NCT03276546

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 8, 2017

Completed
6.4 years until next milestone

Results Posted

Study results publicly available

January 22, 2024

Completed
Last Updated

January 22, 2024

Status Verified

January 1, 2024

Enrollment Period

8 months

First QC Date

August 31, 2017

Results QC Date

February 17, 2022

Last Update Submit

January 17, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (4)

  • Completion Rate

    3 months

  • Diet Behaviour - Fibre Intake

    3 months

  • Physical Activity Behaviour

    3 months

  • Objective Measure of Physical Activity

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

Study Arms (1)

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

Behavioral: shared decision-making tool (SHARE-D)

Interventions

questionnaire

Also known as: questionnaire
SHARE-D decision tool use

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Health Behavior

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Results Point of Contact

Title
Professor Margaret Cupples
Organization
Queen's University, Belfast

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 31, 2017

First Posted

September 8, 2017

Study Start

June 1, 2016

Primary Completion

January 31, 2017

Study Completion

January 31, 2017

Last Updated

January 22, 2024

Results First Posted

January 22, 2024

Record last verified: 2024-01