Health Behavior
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALshared decision-making tool (SHARE-D)
questionnaire
Sponsors
Northern Ireland Chest Heart and Stroke
Queen's University, Belfast
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment Rate | 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
| Measure | Time frame | Description |
|---|---|---|
| Completion Rate | 3 months | numbers of enrolled participants who complete all assessments and reviews |
| Diet Behaviour - Fibre Intake | 3 months | Dietary Instrument for Nutritional Education (DINE) questionnaire - measure of diet fibre content; maximum score = 61; minimum = 3; higher score indicates better outcome |
| Physical Activity Behaviour | 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 |
| Objective Measure of Physical Activity | 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 |
Participant flow
Recruitment details
recruited from general practice; July-October 2016
Participants by arm
| Arm | Count |
|---|---|
| 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 | 23 |
| Total | 23 |
Baseline characteristics
| Characteristic | SHARE-D Decision Tool Use |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 8 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants |
| BMI Normal (18.5 - 24.9 kg/m^2) | 1 Participants |
| BMI Obese (30 - >40 kg/m^2) | 19 Participants |
| BMI Overweight (25 - 29.9 kg/m^2) | 3 Participants |
| DINE (Fibre score) | 35.35 units on a scale STANDARD_DEVIATION 11.23 |
| DINE (unsaturated fat score) | 5.91 units on a scale STANDARD_DEVIATION 1.86 |
| Numbers doing >30minutes of MVPA/day (accelerometer data) | 6 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 23 Participants |
| Region of Enrollment United Kingdom | 23 Participants |
| Self-report of sedentary behaviour, based on number of hours/ day watching TV | 14 number of participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 23 |
| other Total, other adverse events | 0 / 23 |
| serious Total, serious adverse events | 0 / 23 |
Outcome results
Primary
Recruitment Rate
numbers of patients attending a baseline assessment, compared to numbers invited to participate
Time frame: 4 months overall recruitment (responses to invitations recorded within 4 weeks of invitation being sent)
Population: 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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SHARE-D Decision Tool Use | Recruitment Rate | Number who responded positively to invitation | 45 Participants |
| SHARE-D Decision Tool Use | Recruitment Rate | Number who attended baseline assessment | 23 Participants |
Secondary
Completion Rate
numbers of enrolled participants who complete all assessments and reviews
Time frame: 3 months
Population: Number (%) of those who attended baseline assessments and completed all assessments and follow-up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SHARE-D Decision Tool Use | Completion Rate | 20 Participants |
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
Time frame: 3 months
Population: Fibre score, higher score better diet
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SHARE-D Decision Tool Use | Diet Behaviour - Fibre Intake | Mean Fibre Score (SD) baseline | 35.35 score on a scale | Standard Deviation 11.23 |
| SHARE-D Decision Tool Use | Diet Behaviour - Fibre Intake | Mean Fibre Score (SD) 3 months | 34.60 score on a scale | Standard Deviation 11.81 |
Secondary
Objective Measure of Physical Activity
accelerometer measurement of duration of light, moderate and vigorous physical activity per day over a 7-day period
Time frame: 2 periods of 7-day measurement: baseline and after 3 months
Population: 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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SHARE-D Decision Tool Use | Objective Measure of Physical Activity | achieved 30 mins MVPA/day at baseline | 16 Participants |
| SHARE-D Decision Tool Use | Objective Measure of Physical Activity | achieved 30 mins MVPA/day at 3 months | 5 Participants |
| SHARE-D Decision Tool Use | Objective Measure of Physical Activity | did <30 mins MVPA/day at baseline | 10 Participants |
| SHARE-D Decision Tool Use | Objective Measure of Physical Activity | did <30mins/day MVPA at 3 months | 11 Participants |
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 frame: 3 months
Population: Time spent watching TV\>2hrs/weekday represents time spent in sedentary behaviour
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SHARE-D Decision Tool Use | Physical Activity Behaviour | Number watching TV>2hrs/weekday at baseline | 14 participants |
| SHARE-D Decision Tool Use | Physical Activity Behaviour | Number watching TV >2hrs/ weekday at 3 months | 16 participants |