A Group Intervention for Promoting Health-related Habits (LEV-G)

Disability Physical Clinical Trial

Official title:

A Group Intervention for Promoting Health-related Habits in Individuals With Disabilities (LEV-G)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06404632
• Other study ID #: The LEV Project (group)
• Status: Recruiting
• Phase: N/A
• Start date: April 12, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2024
• Source: Region Stockholm
• Contact: Douglas Sjöwall, PhD
• Phone: +46 (0)739568658
• Email: douglas.sjowall[@]ki.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Health-related habits influences mental and physical health. Still, treatment of health-related habits, which can help to remedy health problems, is often not done at all or very superficially. Multiple 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. The Lev-g intervention is intended for groups. There is also an individual version of Lev that has its on registration in Clinical Trails.

Description:

Lev is a brief, transdiagnostic, interprofessional intervention targeting health-related habits that is intended for several care settings. The main population intended is individuals with neurodevelopmental disorders or parents or close relations to children with disabilities. 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:

Completion: How many participants that started Lev completed the intervention? What were the reasons for not not completing Lev? How many sessions did the participants complete? Lev includes screening (Lev-s), three sessions + one booster session.

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.

Do the intervention lead to adverse events? To what extent were individual goals met?

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 80 Years

Eligibility

Inclusion Criteria:

• both adults with and without disabilities recruited from different healthcare contexts.

Exclusion Criteria:

• 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).

Related Conditions & MeSH terms

• Acceptability of Health Care
• Disabilities Mental
• Disability Physical
• Life Style

Intervention

Behavioral:
• Lev-g
Lev-g includes three sessions + a booster session using psychoeducation, motivational interviewing, and applied behavioral analyses. Lev-g is done in groups to enable support and tips from others.

Locations

Country	Name	City	State
Sweden	Region Stockholm	Stockholm	Stockholm, Sweden

Sponsors (3)

Lead Sponsor	Collaborator
Region Stockholm	Karolinska Institutet, Promobilia Foundation

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Completion rate participants	How many of the participants that started using Lev (i.e., completing screening with Lev-s) completed Lev (i.e., completing, 3 out of 4 session)	within 3-4 months
Secondary	Level of treatment credibility participants	Was Lev perceived as creditable 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.	Before and after taking part in Lev (after refers to completing the three sessions i.e, not including the booster session after three months). I.e within 6 weeks
Secondary	Level of treatment credibility healthcare workers	Was Lev perceived as creditable 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.	Before and after taking part in Lev (after refers to completing the three sessions i.e, not including the booster session after three months)I.e within 6 weeks
Secondary	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?	After completing the first session in Lev. An average of 1-2 weeks from baseline
Secondary	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?	After completing the second session in Lev. An average of 2-3 weeks from baseline
Secondary	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?	After completing the third session in Lev. An average of 3-4 weeks from baseline
Secondary	Treatment satisfaction participants (individual sessions)	Treatment satisfaction will be evaluated after booster session 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?	After completing the booster session in Lev. An average of 3-4 month from baseline
Secondary	Treatment satisfaction participants (the three sessions)	Treatment satisfaction will be evaluated after competing the three sessions 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	Directly after completing the last treatment module in LEV (approximately at 3-4 weeks from baseline)]
Secondary	Treatment satisfaction participants (the whole intervention including the booster session)	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	Directly after completing the last treatment module in LEV (approximately at 3-4 month from baseline)]
Secondary	Open answer questions regarding Treatment satisfaction measured by The Evaluation Questionnaire for participants	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.; 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	Directly after completing the third session in LEV (approximately at 3-4 weeks from baseline)]
Secondary	Open answer questions regarding Treatment satisfaction measured by The Evaluation Questionnaire for participants	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.; 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	Directly after completing the booster session in LEV (approximately at 3-4 month from baseline)]
Secondary	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?	After completing the first session in Lev. An average of 1-2 weeks from baseline
Secondary	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?	After completing the first session in Lev. An average of 2-3 weeks from baseline
Secondary	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?	After completing the first session in Lev. An average of 3-4 weeks from baseline
Secondary	Treatment satisfaction healthcare workers (individual sessions)	Treatment satisfaction will be evaluated after the booster session 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?	After completing the first session in Lev. An average of 3-4 months from baseline
Secondary	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)	Directly after completing the third treatment module in LEV (approximately at 3-4 weeks)
Secondary	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)	Directly after completing the booster session module in LEV (approximately at 3-4 months)
Secondary	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.	During the intervention up to week approximately 3-4 months
Secondary	To what extent were individual goals met?	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.	Directly after completing the third treatment module in LEV (approximately at 3-4 weeks)
Secondary	To what extent were individual goals met?	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.	Directly after completing the booster session module in LEV (approximately at 3-4 months)
Secondary	Self-efficacy for promoting health behaviors for their children	Participants are asked to assess self-efficacy for promoting health behaviors using the "Parental self-efficacy for healthy dietary and physical activity behaviors in preschool children (PDAP) including 24 items on a 0-10 point scale where high values indicate higher self-efficacy	Directly after completing the third session in LEV (approximately at 3-4 weeks)
Secondary	Self-efficacy for promoting health behaviors for their children	Participants are asked to assess self-efficacy for promoting health behaviors using the "Parental self-efficacy for healthy dietary and physical activity behaviors in preschool children (PDAP) including 24 items on a 0-10 point scale where high values indicate higher self-efficacy	Directly after completing the booster session in LEV (approximately at 3-4 month)
Secondary	Do Lev lead to healthier habits?	The Lev-s will be used to measure diet and physical activity before and after taking part in Lev. The scale includes 4 levels where higher levels indicate healthier habits.	Before and after taking part in Lev (after is after the third, 3-4 weeks, as wells as after the booster session, 3-4 month)