Nutritional DeficiencyRISENCT03297190
Impact on Nutritional Practices: SMS and Interpersonal Communication
A study testing SMS and Interpersonal Counselling in people with Nutritional Deficiency, run by Helen Keller International at 1 site in Tanzania.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Nutritional Deficiency
- What is being tested?
- SMS and Interpersonal Counselling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,245 participants
- Where
- 1 siteTanzania
- Study dates
- 25 Feb 2018to 30 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Mothers of children aged 0-12 mo. or pregnant at time of enrollment
- Consent to participate in the study
Who cannot join
- Unable to consent to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Nutritional Deficiency
- Being tested
- SMS, Interpersonal Counselling
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMSBehavioural
Receipt of SMS messages on nutrition and health topics
Interpersonal CounsellingBehavioural
Interpersonal counselling on health and nutrition topics
| Study group | Role | What they receive |
|---|---|---|
| SMS | Active comparator | Participants will receive SMS messages on nutrition and health related topics Receives: Behavioral: SMS |
| Interpersonal | Active comparator | Participants will receive interpersonal counselling on nutrition and health related topics Receives: Behavioral: Interpersonal Counselling |
| SMS + Interpersonal | Active comparator | Participants will receive SMS messages on nutrition and health related topics as well as interpersonal counselling on nutrition and health related topics Receives: Behavioral: SMS; Behavioral: Interpersonal Counselling |
| Usual Care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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.)
Measured: 24 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2017
- Study start25 Feb 2018
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutritional DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Four arms: (1) SMS only; (2) SMS + interpersonal; (3) interpersonal only; (4) none
- Masking
- None (open label)
- Enrolment
- 2,245 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helen Keller International
- Sponsor type
- University, hospital or other
- Collaborators
- Tanzania Food and Nutrition Centre
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03297190
- Sponsor's protocol ID
- 20171
- Acronym
- RISE
- Status last verified
- Jun 2022
- First submitted
- 26 Sep 2017
- Last updated
- 16 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymous data to be shared after data analysis is completed.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact of Text Messages and Interpersonal Community Support Groups on MICN Practices in Tanzania
- ClinicalTrials.gov ID
- NCT03297190
- Acronym / sponsor ID
- RISE / 20171
- Conditions
- Nutritional Deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,245 participants (actual)
- Lead sponsor
- Helen Keller InternationalUniversity, hospital or other
- Collaborators
- Tanzania Food and Nutrition Centre
- Study start
- 25 Feb 2018 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 29 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Four arms: (1) SMS only; (2) SMS + interpersonal; (3) interpersonal only; (4) none
| Arm | Type | Receives |
|---|---|---|
| SMS | Active comparator | Behavioral: SMSParticipants will receive SMS messages on nutrition and health related topics |
| Interpersonal | Active comparator | Behavioral: Interpersonal CounsellingParticipants will receive interpersonal counselling on nutrition and health related topics |
| SMS + Interpersonal | Active comparator | Behavioral: SMS, Behavioral: Interpersonal CounsellingParticipants will receive SMS messages on nutrition and health related topics as well as interpersonal counselling on nutrition and health related topics |
| Usual Care | No intervention | – |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Mothers of children aged 0-12 mo. or pregnant at time of enrollment
- Consent to participate in the study
Key exclusion criteria (1 listed)
- Unable to consent to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SMSReceipt of SMS messages on nutrition and health topics | Behavioural | SMS, SMS + Interpersonal |
| Interpersonal CounsellingInterpersonal counselling on health and nutrition topics | Behavioural | Interpersonal, SMS + Interpersonal |
Primary outcome
Children's Dietary Diversity
Time frame: 24 h
% 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
Time frame: 24 h
% 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
Time frame: 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.)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2022.
- Individual participant dataSharing planned: Yes. Anonymous data to be shared after data analysis is completed.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMS and Interpersonal Counselling in people with Nutritional Deficiency, run by Helen Keller International at 1 site in Tanzania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Children's Dietary Diversity (time frame: 24 h). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2022.