Engaging Religious Leaders to Reduce Blood Pressures in Tanzanian Communities

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Engaging Religious Leaders to Reduce Blood Pressures in Tanzanian Communities

Conditions
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Hypertension

Intervention / Treatment
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* Behavioral: Religious Engagement in Health Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 20 communities will be stratified by population size (< or ≥ 20,000) and randomly ordered within strata using a computerized random number generator. A statistician will generate a list of all of possible random permutations that allocate equal numbers of communities from each stratum to the intervention and to the control. Investigators will then invite two representatives from each of the 20 communities to a public randomization ceremony. During this ceremony, representatives will blindly choose numbered tennis balls from an opaque bag to identify the permutation of allocations that will be used.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control communities<br>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. | |
| Experimental: Religious Engagement in Health Intervention communities<br>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<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Religious Leaders, Community Engagement, Hypertension, Tanzania