InterventionNCT05889936
A Transdiagnostic Intervention for Health-related Habits (LEV)
A study testing Lev in people with Intervention and Life Style, run by Region Stockholm at 1 site in Sweden.
Trial summary
Research problem and specific questions: Health-related habits influences mental and physical health. Still, screening and treatment of health-related habits, which can help to remedy health problems, is not done at all or very superficially. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Intervention, Life Style, Health-Related Behavior
- What is being tested?
- Lev
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSweden
- Study dates
- 25 Jan 2023to 21 Dec 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Study 1 and 2 will include both adults with and without disabilities recruited from different healthcare contexts.
Who cannot join
- Intellectual disability of the degree where the participant is not able to follow the protocol in Lev.
- Insufficient command of the Swedish language/ unable to understand the content.
- Severe psychiatric comorbidity that makes participation difficult (e.g. severe depression, severe suicidality, severe anxiety, ongoing psychosis, manic episode), other circumstances that could make participation hard (e.g. homelessness).
Trial locations and contacts
1 site in 1 country.
About this study
Research problem and specific questions: Health-related habits influences mental and physical health. Still, screening and treatment of health-related habits, which can help to remedy health problems, is not done at all or very superficially. National guidelines emphasize the importance of prioritizing health-related habits, but there is a lack of implemented models. To solve this, the investigators have developed a transdiagnostic, interprofessional material intended for several care settings.
Study 1: Is LEV a feasible intervention in different healthcare contexts? Study 2: A functional roadmap to healthier habits: A thematic analysis of themes form the functional analysis of unhealthy and healthy lifestyle behavior in adults with disabilities This study will use data from study 1.
Read the detailed description
Lev is a brief, transdiagnostic, interprofessional intervention targeting health-related habits that is intended for several care settings.This study will therefore be open for participants recruited from several types of healthcare services in Sweden.
Study 1: The feasibility trial investigates the following questions:
- Eligibility to participate - how many of the healthcare workers that had received training in Lev started using it within 6 months? How many participants that were offered Lev agreed to take part in the intervention?
- What were the reasons for not taking part or not completing Lev? Healthcare workers administering Lev will ask the declining participants for reasons to not take part in the intervention.
- How many sessions and homework assignments did the participants complete? Lev includes screening (Lev-s), three sessions and two pre-specified home assignments. The administrating healthcare worker fills in completed sessions and assignments in the case report form. We will set the time limit to 6 months to complete the three sessions including all homework assignments.
- Were there any differences between healthcare professions regarding how the applied behavioral analysis was performed (e.g., were there any differences regarding strategies suggested to the participant)? During session 2, a functional behavioral analysis is performed to generate strategies to help the participant reach their goal. The investigators will conduct a thematic analysis to identify themes for each healthcare profession administrating Lev. This will answer questions regarding if it is possible to conduct this type of analysis in Lev or if further adjustments are needed.
- Level of acceptability: Was Lev perceived as creditable and satisfactory by healthcare workers and participants? Treatment credibility will be measured before Lev and after the last session for both participants and healthcare workers. Treatment satisfaction will be evaluated after each session and after the intervention is completed. Session evaluations will be done by both participants and healthcare workers.
- Was there any part of Lev that was perceived less satisfactory by participants and healthcare workers? A thematic analysis (Braun et al., 2004) will be performed to extract what was perceived as useful and to identify areas of improvement. This will be done both for participants and the healthcare workers.
- Do the intervention lead to adverse events?
- Do Lev lead to healthier habits?
- To what extent were individual goals met?
- Did Lev lead to increased quality of life?
Study 2:
- What general themes underlying unhealthy and healthy habits can be found in individuals with disabilities?
- How do themes vary for specific living habits?
- How do themes vary for specific disabilities?
- How do themes for questions b and c vary depending on sex?
- Conditions
- Intervention, Life Style, Health-Related Behavior, Feasibility, Quality of Life, Disabilities Physical
- Being tested
- Lev
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevBehavioural
Lev includes three sessions using psychoeducation, motivational interviewing, and applied behavioral analyses. Lev also include two homework assignments. The second session can be repeated if needed. Lev-s and Lev are described in two manuals.
| Study group | Role | What they receive |
|---|---|---|
| Treatment with the Lev-intervention | Experimental | Screening of health-related habits using Lev-s + a three step/session intervention including the standard Lev protocol. Typically given over 10-20 weeks. Receives: Behavioral: Lev |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study 1: Completion rate healthcare workers
how many of the healthcare workers that had received training in Lev started using it within 6 months
Measured: 6 month after completing the training.
Study 1: Completion rate participants
How many of the participants that started using Lev (i.e., completing screening with Lev-s) completed Lev (i.e., completing, 2 out of 3 steps)
Measured: 6 month after starting the screening
Study 1: Level of treatment credibility healthcare workers
Was Lev perceived as creditable and by healthcare workers using Treatment and Credibility Scale. Four items for credibility and one for expectation on a 10 point Likert scale where higher values indicate higher credibility.
Measured: Immediately after the intervention (mean time 20 weeks)
Study 1: Level of treatment credibility participants
Was Lev perceived as creditable and by participants using Treatment and Credibility Scale . Four items for credibility and one for expectation on a 10 point Likert scale where higher values indicate higher credibility.
Measured: Immediately after the intervention (mean time 20 weeks)
Study 1: Treatment satisfaction healthcare workers (individual sessions)
Treatment satisfaction will be evaluated after session 1 using a modified version of the Evaluation Questionnaire including 5 levels where higher levels indicate higher satisfaction.
- The content of this session feels relevant
- The degree of difficulty in conveying the content of the session is at a reasonable level for me as a therapist
- Is there something else you would like to add?
Measured: Immediately after completing session 1. An average of 1-2 months from baseline
Study 1: Treatment satisfaction healthcare workers (individual sessions)
Treatment satisfaction will be evaluated after session 2 using a modified version of the Evaluation Questionnaire including 5 levels where higher levels indicate higher satisfaction.
- The content of this session feels relevant
- The degree of difficulty in conveying the content of the session is at a reasonable level for me as a therapist
- Is there something else you would like to add?
Measured: Immediately after completing session 2. An average of 2-4 months from baseline
Study 1: Treatment satisfaction healthcare workers (individual sessions)
Treatment satisfaction will be evaluated after session 3 using a modified version of the Evaluation Questionnaire including 5 levels where higher levels indicate higher satisfaction.
- The content of this session feels relevant
- The degree of difficulty in conveying the content of the session is at a reasonable level for me as a therapist
- Is there something else you would like to add?
Measured: Immediately after completing session 3. An average of 4-8 months from baseline
Study 1: Treatment satisfaction participants (individual sessions)
Treatment satisfaction will be evaluated after session 1 using a modified version of the Evaluation Questionnaire including 5 levels where higher levels indicate higher satisfaction.
- After the meeting today, my knowledge of how I can change my lifestyle have increased.
- I will benefit from what we talked about during the meeting today
- The content of the meeting felt relevant based on my own experiences
- I understood the advice and strategies I was given that will help my change mine lifestyle habits
- I feel confident in how to use the advice and strategies
- I will use the advice and strategies
- I was listened to, the therapist understood my situation
- I was involved and helped to come up with suggestions for how I can reach my goals
- Is there something else you would like to add?
Measured: After completing the first module in Lev. An average of 1-2 months from baseline
Study 1: Treatment satisfaction participants (individual sessions)
Treatment satisfaction will be evaluated after session 2 using a modified version of the Evaluation Questionnaire including 5 levels where higher levels indicate higher satisfaction.
- After the meeting today, my knowledge of how I can change my lifestyle have increased.
- I will benefit from what we talked about during the meeting today
- The content of the meeting felt relevant based on my own experiences
- I understood the advice and strategies I was given that will help my change mine lifestyle habits
- I feel confident in how to use the advice and strategies
- I will use the advice and strategies
- I was listened to, the therapist understood my situation
- I was involved and helped to come up with suggestions for how I can reach my goals
- Is there something else you would like to add?
Measured: After completing the second module in Lev. An average of 2-4 month from baseline
Study 1: Treatment satisfaction participants (individual sessions)
Treatment satisfaction will be evaluated after session 3 using a modified version of the Evaluation Questionnaire including 5 levels where higher levels indicate higher satisfaction.
- After the meeting today, my knowledge of how I can change my lifestyle have increased.
- I will benefit from what we talked about during the meeting today
- The content of the meeting felt relevant based on my own experiences
- I understood the advice and strategies I was given that will help my change mine lifestyle habits
- I feel confident in how to use the advice and strategies
- I will use the advice and strategies
- I was listened to, the therapist understood my situation
- I was involved and helped to come up with suggestions for how I can reach my goals
- Is there something else you would like to add?
Measured: After completing the third module in Lev. An average of 4-8 month from baseline
Study 1: Treatment satisfaction participants (the whole intervention)
Treatment satisfaction will be evaluated after competing the whole intervention using Patient Evaluation Questionnaire including 5 levels where higher levels indicate higher satisfaction.
- As a whole, the Lev has been clearly focused on how I can live healthier
- My knowledge of how I can have healthier habits has increased
- I can better deal with problems connected to my health-related habits
- I have had the opportunity to contribute opinions during the Lev
- I would consider participating in a similar interventions in the future
The participants also rated the course as a whole following the school grading system ''Failed,'' ''Passed,'' ''Passed with distinction,'' and ''Passed with special
Measured: Directly after completing the last treatment module in LEV (approximately at 10 weeks)
Study 1: Open answer questions regarding Treatment satisfaction measured by The Evaluation Questionnaire
The treatment satisfaction questionnaire also included open questions that will be analyses using a qualitative thematic approach including the following questions:
- I feel that participating in Lev helped me in these ways
- How could the Lev have been better?
- What could I have done differently myself?
- Is there anything else you would like to add?
A qualitative, thematic analysis will be performed to identify more general themes. There is not a template or scale to extract the themes. One rater suggest categories based on the similarity of answers. Another rater organizes the answers in the suggested themes. To be considered a theme, there must be over 85% similarity between raters.
Measured: Directly after completing the last treatment module in LEV (approximately at 20 weeks).
Study 1: Well-being before and after the intervention measures by The Evaluation Questionnaire
("How would you rate your well-being prior to the intervention?", "How would you rate your current well-being") at T1 and T2 on a scale 1-10 (1= very poor, 10= very good)
Measured: Directly after completing the last treatment module in LEV (approximately at 20 weeks)
Study 1: Adverse events after the intervention
Adverse events will be defined as spontaneous oral complaints or instances when patients stated that they experienced negative or unwanted effects during the intervention period.
Serious adverse events will be defined as events that involved hospital care/hospitalization, etc. due to the intervention.
Measured: During the intervention up to week approximately week 20.
Study 2: What general themes underlying unhealthy and healthy habits can be found in individuals with disabilities?
Healthcare workers are instructed to enter what strategies they gave to the participant. Strategies from step 2 (page 16 workbook). The themes are extracted based on answers to the following two questions:
This is what others can do to help me: ....... I can do this myself:...
A qualitative, thematic analysis will be performed to identify more general themes. There is not a template or scale to extract the themes. One rater suggest categories based on the similarity of answers. Another rater organizes the answers in the suggested themes. To be considered a theme, there must be over 85% similarity between raters.
Measured: During the second step in Lev (Approximately at 5-10 weeks)"
Secondary outcomes (6)
Study 1: Quality of life measured with WHOQOL-BREF.
Is Quality of life affected when completing Lev? The intervention group fill in WHOQOL-BREF at baseline and follow-up. 5 level scale where high levels indicate higher quality of life.
Measured: Before and after taking part in Lev (after is approximately at 10-20 weeks
Study 1: Do Lev lead to healthier habits?
The Lev-s will be used to measures living habits before and after taking part in Lev. The scale includes 4 levels where higher levels indicate healthier habits.
Measured: Before and after taking part in Lev (after is approximately at 10-20 weeks
Study 1: To what extent were individual goals met?
During session 1 in the intervention, individual goals are set. The healthcare worker assesses to what extent the goals have been met using the goal attainment scale. 5 point scale where high vales indicate that goals have been reached to a higher extent.
Measured: After completing the whole intervention (approximately at 10-20 weeks
Study 2: How do the themes (e.g., situation, context, behavior, short term gratification) behind unhealthy habits vary for specific living habits?
To understand what what underlying behavior and situations that underlies specific unhealthy habits investigators will conduct exploratory qualitative thematic analysis.
A qualitative, thematic analysis will be performed to identify more general themes. There is not a template or scale to extract the themes. One rater suggest categories based on the similarity of answers. Another rater organizes the answers in the suggested themes. To be considered a theme, there must be over 85% similarity between raters.
Measured: During the second step in Lev (Approximately at 5-10 weeks)
Study 2: How do the themes behind unhealthy habits vary for different disabilities?
To understand what underlying behavior and situations that underlies unhealthy habits in different groups of disabilities we will conduct exploratory qualitative thematic analysis.
A qualitative, thematic analysis will be performed to identify more general themes. There is not a template or scale to extract the themes. One rater suggest categories based on the similarity of answers. Another rater organizes the answers in the suggested themes. To be considered a theme, there must be over 85% similarity between raters.
Measured: During the second step in Lev (Approximately at 5-10 weeks)
Study 2: How do the themes behind unhealthy habits vary depending on sex?
To understand if underlying behavior and situations that underlies unhealthy habits differ depending on sex we will conduct the thematic analysis also separately for sexes.
A qualitative, thematic analysis will be performed to identify more general themes. There is not a template or scale to extract the themes. One rater suggest categories based on the similarity of answers. Another rater organizes the answers in the suggested themes. To be considered a theme, there must be over 85% similarity between raters.
Measured: During the second step in Lev (Approximately at 5-10 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start25 Jan 2023
- Primary completion21 Dec 2023
- Study completion21 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InterventionStudies of the same condition, open and under way.
- More trials run by Region StockholmThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Feasibility trial with pre, peri and post measurements
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Stockholm
- Sponsor type
- Other government
- Collaborators
- Karolinska Institutet
- Responsible party
- Principal investigator, Douglas Sjowall, Region Stockholm
- Investigators
- Douglas Sjöwall, PhD, Principal investigator, Regions StockholmJoakim Lavesson, Bachelor, Study chair, Region Stockholm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05889936
- Sponsor's protocol ID
- The LEV Project
- Status last verified
- May 2024
- First submitted
- 12 Mar 2023
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Douglas Sjöwall will be responsible for granting access to data only to researchers who are participating in the publications for study 1 and 2.
Publications
Sjowall D, Brar A, Fladvad A, Langh U, Hirvikoski T. Feasibility trial of a transdiagnostic individual lifestyle evaluation and intervention (Lev-i) for health behavior change. PLoS One. 2026 Jan 12;21(1):e0339500. doi: 10.1371/journal.pone.0339500. eCollection 2026.
PubMed 41525256
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Transdiagnostic Intervention for Health-related Habits (LEV)
- ClinicalTrials.gov ID
- NCT05889936
- Acronym / sponsor ID
- The LEV Project
- Conditions
- Intervention, Life Style, Health-Related Behavior, Feasibility, Quality of Life, Disabilities Physical
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Region StockholmOther government
- Collaborators
- Karolinska Institutet
- Study start
- 25 Jan 2023 (actual)
- Primary completion
- 21 Dec 2023 (actual)
- Study completion
- 21 Dec 2023 (actual)
- First posted
- 5 Jun 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.
Research problem and specific questions: Health-related habits influences mental and physical health. Still, screening and treatment of health-related habits, which can help to remedy health problems, is not done at all or very superficially. National guidelines emphasize the importance of prioritizing health-related habits, but there is a lack of implemented models. To solve this, the investigators have developed a transdiagnostic, interprofessional material intended for several care settings.
Study 1: Is LEV a feasible intervention in different healthcare contexts? Study 2: A functional roadmap to healthier habits: A thematic analysis of themes form the functional analysis of unhealthy and healthy lifestyle behavior in adults with disabilities This study will use data from study 1.
Detailed description
Lev is a brief, transdiagnostic, interprofessional intervention targeting health-related habits that is intended for several care settings.This study will therefore be open for participants recruited from several types of healthcare services in Sweden.
Study 1: The feasibility trial investigates the following questions:
- Eligibility to participate - how many of the healthcare workers that had received training in Lev started using it within 6 months? How many participants that were offered Lev agreed to take part in the intervention?
- What were the reasons for not taking part or not completing Lev? Healthcare workers administering Lev will ask the declining participants for reasons to not take part in the intervention.
- How many sessions and homework assignments did the participants complete? Lev includes screening (Lev-s), three sessions and two pre-specified home assignments. The administrating healthcare worker fills in completed sessions and assignments in the case report form. We will set the time limit to 6 months to complete the three sessions including all homework assignments.
- Were there any differences between healthcare professions regarding how the applied behavioral analysis was performed (e.g., were there any differences regarding strategies suggested to the participant)? During session 2, a functional behavioral analysis is performed to generate strategies to help the participant reach their goal. The investigators will conduct a thematic analysis to identify themes for each healthcare profession administrating Lev. This will answer questions regarding if it is possible to conduct this type of analysis in Lev or if further adjustments are needed.
- Level of acceptability: Was Lev perceived as creditable and satisfactory by healthcare workers and participants? Treatment credibility will be measured before Lev and after the last session for both participants and healthcare workers. Treatment satisfaction will be evaluated after each session and after the intervention is completed. Session evaluations will be done by both participants and healthcare workers.
- Was there any part of Lev that was perceived less satisfactory by participants and healthcare workers? A thematic analysis (Braun et al., 2004) will be performed to extract what was perceived as useful and to identify areas of improvement. This will be done both for participants and the healthcare workers.
- Do the intervention lead to adverse events?
- Do Lev lead to healthier habits?
- To what extent were individual goals met?
- Did Lev lead to increased quality of life?
Study 2:
- What general themes underlying unhealthy and healthy habits can be found in individuals with disabilities?
- How do themes vary for specific living habits?
- How do themes vary for specific disabilities?
- How do themes for questions b and c vary depending on sex?
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Feasibility trial with pre, peri and post measurements
| Arm | Type | Receives |
|---|---|---|
| Treatment with the Lev-intervention | Experimental | Behavioral: LevScreening of health-related habits using Lev-s + a three step/session intervention including the standard Lev protocol. Typically given over 10-20 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Study 1 and 2 will include both adults with and without disabilities recruited from different healthcare contexts.
Key exclusion criteria (3 listed)
- Intellectual disability of the degree where the participant is not able to follow the protocol in Lev.
- Insufficient command of the Swedish language/ unable to understand the content.
- Severe psychiatric comorbidity that makes participation difficult (e.g. severe depression, severe suicidality, severe anxiety, ongoing psychosis, manic episode), other circumstances that could make participation hard (e.g. homelessness).
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 |
|---|---|---|
| LevLev includes three sessions using psychoeducation, motivational interviewing, and applied behavioral analyses. Lev also include two homework assignments. The second session can be repeated if needed. Lev-s and Lev are described in two manuals. | Behavioural | Treatment with the Lev-intervention |
Primary outcome
Study 1: Completion rate healthcare workers
Time frame: 6 month after completing the training.
how many of the healthcare workers that had received training in Lev started using it within 6 months
Study 1: Completion rate participants
Time frame: 6 month after starting the screening
How many of the participants that started using Lev (i.e., completing screening with Lev-s) completed Lev (i.e., completing, 2 out of 3 steps)
Study 1: Level of treatment credibility healthcare workers
Time frame: Immediately after the intervention (mean time 20 weeks)
Was Lev perceived as creditable and by healthcare workers using Treatment and Credibility Scale. Four items for credibility and one for expectation on a 10 point Likert scale where higher values indicate higher credibility.
Study 1: Level of treatment credibility participants
Time frame: Immediately after the intervention (mean time 20 weeks)
Was Lev perceived as creditable and by participants using Treatment and Credibility Scale . Four items for credibility and one for expectation on a 10 point Likert scale where higher values indicate higher credibility.
Study 1: Treatment satisfaction healthcare workers (individual sessions)
Time frame: Immediately after completing session 1. An average of 1-2 months from baseline
Treatment satisfaction will be evaluated after session 1 using a modified version of the Evaluation Questionnaire including 5 levels where higher levels indicate higher satisfaction. 1. The content of this session feels relevant 2. The degree of difficulty in conveying the content of the session is at a reasonable level for me as a therapist 3. Is there something else you would like to add?
Study 1: Treatment satisfaction healthcare workers (individual sessions)
Time frame: Immediately after completing session 2. An average of 2-4 months from baseline
Treatment satisfaction will be evaluated after session 2 using a modified version of the Evaluation Questionnaire including 5 levels where higher levels indicate higher satisfaction. 1. The content of this session feels relevant 2. The degree of difficulty in conveying the content of the session is at a reasonable level for me as a therapist 3. Is there something else you would like to add?
Study 1: Treatment satisfaction healthcare workers (individual sessions)
Time frame: Immediately after completing session 3. An average of 4-8 months from baseline
Treatment satisfaction will be evaluated after session 3 using a modified version of the Evaluation Questionnaire including 5 levels where higher levels indicate higher satisfaction. 1. The content of this session feels relevant 2. The degree of difficulty in conveying the content of the session is at a reasonable level for me as a therapist 3. Is there something else you would like to add?
Study 1: Treatment satisfaction participants (individual sessions)
Time frame: After completing the first module in Lev. An average of 1-2 months from baseline
Treatment satisfaction will be evaluated after session 1 using a modified version of the Evaluation Questionnaire including 5 levels where higher levels indicate higher satisfaction. 1. After the meeting today, my knowledge of how I can change my lifestyle have increased. 2. I will benefit from what we talked about during the meeting today 3. The content of the meeting felt relevant based on my own experiences 4. I understood the advice and strategies I was given that will help my change mine lifestyle habits 5. I feel confident in how to use the advice and strategies 6. I will use the advice and strategies 7. I was listened to, the therapist understood my situation 8. I was involved and helped to come up with suggestions for how I can reach my goals 9. Is there something else you would like to add?
Study 1: Treatment satisfaction participants (individual sessions)
Time frame: After completing the second module in Lev. An average of 2-4 month from baseline
Treatment satisfaction will be evaluated after session 2 using a modified version of the Evaluation Questionnaire including 5 levels where higher levels indicate higher satisfaction. 1. After the meeting today, my knowledge of how I can change my lifestyle have increased. 2. I will benefit from what we talked about during the meeting today 3. The content of the meeting felt relevant based on my own experiences 4. I understood the advice and strategies I was given that will help my change mine lifestyle habits 5. I feel confident in how to use the advice and strategies 6. I will use the advice and strategies 7. I was listened to, the therapist understood my situation 8. I was involved and helped to come up with suggestions for how I can reach my goals 9. Is there something else you would like to add?
Study 1: Treatment satisfaction participants (individual sessions)
Time frame: After completing the third module in Lev. An average of 4-8 month from baseline
Treatment satisfaction will be evaluated after session 3 using a modified version of the Evaluation Questionnaire including 5 levels where higher levels indicate higher satisfaction. 1. After the meeting today, my knowledge of how I can change my lifestyle have increased. 2. I will benefit from what we talked about during the meeting today 3. The content of the meeting felt relevant based on my own experiences 4. I understood the advice and strategies I was given that will help my change mine lifestyle habits 5. I feel confident in how to use the advice and strategies 6. I will use the advice and strategies 7. I was listened to, the therapist understood my situation 8. I was involved and helped to come up with suggestions for how I can reach my goals 9. Is there something else you would like to add?
Study 1: Treatment satisfaction participants (the whole intervention)
Time frame: Directly after completing the last treatment module in LEV (approximately at 10 weeks)
Treatment satisfaction will be evaluated after competing the whole intervention using Patient Evaluation Questionnaire including 5 levels where higher levels indicate higher satisfaction. 1. As a whole, the Lev has been clearly focused on how I can live healthier 2. My knowledge of how I can have healthier habits has increased 3. I can better deal with problems connected to my health-related habits 4. I have had the opportunity to contribute opinions during the Lev 5. I would consider participating in a similar interventions in the future The participants also rated the course as a whole following the school grading system ''Failed,'' ''Passed,'' ''Passed with distinction,'' and ''Passed with special
Study 1: Open answer questions regarding Treatment satisfaction measured by The Evaluation Questionnaire
Time frame: Directly after completing the last treatment module in LEV (approximately at 20 weeks).
The treatment satisfaction questionnaire also included open questions that will be analyses using a qualitative thematic approach including the following questions: 1. I feel that participating in Lev helped me in these ways 2. How could the Lev have been better? 3. What could I have done differently myself? 4. Is there anything else you would like to add? A qualitative, thematic analysis will be performed to identify more general themes. There is not a template or scale to extract the themes. One rater suggest categories based on the similarity of answers. Another rater organizes the answers in the suggested themes. To be considered a theme, there must be over 85% similarity between raters.
Study 1: Well-being before and after the intervention measures by The Evaluation Questionnaire
Time frame: Directly after completing the last treatment module in LEV (approximately at 20 weeks)
("How would you rate your well-being prior to the intervention?", "How would you rate your current well-being") at T1 and T2 on a scale 1-10 (1= very poor, 10= very good)
Study 1: Adverse events after the intervention
Time frame: During the intervention up to week approximately week 20.
Adverse events will be defined as spontaneous oral complaints or instances when patients stated that they experienced negative or unwanted effects during the intervention period. Serious adverse events will be defined as events that involved hospital care/hospitalization, etc. due to the intervention.
Study 2: What general themes underlying unhealthy and healthy habits can be found in individuals with disabilities?
Time frame: During the second step in Lev (Approximately at 5-10 weeks)"
Healthcare workers are instructed to enter what strategies they gave to the participant. Strategies from step 2 (page 16 workbook). The themes are extracted based on answers to the following two questions: This is what others can do to help me: ....... I can do this myself:... A qualitative, thematic analysis will be performed to identify more general themes. There is not a template or scale to extract the themes. One rater suggest categories based on the similarity of answers. Another rater organizes the answers in the suggested themes. To be considered a theme, there must be over 85% similarity between raters.
6 secondary outcomes
Study 1: Quality of life measured with WHOQOL-BREF.
Time frame: Before and after taking part in Lev (after is approximately at 10-20 weeks
Study 1: Do Lev lead to healthier habits?
Time frame: Before and after taking part in Lev (after is approximately at 10-20 weeks
Study 1: To what extent were individual goals met?
Time frame: After completing the whole intervention (approximately at 10-20 weeks
Study 2: How do the themes (e.g., situation, context, behavior, short term gratification) behind unhealthy habits vary for specific living habits?
Time frame: During the second step in Lev (Approximately at 5-10 weeks)
Study 2: How do the themes behind unhealthy habits vary for different disabilities?
Time frame: During the second step in Lev (Approximately at 5-10 weeks)
Study 2: How do the themes behind unhealthy habits vary depending on sex?
Time frame: During the second step in Lev (Approximately at 5-10 weeks)
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 7 May 2024.
- Derived from this study: PubMed 41525256Sjowall D, Brar A, Fladvad A, Langh U, Hirvikoski T. Feasibility trial of a transdiagnostic individual lifestyle evaluation and intervention (Lev-i) for health behavior change. PLoS One. 2026 Jan 12;21(1):e0339500. doi: 10.1371/journal.pone.0339500. eCollection 2026.
- Individual participant dataSharing planned: No. Douglas Sjöwall will be responsible for granting access to data only to researchers who are participating in the publications for study 1 and 2.
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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.
Douglas Sjöwall, PhD principal investigator
Regions Stockholm
Joakim Lavesson, Bachelor study chair
Region Stockholm
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lev in people with Intervention and Life Style, run by Region Stockholm at 1 site in Sweden.
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 3 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 7 May 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 Sweden. 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?
Study 1: Completion rate healthcare workers (time frame: 6 month after completing the training.). The study lists 15 primary outcomes in all. 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 NCT05889936, which also lists 1 linked publication.
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 7 May 2024.