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Rural families fight heart disease and diabetes together in new study

NCT ID NCT04891575

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a family-focused lifestyle program designed to help rural Hispanic and non-Hispanic adults lower their risk for heart disease and type 2 diabetes. Over 500 participants took part in a culturally tailored program that encouraged healthy eating, physical activity, and other heart-healthy habits. The goal was to see if this approach could help families make lasting changes to prevent these serious conditions.

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

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

504 people

The number who actually took part.

Started

Sep 2021

Finished

Jan 2026

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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: Primary participants are rural-dwelling Hispanic and non-Hispanic adults who are at-risk for type 2 diabetes or cardiovascular disease and have a family member who is willing to participate if the primary participant is randomly selected to participate with a family member. Inclusion criteria for the primary participant: * Is Hispanic or non-Hispanic adult * Is 18 years of age and older * Is a primary Spanish or English speaker * Has internet access * Has two or more risk factors for type 2 diabetes or cardiovascular disease including: 1. clinical diagnosis of hypertension; 2. clinical diagnosis of hyperlipidemia; 3. clinical diagnosis of prediabetes; 4. overweight or obese (body mass index ≥ 25 kg/m2); 5. is a current cigarette smoker; 6. male 45 years of age or older or female 55 years of age or older; 7. family history in first degree relative of type 2 diabetes or cardiovascular disease; or 8. is a female with a history of gestational diabetes mellitus or polycystic ovary syndrome. * Lives in rural Kentucky * Is willing to participate in the study for the next 12 months Inclusion criteria for the co-participating family member if primary participant is randomly selected to participate with a family member * Is 18 years of age and older * Is a primary Spanish or English speaker * Lives in the same household or in close proximity (no further than 25 miles distance) to the primary participant * Has internet access * Is willing to participate in the study for the next 12 months Exclusion Criteria: Exclusion criteria for family dyads: Primary participant and family member participant will be excluded if they: * Have cognitive impairment that preclude them from understanding the consent process, answering questionnaires, or participating in the intervention; * Have a major psychiatric (e.g., schizophrenia) condition; * Are pregnant or nursing or plan on becoming pregnant within the next year since dietary needs will be different. Exclusion criteria that apply only to the primary participant: * Have known coronary artery or cerebrovascular disease; * Have a diagnosis of type 1 or type 2 diabetes; * Have medical contraindications to participate in a lifestyle intervention that includes unsupervised physical activity and weight loss

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • 2201 Regency Rd.

    Lexington, Kentucky, 40503, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.