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Engaging Religious Leaders to Reduce Blood Pressures in Tanzanian Communities

Primary Purpose

Hypertension

Status
Recruiting
Phase
Not Applicable
Locations
Tanzania
Study Type
Interventional
Intervention
Religious Engagement in Health Intervention
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Religious Leaders, Community Engagement, Hypertension, Tanzania

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • CommunityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control communities

Religious Engagement in Health Intervention communities

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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
Change in treatment of hypertension
Change in percent of people with hypertension who are on treatment for hypertension, from baseline to 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
Change in Body Mass Index
Change in body mass index between baseline and 12 months.
Change in Body Mass Index
Change in body mass index between baseline and 24 months.
Change in waist circumference
Change in waist circumference between baseline and 12 months
Change in waist circumference
Change in waist circumference between baseline and 24 months
Change in fruit intake
Change in reported number of servings of fruits consumed per week between baseline and 12 months
Change in fruit intake
Change in reported number of servings of fruits consumed per week between baseline and 24 months
Change in vegetables intake
Change in reported number of servings of vegetables consumed per week between baseline and 12 months
Change in vegetables intake
Change in reported number of servings of vegetables consumed per week between baseline and 24 months
Change in minutes of physical exercise per week
Change in minutes of physical exercise per week between baseline and 12 months
Change in minutes of physical exercise per week
Change in minutes of physical exercise per week between baseline and 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
Effectiveness of the intervention
Percentage of community members initiating anti-hypertensive medications
Adoption of the intervention
Percentage of community members report being educated about blood pressure by religious leader in past 12 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
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.

Full Information

First Posted
June 8, 2022
Last Updated
April 10, 2023
Sponsor
Weill Medical College of Cornell University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT05416372
Brief Title
Engaging Religious Leaders to Reduce Blood Pressures in Tanzanian Communities
Official Title
Engaging Religious Leaders to Reduce Blood Pressures in Tanzanian Communities
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 20, 2023 (Actual)
Primary Completion Date
January 2026 (Anticipated)
Study Completion Date
December 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Religious Leaders, Community Engagement, Hypertension, Tanzania

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
24000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control communities
Arm Type
No Intervention
Arm Description
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.
Arm Title
Religious Engagement in Health Intervention communities
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Religious Engagement in Health Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean change in community systolic blood pressure
Description
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.
Time Frame
Baseline; 12months
Secondary Outcome Measure Information:
Title
Change in awareness of hypertension
Description
Change in the percent of people with hypertension who are aware that they have hypertension, from baseline to 12 months
Time Frame
Baseline; 12 months
Title
Change in awareness of hypertension
Description
Change in the percent of people with hypertension who are aware that they have hypertension, from baseline to 24 months
Time Frame
Baseline; 24 months
Title
Change in treatment of hypertension
Description
Change in percent of people with hypertension who are on treatment for hypertension, from baseline to 12 months
Time Frame
Baseline; 12 months
Title
Change in treatment of hypertension
Description
Change in percent of people with hypertension who are on treatment for hypertension, from baseline to 24 months
Time Frame
Baseline; 24 months
Title
Change in Body Mass Index
Description
Change in body mass index between baseline and 12 months.
Time Frame
Baseline; 12 months
Title
Change in Body Mass Index
Description
Change in body mass index between baseline and 24 months.
Time Frame
Baseline; 24 months
Title
Change in waist circumference
Description
Change in waist circumference between baseline and 12 months
Time Frame
Baseline; 12 months
Title
Change in waist circumference
Description
Change in waist circumference between baseline and 24 months
Time Frame
Baseline; 24 months
Title
Change in fruit intake
Description
Change in reported number of servings of fruits consumed per week between baseline and 12 months
Time Frame
Baseline; 12 months
Title
Change in fruit intake
Description
Change in reported number of servings of fruits consumed per week between baseline and 24 months
Time Frame
Baseline; 24 months
Title
Change in vegetables intake
Description
Change in reported number of servings of vegetables consumed per week between baseline and 12 months
Time Frame
Baseline; 12 months
Title
Change in vegetables intake
Description
Change in reported number of servings of vegetables consumed per week between baseline and 24 months
Time Frame
Baseline; 24 months
Title
Change in minutes of physical exercise per week
Description
Change in minutes of physical exercise per week between baseline and 12 months
Time Frame
Baseline; 12 months
Title
Change in minutes of physical exercise per week
Description
Change in minutes of physical exercise per week between baseline and 24 months
Time Frame
Baseline; 24 months
Title
Reach of the intervention
Description
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
Time Frame
24 months
Title
Effectiveness of the intervention
Description
Percentage of community members initiating anti-hypertensive medications
Time Frame
24 months
Title
Adoption of the intervention
Description
Percentage of community members report being educated about blood pressure by religious leader in past 12 months
Time Frame
24 months
Title
Maintenance of the intervention
Description
Percentage of community members report hearing blood pressure discussed in religious context in past 12 months; self-efficacy for blood pressure
Time Frame
24 months
Title
Mean change in community systolic blood pressure
Description
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.
Time Frame
Baseline; 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Megan Urry, MPH
Phone
646-962-8140
Email
meu7003@med.cornell.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Lindsey Reif, MPH, PhD
Phone
646-962-8140
Email
lir2020@med.cornell.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer A Downs, MD, PhD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert N Peck, MD, PhD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Community
City
Wards
State/Province
Mwanza, Geita, And Simiyu Regions
Country
Tanzania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Regional Medical Officer
Phone
0282500690

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

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Engaging Religious Leaders to Reduce Blood Pressures in Tanzanian Communities

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