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Completed

NCT Number: NCT03276546

SHARE-D: a Decision Tool to Help Patients Make Informed Lifestyle Choices

More information is needed about effective ways to help people begin to change their lifestyle behaviours, particularly physical activity and diet. The investigators propose to test a 'tool' that can be used to guide discussions between people and health professionals about their physical activity and diet habits, so that people may be supported better in making decisions about why and how they might begin to fit more exercise and healthy food into their daily routines and make long-term changes. The investigators will explore the feasibility of using this tool in general practice, reviewing behaviours after 1 and 3 months. Patients' and healthcare professionals' views of its use and how it influenced decisions will inform development of the tool's design and a study of its effectiveness in helping people to begin to change their behaviour and achieve healthy lifestyles.

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Key information

Conditions

Health Behavior Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Healthier lifestyles, relating to physical activity and diet, reduce the risk of heart disease and stroke. However, making and sustaining lifestyle changes is difficult. More information is needed about effective ways to help people begin to change their lifestyle behaviours. The investigators propose to test the feasibility of using a 'tool' (the SHARED-D questionnaire) in guiding discussions between people and health professionals about physical activity and diet, and support people in making decisions about why and how they might begin to fit more exercise and healthy food into their daily routines. The 'tool' (SHARE-D) consists of questions to help people think about their personal circumstances and their motivation, opportunities, capabilities and priorities, and includes information about heart disease and stroke.

The investigators will explore the use of this tool in general practice, assessing patients' physical activity and diet behaviour after 1 and 3 months. Patients' and healthcare professionals' views of its use and how it influenced decisions will help to improve the tool's design. Participants' opinions regarding its format and method of delivery will inform future plans for its use and the design of a study of its effectiveness in helping people to begin to change their behaviour and achieve healthy lifestyles, hoping to lead to improved quality of life for people with heart disease and stroke.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 18 years or over
  • With or at high risk of coronary heart disease
  • Overweight or physically inactive

Exclusion criteria

  • Unable to complete questionnaires
  • Unable to make independent changes to physical activity or diet habits

Treatment and study plan

shared decision-making tool (SHARE-D)

Behavioral

questionnaire

Other names: questionnaire

Primary outcomes

  1. Recruitment Rate

    Time frame: 4 months overall recruitment (responses to invitations recorded within 4 weeks of invitation being sent)

    numbers of patients attending a baseline assessment, compared to numbers invited to participate

Secondary outcomes

  1. Completion Rate

    Time frame: 3 months

    numbers of enrolled participants who complete all assessments and reviews

  2. Diet Behaviour - Fibre Intake

    Time frame: 3 months

    Dietary Instrument for Nutritional Education (DINE) questionnaire - measure of diet fibre content; maximum score = 61; minimum = 3; higher score indicates better outcome

  3. Physical Activity Behaviour

    Time frame: 3 months

    RPAQ questionnaire -self-reported frequency of episodes of different activities representing levels of sedentary behaviour and of light, moderate and vigorous physical activity in 4 weeks prior to completion of the questionnaire; focus on measure of sedentary behaviour indicated by time (hours) spent watching TV/weekday

  4. Objective Measure of Physical Activity

    Time frame: 2 periods of 7-day measurement: baseline and after 3 months

    accelerometer measurement of duration of light, moderate and vigorous physical activity per day over a 7-day period

Sponsors and collaborators

Lead sponsor

Queen's University, Belfast

Other

Collaborators

  • Northern Ireland Chest Heart and Stroke

Registry information

Official study title

SHARE-D: a Decision Tool to Help Patients With, or at Risk of, Coronary Heart Disease Make Informed Lifestyle Choices: Feasibility Study

Acronym: SHARE-D

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 8, 2017
Registry last updated
Jan 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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