Trial Outcomes & Findings for Engaging Religious Leaders to Reduce Blood Pressures in Tanzanian Communities (NCT NCT05416372)

Results Overview

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.

Recruitment status

SUSPENDED

Study phase

NA

Target enrollment

16046 participants

Primary outcome timeframe

Baseline; 12months

Results posted on

2026-07-22

Participant Flow

Religious leaders and health care workers were not considered enrolled in the study.

Unit of analysis: Communities

Participant milestones

Participant milestones
Measure	Control Communities 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.	Religious Engagement in Health Intervention Communities 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.
Overall Study STARTED	8030 10	8016 10
Overall Study COMPLETED	8030 10	8016 10
Overall Study NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Baseline Survey and 12 month Survey data reported separately.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Control Communities n=10 Communities 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.	Religious Engagement in Health Intervention Communities n=10 Communities 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.
Mean Change in Community Systolic Blood Pressure	-2.11 mmHg Standard Deviation 2.73	-2.63 mmHg Standard Deviation 2.70

SECONDARY outcome

Timeframe: Baseline; 12 months

Population: Only those participants with hypertension were analyzed for this measure.

Change in the percent of people with hypertension who are aware that they have hypertension, from baseline to 12 months

Outcome measures

Outcome measures
Measure	Control Communities n=10 Communities 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.	Religious Engagement in Health Intervention Communities n=10 Communities 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.
Change in Awareness of Hypertension	4.02 Change in percentage of participants Standard Deviation 7.47	1.97 Change in percentage of participants Standard Deviation 5.14

SECONDARY outcome

Timeframe: Baseline; 24 months

Change in the percent of people with hypertension who are aware that they have hypertension, from baseline to 24 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline; 12 months

Population: Only those participants with hypertension were analyzed for this measure.

Change in percent of people with hypertension who are on treatment for hypertension, from baseline to 12 months

Outcome measures

Outcome measures
Measure	Control Communities n=10 Communities 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.	Religious Engagement in Health Intervention Communities n=10 Communities 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.
Change in Treatment of Hypertension	0.66 Change in percentage of participants Standard Deviation 5.98	-2.37 Change in percentage of participants Standard Deviation 4.29

SECONDARY outcome

Timeframe: Baseline; 24 months

Change in percent of people with hypertension who are on treatment for hypertension, from baseline to 24 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline; 12 months

Change in body mass index between baseline and 12 months.

Outcome measures

Outcome measures
Measure	Control Communities n=10 Communities 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.	Religious Engagement in Health Intervention Communities n=10 Communities 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.
Change in Body Mass Index	0.57 kg/m^2 Standard Deviation 0.39	0.33 kg/m^2 Standard Deviation 0.43

SECONDARY outcome

Timeframe: Baseline; 24 months

Change in body mass index between baseline and 24 months.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline; 12 months

Population: Per protocol, only female participants were analyzed for this measure.

Change in waist circumference between baseline and 12 months

Outcome measures

Outcome measures
Measure	Control Communities n=10 Communities 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.	Religious Engagement in Health Intervention Communities n=10 Communities 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.
Change in Waist Circumference	0.31 cm Standard Deviation 1.02	0.05 cm Standard Deviation 1.13

SECONDARY outcome

Timeframe: Baseline; 24 months

Change in waist circumference between baseline and 24 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline; 12 months

Change in reported number of servings of fruits consumed per week between baseline and 12 months

Outcome measures

Outcome measures
Measure	Control Communities n=10 Communities 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.	Religious Engagement in Health Intervention Communities n=10 Communities 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.
Change in Fruit Intake	0.10 Servings per week Standard Deviation 0.33	-0.07 Servings per week Standard Deviation 0.44

SECONDARY outcome

Timeframe: Baseline; 24 months

Change in reported number of servings of fruits consumed per week between baseline and 24 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline; 12 months

Change in reported number of servings of vegetables consumed per week between baseline and 12 months

Outcome measures

Outcome measures
Measure	Control Communities n=10 Communities 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.	Religious Engagement in Health Intervention Communities n=10 Communities 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.
Change in Vegetables Intake	-0.31 Servings per week Standard Deviation 0.67	-0.33 Servings per week Standard Deviation 0.67

SECONDARY outcome

Timeframe: Baseline; 24 months

Change in reported number of servings of vegetables consumed per week between baseline and 24 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline; 12 months

Change in minutes of physical exercise per week between baseline and 12 months

Outcome measures

Outcome measures
Measure	Control Communities n=10 Communities 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.	Religious Engagement in Health Intervention Communities n=10 Communities 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.
Change in Minutes of Physical Exercise Per Week	-69.99 Minutes of physical activity/week Standard Deviation 74.07	-67.55 Minutes of physical activity/week Standard Deviation 58.73

SECONDARY outcome

Timeframe: Baseline; 24 months

Change in minutes of physical exercise per week between baseline and 24 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 months

Percentage of community members initiating anti-hypertensive medications

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 months

Percentage of community members report being educated about blood pressure by religious leader in past 12 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 months

Percentage of community members report hearing blood pressure discussed in religious context in past 12 months; self-efficacy for blood pressure

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

Adverse Events

Control Communities

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Religious Engagement in Health Intervention Communities

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jennifer Downs, Associate Professor of Medicine

Weill Cornell Medicine

Phone: 1 646 962 8140

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Control Communities n=10 Communities 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.	Religious Engagement in Health Intervention Communities n=10 Communities 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.	Total n=20 Communities Total of all reporting groups
Age, Continuous Baseline Survey Participants	53.0 Years STANDARD_DEVIATION 13.3 • n=4026 Participants • Baseline Survey and 12 month Survey data reported separately.	52.5 Years STANDARD_DEVIATION 13.1 • n=4010 Participants • Baseline Survey and 12 month Survey data reported separately.	52.8 Years STANDARD_DEVIATION 13.2 • n=8036 Participants • Baseline Survey and 12 month Survey data reported separately.
Age, Continuous 12 Month Survey Participants	53.1 Years STANDARD_DEVIATION 13.1 • n=4004 Participants • Baseline Survey and 12 month Survey data reported separately.	52.6 Years STANDARD_DEVIATION 12.8 • n=4006 Participants • Baseline Survey and 12 month Survey data reported separately.	52.9 Years STANDARD_DEVIATION 12.9 • n=8010 Participants • Baseline Survey and 12 month Survey data reported separately.
Sex: Female, Male Baseline Survey Participants · Female	2026 Participants n=4026 Participants • Baseline Survey and 12 month Survey data reported separately.	2007 Participants n=4010 Participants • Baseline Survey and 12 month Survey data reported separately.	4033 Participants n=8036 Participants • Baseline Survey and 12 month Survey data reported separately.
Sex: Female, Male Baseline Survey Participants · Male	2000 Participants n=4026 Participants • Baseline Survey and 12 month Survey data reported separately.	2003 Participants n=4010 Participants • Baseline Survey and 12 month Survey data reported separately.	4003 Participants n=8036 Participants • Baseline Survey and 12 month Survey data reported separately.
Sex: Female, Male 12 month Survey Participants · Female	2003 Participants n=4004 Participants • Baseline Survey and 12 month Survey data reported separately.	2005 Participants n=4006 Participants • Baseline Survey and 12 month Survey data reported separately.	4008 Participants n=8010 Participants • Baseline Survey and 12 month Survey data reported separately.
Sex: Female, Male 12 month Survey Participants · Male	2001 Participants n=4004 Participants • Baseline Survey and 12 month Survey data reported separately.	2001 Participants n=4006 Participants • Baseline Survey and 12 month Survey data reported separately.	4002 Participants n=8010 Participants • Baseline Survey and 12 month Survey data reported separately.
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Tanzania	8030 Participants n=8030 Participants	8016 Participants n=8016 Participants	16046 Participants n=16046 Participants
Religion Baseline Survey Participants · Christian	2736 Participants n=4026 Participants • Baseline Survey and 12 month Survey data reported separately.	2864 Participants n=4010 Participants • Baseline Survey and 12 month Survey data reported separately.	5600 Participants n=8036 Participants • Baseline Survey and 12 month Survey data reported separately.
Religion Baseline Survey Participants · Muslim	94 Participants n=4026 Participants • Baseline Survey and 12 month Survey data reported separately.	213 Participants n=4010 Participants • Baseline Survey and 12 month Survey data reported separately.	307 Participants n=8036 Participants • Baseline Survey and 12 month Survey data reported separately.
Religion Baseline Survey Participants · No religious affiliation	1196 Participants n=4026 Participants • Baseline Survey and 12 month Survey data reported separately.	933 Participants n=4010 Participants • Baseline Survey and 12 month Survey data reported separately.	2129 Participants n=8036 Participants • Baseline Survey and 12 month Survey data reported separately.
Religion 12 month Survey Participants · Christian	2612 Participants n=4004 Participants • Baseline Survey and 12 month Survey data reported separately.	2723 Participants n=4006 Participants • Baseline Survey and 12 month Survey data reported separately.	5335 Participants n=8010 Participants • Baseline Survey and 12 month Survey data reported separately.
Religion 12 month Survey Participants · Muslim	81 Participants n=4004 Participants • Baseline Survey and 12 month Survey data reported separately.	198 Participants n=4006 Participants • Baseline Survey and 12 month Survey data reported separately.	279 Participants n=8010 Participants • Baseline Survey and 12 month Survey data reported separately.
Religion 12 month Survey Participants · No religious affiliation	1311 Participants n=4004 Participants • Baseline Survey and 12 month Survey data reported separately.	1085 Participants n=4006 Participants • Baseline Survey and 12 month Survey data reported separately.	2396 Participants n=8010 Participants • Baseline Survey and 12 month Survey data reported separately.
Systolic blood pressure Baseline Survey Participants	128 mmHg STANDARD_DEVIATION 22.0 • n=4026 Participants • Baseline Survey and 12 month Survey data reported separately.	129 mmHg STANDARD_DEVIATION 21.8 • n=4010 Participants • Baseline Survey and 12 month Survey data reported separately.	129 mmHg STANDARD_DEVIATION 21.9 • n=8036 Participants • Baseline Survey and 12 month Survey data reported separately.
Systolic blood pressure 12 month Survey Participants	126 mmHg STANDARD_DEVIATION 22.2 • n=4004 Participants • Baseline Survey and 12 month Survey data reported separately.	126 mmHg STANDARD_DEVIATION 21.6 • n=4006 Participants • Baseline Survey and 12 month Survey data reported separately.	126 mmHg STANDARD_DEVIATION 21.9 • n=8010 Participants • Baseline Survey and 12 month Survey data reported separately.