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Clinical Trials/NCT04761016
NCT04761016
Completed
N/A

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

Baylor Research Institute1 site in 1 country202 target enrollmentApril 1, 2021

Overview

Phase
N/A
Intervention
Usual Care
Conditions
Diabetes
Sponsor
Baylor Research Institute
Enrollment
202
Locations
1
Primary Endpoint
Allostatic load
Status
Completed
Last Updated
2 months ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2021
End Date
May 18, 2025
Last Updated
2 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Arms & Interventions

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.

Intervention: Usual Care

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.

Intervention: I-POP + CHW navigation

Outcomes

Primary Outcomes

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: 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: 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: 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: 10-months

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

HbA1c

Time Frame: 10-months

Finger stick blood measure (%)

Lipids

Time Frame: 10-months

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

Blood pressure

Time Frame: 10-months

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

C-Reactive protein

Time Frame: Baseline

4mL saliva collected fasting in the morning. \[Scale: measured in a continuous scale. Normal range 25 pg/mL - 1600 pg/mL. Value exceeded the normal range indicates higher level of inflammation.\]

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

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)

HbA1c

Time Frame: Baseline

Finger stick blood measure (%)

HbA1c

Time Frame: 6-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)

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

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. \[scale: Count of risk factors. May be dichotomized as high risk = 6 to 10, low risk=0 to 5\]

Cortisol

Time Frame: Baseline

4mL saliva collected fasting in the morning. \[Scale: measured in a continuous scale. Normal range 0.007 - 0.115 ug/dL. Value exceeded the normal range indicates higher level of stress.\]

Secondary Outcomes

  • Diet(10-months)
  • Physical activity(10-months)
  • Services utilization(10-months)
  • Social determinants(10-months)
  • Perceived stress(10-months)
  • Medication use(10-months)
  • Social determinants(Baseline)
  • Social determinants(6-months)
  • Perceived stress(Baseline)
  • Perceived stress(6-months)
  • Medication use(Baseline)
  • Medication use(6-months)
  • Diet(Baseline)
  • Diet(6-months)
  • Physical activity(Baseline)
  • Physical activity(6-months)
  • Services utilization(Baseline)
  • Services utilization(6-months)

Study Sites (1)

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