Building Connections

NCT ID: NCT07091032

Last Updated: 2025-11-18

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

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

3600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-07

Study Completion Date

2029-12-30

Brief Summary

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Building Connections seeks to address health and healthcare inequities in socially vulnerable communities. The project will be conducted in collaboration with clinical practices across Massachusetts, serving a diverse population heavily represented in Community Clinics and Health Centers. The program will offer evidence-based interventions in obesity/weight management, cancer screening, and mental health.

Detailed Description

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Conditions

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Cancer Colorectal Cancer Cervix Depression, Anxiety Obesity

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Treatment as Usual (TAU)

This comparison condition will involve treatment as usual at the clinical sites.

Group Type ACTIVE_COMPARATOR

Treatment as Usual

Intervention Type OTHER

This is the comparison condition, in which participants will receive treatment as usual for their conditions at the clinic.

Intervention

The Building Connections intervention combines 3 interventions for Obesity, Cancer Screening, and Mental Health.

Group Type EXPERIMENTAL

Building Connections Intervention

Intervention Type BEHAVIORAL

The combined Building Connections intervention incorporates three areas. Participants take part in those for which they are eligible. The obesity/weight management intervention offers coaching and support for education on evidence-based anti-obesity medications (AOM) and a lifestyle behavioral intervention offered by Community Health Workers focused on diet and physical activity. The cancer screening intervention focuses on developing workflows and systems to offer a CHW-delivered population-based intervention to improve colorectal and cervical cancer, focusing on newer screening modalities and monitoring adherence for individuals with a positive screening test result. The mental health intervention uses the evidence-based Strong Minds intervention, a 10-session psychoeducational program provided by trained community health workers with clinical supervision. The skills-based intervention uses an integrative approach aimed at improving depression, anxiety, and trauma-related symptoms.

Interventions

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Treatment as Usual

This is the comparison condition, in which participants will receive treatment as usual for their conditions at the clinic.

Intervention Type OTHER

Building Connections Intervention

The combined Building Connections intervention incorporates three areas. Participants take part in those for which they are eligible. The obesity/weight management intervention offers coaching and support for education on evidence-based anti-obesity medications (AOM) and a lifestyle behavioral intervention offered by Community Health Workers focused on diet and physical activity. The cancer screening intervention focuses on developing workflows and systems to offer a CHW-delivered population-based intervention to improve colorectal and cervical cancer, focusing on newer screening modalities and monitoring adherence for individuals with a positive screening test result. The mental health intervention uses the evidence-based Strong Minds intervention, a 10-session psychoeducational program provided by trained community health workers with clinical supervision. The skills-based intervention uses an integrative approach aimed at improving depression, anxiety, and trauma-related symptoms.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

Obesity: Patients with a body mass index of 30 kg/m2 or greater (i.e., obese category).

Cancer screening: Average-risk patients without recommended colorectal or cervical cancer screenings for their age group and biological sex. Specifically:


And/or


Mental health: Patients with moderate to severe depression or anxiety symptoms.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Margarita Alegria, PhD

Chief, Disparities Research Unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Disparities Research Unit, Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Margarita Alegria, Ph.D.

Role: CONTACT

617-724-1237

Sheri Markle, MIA

Role: CONTACT

617-724-1237

Other Identifiers

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2025P000661

Identifier Type: -

Identifier Source: org_study_id

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