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| Name | Class |
|---|---|
| Northern Ireland Chest Heart and Stroke | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHARE-D decision tool use | Experimental | The intervention, a shared decision-making tool ('SHARE-D'), which is a paper-based questionnaire, will be used jointly by a health professional and patient to facilitate decision-making about initiating change in physical activity or diet behaviour |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| shared decision-making tool (SHARE-D) | Behavioral | questionnaire |
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| Measure | Description | Time Frame |
|---|---|---|
| Recruitment Rate | numbers of patients attending a baseline assessment, compared to numbers invited to participate | 4 months overall recruitment (responses to invitations recorded within 4 weeks of invitation being sent) |
| Measure | Description | Time Frame |
|---|---|---|
| Completion Rate | numbers of enrolled participants who complete all assessments and reviews | 3 months |
| Diet Behaviour - Fibre Intake | Dietary Instrument for Nutritional Education (DINE) questionnaire - measure of diet fibre content; maximum score = 61; minimum = 3; higher score indicates better outcome |
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Inclusion Criteria:
Exclusion Criteria:
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recruited from general practice; July-October 2016
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| ID | Title | Description |
|---|---|---|
| FG000 | SHARE-D Decision Tool Use | The intervention, a shared decision-making tool ('SHARE-D'), which is a paper-based questionnaire, will be used jointly by a health professional and patient to facilitate decision-making about initiating change in physical activity or diet behaviour shared decision-making tool (SHARE-D): questionnaire |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | SHARE-D Decision Tool Use | The intervention, a shared decision-making tool ('SHARE-D'), which is a paper-based questionnaire, will be used jointly by a health professional and patient to facilitate decision-making about initiating change in physical activity or diet behaviour shared decision-making tool (SHARE-D): questionnaire |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Recruitment Rate | numbers of patients attending a baseline assessment, compared to numbers invited to participate | Responses recorded within 4 weeks of invitation being sent; participants enrolled were those who completed baseline assessment - recruitment constrained by availability of researcher, space in practice, other commitments of potential participants and study timeline | Posted | Count of Participants | Participants | 4 months overall recruitment (responses to invitations recorded within 4 weeks of invitation being sent) |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SHARE-D Decision Tool Use | The intervention, a shared decision-making tool ('SHARE-D'), which is a paper-based questionnaire, will be used jointly by a health professional and patient to facilitate decision-making about initiating change in physical activity or diet behaviour shared decision-making tool (SHARE-D): questionnaire |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Margaret Cupples | Queen's University, Belfast | 07714233204 | m.cupples@qub.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 7, 2016 | Sep 19, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015438 | Health Behavior |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| 3 months |
| Physical Activity Behaviour | 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 | 3 months |
| Objective Measure of Physical Activity | accelerometer measurement of duration of light, moderate and vigorous physical activity per day over a 7-day period | 2 periods of 7-day measurement: baseline and after 3 months |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Number of participants in each race category | Count of Participants | Participants |
|
| Region of Enrollment | Recruited from general practice, Northern Ireland, UK; data collected by questionnaire | Count of Participants | Participants |
|
| BMI | classification of participants based on categories of BMI | Count of Participants | Participants |
|
| DINE (Fibre score) | DINE (Dietary Instrument for Nutritional Education) questionnaire data provide a numerical score for the fibre content of food consumed. The score is based on 19-item questionnaire related to the frequency of eating various foods for which fibre content has been analysed and a 'fibre' score attributed. Higher scores represent better outcomes/ healthier diet. A score <30 = low fibre intake; 30-40 = medium fibre intake; >40 = high fibre intake. Max score for fibre consumption is 88; minimum is 1. | Mean | Standard Deviation | units on a scale |
|
| DINE (unsaturated fat score) | The DINE (Dietary Instrument for Nutritional Education) questionnaire provides a numerical score for the unsaturated fat content of food consumed. The score is based on frequency of eating various foods for which unsaturated fat content has been analysed and an 'unsaturated fat' score attributed. Higher scores represent better outcomes/ healthier diet. A score <6 = unsaturated fat intake; 6-9 = medium unsaturated fat intake; >9 = high unsaturated fat intake. Minimum score is 3 ; maximum is 12. | Mean | Standard Deviation | units on a scale |
|
| Self-report of sedentary behaviour, based on number of hours/ day watching TV | Self-reported time (hours) spent in various activities during the week prior to completion of the Recent Physical Activity Questionnaire (RPAQ); measure of sedentary behaviour focused on numbers reporting watching TV for >2hrs/ weekday. | Number | number of participants |
|
| Numbers doing >30minutes of MVPA/day (accelerometer data) | accelerometer recording, measured over 7 days at baseline - objective measure of step counts and time spent (minutes/day) of sedentary behaviour and moderate and vigorous physical activity (MVPA); measure used in study to assess numbers doing >30minutes of MVPA/day (achieving physical activity recommendations) | Count of Participants | Participants |
|
|
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| Secondary | Completion Rate | numbers of enrolled participants who complete all assessments and reviews | Number (%) of those who attended baseline assessments and completed all assessments and follow-up | Posted | Count of Participants | Participants | 3 months |
|
|
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| Secondary | Diet Behaviour - Fibre Intake | Dietary Instrument for Nutritional Education (DINE) questionnaire - measure of diet fibre content; maximum score = 61; minimum = 3; higher score indicates better outcome | Fibre score, higher score better diet | Posted | Mean | Standard Deviation | score on a scale | 3 months |
|
|
|
| Secondary | Physical Activity Behaviour | 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 | Time spent watching TV>2hrs/weekday represents time spent in sedentary behaviour | Posted | Number | participants | 3 months |
|
|
|
| Secondary | Objective Measure of Physical Activity | accelerometer measurement of duration of light, moderate and vigorous physical activity per day over a 7-day period | accelerometer measurement of duration of moderate and vigorous physical activity (MVPA) per day over a 7-day period, measuring number achieving 30 minutes of MVPA/day at baseline and after 3 months | Posted | Count of Participants | Participants | 2 periods of 7-day measurement: baseline and after 3 months |
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| 0 |
| 23 |
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| 23 |
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| 23 |
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| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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|
| Title | Measurements |
|---|---|
|
| did <30mins/day MVPA at 3 months |
|