Food incentives to improve completion of tuberculosis treatment: randomised controlled trial in Dili, Timor-Leste

The BMJ
Oct 2009
Citations:99
Influential Citations:7
Interventional (Human) Studies
87
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Methods
Parallel-group randomized controlled trial conducted at three community clinics in Dili, Timor-Leste. 270 adults aged ≥18 with untreated newly diagnosed pulmonary tuberculosis were randomized to nutritional advice alone (n=133) or nutritional advice plus food incentives (n=137). Randomization used computer-generated sequences with allocation concealed by sequentially numbered, opaque sealed envelopes and stratified by clinic and smear status; an independent observer blinded to allocation assessed the primary outcome; participants and treatment providers were aware of allocation. Follow-up through July 2006.
Intervention
Intensive-phase: daily hot clinic meal for 8 weeks (one balanced bowl meal including locally prepared meat, red kidney beans, vegetables, and rice). Continuation-phase: take-home food parcels for 24 weeks containing unprepared foods (red kidney beans, rice, oil) to provide one daily meal. Regimen aligned with standard TB treatment (2 months intensive, 6 months continuation).
Results
Primary outcome: completion of treatment did not differ (intervention 76% vs control 78%), RR 0.98 (0.86–1.11), P=0.70. Adherence during the intensive phase was lower with food (86.7% vs 91.4%, P=0.02); continuation-phase adherence was similar (~98%). Weight gain was higher with food at end of treatment (10.1% vs 7.5%, P=0.04), and greater weight gain occurred among those underweight at baseline (BMI <16.0; crude OR 3.62, P=0.009; adjusted OR 3.37, P=0.002). Among smear-positive patients, there was a non-significant trend toward faster sputum clearance; adverse events included more itch in the food group (21% vs 9%, P=0.008). Conclusion: Food incentives did not improve TB treatment outcomes in this setting; modest weight gain occurred and underweight patients may benefit; higher adverse events and logistical costs argue against routine use without further evidence. Further studies in different settings and with different outcomes are needed to clarify context and cost-effectiveness.
Limitations
Civil conflict in Dili during the latter part of the study disrupted service delivery and adherence; no immunological/biomarker or cost-effectiveness data were collected; power limitations for subgroup analyses; generalizability to other settings may be limited.

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 ...