The Food Incentives for Tuberculosis Treatment Compliance study in Dili, East Timor (FITTCET)

ISRCTN	ISRCTN11134588
DOI	https://doi.org/10.1186/ISRCTN11134588
ClinicalTrials.gov (NCT)	NCT00192556
Protocol serial number	A30746
Sponsor	UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR)
Funders	United Nations Children's Fund (UNICEF), United Nations Development Programme (UNDP), World Bank, World Health Organization (WHO) - Special Programme for Research and Training in Tropical Diseases (TDR)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr S. Wayling
Scientific

20, Avenue Appia
Geneva-27
CH-1211
Switzerland

Phone	+41 (0)22 791 3909
Email	waylings@who.int

Primary study design	Interventional
Study design	Randomised trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	FITTCET
Study objectives	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(s)	Full ethics approval received on the 17th March 2005.
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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).
Key secondary outcome measure(s)	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
Completion date	30/06/2006

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	270
Key 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
Key exclusion criteria	Does not comply with inclusion criteria.
Date of first enrolment	01/04/2005
Date of final enrolment	30/06/2006

20, Avenue Appia

Geneva-27
CH-1211
Switzerland

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	26/10/2009		Yes	No