SMS-based Mobile Health Intervention for Nutritional Status and Treatment Outcome Among TB Patients

January 23, 2020 updated by: Zekariyas Sahile, Addis Ababa University

SMS-based Mobile Health Intervention for Nutritional Status and Treatment Outcomes Among TB Patients in Addis Ababa, Ethiopia: A Cluster Randomized Trial (CRT)

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

440

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Ethiopia
      • Addis Ababa, Ethiopia
        • Addis Ababa Health Bureau
        • Contact:
        • Principal Investigator:
          • Zekariyas Sa Nezenega, MPH
        • Sub-Investigator:
          • Damen Haile Mariam, PhD
        • Sub-Investigator:
          • Jeffrey collins, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SMS group
Nutrition-related SMS messages in addition to standard of care TB treatment with directly observed therapy
Behavioral: SMS-based Mobile Health intervention
Nutritional related SMS text message mobile health intervention will be provided to Tuberculosis patients.
No Intervention: Control group
Standard care of TB treatment with directly observed therapy alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nutritional status change
Time Frame: 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.
Change from baseline BMI at end of 2 months and 6 months treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dietary practice change
Time Frame: 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
Change from baseline dietary practice at end of 6 months treatment
Treatment outcome
Time Frame: 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.
End of six months TB treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Addis Ababa University

Collaborators

Fogarty International Center of the National Institute of Health

Investigators

  • Study Chair: Damen Haile Mariam, Addis Ababa University School of Public Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2020

Primary Completion (Anticipated)

September 1, 2020

Study Completion (Anticipated)

March 1, 2021

Study Registration Dates

First Submitted

January 20, 2020

First Submitted That Met QC Criteria

January 23, 2020

First Posted (Actual)

January 27, 2020

Study Record Updates

Last Update Posted (Actual)

January 27, 2020

Last Update Submitted That Met QC Criteria

January 23, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TB-MeNu
  • D43TW009127 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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