The Food Incentives for Tuberculosis Treatment Compliance study in Dili, East Timor (FITTCET)
| ISRCTN | ISRCTN11134588 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11134588 |
| ClinicalTrials.gov number | NCT00192556 |
| Secondary identifying numbers | A30746 |
- Submission date
- 12/09/2005
- Registration date
- 25/11/2005
- Last edited
- 28/10/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr S. Wayling
Scientific
Scientific
20, Avenue Appia
Geneva-27
CH-1211
Switzerland
| Phone | +41 (0)22 791 3909 |
|---|---|
| waylings@who.int |
Study information
| Study design | Randomised trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 | 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 study start date | 01/04/2005 |
| Completion date | 30/06/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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 |
Locations
Countries of recruitment
- Switzerland
- Timor-Leste
Study participating centre
20, Avenue Appia
Geneva-27
CH-1211
Switzerland
CH-1211
Switzerland
Sponsor information
UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR)
Other
Other
20, Avenue Appia
Geneva-27
CH-1211
Switzerland
| Phone | +41 (0)22 791 3909 |
|---|---|
| waylings@who.int | |
| Website | http://www.who.int |
"ROR" |
https://ror.org/01f80g185 |
Funders
Funder type
Other
United Nations Children's Fund (UNICEF)
No information available
United Nations Development Programme (UNDP)
No information available
World Bank
No information available
World Health Organization (WHO) - Special Programme for Research and Training in Tropical Diseases (TDR)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 26/10/2009 | Yes | No |
