Building Connections

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT07091032
Status
Recruiting

Conditions

  • Cancer Cervix
  • Cancer Colorectal
  • Depression, Anxiety
  • Obesity

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Treatment as Usual — OTHER
    This is the comparison condition, in which participants will receive treatment as usual for their conditions at the clinic.
  • Building Connections Intervention — 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.

Study Details

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.

Key Dates

Start date
Aug 7, 2025
Status verified
Nov 2025
Primary completion
Dec 30, 2029
Completion
Dec 30, 2029

Study Design

Enrollment
3,600 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Treatment as Usual (TAU)
    This comparison condition will involve treatment as usual at the clinical sites.
  • Experimental: Intervention
    The Building Connections intervention combines 3 interventions for Obesity, Cancer Screening, and Mental Health.

Primary Outcome Measure

Self-reported height/weight for Body Mass Index (BMI) [ Time Frame: Baseline, month 6, and month 12 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Disparities Research Unit, Massachusetts General HospitalBostonMassachusetts02114-

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