An interventional study of The immediate (treatment) arm, will receive the FaCe-D intervention comprising of 'HOME VISITS, DIET, PHYSICAL ACTIVITY AND HEALTH MESSAGING and Control Arm - standard of care in Adolescent Behavior, Lifestyle Modification and Cardiovascular Disease Other, sponsored by MRC/UVRI and LSHTM Uganda Research Unit. Recruiting at 2 sites in Uganda. Open to participants aged 10 Years to 19 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-12.
Sponsored by MRC/UVRI and LSHTM Uganda Research Unit · Not applicable, Interventional, and Prevention
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.
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.
305 studies on the registry are indexed under Adolescent Behavior; 47 are open to participants now.
This study's planned enrollment of 1,280 is above the median of 172 across 256 interventional studies indexed under Adolescent Behavior.
Browse Adolescent Behavior studies →MRC/UVRI and LSHTM Uganda Research Unit is the lead sponsor of 14 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Other: Control Arm - standard of care
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)
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.
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
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
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Before data is made available, it will be deidentified
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: After the publication of the main results with no end date
Access criteria: A link shall be provided
Started Jul 2025 (actual). Primary completion is estimated for Jan 2027, 18 months after the start.
Of 195 non-industry interventional studies with no phase under Adolescent Behavior, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 43. This study's planned 18 months is below that.
Counting every sponsor, half of 198 studies reached it within 20 months; a quarter within 8 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
MRC/UVRI and LSHTM Uganda Research Unit