Impact on Nutritional Practices: SMS and Interpersonal Communication (RISE)

Evaluating the Impact of Text Messages and Interpersonal Community Support Groups on MICN Practices in Tanzania

This cluster randomized controlled study aims to add to the evidence base on mHealth interventions by assessing the main effects of delivering nutrition messages on key maternal, infant, and young child nutrition (MIYCN) behaviors and outcomes through three innovative behavior change strategies. The strategies compared will be: (i) an interpersonal communication strategy using the Tanzanian government's Mkoba wa Siku 1000 maternal, infant and young child nutrition (MIYCN) curriculum (MwS) through clinic- and community-based channels, (ii) the mNutrition SMS text messaging module of the government's Wazazi Nipendeni program, and (iii) the combination of both of these strategies (interpersonal and SMS messaging). They will be compared with the current standard of care in Tanzania. The goal will be to determine which has the greatest impact on key MIYCN and hygiene practices and care-seeking behaviors. It will be paired with a costing analysis so that these effects can be understood in the context of their costs.

Study Overview

• Status: Completed
• Conditions: Nutritional Deficiency
• Intervention / Treatment: Behavioral: SMS; Behavioral: Interpersonal Counselling

• Study Type: Interventional
• Enrollment (Actual): 2245
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Tanzania
  • Dar es Salaam, Tanzania, 11
    • HKI-Tanzania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Mothers of children aged 0-12 mo. or pregnant at time of enrollment
• Consent to participate in the study

Exclusion Criteria:

• Unable to consent to participate in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Usual Care
ACTIVE_COMPARATOR: SMS; Participants will receive SMS messages on nutrition and health related topics	Behavioral: SMS; Receipt of SMS messages on nutrition and health topics
ACTIVE_COMPARATOR: Interpersonal; Participants will receive interpersonal counselling on nutrition and health related topics	Behavioral: Interpersonal Counselling; Interpersonal counselling on health and nutrition topics
ACTIVE_COMPARATOR: SMS + Interpersonal; Participants will receive SMS messages on nutrition and health related topics as well as interpersonal counselling on nutrition and health related topics	Behavioral: SMS; Receipt of SMS messages on nutrition and health topics; Behavioral: Interpersonal Counselling; Interpersonal counselling on health and nutrition topics

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Children's Dietary Diversity	% of children 6-29 mo. who consumed the minimum dietary diversity (received foods from ≥4 food groups on the previous day)	24 h
Women's dietary diversity	% who consumed food items from at least five out of ten defined food groups in the previous 24 hours (WDDS)	24 h
Children's Minimum Meal Frequency	% of children 6-29 mo. who consumed the minimum meal frequency the prior day (2/day for breastfed infants 6-8 mo.; 3/day for breastfed infants 9-29 mo.; 4/day for non-breastfed infants 6-29 mo.)	24 h

Collaborators and Investigators

• Sponsor: Helen Keller International
• Collaborators: Tanzania Food and Nutrition Centre

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 25, 2018
• Primary Completion (ACTUAL): September 30, 2019
• Study Completion (ACTUAL): September 30, 2019

Study Registration Dates

• First Submitted: September 26, 2017
• First Submitted That Met QC Criteria: September 26, 2017
• First Posted (ACTUAL): September 29, 2017

Study Record Updates

• Last Update Posted (ACTUAL): June 16, 2022
• Last Update Submitted That Met QC Criteria: June 15, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition
• Other Study ID Numbers: 20171 (Other Identifier: City of Hope Medical Center)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymous data to be shared after data analysis is completed.
• IPD Sharing Time Frame: Approximately 12 mo. after completion, indefinitely
• IPD Sharing Access Criteria: Fill out data use agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No