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Food incentives to improve completion of tuberculosis treatment: randomised controlled trial in Dili, Timor-Leste
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 di...
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Formato: | Texto |
Lenguaje: | English |
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BMJ Publishing Group Ltd.
2009
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2767482/ https://www.ncbi.nlm.nih.gov/pubmed/19858174 http://dx.doi.org/10.1136/bmj.b4248 |
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author | Martins, Nelson Morris, Peter Kelly, Paul M |
author_facet | Martins, Nelson Morris, Peter Kelly, Paul M |
author_sort | Martins, Nelson |
collection | PubMed |
description | 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. |
format | Text |
id | pubmed-2767482 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2009 |
publisher | BMJ Publishing Group Ltd. |
record_format | MEDLINE/PubMed |
spelling | pubmed-27674822010-01-14 Food incentives to improve completion of tuberculosis treatment: randomised controlled trial in Dili, Timor-Leste Martins, Nelson Morris, Peter Kelly, Paul M BMJ Research 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. BMJ Publishing Group Ltd. 2009-10-26 /pmc/articles/PMC2767482/ /pubmed/19858174 http://dx.doi.org/10.1136/bmj.b4248 Text en 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. |
spellingShingle | Research Martins, Nelson Morris, Peter Kelly, Paul M Food incentives to improve completion of tuberculosis treatment: randomised controlled trial in Dili, Timor-Leste |
title | Food incentives to improve completion of tuberculosis treatment: randomised controlled trial in Dili, Timor-Leste |
title_full | Food incentives to improve completion of tuberculosis treatment: randomised controlled trial in Dili, Timor-Leste |
title_fullStr | Food incentives to improve completion of tuberculosis treatment: randomised controlled trial in Dili, Timor-Leste |
title_full_unstemmed | Food incentives to improve completion of tuberculosis treatment: randomised controlled trial in Dili, Timor-Leste |
title_short | Food incentives to improve completion of tuberculosis treatment: randomised controlled trial in Dili, Timor-Leste |
title_sort | food incentives to improve completion of tuberculosis treatment: randomised controlled trial in dili, timor-leste |
topic | Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2767482/ https://www.ncbi.nlm.nih.gov/pubmed/19858174 http://dx.doi.org/10.1136/bmj.b4248 |
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