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

Nelson Martins, Peter Morris, Paul M Kelly, Nelson Martins, Peter Morris, Paul M Kelly

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 >or=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 NCT00192556.

Conflict of interest statement

Competing interests: None declared.

Figures

https://www.ncbi.nlm.nih.gov/pmc/articles/instance/4787394/bin/marn670190.f1_default.jpg
Fig 1 Flow of participants through study. Original sample included all diagnoses of tuberculosis in three clinics during study period, March 2005 to July 2006. Ineligible patients included 62 (25%) previously treated for tuberculosis, 176 (72%) aged <18, and 7 (3%) pregnant women. Others excluded, according to selection criteria, included 211 (79%) transferred out before enrolment, 42 (16%) community directly observed treatment (clinician’s decision), 7 (3%) unable to agree to complete treatment, 5 (2%) default before enrolment, 1 (0.5%) died before enrolment. Refusals: 43 (83%) unwilling to attend for midday meal; 9 (17%) chose community DOT (unable to attend clinic, self assessed disease severity). Loss to follow-up means transferred out to another clinic during treatment
https://www.ncbi.nlm.nih.gov/pmc/articles/instance/4787394/bin/marn670190.f2_default.jpg
Fig 2 Kaplan-Meier plot showing time to default by group. Hazard ratio for time to default 1.10 (0.66 to 1.82), P=0.7. Not significantly influenced by age, sex, or result of smear test
https://www.ncbi.nlm.nih.gov/pmc/articles/instance/4787394/bin/marn670190.f3_default.jpg
Fig 3 Cough clearance in patients with tuberculosis
https://www.ncbi.nlm.nih.gov/pmc/articles/instance/4787394/bin/marn670190.f4_default.jpg
Fig 4 Weight gain in patients with tuberculosis

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Source: PubMed

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