Food incentives to improve completion of tuberculosis treatment: randomised controlled trial in Dili, Timor-Leste
What this study found
Food supplementation did not improve the primary outcome of tuberculosis treatment completion. Completion was 103/136 (76%) in the intervention group versus 100/129 (78%) in controls, RR 0.98 (0.86 to 1.11), P = 0.7. Intensive-phase adherence was actually lower with food support, 86.7% (18.6) versus 91.4% (13.3), P = 0.02. The intervention modestly improved weight gain at 8 weeks, 5.2% (6.2) versus 3.5% (6.3), P = 0.04, and at 32 weeks, 10.1% (9.6) versus 7.5% (7.6), P = 0.04. Itch was more common in the intervention group, 21% versus 9%, RR 2.27 (1.20 to 4.26), P = 0.008.
- Study & population
- Randomized controlled trial in adults with newly diagnosed pulmonary tuberculosis in Dili, Timor-Leste, recruited from three community clinics.
- Intervention
- Adults receiving standard tuberculosis treatment were given culturally appropriate food support in addition to usual care.
- Key limitation
- The trial was conducted in one city among predominantly poor, malnourished adults with pulmonary tuberculosis, so generalizability to other settings is limited.
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Open PDFOriginal abstract
Objective To determine the effectiveness of the provision of whole food to enhance completion of treatment for tuberculosis. Design Parallel group randomised controlled trial. Setting Three primary care clinics in Dili, Timor-Leste. Participants 270 adults aged ≥18 with previously untreated newly diagnosed pulmonary tuberculosis. Main outcome measures Completion of treatment (including cure). Secondary outcomes included adherence to treatment, weight gain, and clearance of sputum smears. Outcomes were assessed remotely, blinded to allocation status. Interventions Participants started standard tuberculosis treatment and were randomly assigned to intervention (nutritious, culturally appropriate daily meal (weeks 1-8) and food package (weeks 9-32) (n=137) or control (nutritional advice, n=133) groups. Randomisation sequence was computer generated with allocation concealment by sequentially numbered, opaque, sealed envelopes. Results Most patients with tuberculosis were poor, malnourished men living close to the clinics; 265/270 (98%) contributed to the analysis. The intervention had no significant beneficial or harmful impact on the outcome of treatment (76% v 78% completion, P=0.7) or adherence (93% for both groups, P=0.7) but did lead to improved weight gain at the end of treatment (10.1% v 7.5% improvement, P=0.04). Itch was more common in the intervention group (21% v 9%, P<0.01). In a subgroup analysis of patients with positive results on sputum smears, there were clinically important improvements in one month sputum clearance (85% v 67%, P=0.13) and completion of treatment (78% v 68%, P=0.3). Conclusion Provision of food did not improve outcomes with tuberculosis treatment in these patients in Timor-Leste. Further studies in different settings and measuring different outcomes are required. Trial registration Clinical Trials NCT0019256.