A Family-centred Approach Enhancing Cardiovascular Health in Ugandan Adolescents and Their Families

NCT07265453 | Recruiting DMC

• 1 other identifier: RGJB230801
• Study Type: interventional
• Target: 1,280
• Locations: 1 country
• Sites: 2

Brief Summary

The FaCe-D Study, with funding from the Canadian Institute for Health Research (CIHR) through Global Alliance for Chronic Diseases (GACD) aims to adapt and implement an evidence-based family centred approach (FCA) to prevent cardiovascular diseases (CVD) among adolescents and their families. This 5-year implementation science study will be conducted in 16 villages in Jinja district and another 16 in Kampala beginning April 2024 to evaluate the effectiveness of FCA in reducing the risk of CVD in Uganda and to assess feasibility, adoption, while measuring the costs of implementation. The study will be implemented by a group of researchers from MRC/UVRI \& LSHTM, University of British Columbia (Canada), TASO (Uganda) and University of California San Francisco (UCSF) - USA with guidance from the Ministry of Health - Uganda.

Conditions

Adolescent Behavior; Lifestyle Modification; Cardiovascular Disease Other

Keywords

cardiovascular risk; CVD; Ideal cardiovascular health; physical activity diary; food diary; diet diary; family centered

Outcome Measures

Primary Outcomes (1)

• Ideal cardiovascular health

  Ideal cardiovascular health (ICH) will be determined by the total score on the American Heart Association's 'Life's Simple 7' tool. The score ranges from 0 to 7 points, where a higher score represents better cardiovascular health.

  after 12 months of follow-up

Secondary Outcomes (1)

• sleep quality

  12 months

Study Arms (2)

FaCe-D Control arm

ACTIVE COMPARATOR

Other: Control Arm - standard of care

FaCe-D Intervention

EXPERIMENTAL

Family-centred approach for lifestyle changes and behavioural modification

Behavioral: The immediate (treatment) arm, will receive the FaCe-D intervention comprising of 'HOME VISITS, DIET, PHYSICAL ACTIVITY AND HEALTH MESSAGING

Interventions

Control Arm - standard of care OTHER

Arm Description: They will continue to receive standard care with VHts performing their usual roles of health promotion for both communicable and non-communicable diseases as outlined by the Ministry of Health guidelines. This standard care involves visits by the VHT at least once a quarter to check hygiene and environment, children's immunisation status and other health promotion activities. The VHT may or may not involve the entire family/household.

FaCe-D Control arm

The immediate (treatment) arm, will receive the FaCe-D intervention comprising of 'HOME VISITS, DIET, PHYSICAL ACTIVITY AND HEALTH MESSAGING BEHAVIORAL

The participants will receive the FaCe-D intervention comprising of dietary and exercise interventions delivered by Village Health Teams (VHTs)

FaCe-D Intervention

Eligibility Criteria

• Age: 10 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Aged 10 -19 years
• Household head/parent has provided consent/permission
• Planning to continue staying in the study village for the next 12 months

You may not qualify if:

• 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

Sponsors & Collaborators

• MRC/UVRI and LSHTM Uganda Research Unit: lead
• University of California: collaborator
• The AIDS Support Organization: collaborator
• University of British Columbia: collaborator

Study Sites (2)

TASO Jinja

Jinja, Uganda

RECRUITING

Kiswa Health center III

Kampala, Uganda

RECRUITING

MeSH Terms

Conditions

Adolescent Behavior

Interventions

Therapeutics; Diet; Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Prof Rachel King, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Prof David Moore, PhD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

• Dr Josephine Birungi

  MRC/UVRI and LSHTM Uganda Research Unit

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arthur Namara, MSc

CONTACT

+256782199612; arthur.namara@mrcuganda.org

Chairperson, UVRI REC, PhD

CONTACT

+256414321962; tlutalo@uvri.go.ug

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2025
• First Posted: December 4, 2025
• Study Start: July 5, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: After the publication of the main results with no end date
• Access Criteria: A link shall be provided

Locations

UG (2)