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Found 2 Actively Recruiting clinical trials
Actively Recruiting
Healthy Volunteer
Researchers are evaluating the impact of combining a leadership alignment strategy with a champion implementation strategy compared to using a champion strategy alone to improve integration of an evidence-based mental health treatment model in multiple medical care settings in Malawi. This study addresses the mental health treatment gap in low- and middle-income countries by focusing on ways to better support implementation efforts through leadership engagement and organizational climate alignment. The study compares two groups one receiving an adapted Leadership and Organizational Change for Implementation LOCI strategy plus the champion strategy, and the other receiving only the champion strategy with enhanced usual outpatient care. The LOCI strategy includes leadership engagement through data feedback, leadership training, coaching, and alignment activities, while the champion strategy involves trained district champions who serve as change agents supported by training and supervision. This is a cluster-randomized controlled trial conducted over a 12-month randomized period. Participants are patients aged 18 or older receiving medical care in participating districts who screen positive for elevated common mental disorder symptoms. Researchers will measure outcomes such as screening rates, suicide risk assessments, initiation of mental health treatment, adherence to treatment guidelines during follow-up, and counseling session fidelity over 12 months. Secondary outcomes include mental health remission at 3 months and chronic condition control at 6 months. The study involves behavioral interventions and will monitor integration progress and treatment quality.
Actively Recruiting
Researchers are evaluating whether adding choline to ready-to-use therapeutic food RUTF can improve cognitive development in children aged 6 to 59 months with severe acute malnutrition SAM in Malawi. SAM affects millions of children worldwide, leading to increased risks of infection, hospitalization, death, stunted growth, and impaired cognitive development. Previous studies indicated that modifying the fatty acid content of RUTF improved brain development, and this study explores if adding choline, an essential nutrient for brain function, offers additional cognitive benefits. This trial compares two groups of children one receiving RUTF with an added daily dose of 500 mg choline C-RUTF and the other receiving standard RUTF with only 5 mg choline for masking S-RUTF. Both groups receive two sachets daily, providing approximately 1000 Kcal, 14g protein, 28g fat, and 14 micronutrients. Children are treated for up to 12 weeks or until recovery, with follow-up visits every two weeks to monitor health, growth, and RUTF supply. Participants undergo cognitive testing using the Malawi Developmental Assessment Tool MDAT at the end of treatment and again 5 to 7 months later to assess long-term development. Researchers collect blood samples and track recovery, growth rates, and health outcomes during treatment and follow-up. The study aims to measure differences in cognitive scores six months after treatment to determine if choline supplementation aids brain development in malnourished children.