An Evaluation of the Active Herts Physical Activity Programme

Physical Activity Clinical Trial

Official title:

Physical Activity Promotion in Areas of Deprivation for Inactive Adults With Cardiovascular Disease (CVD) Risk: An Evaluation of Active Herts

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03153098
• Other study ID #: ActiveHerts
• Status: Recruiting
• Phase: N/A
• First received: May 5, 2017
• Last updated: May 12, 2017
• Start date: January 7, 2016
• Est. completion date: January 7, 2019

Study information

• Verified date: April 2017
• Source: University of East Anglia
• Contact: Andy Jones, Prof
• Phone: 0044 1603 593127
• Email: A.P.Jones[@]uea.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 739
• Est. completion date: January 7, 2019
• Est. primary completion date: January 7, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• participants not able to give informed consent

Related Conditions & MeSH terms

• Physical Activity

Intervention

Behavioral:
• Active 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.

Locations

Country	Name	City	State
United Kingdom	University of East Anglia	Norwich

Sponsors (8)

Lead Sponsor	Collaborator
University of East Anglia	Broxbourne Borough Council, East and North Hertfordshire Clinical Commisioning Group, Hertfordshire Public Health, Hertfordshire Sports Partnership, Hertfordshire Valley Clinical Commisioning Group, Sport England, University of Hertfordshire

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Delivery fidelity	A process evaluation of Active Herts will take place in three phases with each phase exploring a different theme. Data will be collected in the form of one-to-one interviews with stakeholders, group interviews with the Get Active Specialists, and focus groups with participants. Stakeholders interviewed will include commissioners, higher intervention management, project delivery partners, and health service practitioners.	End February 2017, Summer 2017, Autumn 2018
Other	Programme cost-effectiveness	The economic evaluation will examine the costs of delivery of the Active Herts intervention against the benefits gained in terms of reduced risk of morbidity from a range of chronic conditions, the risk of which is associated with physical inactivity.	October 2017 - October 2018
Primary	Change in Physical activity from baseline	Assessed using the International Physical Activity Questionnaire (IPAQ)	12 months
Secondary	Change in mental well-being from baseline	Assessed using Warwick Edinburgh well-being scale	Short term (3 months), longer term (6 and 12 months)
Secondary	Change in perceptions of health from baseline	EuroQOL five dimensions questionnaire (EQ-5D)	Short term (3 months), longer term (6 and 12 months)
Secondary	Readiness to change behaviour	Key determinants of behaviour - measured using COM-B Capability, Opportunity, and Motivation	Short term (3 months), longer term (6 and 12 months)

External Links

•   Website for community intervention