Health TrialsbyHealthPanel

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

ConditionsAdolescent BehaviorLifestyle ModificationCardiovascular Disease Other
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-19
SponsorMRC/UVRI and LSHTM Uganda Research Unit

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Aged 10 -19 years

Household head/parent has provided consent/permission

Planning to continue staying in the study village for the next 12 months

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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)

  • Control Arm - standard of care

    Other intervention

    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.

Treatment groups

1,280 Participants
are divided into 2 treatment groups
Group A: FaCe-D Control armActive comparator 1 intervention
Group B: FaCe-D InterventionExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
after 12 months of follow-up

Secondary outcomes

1

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.

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

MRC/UVRI and LSHTM Uganda Research Unit

Lead sponsor

University of California

Collaborator

The AIDS Support Organization

Collaborator

University of British Columbia

Collaborator

Source ClinicalTrials.gov
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