RISE: Impact on Nutritional Practices: SMS and Interpersonal Communication

• Sponsor: Helen Keller International (Other)
• Overall Status: Completed
• CT.gov ID: NCT03297190
• Collaborator: Tanzania Food and Nutrition Centre (Other)
• Enrollment: 2,245
• Location: 1
• Arms: 4
• Actual Duration (Months): 19.1
• Patients Per Site Per Month: 117.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Nutritional Deficiency	Behavioral: SMS; Behavioral: Interpersonal Counselling	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 2245 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Intervention Model Description: Four arms: (1) SMS only; (2) SMS + interpersonal; (3) interpersonal only; (4) noneFour arms: (1) SMS only; (2) SMS + interpersonal; (3) interpersonal only; (4) none
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Evaluating the Impact of Text Messages and Interpersonal Community Support Groups on MICN Practices in Tanzania
• Actual Study Start Date: Feb 25, 2018
• Actual Primary Completion Date: Sep 30, 2019
• Actual Study Completion Date: Sep 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
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
No Intervention: Usual Care

Outcome Measures

Primary Outcome Measures

1. Children's Dietary Diversity [24 h]

   % of children 6-29 mo. who consumed the minimum dietary diversity (received foods from ≥4 food groups on the previous day)

2. Women's dietary diversity [24 h]

   % who consumed food items from at least five out of ten defined food groups in the previous 24 hours (WDDS)

3. Children's Minimum Meal Frequency [24 h]

   % 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.)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	HKI-Tanzania	Dar es Salaam		Tanzania	11

Sponsors and Collaborators

• Helen Keller International
• Tanzania Food and Nutrition Centre

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Helen Keller International
• ClinicalTrials.gov Identifier: NCT03297190
• Other Study ID Numbers: 20171
• First Posted: Sep 29, 2017
• Last Update Posted: Jun 16, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Malnutrition

Study Results

No Results Posted as of Jun 16, 2022