Recruiting

Health Interventions

Sponsor:

Massachusetts General Hospital

Code:

NCT07091032

Conditions

Cancer Colorectal

Cancer Cervix

Depression, Anxiety

Obesity

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Treatment as Usual

Building Connections Intervention

Study Details

Brief 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.

Conditions

Cancer Colorectal

Cancer Cervix

Depression, Anxiety

Obesity

Study ID

NCT07091032

Start date

Aug 7, 2025

Status verified date

Nov, 2025

Completion date

Dec 30, 2029

Anticipated

Primary completion date

Dec 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

3600 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Prevention

Interventions and Outcome Measures

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.

Interventions

Treatment as Usual

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

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.

Primary outcome measure

  • Self-reported height/weight for Body Mass Index (BMI) [ Time Frame: Baseline, month 6, and month 12 ]
  • Rate of cancer screening test completion [ Time Frame: Baseline, month 6, month 12 ]
  • Computerized Adaptive Testing (CAT) of Mental Health (MH) [ Time Frame: Baseline, month 6, month 12 ]

Central Contacts and Locations

Central contacts

Margarita Alegria, Ph.D.

617-724-1237malegria@mgh.harvard.edu

Sheri Markle, MIA

617-724-1237smarkle@mgh.harvard.edu

Locations

Disparities Research Unit, Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Nov 18, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2025-11-18.