The Integrated Population (I-POP) Health Trial (I-POP)

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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension; Obesity; Diabetes; Chronic Kidney Diseases; Chronic Disease
• Intervention / Treatment: Other: Usual Care; Other: I-POP + CHW navigation

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.

• Study Type: Interventional
• Enrollment (Actual): 202
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75210
      • Baylor Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; 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.	Other: Usual Care; 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.
Experimental: I-POP CHW Intervention; 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.	Other: I-POP + CHW navigation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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]	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].	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.]	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.]	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.]	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.]	6-months
Body mass index	Weight in pounds (lbs) divided by height in inches (in) squared and multiplying by a conversion factor of 703	Baseline
Body mass index	Weight in pounds (lbs) divided by height in inches (in) squared and multiplying by a conversion factor of 703	6-months
Body mass index	Weight in pounds (lbs) divided by height in inches (in) squared and multiplying by a conversion factor of 703	10-months
Waist - to - Hip ratio	Waist circumference (centimeters) divided by circumference of hips (centimeters)	Baseline
Waist - to - Hip ratio	Waist circumference (centimeters) divided by circumference of hips (centimeters)	6-months
Waist - to - Hip ratio	Waist circumference (centimeters) divided by circumference of hips (centimeters)	10-months
HbA1c	Finger stick blood measure (%)	Baseline
HbA1c	Finger stick blood measure (%)	6-months
HbA1c	Finger stick blood measure (%)	10-months
Lipids	Finger stick blood measure collected fasting via fingerstick (mg/dL)	Baseline
Lipids	Finger stick blood measure collected fasting via fingerstick (mg/dL)	6-months
Lipids	Finger stick blood measure collected fasting via fingerstick (mg/dL)	10-months
Blood pressure	Stadiometer used to measure systolic and diastolic pressures to nearest 1 mm Hg	Baseline
Blood pressure	Stadiometer used to measure systolic and diastolic pressures to nearest 1 mm Hg	6-months
Blood pressure	Stadiometer used to measure systolic and diastolic pressures to nearest 1 mm Hg	10-months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.]	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.]	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.]	10-months
Physical activity	Measured by self report questionnaire [type, frequency, and time completed in minutes]	Baseline
Physical activity	Measured by self report questionnaire [type, frequency, and time completed in minutes]	6-months
Physical activity	Measured by self report questionnaire [type, frequency, and time completed in minutes]	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.]	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.]	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.]	10-months
Social determinants	Measured by self-report survey	Baseline
Social determinants	Measured by self-report survey	6-months
Social determinants	Measured by self-report survey	10-months
Perceived stress	Measured by Perceived Stress Scale (PSS-10) [scale: high risk=40, moderate risk=20, low risk=0]	Baseline
Perceived stress	Measured by Perceived Stress Scale (PSS-10) [scale: high risk=40, moderate risk=20, low risk=0]	6-months
Perceived stress	Measured by Perceived Stress Scale (PSS-10) [scale: high risk=40, moderate risk=20, low risk=0]	10-months
Medication use	Measured by self-report survey	Baseline
Medication use	Measured by self-report survey	6-months
Medication use	Measured by self-report survey	10-months

Collaborators and Investigators

• Sponsor: Baylor Research Institute
• Investigators: Principal Investigator: Heather Kitzman, PhD, Baylor Scott and White Health

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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/
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Actual): May 18, 2023
• Study Completion (Actual): May 18, 2025

Study Registration Dates

• First Submitted: January 28, 2021
• First Submitted That Met QC Criteria: February 17, 2021
• First Posted (Actual): February 18, 2021

Study Record Updates

• Last Update Posted (Actual): February 12, 2026
• Last Update Submitted That Met QC Criteria: February 10, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Community Health Worker; Allostatic load; Ethnic minority; Health services delivery
• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Nutrition Disorders; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Disease Attributes; Metabolic Diseases; Overnutrition; Body Weight; Glucose Metabolism Disorders; Renal Insufficiency; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Hypertension; Diabetes Mellitus; Renal Insufficiency, Chronic; Chronic Disease
• Other Study ID Numbers: 021-026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD that underlie results in a publication
• IPD Sharing Time Frame: Within 6 months of study completion
• IPD Sharing Access Criteria: Available by contacting study PI or reading publication
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No