A Family-centred Approach Enhancing Cardiovascular Health in Ugandan Adolescents and Their Families
NCT ID: NCT07265453
Last Updated: 2025-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1280 participants
INTERVENTIONAL
2025-07-05
2028-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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FaCe-D Control arm
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.
FaCe-D Intervention
Family-centred approach for lifestyle changes and behavioural modification
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)
Interventions
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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)
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.
Eligibility Criteria
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Inclusion Criteria
* Household head/parent has provided consent/permission
* Planning to continue staying in the study village for the next 12 months
Exclusion Criteria
* Pregnant or lactating
* Known to have a chronic condition such as mental illness
* The adolescent does not assent or consent
10 Years
19 Years
ALL
Yes
Sponsors
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University of California
OTHER
The AIDS Support Organization
OTHER
University of British Columbia
OTHER
MRC/UVRI and LSHTM Uganda Research Unit
OTHER
Responsible Party
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Principal Investigators
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Dr Josephine Birungi
Role: PRINCIPAL_INVESTIGATOR
MRC/UVRI and LSHTM Uganda Research Unit
Prof Rachel King, PhD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Prof David Moore, PhD
Role: PRINCIPAL_INVESTIGATOR
University of British Columbia
Locations
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TASO Jinja
Jinja, , Uganda
Kiswa Health center III
Kampala, , Uganda
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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RGJB230801
Identifier Type: -
Identifier Source: org_study_id
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