Condition category
Infections and Infestations
Date applied
12/09/2005
Date assigned
25/11/2005
Last edited
28/10/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr S. Wayling

ORCID ID

Contact details

20
Avenue Appia
Geneva-27
CH-1211
Switzerland
+41 (0)22 791 3909
waylings@who.int

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00192556

Protocol/serial number

A30746

Study information

Scientific title

Acronym

FITTCET

Study hypothesis

Food incentives are an achievable, effective method of encouraging full adherence to Directly Observed Treatment-Short Course Programme (DOTS) and thus improved treatment outcomes in Dili, Timor-Leste.

Ethics approval

Full ethics approval received on the 17th March 2005.

Study design

Randomised trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Tuberculosis

Intervention

Patients enrolled will be randomised to receive either the food intervention or nutritional advice and followed for duration of treatment (eight months)

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The proportion of patients who successfully complete the eight month course of TB treatment and achieve cure in each group (treatment success) and the proportion of patients who do not complete treatment or have persistent disease (treatment failure).

Secondary outcome measures

1. The proportion of clinic visits compared with expected, measured weekly for first 2 months then monthly for next 6 months
2. Response to treatment measures:
2.1. Symptoms (cough, sputum, fever), measured at 4, 8, 24 and 32 weeks
2.2. Changes in weight and Body Mass Index (BMI), measured at 4, 8, 24 and 32 weeks
2.3. Sputum clearance, measured at at 8 weeks
2.4. Nutritional markers, measured at 4, 8, 24 and 32 weeks

Overall trial start date

01/04/2005

Overall trial end date

30/06/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Adult Tuberculosis (TB) patients diagnosed at one of the participating clinics during the study period will be eligible for enrolment if they are:
1. 18 years of age or older
2. Diagnosed to have tuberculosis (sputum smear positive or smear negative or extrapulmonary TB) using the standard National Tuberculosis Programme (NTP) definition for this diagnosis
3. Have never received more than one month of anti-tuberculosis treatment in the past
4. Not pregnant
5. Voluntarily accept to be involved in this study

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

270

Participant exclusion criteria

Does not comply with inclusion criteria.

Recruitment start date

01/04/2005

Recruitment end date

30/06/2006

Locations

Countries of recruitment

Timor-Leste

Trial participating centre

20, Avenue Appia
Geneva-27
CH-1211
Switzerland

Sponsor information

Organisation

UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR)

Sponsor details

20
Avenue Appia
Geneva-27
CH-1211
Switzerland
+41 (0)22 791 3909
waylings@who.int

Sponsor type

Other

Website

http://www.who.int

Funders

Funder type

Other

Funder name

United Nations Children's Fund (UNICEF)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

United Nations Development Programme (UNDP)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

World Bank

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

World Health Organization (WHO) - Special Programme for Research and Training in Tropical Diseases (TDR)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19858174

Publication citations

  1. Results

    Martins N, Morris P, Kelly PM, Food incentives to improve completion of tuberculosis treatment: randomised controlled trial in Dili, Timor-Leste., BMJ, 2009, 339, b4248.

Additional files

Editorial Notes