Adolescent BehaviorFaCe-DNCT07265453
A Family-centred Approach Enhancing Cardiovascular Health in Ugandan Adolescents and Their Families
A study testing The immediate (treatment) arm, will receive the FaCe-D intervention comprising of 'HOME VISITS, DIET, PHYSICAL ACTIVITY AND HEALTH MESSAGING in people with Adolescent Behavior and Lifestyle Modification, run by MRC/UVRI and LSHTM Uganda Research Unit at 2 sites in Uganda.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Adolescent Behavior, Lifestyle Modification, Cardiovascular Disease Other
- What is being tested?
- The immediate (treatment) arm, will receive the FaCe-D intervention comprising of 'HOME VISITS, DIET, PHYSICAL ACTIVITY AND HEALTH MESSAGING
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,280 participants
- Where
- 2 sitesUganda
- Study dates
- 5 Jul 2025to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Aged 10 -19 years
- Household head/parent has provided consent/permission
- Planning to continue staying in the study village for the next 12 months
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Uganda2 sites, 2 recruiting
- Recruiting
TASO Jinja
Jinja
Sanula Nanozi, BSc Nursing, 256788343149, nanozis@tasouganda.org
Dr Simple Ouma, PhD Candidate, +256707708818, simple.ouma.22@ucl.ac.uk
- Recruiting
Kiswa Health center III
Kampala
Isaac Kintu, MSc, +256750814989, isaac.kintu@mrcuganda.org
Dr Ivan Namakoola, MSc Clinical Trials
About this study
Official title: 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.
Read the 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.
- Being tested
- The immediate (treatment) arm, will receive the FaCe-D intervention comprising of 'HOME VISITS, DIET, PHYSICAL ACTIVITY AND HEALTH MESSAGING, Control Arm - standard of care
- Keywords
- cardiovascular risk, CVD, Ideal cardiovascular health, physical activity diary, food diary, diet diary, family centered
- Medical subject headings
- Adolescent Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The immediate (treatment) arm, will receive the FaCe-D intervention comprising of 'HOME VISITS, DIET, PHYSICAL ACTIVITY AND HEALTH MESSAGINGBehavioural
The participants will receive the FaCe-D intervention comprising of dietary and exercise interventions delivered by Village Health Teams (VHTs)
Control Arm - standard of careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| FaCe-D Control arm | Active comparator | Not described Receives: Other: Control Arm - standard of care |
| FaCe-D Intervention | Experimental | Family-centred approach for lifestyle changes and behavioural modification Receives: Behavioral: The immediate (treatment) arm, will receive the FaCe-D intervention comprising of 'HOME VISITS, DIET, PHYSICAL ACTIVITY AND HEALTH MESSAGING |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start5 Jul 2025
- Primary completionJan 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MRC/UVRI and LSHTM Uganda Research Unit
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, The AIDS Support Organization, University of British Columbia
- Responsible party
- Sponsor
- Investigators
- Prof Rachel King, PhD, Principal investigator, University of California, San FranciscoProf David Moore, PhD, Principal investigator, University of British ColumbiaDr Josephine Birungi, Principal investigator, MRC/UVRI and LSHTM Uganda Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07265453
- Sponsor's protocol ID
- RGJB230801
- Acronym
- FaCe-D
- Status last verified
- Dec 2025
- First submitted
- 9 Aug 2025
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Before data is made available, it will be deidentified
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Family Centred Approach to Enhance Lifestyle Change and Behavioural Modification for Prevention of Cardiovascular Diseases Among Adolescents and Their Families in Uganda
- ClinicalTrials.gov ID
- NCT07265453
- Acronym / sponsor ID
- FaCe-D / RGJB230801
- Keywords
- cardiovascular risk, CVD, Ideal cardiovascular health, physical activity diary, food diary, diet diary, family centered
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,280 participants (estimated)
- Lead sponsor
- MRC/UVRI and LSHTM Uganda Research UnitUniversity, hospital or other
- Collaborators
- University of California, The AIDS Support Organization, University of British Columbia
- Study start
- 5 Jul 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 4 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FaCe-D Control arm | Active comparator | Other: Control Arm - standard of care |
| FaCe-D Intervention | Experimental | Behavioral: The immediate (treatment) arm, will receive the FaCe-D intervention comprising of 'HOME VISITS, DIET, PHYSICAL ACTIVITY AND HEALTH MESSAGINGFamily-centred approach for lifestyle changes and behavioural modification |
Who may qualify
- Ages
- 10 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Aged 10 -19 years
- Household head/parent has provided consent/permission
- Planning to continue staying in the study village for the next 12 months
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The immediate (treatment) arm, will receive the FaCe-D intervention comprising of 'HOME VISITS, DIET, PHYSICAL ACTIVITY AND HEALTH MESSAGINGThe participants will receive the FaCe-D intervention comprising of dietary and exercise interventions delivered by Village Health Teams (VHTs) | Behavioural | FaCe-D Intervention |
| Control Arm - standard of careArm 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. | Other | FaCe-D Control arm |
Primary outcome
Ideal cardiovascular health
Time frame: after 12 months of follow-up
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.
1 secondary outcome
sleep quality
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Individual participant dataSharing planned: Yes. Before data is made available, it will be deidentified
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Prof Rachel King, PhD principal investigator
University of California, San Francisco
Prof David Moore, PhD principal investigator
University of British Columbia
Dr Josephine Birungi principal investigator
MRC/UVRI and LSHTM Uganda Research Unit
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The immediate (treatment) arm, will receive the FaCe-D intervention comprising of 'HOME VISITS, DIET, PHYSICAL ACTIVITY AND HEALTH MESSAGING in people with Adolescent Behavior and Lifestyle Modification, run by MRC/UVRI and LSHTM Uganda Research Unit at 2 sites in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arthur Namara, MSc (+256782199612, arthur.namara@mrcuganda.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ideal cardiovascular health (time frame: after 12 months of follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025.