This is a 12-month behavioral cluster-randomized trial testing a church-based intervention to reduce blood pressure in African Americans with uncontrolled blood pressure.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
312
The Heart to Heart intervention will be delivered at the churches over 6 months. The intervention consists of 12 bible study sessions (45 minutes) led by the Senior Pastor and 24 behavior change small group sessions (90 minutes) led by a trained Rush staff interventionist. These sessions are open to the entire church membership and focus on improving diet and physical well being. A community health worker will provide individualized support to participants with uncontrolled blood pressure who do not reduce their blood pressure by participating in small groups.
The Money Smart program for adults was developed by the Federal Deposit Insurance Corporation (FDIC). It consists of training modules that cover basic financial topics including deposit and credit services offered by financial institutions, how to obtain and use credit effectively, and the basics of building or repairing credit. This group-based program will be delivered in 14 sessions over 6 months and will be led by a trained instructor.
Rush University Medical Center
Chicago, Illinois, United States
RECRUITINGChange in Blood pressure
The primary outcome is systolic blood pressure at 6 months post start of the intervention. The Omron digital blood pressure monitor will be utilized to measure blood pressure (Omron Healthcare, Inc., Lake Forest, IL). The participant will sit quietly for \>5 minutes, 3 readings will be taken 1-2 minutes apart while seated, and an average of the last 2 readings will be taken to evaluate blood pressure.
Time frame: Measured at baseline and 6 months and 12 months after start of the intervention
Change in Medication adherence
Medication adherence will be measured using the 15-item Adherence to Refills and Medications Scale (ARMS). The items are evaluated on a 4-point scale ranging from "none of the time" to "all of the time".
Time frame: Measured at baseline and 6 months and 15 months after start of the intervention
Change in DASH diet adherence
Adherence to the Dietary Approaches to Stop Hypertension (DASH) diet will be measured using the food frequency questionnaire developed by Viocare (Princeton, NJ). This 156-item graphical, web-based FFQ queries respondents about usual intakes of 156 food and beverage items over the past three months. It also provides food and nutrient analyses to the research team based on the Nutrition Data System for Research 2018 (NDSR, University of Minnesota, Minneapolis, MN).
Time frame: Measured at baseline and 6 months and 15 months after start of the intervention
Change in Self efficacy
Self efficacy will be measured using the Hypertension Self-Care Profile Self-efficacy scale which evaluates self efficacy for 8 common self care recommendations for individuals with hypertension. The items are evaluated on a 4-point scale ranging from "not confident" to "very confident".
Time frame: Measured at baseline and 6 months and 15 months after start of the intervention
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Change in Quality of life
Quality of life will be measured using the EuroQual (EQ-5D-5L) questionnaire. The measure evaluates the participant's perception of their "health today" with respect to mobility, self-care, usual activities, pain/discomfort, and anxiety depression. The items are evaluated on a 5-point scale ranging from "no problem" in the area to "extreme problem" in the area.
Time frame: Measured at baseline and 6 months and 15 months after start of the intervention
Change in Social support
Social support for eating a healthy diet will be measured using a 4-item questionnaire which will evaluate the participant's perception of social support received from family members, friends, church members, and their Pastor. The items are evaluated on a 5-point scale ranging from "never" to "always".
Time frame: Measured at baseline and 6 months and 15 months after start of the intervention
Change in Hypertension knowledge
Hypertension knowledge will be evaluated using a 10-item questionnaire adapted from the Hypertension Evaluation of Lifestyle and Management (HELM) Knowledge Scale. Systolic and diastolic blood pressure measurements will be evaluated using the following 4 categories: high, low, normal, and don't know. The frequency with which medication should be taken, lifestyle factors associated with hypertension, and health risks associated with hypertension will also be evaluated.
Time frame: Measured at baseline and 6 months and 15 months after start of the intervention
Change in Nutrition knowledge
Nutrition knowledge will be evaluated using an 18-item survey adapted from the International Food Policy Study 2020 - United States Survey. Common foods and food labels are evaluated on a 10-point scale ranging from "not healthy at all" to "extremely healthy".
Time frame: Measured at baseline and 6 months and 15 months after start of the intervention
Change in Barriers to medication use
Barriers to medication use will be measured using the 15-item BRIGHT study Barriers to Medication Scale. The scale evaluates different reasons why it is difficult for participants to take medications or to take the medications on time. The items are evaluated on a 5-point scale ranging from "never" to "all the time".
Time frame: Measured at baseline and 6 months and 15 months after start of the intervention