DiabetesI-POPNCT04761016

The Integrated Population (I-POP) Health Trial

A study testing I-POP + CHW navigation in people with Diabetes and Hypertension, run by Baylor Research Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 to 99 yearsHealthy volunteers can take part
Conditions the study is for: Diabetes, Hypertension, Chronic Kidney Diseases
What is being tested?: I-POP + CHW navigation
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 202 participants
Where: 1 siteUnited States
Study dates: 1 Apr 2021to 18 May 2025
Phase: Interventional
Are there results?: None posted in the registry

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 to 99 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Baylor Research Institute
Dallas, Texas, 75210

Other trials in United States

About this study

Official title: The Role of Community Health Workers to Reduce Health Disparities Using a Multi-Level Integrated Population Health Intervention

Read the detailed description

The I-POP+CHW participants will be paired with a CHW at baseline to assist with navigation for 10-months between health and wellness services in the selected zip codes: 75210, 75215, 75216, 75217, 75223, or 75227. Participants will receive a multi-level intervention utilizing the current I-POP Health model that includes: 1) Access to health services (including oral health), 2) Access to clinical prevention services, 3) Access to education and facilities to increase physical activity and improved nutrition choices, and 4) Scheduled visits with CHWs for education and navigation. Individuals will complete study measures at baseline, 6-months, and 10-months.

The control group participants will receive access to the same I-POP Health resources without CHW navigation until the end of 10-months (delayed CHW navigation). The current usual care model is outlined below (section 2.3) Participants will complete study measures at baseline, 6-months, and 10-months timepoints. Upon completion of 10-months measures, these individuals will be assigned a CHW and receive delayed navigation.

Conditions: Diabetes, Hypertension, Chronic Kidney Diseases, Obesity, Chronic Disease
Being tested: Usual Care, I-POP + CHW navigation
Keywords: Community Health Worker, Allostatic load, Ethnic minority, Health services delivery
Medical subject headings: Diabetes Mellitus, Hypertension, Renal Insufficiency, Chronic, Obesity, Chronic Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Usual CareOther
The current I-POP health model includes: 1) BSW HWC primary care medical home (for uninsured or Medicare patients), 2)BSW HWC providing diabetes prevention, nutrition education, weight loss, farm stands, physical activity programming (in collaboration with its onsite City of Dallas Park and Recreation Center), 3) BSW HWC programming at community sites in 75210, 4) Referrals to Parkland Hatcher Station clinic that provides health care to Medicaid patients, 5) Referrals between Parkland Hatcher Station and BSW HWC programming, 6) Community improvement in collaboration with Frazier Revitalization Inc. Individuals will have access to resources within our current, ongoing I-POP Health model, but without CHW navigation between BSW HWC and local service providers. Participants will complete follow-up visits for collection of study measures with study personnel at 6- and 10- months. At the end of the 10-month follow-up period, participants receive an assigned CHW and CHW-navigation.
I-POP + CHW navigationOther
Individuals randomized to this condition will be paired with a CHW to assist with navigation of I-POP Health resources at BSW HWC and entities in local zip codes. CHW navigation will occur through monthly one-on-one follow-up visits for a period of 10-months. Participants will complete study visits for collection of data measures at baseline, 6- and 10- month timepoints. Study participation ends with completion of 10-months data measures.

Study groups in NCT04761016
Study group	Role	What they receive
Control	Active comparator	Control group participants will receive access to the same I-POP Health resources without CHW navigation until the end of 10-months (delayed CHW navigation). The current usual care model is outlined. Participants will complete study measures at baseline, 6-months, and 10-months timepoints. Upon completion of 10-months measures, these individuals will be assigned a CHW and receive delayed navigation. Receives: Other: Usual Care
I-POP CHW Intervention	Experimental	I-POP+CHW participants will be paired with a CHW at baseline to assist with navigation for 10-months between health and wellness services in the selected zip codes: 75210, 75215, 75216, 75217, 75223, or 75227. Participants will receive a multi-level intervention utilizing the current I-POP Health model that includes: 1) Access to health services (including oral health), 2) Access to clinical prevention services, 3) Access to education and facilities to increase physical activity and improved nutrition choices, and 4) Scheduled visits with CHWs for education and navigation. Individuals will complete study measures at baseline, 6-months, and 10-months. Receives: Other: I-POP + CHW navigation

What is being measured

The primary outcome is the main question the study is designed to answer.

Allostatic load
A composite score of 10 biomarkers to measure chronic stress and health outcomes. The biomarkers are BMI, waist-to-hip ratio, HDL, TC/HDL ratio, triglycerides, HbA1c, SBP, DBP, C-reactive protein, and cortisol. For each marker a value of 1 will be assigned if that exceed the third quartile except for HDL where a value of 1 will be assigned if lower than first quartile; otherwise a score of zero will be assigned. [scale: Count of risk factors. May be dichotomized as high risk = 6 to 10, low risk=0 to 5]
Measured: Baseline
Allostatic load
A composite score of 10 biomarkers to measure chronic stress and health outcomes. The biomarkers are BMI, waist-to-hip ratio, HDL, TC/HDL ratio, triglycerides, HbA1c, SBP, DBP, C-reactive protein, and cortisol. For each marker a value of 1 will be assigned if that exceed the third quartile except for HDL where a value of 1 will be assigned if lower than first quartile; otherwise a score of zero will be assigned. [scale: Count of risk factors. May be dichotomized as high risk = 6 to 10, low risk=0 to 5].
Measured: 6-months
Cortisol
4mL saliva collected fasting in the morning. [Scale: measured in a continuous scale. Normal range 0.007 - 0.115 ug/dL. Value exceeded the normal range indicates higher level of stress.]
Measured: Baseline
Cortisol
4mL saliva collected fasting in the morning. [Scale: measured in a continuous scale. Normal range 0.007 - 0.115 ug/dL. Value exceeded the normal range indicates higher level of stress.]
Measured: 6-months
C-Reactive protein
4mL saliva collected fasting in the morning. [Scale: measured in a continuous scale. Normal range 25 pg/mL - 1600 pg/mL. Value exceeded the normal range indicates higher level of inflammation.]
Measured: Baseline
C-Reactive protein
4mL saliva collected fasting in the morning. [Scale: measured in a continuous scale. Normal range 25 pg/mL - 1600 pg/mL. Value exceeded the normal range indicates higher level of inflammation.]
Measured: 6-months
Body mass index
Weight in pounds (lbs) divided by height in inches (in) squared and multiplying by a conversion factor of 703
Measured: Baseline
Body mass index
Weight in pounds (lbs) divided by height in inches (in) squared and multiplying by a conversion factor of 703
Measured: 6-months
Body mass index
Weight in pounds (lbs) divided by height in inches (in) squared and multiplying by a conversion factor of 703
Measured: 10-months
Waist - to - Hip ratio
Waist circumference (centimeters) divided by circumference of hips (centimeters)
Measured: Baseline
Waist - to - Hip ratio
Waist circumference (centimeters) divided by circumference of hips (centimeters)
Measured: 6-months
Waist - to - Hip ratio
Waist circumference (centimeters) divided by circumference of hips (centimeters)
Measured: 10-months
HbA1c
Finger stick blood measure (%)
Measured: Baseline
HbA1c
Finger stick blood measure (%)
Measured: 6-months
HbA1c
Finger stick blood measure (%)
Measured: 10-months
Lipids
Finger stick blood measure collected fasting via fingerstick (mg/dL)
Measured: Baseline
Lipids
Finger stick blood measure collected fasting via fingerstick (mg/dL)
Measured: 6-months
Lipids
Finger stick blood measure collected fasting via fingerstick (mg/dL)
Measured: 10-months
Blood pressure
Stadiometer used to measure systolic and diastolic pressures to nearest 1 mm Hg
Measured: Baseline
Blood pressure
Stadiometer used to measure systolic and diastolic pressures to nearest 1 mm Hg
Measured: 6-months
Blood pressure
Stadiometer used to measure systolic and diastolic pressures to nearest 1 mm Hg
Measured: 10-months

Secondary outcomes (18)

Diet
Measured by self report Dietary Screening questionnaire (DSQ). [scale: dietary nutrients will be calculated on a continuous scale based on NHANES guideline. Score: 0 to any positive value. A score above or below the threshold based on 2000 calories per day would indicate worse outcome.]
Measured: Baseline
Diet
Measured by self report Dietary Screening questionnaire (DSQ). [scale: dietary nutrients will be calculated on a continuous scale based on NHANES guideline. Score: 0 to any positive value. A score above or below the threshold based on 2000 calories per day would indicate worse outcome.]
Measured: 6-months
Diet
Measured by self report Dietary Screening questionnaire (DSQ). [scale: dietary nutrients will be calculated on a continuous scale based on NHANES guideline. Score: 0 to any positive value. A score above or below the threshold based on 2000 calories per day would indicate worse outcome.]
Measured: 10-months
Physical activity
Measured by self report questionnaire [type, frequency, and time completed in minutes]
Measured: Baseline
Physical activity
Measured by self report questionnaire [type, frequency, and time completed in minutes]
Measured: 6-months
Physical activity
Measured by self report questionnaire [type, frequency, and time completed in minutes]
Measured: 10-months
Services utilization
Measured by self-report survey. [scale: count the number visits at healthcare or wellness centers. A higher score would indicate better utilization.]
Measured: Baseline
Services utilization
Measured by self-report survey. [scale: count the number visits at healthcare or wellness centers. A higher score would indicate better utilization.]
Measured: 6-months
Services utilization
Measured by self-report survey. [scale: count the number visits at healthcare or wellness centers. A higher score would indicate better utilization.]
Measured: 10-months
Social determinants
Measured by self-report survey
Measured: Baseline
Social determinants
Measured by self-report survey
Measured: 6-months
Social determinants
Measured by self-report survey
Measured: 10-months
Perceived stress
Measured by Perceived Stress Scale (PSS-10) [scale: high risk=40, moderate risk=20, low risk=0]
Measured: Baseline
Perceived stress
Measured by Perceived Stress Scale (PSS-10) [scale: high risk=40, moderate risk=20, low risk=0]
Measured: 6-months
Perceived stress
Measured by Perceived Stress Scale (PSS-10) [scale: high risk=40, moderate risk=20, low risk=0]
Measured: 10-months
Medication use
Measured by self-report survey
Measured: Baseline
Medication use
Measured by self-report survey
Measured: 6-months
Medication use
Measured by self-report survey
Measured: 10-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Apr 202118 May 2025

First posted18 Feb 2021
Study start1 Apr 2021
Primary completion18 May 2023
Study completion18 May 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (15)Papers the sponsor has linked to this study.
Other trials for DiabetesStudies of the same condition, open and under way.
More trials run by Baylor Research InstituteThe 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: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 202 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04761016
Sponsor's protocol ID: 021-026
Acronym: I-POP
Status last verified: Feb 2026
First submitted: 28 Jan 2021
Last updated: 12 Feb 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: All IPD that underlie results in a publication

Publications

Kitzman H, Dodgen L, Mamun A, Slater JL, King G, Slater D, King A, Mandapati S, DeHaven M. Community-based participatory research to design a faith-enhanced diabetes prevention program: The Better Me Within randomized trial. Contemp Clin Trials. 2017 Nov;62:77-90. doi: 10.1016/j.cct.2017.08.003. Epub 2017 Aug 12.
PubMed 28807739
Tan M, Mamun A, Kitzman H, Dodgen L. Longitudinal Changes in Allostatic Load during a Randomized Church-based, Lifestyle Intervention in African American Women. Ethn Dis. 2019 Apr 18;29(2):297-308. doi: 10.18865/ed.29.2.297. eCollection 2019 Spring.
PubMed 31057315
Tan M, Mamun A, Kitzman H, Mandapati SR, Dodgen L. Neighborhood Disadvantage and Allostatic Load in African American Women at Risk for Obesity-Related Diseases. Prev Chronic Dis. 2017 Nov 22;14:E119. doi: 10.5888/pcd14.170143.
PubMed 29166248
Kim K, Choi JS, Choi E, Nieman CL, Joo JH, Lin FR, Gitlin LN, Han HR. Effects of Community-Based Health Worker Interventions to Improve Chronic Disease Management and Care Among Vulnerable Populations: A Systematic Review. Am J Public Health. 2016 Apr;106(4):e3-e28. doi: 10.2105/AJPH.2015.302987. Epub 2016 Feb 18.
PubMed 26890177
Nelson HD, Cantor A, Wagner J, Jungbauer R, Quinones A, Fu R, Stillman L, Kondo K. Achieving Health Equity in Preventive Services [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2019 Dec. Report No.: 20-EHC002-EF. Available from http://www.ncbi.nlm.nih.gov/books/NBK550958/
PubMed 31841291
Wesson D, Kitzman H, Halloran KH, Tecson K. Innovative Population Health Model Associated With Reduced Emergency Department Use And Inpatient Hospitalizations. Health Aff (Millwood). 2018 Apr;37(4):543-550. doi: 10.1377/hlthaff.2017.1099.
PubMed 29608367
Wesson DE, Kitzman HE. How Academic Health Systems Can Achieve Population Health in Vulnerable Populations Through Value-Based Care: The Critical Importance of Establishing Trusted Agency. Acad Med. 2018 Jun;93(6):839-842. doi: 10.1097/ACM.0000000000002140.
PubMed 29342009
Flegal KM, Kruszon-Moran D, Carroll MD, Fryar CD, Ogden CL. Trends in Obesity Among Adults in the United States, 2005 to 2014. JAMA. 2016 Jun 7;315(21):2284-91. doi: 10.1001/jama.2016.6458.
PubMed 27272580
Howard JT, Sparks PJ. Does allostatic load calculation method matter? Evaluation of different methods and individual biomarkers functioning by race/ethnicity and educational level. Am J Hum Biol. 2016 Sep 10;28(5):627-35. doi: 10.1002/ajhb.22843. Epub 2016 Feb 15.
PubMed 26877153
Upchurch DM, Stein J, Greendale GA, Chyu L, Tseng CH, Huang MH, Lewis TT, Kravitz HM, Seeman T. A Longitudinal Investigation of Race, Socioeconomic Status, and Psychosocial Mediators of Allostatic Load in Midlife Women: Findings From the Study of Women's Health Across the Nation. Psychosom Med. 2015 May;77(4):402-12. doi: 10.1097/PSY.0000000000000175.
PubMed 25886828
Chang A, Patberg E, Cueto V, Li H, Singh B, Kenya S, Alonzo Y, Carrasquillo O. Community Health Workers, Access to Care, and Service Utilization Among Florida Latinos: A Randomized Controlled Trial. Am J Public Health. 2018 Sep;108(9):1249-1251. doi: 10.2105/AJPH.2018.304542. Epub 2018 Jul 19.
PubMed 30024805
Johnson TL, Van Der Heijde M, Davenport S, et al. Population health in primary care: Cost, quality and experience impact. The American Journal of Accountable Care. 2017;5(3):10-20.
Kindig D, Stoddart G. What is population health? Am J Public Health. 2003 Mar;93(3):380-3. doi: 10.2105/ajph.93.3.380.
PubMed 12604476
Lushniak BD, Alley DE, Ulin B, Graffunder C. The National Prevention Strategy: leveraging multiple sectors to improve population health. Am J Public Health. 2015 Feb;105(2):229-31. doi: 10.2105/AJPH.2014.302257. No abstract available.
PubMed 25521895
Paskett E, Thompson B, Ammerman AS, Ortega AN, Marsteller J, Richardson D. Multilevel Interventions To Address Health Disparities Show Promise In Improving Population Health. Health Aff (Millwood). 2016 Aug 1;35(8):1429-34. doi: 10.1377/hlthaff.2015.1360.
PubMed 27503968

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Role of Community Health Workers to Reduce Health Disparities Using a Multi-Level Integrated Population Health Intervention
ClinicalTrials.gov ID: NCT04761016
Acronym / sponsor ID: I-POP / 021-026
Conditions: Diabetes, Hypertension, Chronic Kidney Diseases, Obesity, Chronic Disease
Keywords: Community Health Worker, Allostatic load, Ethnic minority, Health services delivery
Study type: Interventional
Recruitment status: Completed
Enrolment: 202 participants (actual)
Lead sponsor: Baylor Research InstituteUniversity, hospital or other
Study start: 1 Apr 2021 (actual)
Primary completion: 18 May 2023 (actual)
Study completion: 18 May 2025 (actual)
First posted: 18 Feb 2021 (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.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Control	Active comparator	Other: Usual CareControl group participants will receive access to the same I-POP Health resources without CHW navigation until the end of 10-months (delayed CHW navigation). The current usual care model is outlined. Participants will complete study measures at baseline, 6-months, and 10-months timepoints. Upon completion of 10-months measures, these individuals will be assigned a CHW and receive delayed navigation.
I-POP CHW Intervention	Experimental	Other: I-POP + CHW navigationI-POP+CHW participants will be paired with a CHW at baseline to assist with navigation for 10-months between health and wellness services in the selected zip codes: 75210, 75215, 75216, 75217, 75223, or 75227. Participants will receive a multi-level intervention utilizing the current I-POP Health model that includes: 1) Access to health services (including oral health), 2) Access to clinical prevention services, 3) Access to education and facilities to increase physical activity and improved nutrition choices, and 4) Scheduled visits with CHWs for education and navigation. Individuals will complete study measures at baseline, 6-months, and 10-months.

Who may qualify

Ages: 18 to 99 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (6 listed)

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

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
Usual CareThe current I-POP health model includes: 1) BSW HWC primary care medical home (for uninsured or Medicare patients), 2)BSW HWC providing diabetes prevention, nutrition education, weight loss, farm stands, physical activity programming (in collaboration with its onsite City of Dallas Park and Recreation Center), 3) BSW HWC programming at community sites in 75210, 4) Referrals to Parkland Hatcher Station clinic that provides health care to Medicaid patients, 5) Referrals between Parkland Hatcher Station and BSW HWC programming, 6) Community improvement in collaboration with Frazier Revitalization Inc. Individuals will have access to resources within our current, ongoing I-POP Health model, but without CHW navigation between BSW HWC and local service providers. Participants will complete follow-up visits for collection of study measures with study personnel at 6- and 10- months. At the end of the 10-month follow-up period, participants receive an assigned CHW and CHW-navigation.	Other	Control
I-POP + CHW navigationIndividuals randomized to this condition will be paired with a CHW to assist with navigation of I-POP Health resources at BSW HWC and entities in local zip codes. CHW navigation will occur through monthly one-on-one follow-up visits for a period of 10-months. Participants will complete study visits for collection of data measures at baseline, 6- and 10- month timepoints. Study participation ends with completion of 10-months data measures.	Other	I-POP CHW Intervention

Primary outcome

Allostatic load
Time frame: Baseline
A composite score of 10 biomarkers to measure chronic stress and health outcomes. The biomarkers are BMI, waist-to-hip ratio, HDL, TC/HDL ratio, triglycerides, HbA1c, SBP, DBP, C-reactive protein, and cortisol. For each marker a value of 1 will be assigned if that exceed the third quartile except for HDL where a value of 1 will be assigned if lower than first quartile; otherwise a score of zero will be assigned. [scale: Count of risk factors. May be dichotomized as high risk = 6 to 10, low risk=0 to 5]
Allostatic load
Time frame: 6-months
A composite score of 10 biomarkers to measure chronic stress and health outcomes. The biomarkers are BMI, waist-to-hip ratio, HDL, TC/HDL ratio, triglycerides, HbA1c, SBP, DBP, C-reactive protein, and cortisol. For each marker a value of 1 will be assigned if that exceed the third quartile except for HDL where a value of 1 will be assigned if lower than first quartile; otherwise a score of zero will be assigned. [scale: Count of risk factors. May be dichotomized as high risk = 6 to 10, low risk=0 to 5].
Cortisol
Time frame: Baseline
4mL saliva collected fasting in the morning. [Scale: measured in a continuous scale. Normal range 0.007 - 0.115 ug/dL. Value exceeded the normal range indicates higher level of stress.]
Cortisol
Time frame: 6-months
4mL saliva collected fasting in the morning. [Scale: measured in a continuous scale. Normal range 0.007 - 0.115 ug/dL. Value exceeded the normal range indicates higher level of stress.]
C-Reactive protein
Time frame: Baseline
4mL saliva collected fasting in the morning. [Scale: measured in a continuous scale. Normal range 25 pg/mL - 1600 pg/mL. Value exceeded the normal range indicates higher level of inflammation.]
C-Reactive protein
Time frame: 6-months
4mL saliva collected fasting in the morning. [Scale: measured in a continuous scale. Normal range 25 pg/mL - 1600 pg/mL. Value exceeded the normal range indicates higher level of inflammation.]
Body mass index
Time frame: Baseline
Weight in pounds (lbs) divided by height in inches (in) squared and multiplying by a conversion factor of 703
Body mass index
Time frame: 6-months
Weight in pounds (lbs) divided by height in inches (in) squared and multiplying by a conversion factor of 703
Body mass index
Time frame: 10-months
Weight in pounds (lbs) divided by height in inches (in) squared and multiplying by a conversion factor of 703
Waist - to - Hip ratio
Time frame: Baseline
Waist circumference (centimeters) divided by circumference of hips (centimeters)
Waist - to - Hip ratio
Time frame: 6-months
Waist circumference (centimeters) divided by circumference of hips (centimeters)
Waist - to - Hip ratio
Time frame: 10-months
Waist circumference (centimeters) divided by circumference of hips (centimeters)
HbA1c
Time frame: Baseline
Finger stick blood measure (%)
HbA1c
Time frame: 6-months
Finger stick blood measure (%)
HbA1c
Time frame: 10-months
Finger stick blood measure (%)
Lipids
Time frame: Baseline
Finger stick blood measure collected fasting via fingerstick (mg/dL)
Lipids
Time frame: 6-months
Finger stick blood measure collected fasting via fingerstick (mg/dL)
Lipids
Time frame: 10-months
Finger stick blood measure collected fasting via fingerstick (mg/dL)
Blood pressure
Time frame: Baseline
Stadiometer used to measure systolic and diastolic pressures to nearest 1 mm Hg
Blood pressure
Time frame: 6-months
Stadiometer used to measure systolic and diastolic pressures to nearest 1 mm Hg
Blood pressure
Time frame: 10-months
Stadiometer used to measure systolic and diastolic pressures to nearest 1 mm Hg

18 secondary outcomes

Diet
Time frame: Baseline
Diet
Time frame: 6-months
Diet
Time frame: 10-months
Physical activity
Time frame: Baseline
Physical activity
Time frame: 6-months
Physical activity
Time frame: 10-months
Services utilization
Time frame: Baseline
Services utilization
Time frame: 6-months
Services utilization
Time frame: 10-months
Social determinants
Time frame: Baseline
Social determinants
Time frame: 6-months
Social determinants
Time frame: 10-months
Perceived stress
Time frame: Baseline
Perceived stress
Time frame: 6-months
Perceived stress
Time frame: 10-months
Medication use
Time frame: Baseline
Medication use
Time frame: 6-months
Medication use
Time frame: 10-months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
Background: PubMed 28807739Kitzman H, Dodgen L, Mamun A, Slater JL, King G, Slater D, King A, Mandapati S, DeHaven M. Community-based participatory research to design a faith-enhanced diabetes prevention program: The Better Me Within randomized trial. Contemp Clin Trials. 2017 Nov;62:77-90. doi: 10.1016/j.cct.2017.08.003. Epub 2017 Aug 12.
Background: PubMed 31057315Tan M, Mamun A, Kitzman H, Dodgen L. Longitudinal Changes in Allostatic Load during a Randomized Church-based, Lifestyle Intervention in African American Women. Ethn Dis. 2019 Apr 18;29(2):297-308. doi: 10.18865/ed.29.2.297. eCollection 2019 Spring.
Background: PubMed 29166248Tan M, Mamun A, Kitzman H, Mandapati SR, Dodgen L. Neighborhood Disadvantage and Allostatic Load in African American Women at Risk for Obesity-Related Diseases. Prev Chronic Dis. 2017 Nov 22;14:E119. doi: 10.5888/pcd14.170143.
Background: PubMed 26890177Kim K, Choi JS, Choi E, Nieman CL, Joo JH, Lin FR, Gitlin LN, Han HR. Effects of Community-Based Health Worker Interventions to Improve Chronic Disease Management and Care Among Vulnerable Populations: A Systematic Review. Am J Public Health. 2016 Apr;106(4):e3-e28. doi: 10.2105/AJPH.2015.302987. Epub 2016 Feb 18.
Background: PubMed 31841291Nelson HD, Cantor A, Wagner J, Jungbauer R, Quinones A, Fu R, Stillman L, Kondo K. Achieving Health Equity in Preventive Services [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2019 Dec. Report No.: 20-EHC002-EF. Available from http://www.ncbi.nlm.nih.gov/books/NBK550958/
Background: PubMed 29608367Wesson D, Kitzman H, Halloran KH, Tecson K. Innovative Population Health Model Associated With Reduced Emergency Department Use And Inpatient Hospitalizations. Health Aff (Millwood). 2018 Apr;37(4):543-550. doi: 10.1377/hlthaff.2017.1099.
Background: PubMed 29342009Wesson DE, Kitzman HE. How Academic Health Systems Can Achieve Population Health in Vulnerable Populations Through Value-Based Care: The Critical Importance of Establishing Trusted Agency. Acad Med. 2018 Jun;93(6):839-842. doi: 10.1097/ACM.0000000000002140.
Background: PubMed 27272580Flegal KM, Kruszon-Moran D, Carroll MD, Fryar CD, Ogden CL. Trends in Obesity Among Adults in the United States, 2005 to 2014. JAMA. 2016 Jun 7;315(21):2284-91. doi: 10.1001/jama.2016.6458.
Background: PubMed 26877153Howard JT, Sparks PJ. Does allostatic load calculation method matter? Evaluation of different methods and individual biomarkers functioning by race/ethnicity and educational level. Am J Hum Biol. 2016 Sep 10;28(5):627-35. doi: 10.1002/ajhb.22843. Epub 2016 Feb 15.
Background: PubMed 25886828Upchurch DM, Stein J, Greendale GA, Chyu L, Tseng CH, Huang MH, Lewis TT, Kravitz HM, Seeman T. A Longitudinal Investigation of Race, Socioeconomic Status, and Psychosocial Mediators of Allostatic Load in Midlife Women: Findings From the Study of Women's Health Across the Nation. Psychosom Med. 2015 May;77(4):402-12. doi: 10.1097/PSY.0000000000000175.
Background: PubMed 30024805Chang A, Patberg E, Cueto V, Li H, Singh B, Kenya S, Alonzo Y, Carrasquillo O. Community Health Workers, Access to Care, and Service Utilization Among Florida Latinos: A Randomized Controlled Trial. Am J Public Health. 2018 Sep;108(9):1249-1251. doi: 10.2105/AJPH.2018.304542. Epub 2018 Jul 19.
BackgroundJohnson TL, Van Der Heijde M, Davenport S, et al. Population health in primary care: Cost, quality and experience impact. The American Journal of Accountable Care. 2017;5(3):10-20.
Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication

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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. This study is not recruiting at the moment.

Heather Kitzman, PhD principal investigator

Baylor Scott and White Health

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing I-POP + CHW navigation in people with Diabetes and Hypertension, run by Baylor Research Institute at 1 site 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 6 inclusion and 6 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: finished, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Allostatic load (time frame: Baseline). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04761016, which also lists 15 linked publications.

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 12 Feb 2026; AzTrials last refreshed its copy on 6 Nov 2026.