CompletedNot Applicable

The Integrated Population (I-POP) Health Trial

United States202 participantsStarted 2021-04-01

Plain-language summary

The primary aim of this study is to determine whether community health worker (CHW) navigation improves outcomes of chronic disease and chronic disease risk factors in a low-income, primarily ethnic minority population when combined with an evidence-based population health model as compared to usual care after 10 months.

Who can participate

Age range

18 Years – 99 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age 18 years or older * Ability to alter diet and/or physical activity * Willing to participate in a 10-month study * Resident of selected zip codes: 75210, 75215, 75216, 75217, 75223, or 75227 * Not having utilized BSW HWC membership services within the past 12 months * Not planning to move outside of the selected zip code area within the next 6 months Exclusion Criteria: * Below the age of 18 years * Unable or unwilling to alter diet and/or physical activity * Not willing to participate in a 10-month study * Not resident of local selected zip codes: 75210, 75215, 75216, 75217, 75223, or 75227 * Currently using or have used BSW HWC membership services within the past 12 months * Planning to move outside of the selected zip code area within the next 6 months

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Allostatic load

Timeframe: Baseline

Allostatic load

Timeframe: 6-months

Cortisol

Timeframe: Baseline

Cortisol

Timeframe: 6-months

C-Reactive protein

Timeframe: Baseline

C-Reactive protein

Timeframe: 6-months

Body mass index

Timeframe: Baseline

Body mass index

Timeframe: 6-months

Trial details

NCT IDNCT04761016

SponsorBaylor Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-05-18

View on ClinicalTrials.gov More Diabetes trials

Plain-language summary

Who can participate

Age range

18 Years – 99 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.