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NCT Number: NCT06742645

The Use of Brief Motivational Interviewing in Community Health Centers.

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dipartimento Sanità Pubblica

Bologna, IT, 40100, Italy

Location status: Recruiting

Location contact

Paolo Pandolfi, Doctor

CONTACT

[email protected]

0039516224423

Paolo Pandolfi, Doctor

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

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.
  • first visit to a service not indicated in the inclusion criteria
  • not resident in the territory of the AUSL of Bologna
  • age <18 years

Treatment and study plan

Brief Motivational Interviewing

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.

Standard of Care (SOC)

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

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Muriel Assunta Musti, Statistic

CONTACT

[email protected]

003951286 9397

Paolo Pandolfi, Doctor

CONTACT

[email protected]

0039516224423

Sponsors and collaborators

Lead sponsor

Azienda Usl di Bologna

Other Gov

Registry information

Official study title

The Use of Brief Motivational Interviewing in Community Health Centers. Controlled Trial on Quality of Life and Perceived Health Status

Acronym: BMICHC

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Dec 19, 2024
Registry last updated
Dec 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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