Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
ID07091032

Building Connections Between Practices, Patients, and Community Health

Led by Massachusetts General Hospital · Updated on 2025-11-18

3600

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying health and healthcare inequalities in socially vulnerable communities by working with clinical practices across Massachusetts that serve diverse populations. The study looks at combining interventions for obesity and weight management, cancer screening, and mental health to improve outcomes in these areas. This program aims to provide evidence-based support in community clinics and health centers to address these important health concerns. The study has two groups: one group receives the usual treatment provided at their clinics, while the other takes part in the Building Connections intervention. This intervention includes coaching and support for obesity management through education on anti-obesity medications and lifestyle changes led by community health workers. It also promotes colorectal and cervical cancer screening using new testing methods and monitoring. Additionally, it offers a 10-session mental health program called Strong Minds to help with depression, anxiety, and trauma symptoms, delivered by trained community health workers under clinical supervision. Participants will be assessed at the beginning of the study, and again at 6 and 12 months. Measurements include self-reported height and weight to calculate body mass index, cancer screening completion rates, and mental health status using computerized adaptive tests. Other evaluations include diet quality, types of cancer screening tests used, and disability assessments. The study will monitor participants' progress and health outcomes over this period to understand how the combined interventions impact obesity, cancer screening, and mental health in these communities.

CONDITIONS

Brief Title

Building Connections

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to 75 years
  • Speak English or Spanish
  • Meet at least one of the following: obese with BMI 30 or greater; due for colorectal or cervical cancer screening based on age and biological sex; or moderate to severe depression or anxiety symptoms
  • Have visited a primary care clinic in the past 2 years
Not Eligible

You will not qualify if you...

  • Currently pregnant
  • Cognitive impairment
  • Do not speak English or Spanish
  • Obesity intervention: prior metabolic or bariatric surgery or planning surgery within 6 months; enrolled in intensive lifestyle program
  • Cancer screening intervention: diagnosed colorectal cancer, ulcerative colitis, Crohn's disease, cervical cancer, or prior hysterectomy
  • Mental health intervention: active suicidality, active substance use disorder, history of schizophrenia or bipolar disorder, or receiving behavioral health care recently or upcoming within 1 month

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Treatment

Duration - Up to 12 months

Participants take part in one or more interventions they are eligible for, including coaching and support for obesity management, cancer screening workflows, and a 10-session mental health psychoeducational program.

Multiple sessions over 12 months depending on intervention components

Long-term Monitoring

Duration - 12 months

Participants are monitored for outcomes such as BMI, cancer screening completion, and mental health status at baseline, 6 months, and 12 months.

3 assessment visits at baseline, month 6, and month 12

Trial Site Locations

Total: 1 location

1

Disparities Research Unit, Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Actively Recruiting

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Research Team

M

Margarita Alegria, Ph.D.

S

Sheri Markle, MIA

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

PREVENTION

Number of Arms

2

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