Clinical trial NCT05416372: 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
Overall status: RECRUITING
Phase: NA
Conditions: Hypertension
Keywords: Religious Leaders
Community Engagement
Hypertension
Tanzania
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2022-06-13
Enrollment: 24000
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Mean change in community systolic blood pressure
timeFrame: Baseline; 12months
Secondary outcomes:
measure: Change in awareness of hypertension
timeFrame: Baseline; 12 months
measure: Change in awareness of hypertension
timeFrame: Baseline; 24 months
measure: Change in treatment of hypertension
timeFrame: Baseline; 12 months
measure: Change in treatment of hypertension
timeFrame: Baseline; 24 months
measure: Change in Body Mass Index
timeFrame: Baseline; 12 months
measure: Change in Body Mass Index
timeFrame: Baseline; 24 months
measure: Change in waist circumference
timeFrame: Baseline; 12 months
measure: Change in waist circumference
timeFrame: Baseline; 24 months
measure: Change in fruit intake
timeFrame: Baseline; 12 months
measure: Change in fruit intake
timeFrame: Baseline; 24 months
measure: Change in vegetables intake
timeFrame: Baseline; 12 months
measure: Change in vegetables intake
timeFrame: Baseline; 24 months
measure: Change in minutes of physical exercise per week
timeFrame: Baseline; 12 months
measure: Change in minutes of physical exercise per week
timeFrame: Baseline; 24 months
measure: Reach of the intervention
timeFrame: 24 months
measure: Effectiveness of the intervention
timeFrame: 24 months
measure: Adoption of the intervention
timeFrame: 24 months
measure: Maintenance of the intervention
timeFrame: 24 months
measure: Mean change in community systolic blood pressure
timeFrame: Baseline; 24 months
Other outcomes:
Locations:
city: Wards
country: Tanzania
facility: Community
state: Mwanza, Geita, And Simiyu Regions
Study officials:
affiliation: Weill Medical College of Cornell University
name: Jennifer A Downs, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Weill Medical College of Cornell University
name: Robert N Peck, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: