Trial Outcomes & Findings for SHARE-D: a Decision Tool to Help Patients Make Informed Lifestyle Choices (NCT NCT03276546)

NCT ID: NCT03276546

Last Updated: 2024-01-22

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

23 participants

Primary outcome timeframe

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

Results posted on

2024-01-22

Participant Flow

recruited from general practice; July-October 2016

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	23
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SHARE-D Decision Tool Use n=23 Participants 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
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	23 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United Kingdom	23 Participants n=5 Participants
BMI Normal (18.5 - 24.9 kg/m^2)	1 Participants n=5 Participants
BMI Overweight (25 - 29.9 kg/m^2)	3 Participants n=5 Participants
BMI Obese (30 - >40 kg/m^2)	19 Participants n=5 Participants
DINE (Fibre score)	35.35 units on a scale STANDARD_DEVIATION 11.23 • n=5 Participants
DINE (unsaturated fat score)	5.91 units on a scale STANDARD_DEVIATION 1.86 • n=5 Participants
Self-report of sedentary behaviour, based on number of hours/ day watching TV	14 number of participants n=5 Participants
Numbers doing >30minutes of MVPA/day (accelerometer data)	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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

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

Outcome measures

Outcome measures
Measure	SHARE-D Decision Tool Use n=162 Participants 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 Recruitment rate: 28% (45/162)
Recruitment Rate Number who responded positively to invitation	45 Participants
Recruitment Rate Number who attended baseline assessment	23 Participants

SECONDARY outcome

Timeframe: 3 months

Population: Number (%) of those who attended baseline assessments and completed all assessments and follow-up

numbers of enrolled participants who complete all assessments and reviews

Outcome measures

Outcome measures
Measure	SHARE-D Decision Tool Use n=23 Participants 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 Recruitment rate: 28% (45/162)
Completion Rate	20 Participants

SECONDARY outcome

Timeframe: 3 months

Population: Fibre score, higher score better diet

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

Outcome measures

Outcome measures
Measure	SHARE-D Decision Tool Use n=23 Participants 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 Recruitment rate: 28% (45/162)
Diet Behaviour - Fibre Intake Mean Fibre Score (SD) baseline	35.35 score on a scale Standard Deviation 11.23
Diet Behaviour - Fibre Intake Mean Fibre Score (SD) 3 months	34.60 score on a scale Standard Deviation 11.81

SECONDARY outcome

Timeframe: 3 months

Population: Time spent watching TV\>2hrs/weekday represents time spent in sedentary 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

Outcome measures

Outcome measures
Measure	SHARE-D Decision Tool Use n=23 Participants 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 Recruitment rate: 28% (45/162)
Physical Activity Behaviour Number watching TV>2hrs/weekday at baseline	14 participants
Physical Activity Behaviour Number watching TV >2hrs/ weekday at 3 months	16 participants

SECONDARY outcome

Timeframe: 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

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

Outcome measures

Outcome measures
Measure	SHARE-D Decision Tool Use n=23 Participants 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 Recruitment rate: 28% (45/162)
Objective Measure of Physical Activity achieved 30 mins MVPA/day at baseline	16 Participants
Objective Measure of Physical Activity achieved 30 mins MVPA/day at 3 months	5 Participants
Objective Measure of Physical Activity did <30 mins MVPA/day at baseline	10 Participants
Objective Measure of Physical Activity did <30mins/day MVPA at 3 months	11 Participants

Adverse Events

SHARE-D Decision Tool Use

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Professor Margaret Cupples

Queen's University, Belfast

Phone: 07714233204

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place