Building Connections
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorMassachusetts General Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
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.
Trial design
Design model
Sequential
Treatments tested in this trial
Treatment as Usual
Other interventionThis is the comparison condition, in which participants will receive treatment as usual for their conditions at the clinic.
Building Connections Intervention
BehavioralThe 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.
Treatment groups
3,600 Participants
are divided into 2 treatment groupsGroup A: Treatment as Usual (TAU)Active comparator 1 intervention
Group B: InterventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Self-reported height/weight for Body Mass Index (BMI)
Calculation of Body Mass Index
Time frame
Baseline, month 6, and month 122
Rate of cancer screening test completion
Number of eligible people who complete a screening test out of total eligible
Time frame
Baseline, month 6, month 123
Computerized Adaptive Testing (CAT) of Mental Health (MH)
CAT-MH Depression/MDD and Anxiety
Time frame
Baseline, month 6, month 12Secondary outcomes
1
Rapid Prime Diet Quality Score Screener (rPDQS)
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.
Time frame
Baseline, month 6, month 122
Cancer screening test type
Screening test type used by people who completed a screening
Time frame
Baseline, month 6, month 123
World Health Organization Disability Assessment Schedule (WHODAS) 2.0
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.
Time frame
Baseline, month 6, month 12Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov