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

NCT04242472 | Unknown

• 2 other identifiers: TB-MeNuD43TW009127
• Study Type: interventional
• Target: 440
• Locations: 1 country
• Sites: 1

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.

Conditions

Tuberculosis; Undernutrition

Keywords

Tuberculosis; Nutrition; Treatment outcome; SMS

Outcome Measures

Primary Outcomes (1)

• Nutritional status change

  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 Outcomes (2)

• Dietary practice change

  Change from baseline dietary practice at end of 6 months treatment

• Treatment outcome

  End of six months TB treatment

Study Arms (2)

SMS group

EXPERIMENTAL

Nutrition-related SMS messages in addition to standard of care TB treatment with directly observed therapy

Behavioral: SMS-based Mobile Health intervention

Control group

NO INTERVENTION

Standard care of TB treatment with directly observed therapy alone

Interventions

SMS-based Mobile Health intervention BEHAVIORAL

Nutritional related SMS text message mobile health intervention will be provided to Tuberculosis patients.

SMS group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Patient whose TB treatment regimen more than 6 months
• Patient who is pregnant and lactating mothers
• Patient who enrolled other Interventional research

Sponsors & Collaborators

• Addis Ababa University: lead
• Fogarty International Center of the National Institute of Health: collaborator

Study Sites (1)

Addis Ababa Health Bureau

Addis Ababa, Ethiopia

Location

MeSH Terms

Conditions

Tuberculosis; Malnutrition

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Damen Haile Mariam

  Addis Ababa University School of Public Health

  STUDY CHAIR

Central Study Contacts

Zekariyas Sa Nezenega

CONTACT

911072963; zekitiru@gmail.com

Damen Haile Mariam

CONTACT

929438641; damengoog@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD candidate

Model Details: A Cluster Randomized Trial (CRT) with parallel design will be employed.

Study Record Dates

• First Submitted: January 20, 2020
• First Posted: January 27, 2020
• Study Start: July 1, 2020
• Primary Completion: September 1, 2020
• Study Completion: March 1, 2021
• Last Updated: January 27, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

ET (1)