The Integrated Population (I-POP) Health Trial

NCT04761016 | Completed

• 1 other identifier: 021-026
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes; Hypertension; Chronic Kidney Diseases; Obesity; Chronic Disease

Keywords

Community Health Worker; Allostatic load; Ethnic minority; Health services delivery

Outcome Measures

Primary Outcomes (21)

• 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 Outcomes (18)

• Diet

  Baseline

• Diet

  6-months

• Diet

  10-months

• Physical activity

  Baseline

• Physical activity

  6-months

Study Arms (2)

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.

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.

Other: I-POP + CHW navigation

Interventions

Usual Care OTHER

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.

Control

I-POP + CHW navigation OTHER

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.

I-POP CHW Intervention

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Baylor Research Institute: lead

Study Sites (1)

Baylor Research Institute

Dallas, Texas, 75210, United States

Location

Related Publications (15)

• 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.

  PMID: 28807739 BACKGROUND

• 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.

  PMID: 31057315 BACKGROUND

• 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.

  PMID: 29166248 BACKGROUND

• 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.

  PMID: 26890177 BACKGROUND

• 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/

  PMID: 31841291 BACKGROUND

• 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.

  PMID: 29608367 BACKGROUND

• 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.

  PMID: 29342009 BACKGROUND

• 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.

  PMID: 27272580 BACKGROUND

• 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.

  PMID: 26877153 BACKGROUND

• 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.

  PMID: 25886828 BACKGROUND

• 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.

  PMID: 30024805 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 12604476 BACKGROUND

• 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.

  PMID: 25521895 BACKGROUND

• 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.

  PMID: 27503968 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus; Hypertension; Renal Insufficiency, Chronic; Obesity; Chronic Disease

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms

Study Officials

• Heather Kitzman, PhD

  Baylor Scott and White Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2021
• First Posted: February 18, 2021
• Study Start: April 1, 2021
• Primary Completion: May 18, 2023
• Study Completion: May 18, 2025
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Within 6 months of study completion
• Access Criteria: Available by contacting study PI or reading publication

Locations

US (1)