Healthy SubjectsBMICHCNCT06742645
The Use of Brief Motivational Interviewing in Community Health Centers.
A study testing Brief Motivational Interviewing in people with Healthy Subjects, run by Azienda Usl di Bologna at 1 site in Italy.
Trial summary
The research project aims to detect the effect of the Brief Motivational Interview (BMI) on the motivation to change risky behaviors and the adoption of healthy lifestyles by citizens attending Community Health Centers (CdC). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Brief Motivational Interviewing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 304 participants
- Where
- 1 siteItaly
- Study dates
- 9 Dec 2024to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- first visit to the Cardiology or Endocrinology/Diabetology or Rheumatology or Basic Dietetics services or other medical specialties of the Borgo-Reno or Navile Community Home or referred to them.
- resident in the AUSL of Bologna
- age ≥18 years
Who cannot join
- second or more visits to the Cardiology or Endocrinology/Diabetology or Rheumatology or Basic Dietetics services, or other medical specialties of the Borgo-Reno or Navile Community House or referred to them.
- first visit to a service not indicated in the inclusion criteria
- not resident in the territory of the AUSL of Bologna
- age <18 years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Dipartimento Sanità Pubblica
Bologna, IT, 40100
Paolo Pandolfi, Doctor, 0039516224423, paolo.pandolfi@ausl.bologna.it
Paolo Pandolfi, Doctor
About this study
Official title: The Use of Brief Motivational Interviewing in Community Health Centers. Controlled Trial on Quality of Life and Perceived Health Status
The research project aims to detect the effect of the Brief Motivational Interview (BMI) on the motivation to change risky behaviors and the adoption of healthy lifestyles by citizens attending Community Health Centers (CdC). The controlled, multicenter, prospective design study involves the enrollment of 304 people, with 152 at the Borgo Reno CdC and 152 at the Navile CdC.
Read the detailed description
The study will include 152 citizens who use the services of the Borgo Reno Community Health Center and 152 citizens from the Navile Community Health Center. Eligible participants will be identified with the help of specialist medical staff and nursing staff at the facility. Once an eligible participant is identified, the Brief Motivational Interview (BMI) can be conducted during regular institutional activities (if the operator on duty at that time is trained to conduct the BMI and after obtaining informed consent and completing the SF-36 questionnaire) or by scheduling an appointment with the nursing and/or facility staff for a dedicated BMI clinic.
Students from the degree courses in "Psychology," "Human Nutrition, Wellness, and Health," and "Wellness, Sport, and Health," who are appropriately trained and authorized, will contribute to the research study by providing all necessary information. Participants in the experimental group who are given an appointment will sign the informed consent for participation and consent for the processing of personal and sensitive data. They will also receive a letter for their general practitioner explaining the study procedures. Inclusion and exclusion criteria will be assessed. If the criteria are met, the citizen will be included in the study.
Citizens enrolled at the Borgo Reno Community Health Center will be assigned to the experimental group (with intervention), while those enrolled at the Navile Community Health Center will be part of the control group (without intervention). A clinic will be dedicated to this study, where professionals (specialist/home nursing staff, dietitians, physiotherapists, IFeC) from the Community Health Center who have received training from the CCM course on Brief Motivational Interviewing will conduct the sessions.
- Conditions
- Healthy Subjects
- Being tested
- Brief Motivational Interviewing, Standard of Care (SOC)
- Keywords
- Motivational Interviewing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Motivational InterviewingBehavioural
Brief Motivational Interviewing (BMI), the object of the training and of the present research study, is an interview methodology that includes the intervention on the motivation to change of subjects with risky behaviors for their health, in order to obtain changes in their lifestyle and maintain correct behaviors for health over time (1). The BMI is mainly based on the Transtheoretical Model of Change by Di Clemente CC. and Prochaska JO (2).
In particular, the BMI has been defined by its creators, Miller and Rollnick, as "a collaborative style of conversation aimed at strengthening motivation and commitment to change" (3), both through defined attitudes, strategies and techniques, and through the exploration of ambivalence or internal fracture, which together with availability and a sense of self-efficacy (4) provides a framework of personal motivation.
Standard of Care (SOC)Behavioural
Standard of Care (SOC) - The health workers of the Navile Community House carry out the outpatient visit and after having identified the health problems they propose a possible treatment. The users belonging to the control arm will complete the SF-36 questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Community House Borgo Reno | Experimental | The health workers of the Borgo Reno Community House perform the outpatient visit and after having identified the health problems they propose a possible treatment. Subsequently, the citizen included in the study is subjected to the intervention, short motivational interview (BMI). By putting the relationship, listening, assertive communication, motivation and direct involvement of the patient in the treatment path in the foreground, the trained workers conduct the BMI to motivate the users of the various services to improve their lifestyles. Objectives to be achieved within six months will be agreed upon. The short motivational interview lasts approximately 15 minutes Receives: Behavioral: Brief Motivational Interviewing |
| Community House Navile | Active comparator | The health workers of the Navile Community House perform the outpatient visit and after having identified the health problems they propose a possible treatment. The users belonging to the control arm will complete the SF-36 questionnaire Send feedback Receives: Behavioral: Standard of Care (SOC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome Measure
The 36-item Short Form Health Survey (SF-36) is a 36-item patient-reported questionnaire that covers eight health domains: physical functioning (10 items), bodily pain (2 items), role limitations due to physical health problems (4 items), role limitations due to personal or emotional problems (4 items), emotional well-being (5 items), social functioning (2 items), energy/fatigue (4 items), and general health perceptions (5 items). Scores for each domain range from 0 to 100, with a higher score defining a more favorable health state.
Measured: From enrollment to the end of treatment at 6 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2024
- Study start9 Dec 2024
- Primary completion30 Sep 2025 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Healthy SubjectsStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- INTERVENTION The health workers of the Borgo Reno Community House perform the outpatient visit and after having identified the health problems they propose a possible treatment. Subsequently, the citizen included in the study is subjected to the intervention, short motivational interview (BMI). By putting the relationship, listening, assertive communication, motivation and direct involvement of the patient in the treatment path in the foreground, the trained workers conduct the BMI to motivate the users of the various services to improve their lifestyles. Objectives to be achieved within six months will be agreed upon. The short motivational interview lasts approximately 15 minutes COMPARISON The health workers of the Navile Community House perform the outpatient visit and after having identified the health problems they propose a possible treatment. The users belonging to the control arm will complete the SF-36 questionnaire
- Masking
- None (open label)
- Enrolment
- 304 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Usl di Bologna
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06742645
- Sponsor's protocol ID
- 24014 - 81-2024-SPER-AUSLBO
- Acronym
- BMICHC
- Status last verified
- Dec 2024
- First submitted
- 11 Dec 2024
- Last updated
- 19 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Ghizzardi G, Arrigoni C, Dellafiore F, Vellone E, Caruso R. Efficacy of motivational interviewing on enhancing self-care behaviors among patients with chronic heart failure: a systematic review and meta-analysis of randomized controlled trials. Heart Fail Rev. 2022 Jul;27(4):1029-1041. doi: 10.1007/s10741-021-10110-z. Epub 2021 Apr 17.
PubMed 33866487Pedamallu H, Ehrhardt MJ, Maki J, Carcone AI, Hudson MM, Waters EA. Technology-Delivered Adaptations of Motivational Interviewing for the Prevention and Management of Chronic Diseases: Scoping Review. J Med Internet Res. 2022 Aug 9;24(8):e35283. doi: 10.2196/35283.
PubMed 35943775Rogers CR. A theory of therapy, personality and interpersonal relationships as developed in the client-centered framework. In: Koch S. (ed). Psychology: a study of a science, vol. III. Formulations of the person in the social context. McGraw Hill, New York, 1959.
Bandura A., Self-efficacy mechanism in human agency. American Psychologist, 1982; 37: 122-47
Miller WR, Rollnick S. Motivational Interviewing. Helping people change. Guilford Press, New York, 1991.
Prochaska JO. Di Clemente CC. Transtheorical therapy: toward a more integrative model of change. Psychotherapy, theory, research and practice 1982.
Britt E, Hudson SM, Blampied NM. Motivational interviewing in health settings: a review. Patient Educ Couns. 2004 May;53(2):147-55. doi: 10.1016/S0738-3991(03)00141-1.
PubMed 15140454
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Brief Motivational Interviewing in Community Health Centers. Controlled Trial on Quality of Life and Perceived Health Status
- ClinicalTrials.gov ID
- NCT06742645
- Acronym / sponsor ID
- BMICHC / 24014 - 81-2024-SPER-AUSLBO
- Conditions
- Healthy Subjects
- Keywords
- Motivational Interviewing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 304 participants (estimated)
- Lead sponsor
- Azienda Usl di BolognaOther government
- Study start
- 9 Dec 2024 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 19 Dec 2024 (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 research project aims to detect the effect of the Brief Motivational Interview (BMI) on the motivation to change risky behaviors and the adoption of healthy lifestyles by citizens attending Community Health Centers (CdC). The controlled, multicenter, prospective design study involves the enrollment of 304 people, with 152 at the Borgo Reno CdC and 152 at the Navile CdC.
Detailed description
The study will include 152 citizens who use the services of the Borgo Reno Community Health Center and 152 citizens from the Navile Community Health Center. Eligible participants will be identified with the help of specialist medical staff and nursing staff at the facility. Once an eligible participant is identified, the Brief Motivational Interview (BMI) can be conducted during regular institutional activities (if the operator on duty at that time is trained to conduct the BMI and after obtaining informed consent and completing the SF-36 questionnaire) or by scheduling an appointment with the nursing and/or facility staff for a dedicated BMI clinic.
Students from the degree courses in "Psychology," "Human Nutrition, Wellness, and Health," and "Wellness, Sport, and Health," who are appropriately trained and authorized, will contribute to the research study by providing all necessary information. Participants in the experimental group who are given an appointment will sign the informed consent for participation and consent for the processing of personal and sensitive data. They will also receive a letter for their general practitioner explaining the study procedures. Inclusion and exclusion criteria will be assessed. If the criteria are met, the citizen will be included in the study.
Citizens enrolled at the Borgo Reno Community Health Center will be assigned to the experimental group (with intervention), while those enrolled at the Navile Community Health Center will be part of the control group (without intervention). A clinic will be dedicated to this study, where professionals (specialist/home nursing staff, dietitians, physiotherapists, IFeC) from the Community Health Center who have received training from the CCM course on Brief Motivational Interviewing will conduct the sessions.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- INTERVENTION The health workers of the Borgo Reno Community House perform the outpatient visit and after having identified the health problems they propose a possible treatment. Subsequently, the citizen included in the study is subjected to the intervention, short motivational interview (BMI). By putting the relationship, listening, assertive communication, motivation and direct involvement of the patient in the treatment path in the foreground, the trained workers conduct the BMI to motivate the users of the various services to improve their lifestyles. Objectives to be achieved within six months will be agreed upon. The short motivational interview lasts approximately 15 minutes COMPARISON The health workers of the Navile Community House perform the outpatient visit and after having identified the health problems they propose a possible treatment. The users belonging to the control arm will complete the SF-36 questionnaire
| Arm | Type | Receives |
|---|---|---|
| Community House Borgo Reno | Experimental | Behavioral: Brief Motivational InterviewingThe health workers of the Borgo Reno Community House perform the outpatient visit and after having identified the health problems they propose a possible treatment. Subsequently, the citizen included in the study is subjected to the intervention, short motivational interview (BMI). By putting the relationship, listening, assertive communication, motivation and direct involvement of the patient in the treatment path in the foreground, the trained workers conduct the BMI to motivate the users of the various services to improve their lifestyles. Objectives to be achieved within six months will be agreed upon. The short motivational interview lasts approximately 15 minutes |
| Community House Navile | Active comparator | Behavioral: Standard of Care (SOC)The health workers of the Navile Community House perform the outpatient visit and after having identified the health problems they propose a possible treatment. The users belonging to the control arm will complete the SF-36 questionnaire Send feedback |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- first visit to the Cardiology or Endocrinology/Diabetology or Rheumatology or Basic Dietetics services or other medical specialties of the Borgo-Reno or Navile Community Home or referred to them.
- resident in the AUSL of Bologna
- age ≥18 years
Key exclusion criteria (4 listed)
- second or more visits to the Cardiology or Endocrinology/Diabetology or Rheumatology or Basic Dietetics services, or other medical specialties of the Borgo-Reno or Navile Community House or referred to them.
- first visit to a service not indicated in the inclusion criteria
- not resident in the territory of the AUSL of Bologna
- age <18 years
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 |
|---|---|---|
| Brief Motivational InterviewingBrief Motivational Interviewing (BMI), the object of the training and of the present research study, is an interview methodology that includes the intervention on the motivation to change of subjects with risky behaviors for their health, in order to obtain changes in their lifestyle and maintain correct behaviors for health over time (1). The BMI is mainly based on the Transtheoretical Model of Change by Di Clemente CC. and Prochaska JO (2). In particular, the BMI has been defined by its creators, Miller and Rollnick, as "a collaborative style of conversation aimed at strengthening motivation and commitment to change" (3), both through defined attitudes, strategies and techniques, and through the exploration of ambivalence or internal fracture, which together with availability and a sense of self-efficacy (4) provides a framework of personal motivation. | Behavioural | Community House Borgo Reno |
| Standard of Care (SOC)Standard of Care (SOC) - The health workers of the Navile Community House carry out the outpatient visit and after having identified the health problems they propose a possible treatment. The users belonging to the control arm will complete the SF-36 questionnaire | Behavioural | Community House Navile |
Primary outcome
Primary Outcome Measure
Time frame: From enrollment to the end of treatment at 6 MONTHS
The 36-item Short Form Health Survey (SF-36) is a 36-item patient-reported questionnaire that covers eight health domains: physical functioning (10 items), bodily pain (2 items), role limitations due to physical health problems (4 items), role limitations due to personal or emotional problems (4 items), emotional well-being (5 items), social functioning (2 items), energy/fatigue (4 items), and general health perceptions (5 items). Scores for each domain range from 0 to 100, with a higher score defining a more favorable health state.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2024.
- Background: PubMed 33866487Ghizzardi G, Arrigoni C, Dellafiore F, Vellone E, Caruso R. Efficacy of motivational interviewing on enhancing self-care behaviors among patients with chronic heart failure: a systematic review and meta-analysis of randomized controlled trials. Heart Fail Rev. 2022 Jul;27(4):1029-1041. doi: 10.1007/s10741-021-10110-z. Epub 2021 Apr 17.
- Background: PubMed 35943775Pedamallu H, Ehrhardt MJ, Maki J, Carcone AI, Hudson MM, Waters EA. Technology-Delivered Adaptations of Motivational Interviewing for the Prevention and Management of Chronic Diseases: Scoping Review. J Med Internet Res. 2022 Aug 9;24(8):e35283. doi: 10.2196/35283.
- BackgroundRogers CR. A theory of therapy, personality and interpersonal relationships as developed in the client-centered framework. In: Koch S. (ed). Psychology: a study of a science, vol. III. Formulations of the person in the social context. McGraw Hill, New York, 1959.
- BackgroundBandura A., Self-efficacy mechanism in human agency. American Psychologist, 1982; 37: 122-47
- BackgroundMiller WR, Rollnick S. Motivational Interviewing. Helping people change. Guilford Press, New York, 1991.
- BackgroundProchaska JO. Di Clemente CC. Transtheorical therapy: toward a more integrative model of change. Psychotherapy, theory, research and practice 1982.
- Background: PubMed 15140454Britt E, Hudson SM, Blampied NM. Motivational interviewing in health settings: a review. Patient Educ Couns. 2004 May;53(2):147-55. doi: 10.1016/S0738-3991(03)00141-1.
- Individual participant dataSharing planned: Yes
Related trials for Healthy Subjects
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Motivational Interviewing in people with Healthy Subjects, run by Azienda Usl di Bologna at 1 site in Italy.
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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 19 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paolo Pandolfi, Doctor (0039516224423, paolo.pandolfi@ausl.bologna.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome Measure (time frame: From enrollment to the end of treatment at 6 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 NCT06742645, which also lists 7 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 19 Dec 2024.