An interventional study of shared decision-making tool (SHARE-D) in Health Behavior, sponsored by Queen's University, Belfast. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-22.
Sponsored by Queen's University, Belfast · Not applicable, Interventional, and Prevention
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.
968 studies on the registry are indexed under Health Behavior; 166 are open to participants now.
This study's enrollment of 23 is below the median of 150 across 825 interventional studies indexed under Health Behavior.
Browse Health Behavior studies →Queen's University, Belfast is the lead sponsor of 117 studies on the registry; 14 are open to participants now.
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Exclusion Criteria:
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
Behavioral: shared decision-making tool (SHARE-D)
questionnaire
Also known as: questionnaire
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)
Completion Rate
numbers of enrolled participants who complete all assessments and reviews
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 2 periods of 7-day measurement: baseline and after 3 months
recruited from general practice; July-October 2016
| Milestone | SHARE-D Decision Tool Use |
|---|---|
| Started | 23 |
| Completed | 20 |
| Not completed | 3 |
numbers of patients attending a baseline assessment, compared to numbers invited to participate
| Participants | SHARE-D Decision Tool Use |
|---|---|
| Number who responded positively to invitation | 45 |
| Number who attended baseline assessment | 23 |
numbers of enrolled participants who complete all assessments and reviews
| Participants | SHARE-D Decision Tool Use |
|---|---|
| Completion Rate | 20 |
Dietary Instrument for Nutritional Education (DINE) questionnaire - measure of diet fibre content; maximum score = 61; minimum = 3; higher score indicates better outcome
| score on a scale | SHARE-D Decision Tool Use |
|---|---|
| Mean Fibre Score (SD) baseline | 35.35 ± 11.23 |
| Mean Fibre Score (SD) 3 months | 34.60 ± 11.81 |
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
| participants | SHARE-D Decision Tool Use |
|---|---|
| Number watching TV>2hrs/weekday at baseline | 14 |
| Number watching TV >2hrs/ weekday at 3 months | 16 |
accelerometer measurement of duration of light, moderate and vigorous physical activity per day over a 7-day period
| Participants | SHARE-D Decision Tool Use |
|---|---|
| achieved 30 mins MVPA/day at baseline | 16 |
| achieved 30 mins MVPA/day at 3 months | 5 |
| did <30 mins MVPA/day at baseline | 10 |
| did <30mins/day MVPA at 3 months | 11 |
Collected over 3 months. Non-serious events are listed at a 0.0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| SHARE-D Decision Tool Use | 0/23 (0%) | 0/23 (0%) | 0/23 (0%) |
| Age, Categorical(Participants) | SHARE-D Decision Tool Use |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 15 |
| >=65 years | 8 |
| Sex: Female, Male(Participants) | SHARE-D Decision Tool Use |
|---|---|
| Female | 10 |
| Male | 13 |
| Race (NIH/OMB)(Participants) | SHARE-D Decision Tool Use |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 23 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | SHARE-D Decision Tool Use |
|---|---|
| United Kingdom | 23 |
| BMI(Participants) | SHARE-D Decision Tool Use |
|---|---|
| Normal (18.5 - 24.9 kg/m^2) | 1 |
| Overweight (25 - 29.9 kg/m^2) | 3 |
| Obese (30 - >40 kg/m^2) | 19 |
| DINE (Fibre score)(units on a scale) | SHARE-D Decision Tool Use |
|---|---|
| Mean | 35.35 ± 11.23 |
| DINE (unsaturated fat score)(units on a scale) | SHARE-D Decision Tool Use |
|---|---|
| Mean | 5.91 ± 1.86 |
| Self-report of sedentary behaviour, based on number of hours/ day watching TV(number of participants) | SHARE-D Decision Tool Use |
|---|---|
| Number | 14 |
1 further baseline measures are reported on the registry.
No study locations are listed for this record.
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Jun 2016 to primary completion in Jan 2017, 7 months.
Results were first posted in Jan 2024, 6 years 11 months after primary completion.
Of 568 non-industry interventional studies with no phase under Health Behavior, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 33. This study's 7 months is below that.
Counting every sponsor, half of 586 studies reached it within 15 months; a quarter within 5 and three quarters within 32.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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