Health Impact 360: Advancing Physical, Social, and Mental Health Among Marginalized Communities for Cardiovascular Health Equity (HI360)

University of Michigan

Status: Active, not recruiting

Conditions: Health Promotion; Cardiovascular Health

Treatments: Other: Usual care - Wait list control; Behavioral: Health Impact 360

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07034352

HUM00256551

OT2HL158287 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The purpose of this clinical trial is to evaluate an evidence-based intervention, Health Impact 360, toward the promotion of cardiovascular health (CVH), including physical, mental, and social health outcomes, among adults living in marginalized communities.

Study hypotheses include:

• Participants in the Health Impact 360 intervention arm will have better CVH (i.e., a higher overall LE8 score) at the 16-week endpoint compared to the control.
• Participants in the Health Impact 360 intervention arm will report better mental health (i.e., a lower perceived stress score) at the 16-week endpoint compared to the control.
• Participants in the Health Impact 360 intervention arm will report better social support and well-being (i.e., higher emotional support and instrumental support scores and reduced social isolation) at the 16-week endpoint compared to control.
• Participants with greater intervention engagement (e.g., better session attendance) will experience greater intervention impacts across all primary and secondary outcomes relative to the minimally engaged peers.

Researchers will compare outcomes among intervention participants to outcomes among delayed intervention control participants who will be invited to participate in Health Impact 360 once all endpoint measures are collected.

Participants will:

• Engage in group-based programming twice per week for 8 weeks
• Engage in group-based programming once per week for 8 weeks
• Participate in survey-based and biometric data collection at two timepoints: baseline and 16-week endpoint
• Self-monitor their physical activity via a study-provided pedometer

Enrollment: 328 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• English or Spanish speaking
• Able to participate in group-based programming

Exclusion criteria

- All pregnant persons to prevent pregnancy-related biometric changes from biasing outcome analyses

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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328 participants in 2 patient groups

Health Impact 360

Experimental group

Description:

16-week, group-based comprehensive health program that covers all behavioral and clinical dimensions of heart health: healthy eating, physical activity, quality sleep, tobacco cessation, blood pressure, cholesterol, Hemoglobin A1c, and Body Mass Index.

Treatment:

Behavioral: Health Impact 360

Usual care - Wait list control

Other group

Description:

Participants that will be on the wait list will be evaluated. These participants will be enrolled into the treatment program 16-20 weeks after the first treatment group.

Treatment:

Other: Usual care - Wait list control