Building Connections

Not Applicable

Not yet recruiting

• Conditions: Cancer Colorectal; Cancer Cervix; Depression, Anxiety; Obesity

• Registration Number: NCT07091032
• Lead Sponsor: Massachusetts General Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-15
• Study Start: 2025-07-21
• Study First Submitted QC: 2025-07-21
• Last Update Submitted: 2025-07-21
• Study First Posted: 2025-07-29
• Last Update Posted: 2025-07-29
• Primary Completion: 2029-12-30
• Study Completion: 2029-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 3600

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: currently taking an anti-obesity medication (AOM); 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

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Self-reported height/weight for Body Mass Index (BMI)	Baseline, month 6, and month 12	Calculation of Body Mass Index
Computerized Adaptive Testing (CAT) of Mental Health (MH)	Baseline, month 6, month 12	CAT-MH Depression/MDD and Anxiety
Rate of cancer screening test completion	Baseline, month 6, month 12	Number of eligible people who complete a screening test out of total eligible

Secondary Outcome Measures

Name	Time	Method
World Health Organization Disability Assessment Schedule (WHODAS) 2.0	Baseline, month 6, month 12	The World Health Organization Disability Assessment Schedule (WHODAS) 2.0 is a 12-item measure of difficulties performing activities in six domains of daily life (1 'None' to 5 'Extreme or cannot do'). Total scores are calculated as the sum of all items (range 12 to 60) and higher scores indicate higher disability.
Rapid Prime Diet Quality Score Screener (rPDQS)	Baseline, month 6, month 12	The Rapid Prime Diet Quality Score Screener (rPDQS) is a 13-item measure about past month consumption of food, categorized by type (less than once per week to twice per day or more). A logic system assigns points to each item (0 'unhealthy dietary pattern' to 2 'healthy dietary pattern'). Total scores are calculated as the sum of all items (range 0 to 26), and higher scores represent healthier dietary patterns.
Cancer screening test type	Baseline, month 6, month 12	Screening test type used by people who completed a screening

Trial Locations

Locations (1)

Disparities Research Unit, Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States