NCT03153098

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
739

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 7, 2016

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

May 5, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 15, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 7, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 7, 2019

Completed
Last Updated

May 15, 2017

Status Verified

April 1, 2017

Enrollment Period

3 years

First QC Date

May 5, 2017

Last Update Submit

May 12, 2017

Conditions

Keywords

physical activityinterventionbehaviour changeinactive adultsbehaviour change techniqueswell-being

Outcome Measures

Primary Outcomes (1)

  • Change in Physical activity from baseline

    Assessed using the International Physical Activity Questionnaire (IPAQ)

    12 months

Secondary Outcomes (3)

  • Change in mental well-being from baseline

    Short term (3 months), longer term (6 and 12 months)

  • Change in perceptions of health from baseline

    Short term (3 months), longer term (6 and 12 months)

  • Readiness to change behaviour

    Short term (3 months), longer term (6 and 12 months)

Other Outcomes (2)

  • Delivery fidelity

    End February 2017, Summer 2017, Autumn 2018

  • Programme cost-effectiveness

    October 2017 - October 2018

Study Arms (2)

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.

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.

Behavioral: Active Herts

Interventions

Active HertsBEHAVIORAL

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.

Also known as: Healthy and Active In Herts
Enhanced deliveryStandard delivery

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • participants not able to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of East Anglia

Norwich, NR4 7TJ, United Kingdom

RECRUITING

Related Publications (2)

  • 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.

  • Howlett 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.

Related Links

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Andy Jones, Prof

    University of East Anglia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2017

First Posted

May 15, 2017

Study Start

January 7, 2016

Primary Completion

January 7, 2019

Study Completion

January 7, 2019

Last Updated

May 15, 2017

Record last verified: 2017-04

Locations