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RECRUITING

NCT07091032

Building Connections

Sponsor: Massachusetts General Hospital

View on ClinicalTrials.gov

Summary

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.

Official title: Building Connections Between Practices, Patients, and Community Health

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

3600

Start Date

2025-08-07

Completion Date

2029-12-30

Last Updated

2025-11-18

Healthy Volunteers

Conditions

Cancer Colorectal Cancer Cervix Depression, Anxiety Obesity

Interventions

OTHER

Treatment as Usual

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

BEHAVIORAL

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.

Inclusion Criteria: * The general inclusion criteria involve being 18+, speaking English or Spanish, and meeting one or more of the following 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: Colon Cancer (CRC) inclusion criteria: Patients aged 45-75 who are due for screenings, with last FIT longer than 1 year ago, last colonoscopy longer than 10 years ago, and last Cologuard longer than 3 years ago. And/or Cervical cancer inclusion criteria: Women and patients with a cervix aged 30-65 who are due for screening: with last pap longer than 3 years ago; last co-test longer than 5 years ago; last primary HPV screening longer than 5 years ago. Mental health: Patients with moderate to severe depression or anxiety symptoms. Exclusion Criteria: * The general exclusion criteria are: those with current pregnancy, or the participant is cognitively impaired, not having a visit to the primary care clinic in the prior 2 years, and speaking a language other than English or Spanish. Exclusion criteria for obesity intervention: had prior metabolic or bariatric surgery or planning to have this surgery in the next 6 months, currently enrolled in an intensive lifestyle program. Exclusion criteria for cancer screening intervention include: Colon Cancer (CRC) exclusion criteria: has colorectal cancer documented in the problem list; has ulcerative colitis or Crohn's disease documented in the problem list Cervical cancer exclusion criteria: has cervical cancer documented in the problem list; has had a prior hysterectomy. Exclusion criteria for mental health: include patients with active suicidality, active substance use disorder, a history of schizophrenia or bipolar disorder, or who are already receiving behavioral health care (therapy sessions in the past 3 months or an appointment upcoming in the next month).

Locations (1)

Disparities Research Unit, Massachusetts General Hospital

Boston, Massachusetts, United States