Engaging Religious Leaders to Reduce Blood Pressures in Tanzanian Communities

The investigators hypothesize that communities in which religious leaders are provided with education about blood pressure and how to measure blood pressure will have lower overall average blood pressures than communities in which religious leaders do not receive education about blood pressure.

Study Overview

• Status: Recruiting
• Conditions: Hypertension
• Intervention / Treatment: Behavioral: Religious Engagement in Health Intervention

Detailed Description

This research is being done to determine whether the Religious Engagement in Health Intervention can reduce community blood pressure. The study is being conducted in the Northwestern Tanzania. 20 communities will be involved: 10 will be randomized to the Religious Engagement in Health Intervention arm, and 10 will be randomized to the control arm. The Religious Engagement in Health Intervention includes the following three evidence-based components: (1) educational sessions for Christian and Muslim leaders on religious teachings and medical aspects of blood pressure, (2) equipping religious leaders to provide blood pressure teaching in their communities using knowledge learned from educational sessions and through longitudinal mentorship meetings, and (3) community blood pressure screening organized by religious leaders in partnership with local health care workers, and referrals for clinical care as needed.

• Study Type: Interventional
• Enrollment (Estimated): 24000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lindsey Reif, MPH, PhD; Phone Number: 646-962-8140; Email: lir2020@med.cornell.edu
• Study Contact Backup: Name: Megan Willkens, BS; Phone Number: 646-962-8140; Email: maw4016@med.cornell.edu

Study Locations

• Tanzania
  • Mwanza, Geita, And Simiyu Regions
    • Wards, Mwanza, Geita, And Simiyu Regions, Tanzania
      • Recruiting
      • Community
      • Contact: Regional Medical Officer; Phone Number: 0282500690

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Adult ≥35 years of age
• Has lived in the community for ≥1 year
• Household identified for random sampling is primary residence: has slept in the household at least once in the past 2 weeks and considers this their primary residence

Exclusion Criteria:

• First-degree relative from the same household already enrolled
• Relative of the same sex from the same household already enrolled

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Religious Engagement in Health Intervention communities; Communities randomized to the intervention arm will receive a strengthening of the capacity to manage blood pressure at their local health center plus Religious Engagement in Health Intervention for blood pressure (BP), which includes three evidence-based components; 1) educational sessions for Christian and Muslim leaders on religious teachings and medical aspects of BP, 2) equipping religious leaders to provide BP teaching in their communities using knowledge learned from educational sessions and through longitudinal mentorship meetings, and 3) community BP screening organized by religious leaders in partnership with local health care workers, and referrals for clinical care as needed.	Behavioral: Religious Engagement in Health Intervention; Religious Engagement in Health Intervention for blood pressure (BP) includes three evidence-based components: (1) educational sessions for Christian and Muslim leaders on religious teachings and medical aspects of BP, (2) equipping religious leaders to provide BP teaching in their communities using knowledge learned from educational sessions and through longitudinal mentorship meetings, and (3) community BP screening organized by religious leaders in partnership with local health care workers, and referrals for clinical care as needed.
No Intervention: Control communities; Communities randomized to the control arm will receive a strengthening of the capacity to manage blood pressure at their local health center. Healthcare workers at the local health center will receive standard supplies, reference materials, and training in blood pressure measurement and management on-site. In the event of any stock-outs due to higher demand for antihypertensives during the trial implementation, the trial will temporarily provide these medications to primary health facilities until the Ministry of Health supply chain is restored. Of note, control communities will receive Religious Engagement in Health Intervention after the trial is complete.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change in community systolic blood pressure	Before and 12 months after the intervention, investigators will estimate the true mean community BP by sampling 400 randomly selected adult community members (age ≥35 years) in each of the 20 communities.	Baseline; 12months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in awareness of hypertension	Change in the percent of people with hypertension who are aware that they have hypertension, from baseline to 12 months	Baseline; 12 months
Change in awareness of hypertension	Change in the percent of people with hypertension who are aware that they have hypertension, from baseline to 24 months	Baseline; 24 months
Change in treatment of hypertension	Change in percent of people with hypertension who are on treatment for hypertension, from baseline to 12 months	Baseline; 12 months
Change in treatment of hypertension	Change in percent of people with hypertension who are on treatment for hypertension, from baseline to 24 months	Baseline; 24 months
Change in Body Mass Index	Change in body mass index between baseline and 12 months.	Baseline; 12 months
Change in Body Mass Index	Change in body mass index between baseline and 24 months.	Baseline; 24 months
Change in waist circumference	Change in waist circumference between baseline and 12 months	Baseline; 12 months
Change in waist circumference	Change in waist circumference between baseline and 24 months	Baseline; 24 months
Change in fruit intake	Change in reported number of servings of fruits consumed per week between baseline and 12 months	Baseline; 12 months
Change in fruit intake	Change in reported number of servings of fruits consumed per week between baseline and 24 months	Baseline; 24 months
Change in vegetables intake	Change in reported number of servings of vegetables consumed per week between baseline and 12 months	Baseline; 12 months
Change in vegetables intake	Change in reported number of servings of vegetables consumed per week between baseline and 24 months	Baseline; 24 months
Change in minutes of physical exercise per week	Change in minutes of physical exercise per week between baseline and 12 months	Baseline; 12 months
Change in minutes of physical exercise per week	Change in minutes of physical exercise per week between baseline and 24 months	Baseline; 24 months
Reach of the intervention	Percentage of religious leaders attending educational seminar and mentorship groups of 240 invited and number of community members reporting having blood pressure measured in the past year	24 months
Effectiveness of the intervention	Percentage of community members initiating anti-hypertensive medications	24 months
Adoption of the intervention	Percentage of community members report being educated about blood pressure by religious leader in past 12 months	24 months
Maintenance of the intervention	Percentage of community members report hearing blood pressure discussed in religious context in past 12 months; self-efficacy for blood pressure	24 months
Mean change in community systolic blood pressure	Before and 24 months after the intervention, investigators will estimate the true mean community BP by sampling 400 randomly selected adult community members (age ≥35 years) in each of the 20 communities.	Baseline; 24 months

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Robert N Peck, MD, PhD, Weill Medical College of Cornell University; Principal Investigator: Jennifer A Downs, MD, PhD, Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2022
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: June 8, 2022
• First Submitted That Met QC Criteria: June 8, 2022
• First Posted (Actual): June 13, 2022

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Hypertension; Tanzania; Community Engagement; Religious Leaders
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 21-06023670; R01HL161673 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified research data sets that document, support, and validate our research findings will be made available under appropriate data-sharing agreements after the main findings from the final research data set have been accepted for publication.
• IPD Sharing Time Frame: Data will be made available at the time of manuscript publication.
• IPD Sharing Access Criteria: De-identified data on community blood pressures, including demographic and clinical data, will be made available under appropriate data-sharing agreements.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No