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Completed

NCT Number: NCT04761016

The Integrated Population (I-POP) Health Trial

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.

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Key information

Conditions

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

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baylor Research Institute

Dallas, Texas, 75210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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]

  2. 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].

  3. 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.]

  4. 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.]

  5. 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.]

  6. 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.]

  7. 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

  8. 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

  9. 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

  10. Waist - to - Hip ratio

    Time frame: Baseline

    Waist circumference (centimeters) divided by circumference of hips (centimeters)

  11. Waist - to - Hip ratio

    Time frame: 6-months

    Waist circumference (centimeters) divided by circumference of hips (centimeters)

  12. Waist - to - Hip ratio

    Time frame: 10-months

    Waist circumference (centimeters) divided by circumference of hips (centimeters)

  13. HbA1c

    Time frame: Baseline

    Finger stick blood measure (%)

  14. HbA1c

    Time frame: 6-months

    Finger stick blood measure (%)

  15. HbA1c

    Time frame: 10-months

    Finger stick blood measure (%)

  16. Lipids

    Time frame: Baseline

    Finger stick blood measure collected fasting via fingerstick (mg/dL)

  17. Lipids

    Time frame: 6-months

    Finger stick blood measure collected fasting via fingerstick (mg/dL)

  18. Lipids

    Time frame: 10-months

    Finger stick blood measure collected fasting via fingerstick (mg/dL)

  19. Blood pressure

    Time frame: Baseline

    Stadiometer used to measure systolic and diastolic pressures to nearest 1 mm Hg

  20. Blood pressure

    Time frame: 6-months

    Stadiometer used to measure systolic and diastolic pressures to nearest 1 mm Hg

  21. Blood pressure

    Time frame: 10-months

    Stadiometer used to measure systolic and diastolic pressures to nearest 1 mm Hg

Secondary outcomes

  1. Diet

    Time frame: Baseline

    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.]

  2. Diet

    Time frame: 6-months

    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.]

  3. Diet

    Time frame: 10-months

    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.]

  4. Physical activity

    Time frame: Baseline

    Measured by self report questionnaire [type, frequency, and time completed in minutes]

  5. Physical activity

    Time frame: 6-months

    Measured by self report questionnaire [type, frequency, and time completed in minutes]

  6. Physical activity

    Time frame: 10-months

    Measured by self report questionnaire [type, frequency, and time completed in minutes]

  7. Services utilization

    Time frame: Baseline

    Measured by self-report survey. [scale: count the number visits at healthcare or wellness centers. A higher score would indicate better utilization.]

  8. Services utilization

    Time frame: 6-months

    Measured by self-report survey. [scale: count the number visits at healthcare or wellness centers. A higher score would indicate better utilization.]

  9. Services utilization

    Time frame: 10-months

    Measured by self-report survey. [scale: count the number visits at healthcare or wellness centers. A higher score would indicate better utilization.]

  10. Social determinants

    Time frame: Baseline

    Measured by self-report survey

  11. Social determinants

    Time frame: 6-months

    Measured by self-report survey

  12. Social determinants

    Time frame: 10-months

    Measured by self-report survey

  13. Perceived stress

    Time frame: Baseline

    Measured by Perceived Stress Scale (PSS-10) [scale: high risk=40, moderate risk=20, low risk=0]

  14. Perceived stress

    Time frame: 6-months

    Measured by Perceived Stress Scale (PSS-10) [scale: high risk=40, moderate risk=20, low risk=0]

  15. Perceived stress

    Time frame: 10-months

    Measured by Perceived Stress Scale (PSS-10) [scale: high risk=40, moderate risk=20, low risk=0]

  16. Medication use

    Time frame: Baseline

    Measured by self-report survey

  17. Medication use

    Time frame: 6-months

    Measured by self-report survey

  18. Medication use

    Time frame: 10-months

    Measured by self-report survey

Sponsors and collaborators

Lead sponsor

Baylor Research Institute

Other

Registry information

Official study title

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

Acronym: I-POP

Important dates

Study start
2021
Primary completion
2023
Study completion
2025
First posted
Feb 18, 2021
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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