Building Connections

NCT07091032 | Recruiting

• 1 other identifier: 2025P000661
• Study Type: interventional
• Target: 3,600
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• Self-reported height/weight for Body Mass Index (BMI)

  Calculation of Body Mass Index

  Baseline, month 6, and month 12

• Rate of cancer screening test completion

  Number of eligible people who complete a screening test out of total eligible

  Baseline, month 6, month 12

• Computerized Adaptive Testing (CAT) of Mental Health (MH)

  CAT-MH Depression/MDD and Anxiety

  Baseline, month 6, month 12

Secondary Outcomes (3)

• Rapid Prime Diet Quality Score Screener (rPDQS)

  Baseline, month 6, month 12

• Cancer screening test type

  Baseline, month 6, month 12

• World Health Organization Disability Assessment Schedule (WHODAS) 2.0

  Baseline, month 6, month 12

Study Arms (2)

Treatment as Usual (TAU)

ACTIVE COMPARATOR

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

Other: Treatment as Usual

Intervention

EXPERIMENTAL

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

Behavioral: Building Connections Intervention

Interventions

Treatment as Usual OTHER

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

Treatment as Usual (TAU)

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.

Intervention

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Disparities Research Unit, Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Colonic Neoplasms; Uterine Cervical Neoplasms; Depression; Anxiety Disorders; Obesity

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Behavioral Symptoms; Behavior; Mental Disorders; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Margarita Alegria, Ph.D.

CONTACT

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

Sheri Markle, MIA

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Disparities Research Unit

Study Record Dates

• First Submitted: July 15, 2025
• First Posted: July 29, 2025
• Study Start: August 7, 2025
• Primary Completion (Estimated): December 30, 2029
• Study Completion (Estimated): December 30, 2029
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)