A Family-centred Approach Enhancing Cardiovascular Health in Ugandan Adolescents and Their Families
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 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.
- Who it may be relevant to
- Registry conditions: Adolescent Behavior, Lifestyle Modification, Cardiovascular Disease Other. Basic parameters: 10 years — 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Uganda
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- 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) - 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.
Primary outcome measures
- Ideal cardiovascular health [Time frame: after 12 months of follow-up]
Secondary outcome measures (1)
- sleep quality [Time frame: 12 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Uganda · 2 centers
- TASO Jinja — Jinja
- Kiswa Health center III — Kampala
Identifiers
NCT: NCT07265453 · RGJB230801