The Use of Brief Motivational Interviewing in Community Health Centers.

NCT ID: NCT06742645

Last Updated: 2024-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

304 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-09

Study Completion Date

2026-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Subjects

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Motivational Interviewing

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Community House Borgo Reno

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

Group Type EXPERIMENTAL

Brief Motivational Interviewing

Intervention Type BEHAVIORAL

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.

Community House Navile

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

Group Type ACTIVE_COMPARATOR

Standard of Care (SOC)

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Brief Motivational Interviewing

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.

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

* not resident in the territory of the AUSL of Bologna
* age \<18 years

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Azienda Usl di Bologna

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Dipartimento Sanità Pubblica

Bologna, IT, Italy

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Italy

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Paolo Pandolfi, Doctor

Role: CONTACT

Phone: 0039516224423

Email: [email protected]

Muriel Assunta Musti, Statistic

Role: CONTACT

Phone: 003951286 9397

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Paolo Pandolfi, Doctor

Role: primary

Paolo Pandolfi, Doctor

Role: backup

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 33866487 (View on PubMed)

Pedamallu 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.

Reference Type BACKGROUND
PMID: 35943775 (View on PubMed)

Rogers 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.

Reference Type BACKGROUND

Bandura A., Self-efficacy mechanism in human agency. American Psychologist, 1982; 37: 122-47

Reference Type BACKGROUND

Miller WR, Rollnick S. Motivational Interviewing. Helping people change. Guilford Press, New York, 1991.

Reference Type BACKGROUND

Prochaska JO. Di Clemente CC. Transtheorical therapy: toward a more integrative model of change. Psychotherapy, theory, research and practice 1982.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 15140454 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

24014 - 81-2024-SPER-AUSLBO

Identifier Type: -

Identifier Source: org_study_id