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Recruiting NCT07034352

Health Impact 360: Advancing Physical, Social, and Mental Health Toward Cardiovascular Disease Prevention in Community Settings

No phase Interventional Health Promotion Cardiovascular Health

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Health Impact 360, Usual care - Wait list control.
Who it may be relevant to
Registry conditions: Health Promotion, Cardiovascular Health. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Interventions

  • Behavioral Health Impact 360
    Participants will be assigned to a team and teams will meet 1-2 times per week for sessions at a local community organization. Sessions will be up to 2 hours long and will include two parts: (1) 30-60 minutes of activities related to physical, mental, social, financial, and community health, and (2) 60-75 minutes of group physical activity (walking), including stretches to warm up and cool down.
  • Other Usual care - Wait list control
    Participants will be on this for approximately 16 weeks and be asked to complete data collection information at baseline and 16 weeks.

Primary outcome measures

  • Change in Cardiovascular health (CVH) based on the Life's Essential 8 score (LE8) [Time frame: Baseline, 16 weeks]
Secondary outcome measures (4)
  • Change in mental health based on the perceived stress scale [Time frame: Baseline, 16 weeks]
  • Change in social health via the 4-item Patient-Reported Outcomes Measurement Information System (PROMIS) emotional support scale [Time frame: Baseline, 16 weeks]
  • Change in social health via the 4-item Patient-Reported Outcomes Measurement Information System (PROMIS) instrumental support scale [Time frame: Baseline, 16 weeks]
  • Change in social health via the 4-item Patient-Reported Outcomes Measurement Information System (PROMIS) social isolation scale [Time frame: Baseline, 16 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 7 centers
  • Community Health and Social Service Centers (CHASS) — Detroit
  • Eastside Community Network (ECN) — Detroit
  • Detroit Hispanic Development Corporation (DHDC) — Detroit
  • Hasselbringe Senior Center — Flint
  • Spirit of Victory — Flint
  • Flint Development Center — Flint
  • RL Jones Community Center — Flint

Identifiers

NCT: NCT07034352 · HUM00256551 · OT2HL158287

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗