Hypertension
Conditions
Keywords
Religious Leaders, Community Engagement, Hypertension, Tanzania
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.
Interventions
BEHAVIORALReligious 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.
Sponsors
Weill Medical College of Cornell University
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Community Systolic Blood Pressure | Baseline; 12months | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Awareness of Hypertension | Baseline; 12 months | Change in the percent of people with hypertension who are aware that they have hypertension, from baseline to 12 months |
| Change in Treatment of Hypertension | Baseline; 12 months | Change in percent of people with hypertension who are on treatment for hypertension, from baseline to 12 months |
| Change in Body Mass Index | Baseline; 12 months | Change in body mass index between baseline and 12 months. |
| Change in Waist Circumference | Baseline; 12 months | Change in waist circumference between baseline and 12 months |
| Change in Fruit Intake | Baseline; 12 months | Change in reported number of servings of fruits consumed per week between baseline and 12 months |
| Change in Vegetables Intake | Baseline; 12 months | Change in reported number of servings of vegetables consumed per week between baseline and 12 months |
| Change in Minutes of Physical Exercise Per Week | Baseline; 12 months | Change in minutes of physical exercise per week between baseline and 12 months |
| Reach of the Intervention | 24 months | 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 | 24 months | Percentage of community members initiating anti-hypertensive medications |
| Adoption of the Intervention | 24 months | Percentage of community members report being educated about blood pressure by religious leader in past 12 months |
| Maintenance of the Intervention | 24 months | 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 | Baseline; 24 months | 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. |
Countries
Tanzania
Contacts
PRINCIPAL_INVESTIGATORJennifer A Downs, MD, PhD
Weill Medical College of Cornell University
PRINCIPAL_INVESTIGATORRobert N Peck, MD, PhD
Weill Medical College of Cornell University
Participant flow
Pre-assignment details
Religious leaders and health care workers were not considered enrolled in the study.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous 12 Month Survey Participants | 52.9 Years STANDARD_DEVIATION 12.9 |
| Age, Continuous Baseline Survey Participants | 52.8 Years STANDARD_DEVIATION 13.2 |
| Race and Ethnicity Not Collected | 0 Participants |
| Region of Enrollment Tanzania | 8016 Participants |
| Religion 12 month Survey Participants Christian | 5335 Participants |
| Religion 12 month Survey Participants Muslim | 198 Participants |
| Religion 12 month Survey Participants No religious affiliation | 1085 Participants |
| Religion Baseline Survey Participants Christian | 5600 Participants |
| Religion Baseline Survey Participants Muslim | 213 Participants |
| Religion Baseline Survey Participants No religious affiliation | 933 Participants |
| Sex: Female, Male 12 month Survey Participants Female | 2003 Participants |
| Sex: Female, Male 12 month Survey Participants Male | 2001 Participants |
| Sex: Female, Male Baseline Survey Participants Female | 2007 Participants |
| Sex: Female, Male Baseline Survey Participants Male | 2000 Participants |
| Systolic blood pressure 12 month Survey Participants | 126 mmHg STANDARD_DEVIATION 21.9 |
| Systolic blood pressure Baseline Survey Participants | 129 mmHg STANDARD_DEVIATION 21.9 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 8,030 | 0 / 8,016 |
| other Total, other adverse events | 0 / 8,030 | 0 / 8,016 |
| serious Total, serious adverse events | 0 / 8,030 | 0 / 8,016 |
Outcome results
None listed