Impact on Nutritional Practices: SMS and Interpersonal Communication (RISE)
Primary Purpose
Nutritional Deficiency
Status
Completed
Phase
Not Applicable
Locations
Tanzania
Study Type
Interventional
Intervention
SMS
Interpersonal Counselling
Sponsored by
About this trial
This is an interventional prevention trial for Nutritional Deficiency
Eligibility Criteria
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
Sites / Locations
- HKI-Tanzania
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
No Intervention
Arm Label
SMS
Interpersonal
SMS + Interpersonal
Usual Care
Arm Description
Participants will receive SMS messages on nutrition and health related topics
Participants will receive interpersonal counselling on nutrition and health related topics
Participants will receive SMS messages on nutrition and health related topics as well as interpersonal counselling on nutrition and health related topics
Outcomes
Primary Outcome Measures
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)
Women's dietary diversity
% who consumed food items from at least five out of ten defined food groups in the previous 24 hours (WDDS)
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.)
Secondary Outcome Measures
Full Information
NCT ID
NCT03297190
First Posted
September 26, 2017
Last Updated
June 15, 2022
Sponsor
Helen Keller International
Collaborators
Tanzania Food and Nutrition Centre
1. Study Identification
Unique Protocol Identification Number
NCT03297190
Brief Title
Impact on Nutritional Practices: SMS and Interpersonal Communication
Acronym
RISE
Official Title
Evaluating the Impact of Text Messages and Interpersonal Community Support Groups on MICN Practices in Tanzania
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
February 25, 2018 (Actual)
Primary Completion Date
September 30, 2019 (Actual)
Study Completion Date
September 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Helen Keller International
Collaborators
Tanzania Food and Nutrition Centre
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nutritional Deficiency
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
Four arms: (1) SMS only; (2) SMS + interpersonal; (3) interpersonal only; (4) none
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2245 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SMS
Arm Type
Active Comparator
Arm Description
Participants will receive SMS messages on nutrition and health related topics
Arm Title
Interpersonal
Arm Type
Active Comparator
Arm Description
Participants will receive interpersonal counselling on nutrition and health related topics
Arm Title
SMS + Interpersonal
Arm Type
Active Comparator
Arm Description
Participants will receive SMS messages on nutrition and health related topics as well as interpersonal counselling on nutrition and health related topics
Arm Title
Usual Care
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
SMS
Intervention Description
Receipt of SMS messages on nutrition and health topics
Intervention Type
Behavioral
Intervention Name(s)
Interpersonal Counselling
Intervention Description
Interpersonal counselling on health and nutrition topics
Primary Outcome Measure Information:
Title
Children's Dietary Diversity
Description
% of children 6-29 mo. who consumed the minimum dietary diversity (received foods from ≥4 food groups on the previous day)
Time Frame
24 h
Title
Women's dietary diversity
Description
% who consumed food items from at least five out of ten defined food groups in the previous 24 hours (WDDS)
Time Frame
24 h
Title
Children's Minimum Meal Frequency
Description
% 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.)
Time Frame
24 h
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
HKI-Tanzania
City
Dar es Salaam
ZIP/Postal Code
11
Country
Tanzania
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
Impact on Nutritional Practices: SMS and Interpersonal Communication
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