Can a Culturally-Tailored program boost heart health in american indian women?
NCT ID NCT07581899
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether an 8-week culturally-adapted program can improve cardiovascular health in American Indian women aged 18-55 who have heart disease risk factors. Participants are randomly assigned to either the program or a control group. Researchers will measure changes in blood pressure, heart rate variability, inflammation, and other health markers over 3 months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- culturally-adapted cardiovascular health promotion intervention (behavioral)
- What this could lead to
- If it works, this could provide an effective, culturally-tailored program to improve heart health and reduce cardiovascular risk in American Indian women.
- What could go wrong
- This is a small, early-stage study with only 70 participants, so results may not apply broadly. The intervention is behavioral, so benefits may be modest and hard to sustain long-term.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 70 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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Jul 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 55 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Women 18-55 years old who self-identify as Lumbee Indian and * Have one or more risk factors for cardiovascular disease: * overweight/obese, defined as BMI \>25 kg/m\^2 * hypertensive as measured by study staff * physical inactivity * Willing and able to follow study procedures Exclusion Criteria: * Women currently enrolled in an organized weight-loss or mindfulness program * Pregnant women or women planning to become pregnant during the study period * Conditions that exclude study enrollment include: * heart murmur * congenital heart disease * family history of sudden death * or orthopedic limitations or health conditions precluding exercise
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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UNC Health Primary and Specialty Care at Pembroke
RECRUITINGPembroke, North Carolina, 28372, United States
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