovascular disease risk and/or mental health concerns? Study protocol for a pragmatic observational evaluation of the 'Active Herts' physical activity programme. BMJ Open. 2017 Nov 25;7(11):e017783. doi: 10.1136/bmjopen-2017-017783.
- Website for community interventionLink provided by the sponsor.
Related trials for Physical Activity
Active, not recruiting
Comparison of the Effects of Kinesio Taping and Interval Exercise in Patients Diagnosed With Venous Insufficiency: A Randomised Controlled Trial
Chronic Venous Insufficiency C2 and Below
Not yet recruiting
Creatine and Beta-Hydroxy-Beta-Methylbutyrate (HMB) Supplementation Plus Home-Based Exercise for Sarcopenia in Huntington's Disease
Huntington Disease, Sarcopenia
Active, not recruiting
Smartphone-Guided Paced Breathing and Aerobic Exercise for Essential Hypertension
Essential (Primary) Hypertension
Not yet recruitingPhase 1/2
A Study of SRN-101 Gene Therapy in Adults With Recurrent High-Grade Glioma (ALERT-1)
Recurrent High Grade Gliomas, Glioblastoma (GBM)
Not yet recruiting
Combined Versus Multicomponent Training in People With Chronic Kidney Disease Stages 3a and 3b
Chronic Kidney Disease Stage 3A, Chronic Kidney Disease Stage 3B
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andy Jones, Prof principal investigator
University of East Anglia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Physical Activity, run by University of East Anglia at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andy Jones, Prof (0044 1603 593127, A.P.Jones@uea.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Physical activity from baseline (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03153098, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2017.