NCT07034352

Brief Summary

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
328

participants targeted

Target at P75+ for not_applicable

Timeline
6mo left

Started Jun 2025

Geographic Reach
1 country

3 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress64%
Jun 2025Nov 2026

First Submitted

Initial submission to the registry

June 13, 2025

Completed
7 days until next milestone

Study Start

First participant enrolled

June 20, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 24, 2025

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

January 20, 2026

Status Verified

January 1, 2026

Enrollment Period

1.4 years

First QC Date

June 13, 2025

Last Update Submit

January 16, 2026

Conditions

Health PromotionCardiovascular Health

Keywords

Health ProgramHealth outcomesBlack, indigenous, people of colorSocial healthWalkingHealth Education and supportMental healthsocial support

Outcome Measures

Primary Outcomes (1)

  • Change in Cardiovascular health (CVH) based on the Life's Essential 8 score (LE8)

    LE8 CVH Score will be averaged for each participant at baseline and 16 weeks on the individual LE8 metrics (i.e., scores of 0-100 for eight items). An average score of 0 to 49 is defined as low CVH, 50 to 79 is moderate CVH, and 80 to 100 is high CVH.

    Baseline, 16 weeks

Secondary Outcomes (4)

  • Change in mental health based on the perceived stress scale

    Baseline, 16 weeks

  • Change in social health via the 4-item Patient-Reported Outcomes Measurement Information System (PROMIS) emotional support scale

    Baseline, 16 weeks

  • Change in social health via the 4-item Patient-Reported Outcomes Measurement Information System (PROMIS) instrumental support scale

    Baseline, 16 weeks

  • Change in social health via the 4-item Patient-Reported Outcomes Measurement Information System (PROMIS) social isolation scale

    Baseline, 16 weeks

Study Arms (2)

Health Impact 360

EXPERIMENTAL

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.

Behavioral: Health Impact 360

Usual care - Wait list control

OTHER

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.

Other: Usual care - Wait list control

Interventions

Health Impact 360BEHAVIORAL

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.

Health Impact 360
Usual care - Wait list controlOTHER

Participants will be on this for approximately 16 weeks and be asked to complete data collection information at baseline and 16 weeks.

Usual care - Wait list control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Community Health and Social Service Centers (CHASS)

Detroit, Michigan, 48209, United States

Location

Eastside Community Network (ECN)

Detroit, Michigan, 48215, United States

Location

Detroit Hispanic Development Corporation (DHDC)

Detroit, Michigan, 48216, United States

Location

MeSH Terms

Conditions

Health EducationPsychological Well-Being

Condition Hierarchy (Ancestors)

Adherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehaviorPersonal Satisfaction

Study Officials

  • Jennifer Garner, PhD, RD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Statisticians will be blinded to arm assignment during analysis.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This is a waitlist-control trial. The intervention-randomized participants will receive the intervention first in "Wave 1" and the participants randomized to the control group, "Wave 2", will experience a delay in access to the program until after the end of the Wave 1 intervention period at each participating site.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 13, 2025

First Posted

June 24, 2025

Study Start

June 20, 2025

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

January 20, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

The data will be made available as soon as the primary team has completed the analysis as proposed in the grant, and no later than time of an associated publication or end of the grant award, whichever comes first. Data deposited in Deep Blue Data will be accessible for at least 10 years, after which it will be appraised for continued preservation by University Library personnel.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
Data deposited in Deep Blue Data will be accessible for at least 10 years, after which it will be appraised for continued preservation by University Library personnel.

Locations

US(3)