Clinical trial NCT04761016: The Integrated Population (I-POP) Health Trial
Official title: The Role of Community Health Workers to Reduce Health Disparities Using a Multi-Level Integrated Population Health Intervention
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes
Hypertension
Chronic Kidney Diseases
Obesity
Chronic Disease
Keywords: Community Health Worker
Allostatic load
Ethnic minority
Health services delivery
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
First posted: 2021-02-18
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Allostatic load
timeFrame: Baseline
measure: Allostatic load
timeFrame: 6-months
measure: Cortisol
timeFrame: Baseline
measure: Cortisol
timeFrame: 6-months
measure: C-Reactive protein
timeFrame: Baseline
measure: C-Reactive protein
timeFrame: 6-months
measure: Body mass index
timeFrame: Baseline
measure: Body mass index
timeFrame: 6-months
measure: Body mass index
timeFrame: 10-months
measure: Waist - to - Hip ratio
timeFrame: Baseline
measure: Waist - to - Hip ratio
timeFrame: 6-months
measure: Waist - to - Hip ratio
timeFrame: 10-months
measure: HbA1c
timeFrame: Baseline
measure: HbA1c
timeFrame: 6-months
measure: HbA1c
timeFrame: 10-months
measure: Lipids
timeFrame: Baseline
measure: Lipids
timeFrame: 6-months
measure: Lipids
timeFrame: 10-months
measure: Blood pressure
timeFrame: Baseline
measure: Blood pressure
timeFrame: 6-months
measure: Blood pressure
timeFrame: 10-months
Secondary outcomes:
measure: Diet
timeFrame: Baseline
measure: Diet
timeFrame: 6-months
measure: Diet
timeFrame: 10-months
measure: Physical activity
timeFrame: Baseline
measure: Physical activity
timeFrame: 6-months
measure: Physical activity
timeFrame: 10-months
measure: Services utilization
timeFrame: Baseline
measure: Services utilization
timeFrame: 6-months
measure: Services utilization
timeFrame: 10-months
measure: Social determinants
timeFrame: Baseline
measure: Social determinants
timeFrame: 6-months
measure: Social determinants
timeFrame: 10-months
measure: Perceived stress
timeFrame: Baseline
measure: Perceived stress
timeFrame: 6-months
measure: Perceived stress
timeFrame: 10-months
measure: Medication use
timeFrame: Baseline
measure: Medication use
timeFrame: 6-months
measure: Medication use
timeFrame: 10-months
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Baylor Research Institute
state: Texas
Study officials:
affiliation: Baylor Scott and White Health
name: Heather Kitzman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
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