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

doi:10.1136/bmj.b4248

Published 26 October 2009, doi:10.1136/bmj.b4248
Cite this as: BMJ 2009;339:b4248

Research

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

Nelson Martins, honorable minister for health¹^,2^,3^,4, Peter Morris, project leader, head, ear and respiratory program¹^,2^,5, Paul M Kelly, director, master of applied epidemiology program¹^,6

¹ Menzies School of Health Research, Darwin, NT, Australia, ² Institute of Advanced Studies, Charles Darwin University, Darwin, ³ Faculdade Saude Publica, Universidade Da Paz, Dili, Timor-Leste, ⁴ Ministry of Health, Dili, Timor-Leste, ⁵ Northern Territory Clinical School, Flinders University, Darwin, ⁶ National Centre for Epidemiology and Population Health, Australian National, University College of Medicine, Biology and Environment, Canberra, ACT, Australia

Correspondence to: P M Kelly, National Centre for Epidemiology and Population Health, College of Medicine, Biology and Environment, Australian National University, Building 62, Corner Mills and Eggleston Rds, Acton, Canberra, ACT 0200, Australia paul.kelly{at}anu.edu.au

Objective To determine the effectiveness of the provision ofwhole 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 newlydiagnosed 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 treatmentand were randomly assigned to intervention (nutritious, culturallyappropriate daily meal (weeks 1-8) and food package (weeks 9-32)(n=137) or control (nutritional advice, n=133) groups. Randomisationsequence was computer generated with allocation concealmentby sequentially numbered, opaque, sealed envelopes.

Results Most patients with tuberculosis were poor, malnourishedmen living close to the clinics; 265/270 (98%) contributed tothe analysis. The intervention had no significant beneficialor 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 leadto improved weight gain at the end of treatment (10.1% v 7.5%improvement, P=0.04). Itch was more common in the interventiongroup (21% v 9%, P<0.01). In a subgroup analysis of patientswith positive results on sputum smears, there were clinicallyimportant improvements in one month sputum clearance (85% v67%, P=0.13) and completion of treatment (78% v 68%, P=0.3).

Conclusion Provision of food did not improve outcomes with tuberculosistreatment in these patients in Timor-Leste. Further studiesin different settings and measuring different outcomes are required.

Trial registration Clinical Trials NCT0019256.

This is an open-access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits use, distribution, and reproduction in any medium, provided the original work is properly cited, the use is non commercial and is otherwise in compliance with the license. See: http://creativecommons.org/licenses/by-nc/2.0/ and http://creativecommons.org/licenses/by-nc/2.0/legalcode.

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