Health BehaviorNCT05820282
Using IF-THEN Plans to Increase Behaviour Change Intervention Delivery
A study testing Volitional help sheet in people with Health Behavior, run by University of Leeds at 1 site in United Kingdom.
Trial summary
The aim of the present research is to test the effectiveness of an implementation intention-based intervention for increasing healthcare professional delivery of behaviour change interventions during routine healthcare. Each participant will be randomly allocated to one of two conditions. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Behavior
- What is being tested?
- Volitional help sheet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,008 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Feb 2022to 31 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18 and over, good verbal and written understanding of English A healthcare professional working in the United Kingdom's NHS
Who cannot join
- Aged under 18 years of age, poor verbal and written understanding of English Not a healthcare professional working in the United Kingdom's NHS
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Using IF-THEN Plans to Increase Healthcare Professional Delivery of Behaviour Change Interventions During Routine Healthcare
The aim of the present research is to test the effectiveness of an implementation intention-based intervention for increasing healthcare professional delivery of behaviour change interventions during routine healthcare.
Each participant will be randomly allocated to one of two conditions. The two conditions are: (1) a control condition, and (2) intervention (form multiple implementation intentions from a drop-down menu). The main outcome measure will be use of face coverings.
Read the detailed description
Background and study aims
Public health policies are used to compel healthcare professionals to deliver health behaviour change interventions during routine practice. Making Every Contact Count, a National Health Service (NHS) policy aimed at patient-facing healthcare professionals, places prevention at the centre of every NHS patient-HCP contact. Our previous research showed decreasing levels of healthcare professional delivery of health behaviour change interventions. The investigators were also able to provide recommendations for interventions to support healthcare professionals' capabilities, opportunities and motivations in order to sustain delivery of behaviour change interventions in the long term. One key recommendation was that interventions designed to bolster people's "automatic motivation" (i.e., habits, emotions) would likely lead to increased delivery of behaviour change interventions.
Our recent qualitative research suggests enhancing healthcare professionals' capabilities to deliver behaviour change interventions could focus on providing the necessary support to capitalize on the opportunities created by new technology-based approaches to healthcare consultations in light of COVID-19. One such approach may be to support healthcare professionals in identifying patients' barriers to behaviour change, and linking them with possible enablers.
Automatic motivation may be a key intervention target, yet more research is needed to examine effective interventions targeting this. There is a long track record of research showing that implementation intentions are an effective means of changing behaviour, and that such changes in behaviour can be sustained over years. Implementation intentions help people overcome automatic motivation by making the critical situations that may elicit unwanted habits more salient, and ensuring that alternative strategies are deployed. They are best thought of as "if-then" plans: specifying an "if" ensures that triggers to unwanted habits receive greater attention and linking "ifs" with "thens" (e.g., signposting to appropriate information) ensures that the appropriate responses are automatized and replace the unwanted habit. Forming "if-then" plans thus overcome habits.
Aims
To test the effectiveness of an implementation intention-based intervention for increase healthcare professional delivery of behaviour change interventions during routine healthcare.
Who can participate?
Participants were identified from a pre-existing sample of healthcare professionals recruited and incentivised by YouGov (a survey panel company) to complete the questionnaire. The sample was intended to be representative of the patient-facing NHS healthcare professional workforce.
What does the study involve?
Participants complete a series of questionnaires about their experiences delivering health behaviour change interventions during routine healthcare, and are then randomly allocated to one of the two groups. Participants in both conditions are presented with a "volitional help sheet" at the end of the questionnaire. The volitional help sheet was based on previous studies that supported implementation intention formation to support health behaviour change. The specific content of the volitional help sheet (i.e. the barriers and enablers to delivering behaviour change interventions) was based on a qualitative study carried out prior to the present study [ref] and the wider literature [refs]. The volitional help sheet consisted of nine critical situations and nine appropriate responses (labelled "solutions"). The barriers to delivering behaviour change items (i.e. "situations") were translated into "if" statements, for example: "If I believe I don't have a good enough relationship with a patient to talk about healthy lifestyle…"; the processes of change items were translated into "then" statements, for example, "then I would refer to a specialist healthcare professional or another member of my team."
Healthcare professionals in the experimental condition were presented with a table with two columns and nine rows. Nine situations (barriers to delivering behaviour change interventions) are presented in the left hand column and nine solutions (or appropriate responses; processes of change) are presented in the right hand column (as separate drop down menus). Participants in this condition are asked to form implementation intentions by linking critical situations with appropriate responses by choosing an appropriate response from the drop down menu for each critical situation. Participants were told they could make as many situation-solution links as they wanted.
Participants in the control condition were presented with a table with two columns containing the same situations and solutions that participants in the experimental group saw. Each situation and solution had a radio button (i.e. a tick box) next to it; participants in the control condition were asked to identify situations and solutions and place a tick next to each one they thought would be useful to them. Therefore, participants in the control condition were not asked to form implementation intentions.
What are the possible benefits and risks of participating?
By taking part, participants will be helping to understand more about brief interventions to support increased delivery of health behaviour change interventions during routine healthcare. By constructing their own "IF-THEN" plans participants are encouraged to construct their own action plans to deal with potential situations where health behaviour change interventions would be beneficial for their patients.
Below are the main ethical issues and how they will be addressed:
Before giving consent (which will be online, as this is an online-based questionnaire), all project participants will be informed that YouGov will ensure that all data collected is stored confidentially in accordance with their privacy policy.
Participants are still free to withdraw themselves/their data until the data is anonymised (one week after the final follow-up questionnaire). There will be no personally identifiable data in the research publication or in the SPSS file that YouGov send to the research team.
Data will not be shared with any researcher or organisation other than in ways detailed on the PIS. Data (which will be anonymised with no identifiable personal information) may be used for secondary analysis within the research team only.
Who is funding the study?
This study was funded by a research grant obtained through the Research England Policy Support Fund.
Study hypothesis
Current study hypothesis as of 17/03/2023:
The condition that completes a volitional help sheet will report higher delivery of health behaviour change interventions at follow-up than the control condition
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet.
Intervention
Participants complete a series of questionnaires about their experiences delivering health behaviour change interventions during routine healthcare and are then randomly assigned to one of the two conditions:
Participants in the experimental condition are presented with a table with two columns and nine rows. Nine situations (barriers to delivering behaviour change interventions) are presented in the left hand column and nine solutions (or appropriate responses; processes of change) are presented in the right hand column (as separate drop down menus). Participants in this condition are asked to form implementation intentions by linking critical situations with appropriate responses by choosing an appropriate response from the drop down menu for each critical situation. Participants are told they can make as many situation-solution links as they wanted.
Participants in the control condition are presented with a table with two columns containing the same situations and solutions that participants in the experimental group see. Each situation and solution has a radio button (i.e. a tick box) next to it; participants in the control condition are asked to identify situations and solutions and place a tick next to each one they think would be useful to them. Therefore, participants in the control condition are not asked to form implementation intentions.
At each time point participants are asked to report whether they have delivered a health behaviour change intervention to patients to see if the intervention has increased delivery of interventions.
Intervention type
Behavioural
Data analysis plan
Randomisation checks
The investigators will run tests on all outcome and demographic variables to determine if there are any baseline differences in any of these between conditions: chi square will be used for categorical variables and MANOVA for continuous variables.
Mixed ANCOVA (intervention condition (2) x time (3) with baseline behaviour plus confounding factors such as age, gender and healthcare professional group as the covariates) will be used to examine associations between experimental condition (experimental versus control group) and reported delivery of behaviour change interventions at each time point. Similar analyses will be performed on secondary outcomes.
- Conditions
- Health Behavior
- Being tested
- Volitional help sheet, Control condition
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Volitional help sheetBehavioural
Participants are asked to choose from a list of strategies for increasing delivery of behaviour change interventions
Control conditionOther
Participants are asked to identify situations and solutions and place a tick next to each one they think would be useful to them. Therefore, participants in the control condition are not asked to form implementation intentions.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Participants in the control condition are presented with a table with two columns containing the same situations and solutions that participants in the experimental group see. Each situation and solution has a radio button (i.e. a tick box) next to it; participants in the control condition are asked to identify situations and solutions and place a tick next to each one they think would be useful to them. Therefore, participants in the control condition are not asked to form implementation intentions. Receives: Other: Control condition |
| Intervention (volitional help sheet) | Experimental | Participants in the experimental condition are presented with a table with two columns and nine rows. Nine situations (barriers to delivering behaviour change interventions) are presented in the left hand column and nine solutions (or appropriate responses; processes of change) are presented in the right hand column (as separate drop down menus). Participants in this condition are asked to form implementation intentions by linking critical situations with appropriate responses by choosing an appropriate response from the drop down menu for each critical situation. Participants are told they can make as many situation-solution links as they wanted. Receives: Behavioral: Volitional help sheet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delivery of health behaviour change interventions
Participants will be asked to rate the extent to which they delivered behaviour change interventions during routine consultations on 0-100% scale using the item, "Of the service users you see in a typical working week, who you think would benefit, with what proportion do you Make Every Contact Count?"
Measured: Change from baseline delivery of health behaviour change interventions at 13 months
Secondary outcomes (1)
Capability, opportunity and motivation (based on Capability, Opportunity, Motivation-Behaviour model)
Measured using the Capability, Opportunity, Motivation questionnaire. Each of the items (physical opportunity and social opportunity measured on a 0-100 scale, and automatic motivation, reflective motivation, physical capability, and psychological capability measured on a 0-10 scale) will be analysed separately as these each measure a separate construct. Higher scores indicate higher agreement with statements.
Measured using the Capability, Opportunity, Motivation questionnaire. Each of the items (physical opportunity and social opportunity measured on a 0-100 scale, and automatic motivation, reflective motivation, physical capability, and psychological capability measured on a 0-10 scale) will be analysed separately as these each measure a separate construct. Higher scores indicate higher agreement with statements.
Measured: Change from baseline Capability, opportunity and motivation at 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start24 Feb 2022
- Primary completion31 May 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,008 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Collaborators
- University of Manchester
- Responsible party
- Principal investigator, Dr Chris Keyworth, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05820282
- Sponsor's protocol ID
- PSYC-398
- Status last verified
- Dec 2024
- First submitted
- 22 Mar 2023
- Last updated
- 9 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Reasonable requests for data will be available from the study team on request
Publications
Vogt KS, Johnson J, Conner M, Armitage CJ, Keyworth C. Barriers and enablers to delivering opportunistic behaviour change interventions during the COVID-19 pandemic: A qualitative study in healthcare professionals. Br J Health Psychol. 2023 Sep;28(3):773-792. doi: 10.1111/bjhp.12653. Epub 2023 Feb 23.
PubMed 36822594Armitage CJ. Evidence that implementation intentions can overcome the effects of smoking habits. Health Psychol. 2016 Sep;35(9):935-43. doi: 10.1037/hea0000344. Epub 2016 Apr 7.
PubMed 27054302
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using IF-THEN Plans to Increase Healthcare Professional Delivery of Behaviour Change Interventions During Routine Healthcare
- ClinicalTrials.gov ID
- NCT05820282
- Acronym / sponsor ID
- PSYC-398
- Conditions
- Health Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,008 participants (actual)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Collaborators
- University of Manchester
- Study start
- 24 Feb 2022 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 19 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the present research is to test the effectiveness of an implementation intention-based intervention for increasing healthcare professional delivery of behaviour change interventions during routine healthcare.
Each participant will be randomly allocated to one of two conditions. The two conditions are: (1) a control condition, and (2) intervention (form multiple implementation intentions from a drop-down menu). The main outcome measure will be use of face coverings.
Detailed description
Background and study aims
Public health policies are used to compel healthcare professionals to deliver health behaviour change interventions during routine practice. Making Every Contact Count, a National Health Service (NHS) policy aimed at patient-facing healthcare professionals, places prevention at the centre of every NHS patient-HCP contact. Our previous research showed decreasing levels of healthcare professional delivery of health behaviour change interventions. The investigators were also able to provide recommendations for interventions to support healthcare professionals' capabilities, opportunities and motivations in order to sustain delivery of behaviour change interventions in the long term. One key recommendation was that interventions designed to bolster people's "automatic motivation" (i.e., habits, emotions) would likely lead to increased delivery of behaviour change interventions.
Our recent qualitative research suggests enhancing healthcare professionals' capabilities to deliver behaviour change interventions could focus on providing the necessary support to capitalize on the opportunities created by new technology-based approaches to healthcare consultations in light of COVID-19. One such approach may be to support healthcare professionals in identifying patients' barriers to behaviour change, and linking them with possible enablers.
Automatic motivation may be a key intervention target, yet more research is needed to examine effective interventions targeting this. There is a long track record of research showing that implementation intentions are an effective means of changing behaviour, and that such changes in behaviour can be sustained over years. Implementation intentions help people overcome automatic motivation by making the critical situations that may elicit unwanted habits more salient, and ensuring that alternative strategies are deployed. They are best thought of as "if-then" plans: specifying an "if" ensures that triggers to unwanted habits receive greater attention and linking "ifs" with "thens" (e.g., signposting to appropriate information) ensures that the appropriate responses are automatized and replace the unwanted habit. Forming "if-then" plans thus overcome habits.
Aims
To test the effectiveness of an implementation intention-based intervention for increase healthcare professional delivery of behaviour change interventions during routine healthcare.
Who can participate?
Participants were identified from a pre-existing sample of healthcare professionals recruited and incentivised by YouGov (a survey panel company) to complete the questionnaire. The sample was intended to be representative of the patient-facing NHS healthcare professional workforce.
What does the study involve?
Participants complete a series of questionnaires about their experiences delivering health behaviour change interventions during routine healthcare, and are then randomly allocated to one of the two groups. Participants in both conditions are presented with a "volitional help sheet" at the end of the questionnaire. The volitional help sheet was based on previous studies that supported implementation intention formation to support health behaviour change. The specific content of the volitional help sheet (i.e. the barriers and enablers to delivering behaviour change interventions) was based on a qualitative study carried out prior to the present study [ref] and the wider literature [refs]. The volitional help sheet consisted of nine critical situations and nine appropriate responses (labelled "solutions"). The barriers to delivering behaviour change items (i.e. "situations") were translated into "if" statements, for example: "If I believe I don't have a good enough relationship with a patient to talk about healthy lifestyle…"; the processes of change items were translated into "then" statements, for example, "then I would refer to a specialist healthcare professional or another member of my team."
Healthcare professionals in the experimental condition were presented with a table with two columns and nine rows. Nine situations (barriers to delivering behaviour change interventions) are presented in the left hand column and nine solutions (or appropriate responses; processes of change) are presented in the right hand column (as separate drop down menus). Participants in this condition are asked to form implementation intentions by linking critical situations with appropriate responses by choosing an appropriate response from the drop down menu for each critical situation. Participants were told they could make as many situation-solution links as they wanted.
Participants in the control condition were presented with a table with two columns containing the same situations and solutions that participants in the experimental group saw. Each situation and solution had a radio button (i.e. a tick box) next to it; participants in the control condition were asked to identify situations and solutions and place a tick next to each one they thought would be useful to them. Therefore, participants in the control condition were not asked to form implementation intentions.
What are the possible benefits and risks of participating?
By taking part, participants will be helping to understand more about brief interventions to support increased delivery of health behaviour change interventions during routine healthcare. By constructing their own "IF-THEN" plans participants are encouraged to construct their own action plans to deal with potential situations where health behaviour change interventions would be beneficial for their patients.
Below are the main ethical issues and how they will be addressed:
Before giving consent (which will be online, as this is an online-based questionnaire), all project participants will be informed that YouGov will ensure that all data collected is stored confidentially in accordance with their privacy policy.
Participants are still free to withdraw themselves/their data until the data is anonymised (one week after the final follow-up questionnaire). There will be no personally identifiable data in the research publication or in the SPSS file that YouGov send to the research team.
Data will not be shared with any researcher or organisation other than in ways detailed on the PIS. Data (which will be anonymised with no identifiable personal information) may be used for secondary analysis within the research team only.
Who is funding the study?
This study was funded by a research grant obtained through the Research England Policy Support Fund.
Study hypothesis
Current study hypothesis as of 17/03/2023:
The condition that completes a volitional help sheet will report higher delivery of health behaviour change interventions at follow-up than the control condition
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet.
Intervention
Participants complete a series of questionnaires about their experiences delivering health behaviour change interventions during routine healthcare and are then randomly assigned to one of the two conditions:
Participants in the experimental condition are presented with a table with two columns and nine rows. Nine situations (barriers to delivering behaviour change interventions) are presented in the left hand column and nine solutions (or appropriate responses; processes of change) are presented in the right hand column (as separate drop down menus). Participants in this condition are asked to form implementation intentions by linking critical situations with appropriate responses by choosing an appropriate response from the drop down menu for each critical situation. Participants are told they can make as many situation-solution links as they wanted.
Participants in the control condition are presented with a table with two columns containing the same situations and solutions that participants in the experimental group see. Each situation and solution has a radio button (i.e. a tick box) next to it; participants in the control condition are asked to identify situations and solutions and place a tick next to each one they think would be useful to them. Therefore, participants in the control condition are not asked to form implementation intentions.
At each time point participants are asked to report whether they have delivered a health behaviour change intervention to patients to see if the intervention has increased delivery of interventions.
Intervention type
Behavioural
Data analysis plan
Randomisation checks
The investigators will run tests on all outcome and demographic variables to determine if there are any baseline differences in any of these between conditions: chi square will be used for categorical variables and MANOVA for continuous variables.
Mixed ANCOVA (intervention condition (2) x time (3) with baseline behaviour plus confounding factors such as age, gender and healthcare professional group as the covariates) will be used to examine associations between experimental condition (experimental versus control group) and reported delivery of behaviour change interventions at each time point. Similar analyses will be performed on secondary outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: Control conditionParticipants in the control condition are presented with a table with two columns containing the same situations and solutions that participants in the experimental group see. Each situation and solution has a radio button (i.e. a tick box) next to it; participants in the control condition are asked to identify situations and solutions and place a tick next to each one they think would be useful to them. Therefore, participants in the control condition are not asked to form implementation intentions. |
| Intervention (volitional help sheet) | Experimental | Behavioral: Volitional help sheetParticipants in the experimental condition are presented with a table with two columns and nine rows. Nine situations (barriers to delivering behaviour change interventions) are presented in the left hand column and nine solutions (or appropriate responses; processes of change) are presented in the right hand column (as separate drop down menus). Participants in this condition are asked to form implementation intentions by linking critical situations with appropriate responses by choosing an appropriate response from the drop down menu for each critical situation. Participants are told they can make as many situation-solution links as they wanted. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Aged 18 and over, good verbal and written understanding of English A healthcare professional working in the United Kingdom's NHS
Key exclusion criteria (1 listed)
- Aged under 18 years of age, poor verbal and written understanding of English Not a healthcare professional working in the United Kingdom's NHS
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Volitional help sheetParticipants are asked to choose from a list of strategies for increasing delivery of behaviour change interventions | Behavioural | Intervention (volitional help sheet) |
| Control conditionParticipants are asked to identify situations and solutions and place a tick next to each one they think would be useful to them. Therefore, participants in the control condition are not asked to form implementation intentions. | Other | Control |
Primary outcome
Delivery of health behaviour change interventions
Time frame: Change from baseline delivery of health behaviour change interventions at 13 months
Participants will be asked to rate the extent to which they delivered behaviour change interventions during routine consultations on 0-100% scale using the item, "Of the service users you see in a typical working week, who you think would benefit, with what proportion do you Make Every Contact Count?"
1 secondary outcome
Capability, opportunity and motivation (based on Capability, Opportunity, Motivation-Behaviour model)
Time frame: Change from baseline Capability, opportunity and motivation at 13 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Background: PubMed 36822594Vogt KS, Johnson J, Conner M, Armitage CJ, Keyworth C. Barriers and enablers to delivering opportunistic behaviour change interventions during the COVID-19 pandemic: A qualitative study in healthcare professionals. Br J Health Psychol. 2023 Sep;28(3):773-792. doi: 10.1111/bjhp.12653. Epub 2023 Feb 23.
- Background: PubMed 27054302Armitage CJ. Evidence that implementation intentions can overcome the effects of smoking habits. Health Psychol. 2016 Sep;35(9):935-43. doi: 10.1037/hea0000344. Epub 2016 Apr 7.
- Intervention pageLink provided by the sponsor.
- Individual participant dataSharing planned: No. Reasonable requests for data will be available from the study team on request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Volitional help sheet in people with Health Behavior, run by University of Leeds at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delivery of health behaviour change interventions (time frame: Change from baseline delivery of health behaviour change interventions at 13 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05820282, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.