NCT07386535

Brief Summary

Expanding evidence-based interventions for hypertension and stroke prevention among youth and their caregivers is crucial for meeting World Health Organization and Nigerian health goals. Innovative strategies are urgently needed to address the burden of hypertension and stroke in Nigeria, aiming to involve local communities, bridge generational gaps, and reduce health disparities. This study aims to determine the effect of a music-inspired intervention and campaign (Music4Health) designed by the community on blood pressure, stroke preparedness and intentions, and uptake of the intervention among youth-caregiver dyads in Nigeria.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,412

participants targeted

Target at P75+ for not_applicable

Timeline
18mo left

Started Feb 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress15%
Feb 2026Oct 2027

First Submitted

Initial submission to the registry

January 27, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 4, 2026

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 26, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 26, 2027

Last Updated

March 4, 2026

Status Verified

March 1, 2026

Enrollment Period

1.7 years

First QC Date

January 27, 2026

Last Update Submit

March 2, 2026

Conditions

High Blood PressureStroke

Keywords

High blood pressureStrokeHypertensionYoung peopleAdult caregiversPrevention

Outcome Measures

Primary Outcomes (4)

  • Proportion of youth participants with blood pressure <120/80 mmHg

    Systolic and diastolic blood pressure among youth participants will be measured three times at each time point using a digital sphygmomanometer by trained community health extension workers. The mean systolic and diastolic blood pressure from the three measures will be calculated for each time point. We will calculate the proportion of youth participants with a mean systolic and diastolic blood pressure \<120/80 mmHg for each time point.

    Months 0, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, and 14

  • Mean change in systolic blood pressure among caregiver participants

    Systolic blood pressure among caregiver participants will be measured three times at each time point using a digital sphygmomanometer by trained community health extension workers. The mean systolic blood pressure from the three measures will be calculated for each time point. Change in systolic blood pressure will be calculated as the difference in systolic blood pressure from baseline (month 0) to each endpoint.

    Months 0, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, and 14

  • Percent accuracy on a stroke knowledge and preparedness assessment

    Stroke knowledge and preparedness will be assessed using a self-administered 13-item multiple-choice tool assessing knowledge of stroke symptoms, appropriate responses to stroke symptoms, and the ability to accurately identify a stroke in case examples. This knowledge assessment tool is a modified version of a tool used in the HipHop Stroke Study.

    Months 0, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, and 14

  • Uptake of music-inspired hypertension/stroke prevention campaign (Music4Health) among youth and caregiver participants

    Uptake of the campaign is defined as the absolute number, proportion, and representativeness of participants who participate in the campaign (i.e., attend listening sessions).

    Months 0, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, and 14

Secondary Outcomes (4)

  • Intervention Acceptability

    Months 0, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, and 14

  • Intervention Fidelity

    Months 0, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, and 14

  • Intervention Reach

    Months 0, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, and 14

  • Intervention Sustainment

    Months 0, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, and 14

Study Arms (1)

Music4Health Intervention

EXPERIMENTAL

Each of the 30 local government areas (LGAs) will be randomly allocated using block randomization to one of the four waves, with 7-8 LGAs allocated to each wave. All waves will begin with a control period with the first wave commencing the intervention period three months following the study start and each subsequent wave commencing one month following the start date of the previous wave's intervention period. Each wave's intervention period will last three months.

Behavioral: Music4Health Intervention

Interventions

Music4Health InterventionBEHAVIORAL

The intervention period will include three Music4Health Day community events. Music4Health Day will adapt content from open call submissions and apprenticeships with community-based teams to meet the music preferences of youth and their caregivers. The events will focus on managing blood pressure, preventing strokes, and stroke preparedness through music-inspired strategies, utilizing rhythms and lyrics. Each Music4Health Day event will include a listening session of a music video with lyrics designed to improve knowledge and awareness of high blood pressure and stroke preparedness. Participants will be provided with MP3 files and YouTube video links containing music, videos, visuals, and health messages. Participants will listen to the intervention at the events and also at their convenience on their mobile phones, followed by weekly text reminders. During the events, music ambassadors will also share personal experiences to promote health messages and foster community engagement.

Also known as: Implementation Phase
Music4Health Intervention

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Youth Participants
  • Aged 14-24 years
  • Reside in one of the 30 selected LGAs
  • Able to provide informed consent
  • Willing to participate in the M4H campaign
  • Caregiver Participants
  • Aged ≥40 years
  • Identified as a caregiver (biological/surrogate parent, grandparent, or close relative)
  • Reside in the same household or have a caregiving relationship with eligible youth
  • Able to provide informed consent
  • General Eligibility for Dyads
  • Must be a youth-caregiver dyad (one youth and one caregiver)
  • Both members must consent to participate and complete baseline assessments
  • Reside in or be affiliated with the selected study LGAs

You may not qualify if:

  • Youth Participants
  • Below 14 or above 24 years
  • Inability to provide informed consent
  • Unwilling to participate in intervention activities
  • Caregiver Participants
  • Below 40 years of age
  • Not serving in a caregiver role to eligible youth
  • Inability to provide informed consent
  • General Eligibility for Dyads
  • Refusal to participate or complete baseline assessments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nigerian Institute of Medical Research

Yaba, Lagos, Nigeria

RECRUITING

Related Publications (6)

  • Trappe HJ. The effects of music on the cardiovascular system and cardiovascular health. Heart. 2010 Dec;96(23):1868-71. doi: 10.1136/hrt.2010.209858.

    PMID: 21062776BACKGROUND

  • Braveman P, Egerter S, Williams DR. The social determinants of health: coming of age. Annu Rev Public Health. 2011;32:381-98. doi: 10.1146/annurev-publhealth-031210-101218.

    PMID: 21091195BACKGROUND

  • Bigna JJ, Noubiap JJ. The rising burden of non-communicable diseases in sub-Saharan Africa. Lancet Glob Health. 2019 Oct;7(10):e1295-e1296. doi: 10.1016/S2214-109X(19)30370-5. No abstract available.

    PMID: 31537347BACKGROUND

  • Ajayi S, Adebiyi A, Kadiri S. Increased urinary sodium excretion is associated with systolic blood pressure in first degree relatives of hypertensive patients in Ibadan, Southwestern Nigeria. Pan Afr Med J. 2018 Nov 9;31:168. doi: 10.11604/pamj.2018.31.168.16611. eCollection 2018.

    PMID: 31086621BACKGROUND

  • Akinyemi RO, Ovbiagele B, Adeniji OA, et al. Stroke in Africa: profile, progress, prospects and priorities. Nature Reviews Neurology. 2021;17(10):634-656.

    BACKGROUND

  • Sarfo FS, Ovbiagele B, Gebregziabher M, et al. Stroke among young West Africans: evidence from the SIREN (Stroke Investigative Research and Educational Network) large multisite case-control study. Stroke. 2018;49(5):1116-1122.

    BACKGROUND

MeSH Terms

Conditions

HypertensionStroke

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Juliet Iwelunmor, PhD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Juliet Iwelunmor, PhD

CONTACT

2405280123ijuliet@wustl.edu

Oliver C Ezechi, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
None (Open Label)
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Model Details: Hybrid Type II stepped-wedge cluster randomized trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2026

First Posted

February 4, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

October 26, 2027

Study Completion (Estimated)

October 26, 2027

Last Updated

March 4, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

NG(1)