The Integrated Population (I-POP) Health Trial
- Conditions
- DiabetesChronic Kidney DiseasesObesityHypertensionChronic Disease
- Interventions
- Other: Usual CareOther: I-POP + CHW navigation
- Registration Number
- NCT04761016
- Lead Sponsor
- Baylor Research Institute
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 202
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Usual Care 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. I-POP CHW Intervention I-POP + CHW navigation 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.
- Primary Outcome Measures
Name Time Method HbA1c 10-months Finger stick blood measure (%)
Allostatic load 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 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 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 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 10-months Waist circumference (centimeters) divided by circumference of hips (centimeters)
Lipids 10-months Finger stick blood measure collected fasting via fingerstick (mg/dL)
Blood pressure 10-months Stadiometer used to measure systolic and diastolic pressures to nearest 1 mm Hg
- Secondary Outcome Measures
Name Time Method Physical activity 10-months Measured by self report questionnaire \[type, frequency, and time completed in minutes\]
Diet 10-months Measured by self report Dietary Screening questionnaire (DSQ). \[scale: dietary nutrients will be calculated on a continuous scale based on NHANES guideline. Score: 0 to any positive value. A score above or below the threshold based on 2000 calories per day would indicate worse outcome.\]
Services utilization 10-months Measured by self-report survey. \[scale: count the number visits at healthcare or wellness centers. A higher score would indicate better utilization.\]
Social determinants 10-months Measured by self-report survey
Perceived stress 10-months Measured by Perceived Stress Scale (PSS-10) \[scale: high risk=40, moderate risk=20, low risk=0\]
Medication use 10-months Measured by self-report survey
Trial Locations
- Locations (1)
Baylor Research Institute
🇺🇸Dallas, Texas, United States