Engaging Religious Leaders to Reduce Blood Pressures in Tanzanian Communities

Hypertension Clinical Trial

Official title:

Engaging Religious Leaders to Reduce Blood Pressures in Tanzanian Communities

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05416372
• Other study ID #: 21-06023670
• Secondary ID: R01HL161673
• Status: Recruiting
• Phase: N/A
• Start date: June 22, 2022
• Est. completion date: December 2027

Study information

• Verified date: November 2023
• Source: Weill Medical College of Cornell University
• Contact: Megan Willkens, BS
• Phone: 646-962-8140
• Email: maw4016[@]med.cornell.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24000
• Est. completion date: December 2027
• Est. primary completion date: January 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension

Intervention

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.

Locations

Country	Name	City	State
Tanzania	Community	Wards	Mwanza, Geita, And Simiyu Regions

Sponsors (2)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in Body Mass Index	Change in body mass index between baseline and 12 months.	Baseline; 12 months
Secondary	Change in Body Mass Index	Change in body mass index between baseline and 24 months.	Baseline; 24 months
Secondary	Change in waist circumference	Change in waist circumference between baseline and 12 months	Baseline; 12 months
Secondary	Change in waist circumference	Change in waist circumference between baseline and 24 months	Baseline; 24 months
Secondary	Change in fruit intake	Change in reported number of servings of fruits consumed per week between baseline and 12 months	Baseline; 12 months
Secondary	Change in fruit intake	Change in reported number of servings of fruits consumed per week between baseline and 24 months	Baseline; 24 months
Secondary	Change in vegetables intake	Change in reported number of servings of vegetables consumed per week between baseline and 12 months	Baseline; 12 months
Secondary	Change in vegetables intake	Change in reported number of servings of vegetables consumed per week between baseline and 24 months	Baseline; 24 months
Secondary	Change in minutes of physical exercise per week	Change in minutes of physical exercise per week between baseline and 12 months	Baseline; 12 months
Secondary	Change in minutes of physical exercise per week	Change in minutes of physical exercise per week between baseline and 24 months	Baseline; 24 months
Secondary	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
Secondary	Effectiveness of the intervention	Percentage of community members initiating anti-hypertensive medications	24 months
Secondary	Adoption of the intervention	Percentage of community members report being educated about blood pressure by religious leader in past 12 months	24 months
Secondary	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
Secondary	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