Health PromotionHI360NCT07034352
Health Impact 360: Advancing Physical, Social, and Mental Health Toward Cardiovascular Disease Prevention in Community Settings
A study testing Health Impact 360 in people with Health Promotion and Cardiovascular Health, run by University of Michigan at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Promotion, Cardiovascular Health
- What is being tested?
- Health Impact 360
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 328 participants
- Where
- 7 sitesUnited States
- Study dates
- 20 Jun 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- English or Spanish speaking
- Able to participate in group-based programming
Who cannot join
- All pregnant persons to prevent pregnancy-related biometric changes from biasing outcome analyses
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 4 recruiting
- Completed
Community Health and Social Service Centers (CHASS)
Detroit, Michigan, 48209
- Completed
Eastside Community Network (ECN)
Detroit, Michigan, 48215
- Completed
Detroit Hispanic Development Corporation (DHDC)
Detroit, Michigan, 48216
- Recruiting
Hasselbringe Senior Center
Flint, Michigan, 48504
Tarnesa Martin, 313-583-7088, healthimpact360@umich.edu
- Recruiting
Spirit of Victory
Flint, Michigan, 48504
Tarnesa Martin, 313-583-7088, healthimpact360@umich.edu
- Recruiting
Flint Development Center
Flint, Michigan, 48505
Latressa Gordon, 313-583-7088, healthimpact360@umich.edu
- Recruiting
RL Jones Community Center
Flint, Michigan, 48505
Latressa Gordon, 313-583-7088, healthimpact360@umich.edu
About this study
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:
Read more
- 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
- Conditions
- Health Promotion, Cardiovascular Health
- Being tested
- Health Impact 360, Usual care - Wait list control
- Keywords
- Health Program, Health outcomes, Social health, Walking, Health Education and support, Mental health, social support, Health disparities, self management
- Medical subject headings
- Health Education, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Impact 360Behavioural
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Usual care - Wait list control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 16 weeks
Secondary outcomes (4)
Change in mental health based on the perceived stress scale
The Perceived Stress Scale (PSS) is a 10-item scale that was developed to measure the degree to which situations in one's life are appraised as stressful. PSS scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 \& 4 = 0) to the four positively stated items (items 4, 5, 7, \& 8) and then summing across all scale items. Scores range from 0 to 40 with higher scores indicating a worse outcome.
Measured: Baseline, 16 weeks
Change in social health via the 4-item Patient-Reported Outcomes Measurement Information System (PROMIS) emotional support scale
This is a 4-item survey that participants select from never (1) - always (5). The score range is from 4-20 with a higher score indicating more emotional support.
Measured: Baseline, 16 weeks
Change in social health via the 4-item Patient-Reported Outcomes Measurement Information System (PROMIS) instrumental support scale
This is a 4-item survey that participants select from never (1) - always (5). The score range is from 4-20 with a higher score indicating more instrumental support.
Measured: Baseline, 16 weeks
Change in social health via the 4-item Patient-Reported Outcomes Measurement Information System (PROMIS) social isolation scale
This is a 4-item survey that participants select from never (1) - always (5). The score range is from 4-20 with a higher score indicating greater social isolation.
Measured: Baseline, 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start20 Jun 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health PromotionStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 328 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Detroit Hispanic Development Corporation, Eastside Community Network, Community Health and Social Service Center (CHASS), Community Based Organization Partners, Michigan United, Hurley Medical Center
- Responsible party
- Principal investigator, Jennifer Garner, University of Michigan
- Investigators
- Jennifer Garner, PhD, RD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07034352
- Sponsor's protocol ID
- HUM00256551
- Other IDs
- OT2HL158287
- Acronym
- HI360
- Status last verified
- Jul 2026
- First submitted
- 13 Jun 2025
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Impact 360: Advancing Physical, Social, and Mental Health Toward Cardiovascular Disease Prevention in Community Settings
- ClinicalTrials.gov ID
- NCT07034352
- Acronym / sponsor ID
- HI360 / HUM00256551
- Conditions
- Health Promotion, Cardiovascular Health
- Keywords
- Health Program, Health outcomes, Social health, Walking, Health Education and support, Mental health, social support, Health disparities
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 328 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Detroit Hispanic Development Corporation, Eastside Community Network, Community Health and Social Service Center (CHASS), Community Based Organization Partners, Michigan United, Hurley Medical Center
- Study start
- 20 Jun 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 24 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Health Impact 360 | Experimental | Behavioral: Health Impact 36016-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. |
| Usual care - Wait list control | Other | Other: Usual care - Wait list controlParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- English or Spanish speaking
- Able to participate in group-based programming
Key exclusion criteria (1 listed)
- All pregnant persons to prevent pregnancy-related biometric changes from biasing outcome analyses
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health Impact 360Participants 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. | Behavioural | Health Impact 360 |
| Usual care - Wait list controlParticipants will be on this for approximately 16 weeks and be asked to complete data collection information at baseline and 16 weeks. | Other | Usual care - Wait list control |
Primary outcome
Change in Cardiovascular health (CVH) based on the Life's Essential 8 score (LE8)
Time frame: Baseline, 16 weeks
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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jennifer Garner, PhD, RD principal investigator
University of Michigan
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Impact 360 in people with Health Promotion and Cardiovascular Health, run by University of Michigan at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michelle Clayson (734-763-2003, mclayson@umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cardiovascular health (CVH) based on the Life's Essential 8 score (LE8) (time frame: Baseline, 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.