Family-centered program to improve cardiovascular health in Ugandan adolescents and their families
A Family Centred Approach to Enhance Lifestyle Change and Behavioural Modification for Prevention of Cardiovascular Diseases Among Adolescents and Their Families in Uganda
This project will test whether a family-centered program of home visits, diet coaching, physical activity support, and health messaging can improve heart-health behaviors and reduce cardiovascular risk in Ugandan adolescents and their families.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1280 (estimated) |
| Ages | 10 Years to 19 Years |
| Sex | All |
| Sponsor | MRC/UVRI and LSHTM Uganda Research Unit Academic / other |
| Locations | 2 sites (Jinja and 1 other locations) |
| Trial ID | NCT07265453 on ClinicalTrials.gov |
What this trial studies
This 5-year implementation project will roll out a family-centred approach (FaCe-D) in 32 villages (16 in Jinja district and 16 in Kampala) beginning April 2024, comparing communities receiving the intervention with those receiving standard care. The FaCe-D intervention includes home visits, diet and physical activity support, and health messaging delivered in the community with involvement of family members and community health workers. Investigators will measure changes in cardiovascular risk factors among adolescents, as well as feasibility, adoption, and the costs of implementation. The program is led by MRC/UVRI & LSHTM Uganda Research Unit in collaboration with UCSF, University of British Columbia, and TASO, with guidance from the Uganda Ministry of Health.
Who should consider this trial
Good fit: Adolescents aged 10–19 who live in the participating villages, have parent/guardian permission, plan to remain in the village for at least 12 months, and who assent to participate are the intended participants.
Not a fit: Adolescents in boarding schools, those who are pregnant or lactating, those with known chronic conditions such as severe mental illness, or those living outside the selected villages are unlikely to receive benefit from this program.
Why it matters
Potential benefit: If successful, the intervention could help families adopt healthier diets and activity habits that lower adolescents' long-term cardiovascular risk, including reductions in blood pressure and weight.
How similar studies have performed: Previous family-centered interventions such as the iHealth T2D work in parts of Asia and the UK have shown reductions in weight and blood pressure, but applying this approach in Uganda is a novel implementation effort.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged 10 -19 years * Household head/parent has provided consent/permission * Planning to continue staying in the study village for the next 12 months Exclusion Criteria: * In a boarding school or planning to join a boarding school * Pregnant or lactating * Known to have a chronic condition such as mental illness * The adolescent does not assent or consent
Where this trial is running
Jinja and 1 other locations
- TASO Jinja — Jinja, Uganda (Recruiting)
- Kiswa Health center III — Kampala, Uganda (Recruiting)
Study contacts
- Principal investigator: Prof Rachel King, PhD — University of California, San Francisco
- Study coordinator: Arthur Namara, MSc
- Email: arthur.namara@mrcuganda.org
- Phone: +256782199612
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.