Primary Care - Prescribing Lifestyle Adjustments for Cardiovascular Health (P-PLAC 2)

University of South Wales

Status: Suspended

Conditions: Behavior Change Interventions; Cardiovascular Diseases; Behavior, Health; Cardiovascular Risk Factor

Treatments: Behavioral: Lifestyle Prescription (LRx)

Study type: Interventional

Funder types: Other

Identifiers

NCT04113213

260480

Details and patient eligibility

About

Prescribing lifestyle changes to patients who are at risk of cardiovascular disease, may be an extremely cost effective mechanism of improving health for the individual themselves and the NHS. It is already proven that positive lifestyle changes such as improved diet, increased physical activity, quitting smoking and reducing alcohol consumption can lower the risk of cardiovascular disease, as well as reduce the risk of all-cause mortality.

P-PLAC2 (Primary Care - Prescribing Lifestyle Adjustments for Cardiovascular Health) is a Phase II interventional study to determine the efficacy of a Lifestyle Prescription (LRx), from the viewpoint of patients and healthcare practitioners. The study uses a mixed methods design, and full study training and support will be provided to staff involved in the recruitment of patients, through to the behaviour change consultation, and end of study.

If the study proves successful, a lifestyle prescription (LRx) could then be made available to support NHS staff throughout all disciplines (specifically those working with patients who are at risk of cardiovascular disease (CVD).

Enrollment: 240 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age 18 and over.
• Able and willing to provide written informed consent.
• Understands spoken and written English.

Exclusion criteria

• Participant is unwilling or unable to provide written informed consent.
• Participant is pregnant.
• Participant has a diagnosed psychological disorder.
• Participant has a drug dependency.
• Participant is housebound, or resides in a nursing home.
• Participant has behavioural issues or learning difficulties.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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240 participants in 2 patient groups

Control

No Intervention group

Description:

Standard care during consultations.

Intervention

Experimental group

Description:

Standard care during consultations with the addition of a physical lifestyle prescription.

Treatment:

Behavioral: Lifestyle Prescription (LRx)