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Recruiting

NCT Number: NCT07091032

Building Connections

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.

Recruiting

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Disparities Research Unit, Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Primary outcomes

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

    Time frame: Baseline, month 6, and month 12

    Calculation of Body Mass Index

  2. Rate of cancer screening test completion

    Time frame: Baseline, month 6, month 12

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

  3. Computerized Adaptive Testing (CAT) of Mental Health (MH)

    Time frame: Baseline, month 6, month 12

    CAT-MH Depression/MDD and Anxiety

Secondary outcomes

  1. Rapid Prime Diet Quality Score Screener (rPDQS)

    Time frame: 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.

  2. Cancer screening test type

    Time frame: Baseline, month 6, month 12

    Screening test type used by people who completed a screening

  3. World Health Organization Disability Assessment Schedule (WHODAS) 2.0

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Margarita Alegria, Ph.D.

CONTACT

[email protected]

617-724-1237

Sheri Markle, MIA

CONTACT

[email protected]

617-724-1237

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

Building Connections Between Practices, Patients, and Community Health

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Jul 29, 2025
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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