Tuberculosis, Undernutrition
Conditions
Keywords
Tuberculosis, Nutrition, Treatment outcome, SMS
Brief summary
Ethiopia is one of the high burden Tuberculosis countries and Tuberculosis is still the leading cause of mortality due to communicable diseases in the country. Nutritional status is one of the predictors of TB treatment outcomes. Thus, the current practices need integration of nutritional intervention in the DOT using Mobile health intervention. However, to investigator's knowledge, there is no sufficient evidence on the effect SMS text Messaging Mobile Health intervention on nutritional status and TB treatment outcomes in Ethiopia.
Detailed description
To ensure the quality of SMS intervention, nutritional related SMS text message will be developed systematically through reviewing literature, systematic reviews and guidelines and appropriate behavioral theories by involving experts and patients. Automated SMS will be sent from one computer database at the scheduled date and time. A validated questionnaire will be adapted and pre-tested to check for any error. Adequate sample size is calculated for both arms with the ratio of 1:1 allocation. Standardized Anthropometric measurement, FANTA Household Dietary Diversity Score and WHO TB treatment outcome classification will be used for assessing the outcome variables. The data collectors will be trained on the objective, screening of eligible participants, the procedure of data collection, and how to assure the quality and security of the data based on the protocol. Continuous supervision will be employed throughout the data collection and intervention period. The data will be collected electronically and will be exported to STATA for analysis. Intention to treat analysis and regression analysis model will be employed.
Interventions
BEHAVIORALSMS-based Mobile Health intervention
Nutritional related SMS text message mobile health intervention will be provided to Tuberculosis patients.
Sponsors
Fogarty International Center of the National Institute of Health
Addis Ababa University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Masking description
Participants and providers will not be blind to the study intervention. Nutrition and tuberculosis treatment outcomes will be assessed by two independent reviewers without knowledge of each participant's treatment allocation.
Intervention model description
A Cluster Randomized Trial (CRT) with parallel design will be employed.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient who is following their anti TB treatment for at most two weeks and below * Patient who have their own mobile phone * Patient who is able to read and understand national official language (Amharic)
Exclusion criteria
* Patient whose TB treatment regimen more than 6 months * Patient who is pregnant and lactating mothers * Patient who enrolled other Interventional research
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nutritional status change | Change from baseline BMI at end of 2 months and 6 months treatment | The nutritional status of the patient will be assessed by Body Mass Index (BMI) that calculated through measuring the body weight and height of the patients using an electronic platform weight scale to the nearest 0.1 kg and height to the nearest centimeter using standardized meter. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dietary practice change | Change from baseline dietary practice at end of 6 months treatment | Patient's dietary diversity practice will be assessed through a standardized tool adapted from FANTA Household Dietary Diversity Score |
| Treatment outcome | End of six months TB treatment | Treatment outcomes will be classified as per WHO Tuberculosis treatment guideline. The classification is made based on the smear sputum examination result at second, five and end of six months treatment and/or treatment completion status. |
Countries
Ethiopia
Contacts
Primary ContactZekariyas Sa Nezenega
Backup ContactDamen Haile Mariam
Outcome results
None listed