A Family-centred Approach Enhancing Cardiovascular Health in Ugandan Adolescents and Their Families (FaCe-D)

A Family Centred Approach to Enhance Lifestyle Change and Behavioural Modification for Prevention of Cardiovascular Diseases Among Adolescents and Their Families in Uganda

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.

Study Overview

• Status: Recruiting
• Conditions: Adolescent Behavior; Lifestyle Modification; Cardiovascular Disease Other
• Intervention / Treatment: Other: Control Arm - standard of care; Behavioral: The immediate (treatment) arm, will receive the FaCe-D intervention comprising of 'HOME VISITS, DIET, PHYSICAL ACTIVITY AND HEALTH MESSAGING

Detailed Description

Uganda faces a growing challenge of non-communicable diseases (NCDs) alongside the existing burden due to HIV/AIDS. By NCDs, the investigators refer to common conditions such as diabetes, cancers, and cardiovascular diseases (including hypertension, stroke, and heart attack). About 38.8% of the population in Uganda has raised blood pressure (pre-hypertension), 34% in urban and 22% in rural areas have hypertension. The risk factors, such as unhealthy diet and physical inactivity, responsible for the development of these NCDs are modifiable and related to behaviour. The investigators propose to adapt, implement and evaluate a family-centred approach to enhance behaviour change among adolescents and their families.

Why focus on Adolescents? The investigators recognize that adolescence is a critical stage marked by significant physical, cognitive, and social changes and time to adopt behaviour that extends into adulthood. Previous studies have shown that even if the signs and symptoms of cardiovascular disease appear in adulthood, the process starts earlier during adolescence. The investigators aim to intervene by working with adolescents and families to change their behaviors and adopt a healthier diet and engage in recommended level of physical.

The iHealth T2D study that was conducted in parts of Asia and the United Kingdom showed that using the family centered approach and working closely with community health care workers led to reduction in body weight, blood pressure and thus reducing the risk of NCDs among the Asian population. The investigators will adapt the iHealth T2D study intervention to the Ugandan context, considering the specific features of the setting, village health team responsibilities and content of the education material. The intervention will promote physical activity and healthy eating habits among families.

The study comprises three phases; a) formative phase which is focusing on adapting the intervention, b) Implementation phase, to implement the adapted intervention and c) evaluation phase, assessing effectiveness and the overall process of the adapted intervention.

• Study Type: Interventional
• Enrollment (Estimated): 1280
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Arthur Namara, MSc; Phone Number: +256782199612; Email: arthur.namara@mrcuganda.org
• Study Contact Backup: Name: Chairperson, UVRI REC, PhD; Phone Number: +256716321962 +256414321962; Email: tlutalo@uvri.go.ug

Study Locations

• Uganda
  • Jinja, Uganda
    • Recruiting
    • TASO Jinja
    • Contact: Sanula Nanozi, BSc Nursing; Phone Number: 256788343149; Email: nanozis@tasouganda.org
    • Contact: Dr Simple Ouma, PhD Candidate; Phone Number: +256707708818; Email: simple.ouma.22@ucl.ac.uk
  • Kampala, Uganda
    • Recruiting
    • Kiswa Health center III
    • Contact: Isaac Kintu, MSc; Phone Number: +256750814989; Email: isaac.kintu@mrcuganda.org
    • Sub-Investigator: Dr Ivan Namakoola, MSc Clinical Trials

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: FaCe-D Control arm	Other: Control Arm - standard of care; 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.
Experimental: FaCe-D Intervention; 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; The participants will receive the FaCe-D intervention comprising of dietary and exercise interventions delivered by Village Health Teams (VHTs)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
sleep quality	Sleep quality will be measured using the Single-Item Sleep Quality Scale (SQS) by Snyder et al. (2018). Participants will report their sleep quality over a 7-day recall period using a 10-point visual analogue scale, where 0=terrible and 10=excellent. Higher scores on the scale indicate better sleep quality.	12 months

Collaborators and Investigators

• Sponsor: MRC/UVRI and LSHTM Uganda Research Unit
• Collaborators: University of British Columbia; The AIDS Support Organization; University of California
• Investigators: Principal Investigator: 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

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: August 9, 2025
• First Submitted That Met QC Criteria: December 2, 2025
• First Posted (Estimated): December 4, 2025

Study Record Updates

• Last Update Posted (Actual): December 12, 2025
• Last Update Submitted That Met QC Criteria: December 4, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: cardiovascular risk; CVD; food diary; family centered; Ideal cardiovascular health; physical activity diary; diet diary
• Additional Relevant MeSH Terms: Behavior; Adolescent Behavior; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Nutritional Physiological Phenomena; Exercise; Diet; Therapeutics
• Other Study ID Numbers: RGJB230801

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Before data is made available, it will be deidentified
• IPD Sharing Time Frame: After the publication of the main results with no end date
• IPD Sharing Access Criteria: A link shall be provided
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No