Diet, HealthyIIMAANJENCT05374837
Mobile Messaging for Improved Nutrition
A study testing Infant and young child feeding voice messaging intervention in people with Diet, Healthy and Anemia, run by Rutgers, The State University of New Jersey at 1 site in Senegal.
Trial summary
This project will examine the impact of an infant and young child feeding (IYCF) voice messaging intervention delivered to mothers and fathers in Senegal on the consumption of a minimum acceptable diet and anemia prevalence in their children. Read more about this study
- Who is it for?
- Ages 6 to 23 monthsHealthy volunteers can take part
- Conditions the study is for
- Diet, Healthy, Anemia
- What is being tested?
- Infant and young child feeding voice messaging intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 488 participants
- Where
- 1 siteSenegal
- Study dates
- 10 Jun 2022to 15 Dec 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 6 to 23 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Residing in Thies, Diourbel or Fatick regions of Senegal
- Household is member of village farming group
- Mothers and fathers (or caregivers) that have a child 6-19 months at baseline
- Mothers and fathers (or caregivers) that are 18 years or older
- Mothers and fathers (or caregivers) have the ability and mental capacity to consent to their participation
- Mother/father (or male/female caregivers) have access to mobile phone
- Child between 6-19 months at baseline
Who cannot join
- -Does not meet study inclusion criteria
Trial locations and contacts
1 site in 1 country.
Senegal1 site
Institut de Recherche en Santé de Surveillance Epidemiologique et de Formation
Dakar
About this study
Official title: The Impact and Implementation of a Mobile Messaging Intervention to Improve Infant and Young Child Nutrition in Senegal
This project will examine the impact of an infant and young child feeding (IYCF) voice messaging intervention delivered to mothers and fathers in Senegal on the consumption of a minimum acceptable diet and anemia prevalence in their children.
Read the detailed description
This is a cluster-randomized control trial (cRCT) conducted with 488 mother, father, and child triads in 104 villages in three regions in Senegal: Thies, Diourbel and Fatick. Mothers and fathers in the experimental group will receive 16 voice and text messages over the course of 16 weeks. One voice and 1 text message with the same content will be sent per week over the 16 week period. We will include eight scripted messages which have previously been piloted. We will also include eight unscripted messages from positive deviants from communities similar to our study population that were included in our pilot study. A text message with the same content as the voice message will be sent to each triad mother and father to increase the reach of the intervention. We will conduct baseline and endline assessments of infant and young child feeding practices in both the experimental and control groups. Primary outcomes will include the prevalence of anemia and minimum acceptable diet in children. Minimum acceptable diet is an indicator of dietary diversity and a proxy for nutrient adequacy. Secondary outcomes include the frequency of consuming key foods targeted in the intervention over the previous 7 days and infant and young child feeding indicators of complementary feeding of the child. In addition, infant and young child feeding knowledge, beliefs, and norms (of mothers and fathers in triads) and intentions (of mothers in triads) will be included as secondary outcomes.
- Conditions
- Diet, Healthy, Anemia
- Being tested
- Infant and young child feeding voice messaging intervention
- Keywords
- Senegal, Infant and young child feeding
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infant and young child feeding voice messaging interventionBehavioural
A mobile voice and text messaging intervention aimed at improving IYCF practices will be delivered to mothers and fathers with young children (6-23 months). A total of 16 voice and text message, with the same content, will be sent over a 16-week period (1 voice + 1 text messages (with same content) per week x 16 weeks). Two types of messages will be included: 1) eight scripted and 2) eight unscripted messages from positive deviants. The content of the messages include: breastfeeding until two years of age, consuming a variety of foods within a given meal, the consistency of porridge (thick rather than thin), limiting sweets and fried foods, the importance of animal source foods, consuming vitamin A rich fruits and vegetables, consuming leafy greens, handwashing and feeding infants and young children fruits and vegetables produced by the household.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | The control group will not receive any intervention. After the endline data collection is completed, the intervention will be delivered to the control group. |
| Infant and young child feeding (IYCF) voice messaging intervention | Experimental | The voice messaging intervention group will receive voice/text messages for a period of 16 weeks. Receives: Behavioral: Infant and young child feeding voice messaging intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Children Who Consume a Minimum Acceptable Diet
The minimum acceptable diet indicator will be used to assess diet quality in children. A list-based recall will be used to assess dietary intake over the previous day. The 24-hour recall will be used to calculate minimum dietary diversity (MDD) (consuming 5 or more of 8 food groups (breast milk; grains, roots, tubers and plantains; pulses (beans, peas, lentils), nuts and seeds; dairy products (milk, infant formula, yogurt, cheese); flesh foods (meat, fish, poultry, organ meats); eggs; vitamin A rich fruits and vegetables; other fruit and vegetables) and minimum meal frequency (MMF) (2x/day for breastfed infants 6-8 months; 3x/day for breastfed children 9-23 months; 4x/day for non-breastfed children 6-23 months). Children who meet the thresholds for both MDD and MMF are defined as consuming a MAD, based on the WHO/UNICEF IYCF indicator.
Measured: At study completion, an average of 4 months after baseline
Anemia Prevalence of Children
Hemocue Hb301 machines to measure hemoglobin levels in children in order to determine anemia prevalence using the WHO cut-offs: mild 10 ≤ hb < 11 g/dl; moderate 7 ≤ hb < 10 d/dl and severe hb < 7 g/dl. A finger prick will be used to obtain a drop of capillary blood that is placed on a cuvette and inserted in the Hemocue machine to obtain an on-the-spot assessment of hemoglobin levels.
Measured: At study completion, an average of 4 months after baseline
Change in Percentage of Children Consuming a Minimum Acceptable Diet Between Baseline and Endline
The change in percentage of children meeting the minimum acceptable diet indicator between baseline and endline will be used to assess diet quality in children. A list-based recall will be used to assess dietary intake over the previous day. The 24-hour recall will be used to calculate minimum dietary diversity (MDD) (consuming 5 or more of 8 food groups (breast milk; grains, roots, tubers and plantains; pulses (beans, peas, lentils), nuts and seeds; dairy products (milk, infant formula, yogurt, cheese); flesh foods (meat, fish, poultry, organ meats); eggs; vitamin A rich fruits and vegetables; other fruit and vegetables) and minimum meal frequency (MMF) (2x/day for breastfed infants 6-8 months; 3x/day for breastfed children 9-23 months; 4x/day for non-breastfed children 6-23 months). Children who meet the thresholds for both MDD and MMF are defined as consuming a MAD, based on the WHO/UNICEF IYCF indicator.
Measured: Between baseline and study completion, an average of 4 months after baseline
Change in Percentage of Children With Anemia Between Baseline and Endline
We will use Hemocue Hb301 machines to measure hemoglobin levels in children in order to determine anemia prevalence using the WHO cut-offs: mild 10 ≤ hb < 11 g/dl; moderate 7 ≤ hb < 10 d/dl and severe hb < 7 g/dl. A finger prick will be used to obtain a drop of capillary blood that is placed on a cuvette and inserted in the Hemocue machine to obtain an on-the-spot assessment of hemoglobin levels. The change in child anemia prevalence between baseline and endline will be examined (calculated as endline-baseline/baseline*100).
Measured: Between baseline and study completion, an average of 4 months after baseline
Secondary outcomes (10)
Frequency of Child Consuming Key Foods in the Past 7 Days
The frequency of the child consuming specific foods targeted in the intervention over the course of the previous week (7 days) will be assessed. More specifically, the number of times that the following foods have been consumed will be assessed: animal source foods, leafy greens, orange colored fruits and vegetables, thick porridge, porridge mixed with nutrient-rich foods, sweets and sugary drinks, fried foods.
Measured: At study completion, an average of 4 months after baseline
Infant and Young Child Feeding (IYCF) Practices Indicators
The WHO/UNICEF IYCF indicators will be used to assess feeding practices. Mothers will be asked about feeding practices as part of the household surveys. The indicators include: ever breastfed, early initiation of breastfeeding, exclusively breastfed for the first two days after birth, bottle feeding 0-23 months, continued breastfeeding 12-23 months, introduction of solid, semi-solid or soft foods 6-8 months, egg and/or flesh food consumption, sweet beverage consumption, unhealthy food consumption, and zero vegetable or fruit. The proportion of children being fed according to the detailed descriptions of these indicators will be assessed based on the WHO/UNICEF IYCF indicator manual.
Measured: At study completion, an average of 4 months after baseline
Mothers and Fathers Infant and Young Child Feeding (IYCF) Knowledge, Attitudes, Norms and Intentions
IYCF knowledge, attitudes, norms and intentions will be assessed using survey questions based on the components of the intervention. Both mothers and fathers will be asked the survey questions as part of the household survey. The questions are grounded in the theory of planned behavior and based on previously published IYCF knowledge, attitudes, norms and intentions questions. The questions have been pilot tested by the project PI.
Measured: At study completion, an average of 4 months after baseline
Number of Children Consuming Minimum Meal Frequency
Minimum meal frequency of (semi) solid or soft foods is assessed by examining the proportion of young children consuming foods: 2x/day for breastfed infants 6-8 months; 3x/day for breastfed children 9-23 months; 4x/day for non-breastfed children 6-23 months)
Measured: At study completion, an average of 4 months after baseline
Number of Children Consuming Minimum Dietary Diversity
The proportion of young children consuming 5 or more of 8 food groups (breast milk; grains, roots, tubers and plantains; pulses (beans, peas, lentils), nuts and seeds; dairy products (milk, infant formula, yogurt, cheese); flesh foods (meat, fish, poultry, organ meats); eggs; vitamin A rich fruits and vegetables; other fruit and vegetables)
Measured: At study completion, an average of 4 months after baseline
Percent Change in Frequency of Consuming Key Foods in the Past 7 Days
The percent change (calculated as endline-baseline/baseline) in the frequency of consuming specific foods targeted in the intervention over the course of the previous week (7 days) will be assessed between baseline and endline. More specifically, the number of times that the following foods have been consumed will be assessed: animal source foods, leafy greens, orange colored fruits and vegetables, thick porridge, porridge mixed with nutrient-rich foods, sweets and sugary drinks, fried foods.
Measured: Between baseline and study completion, an average of 4 months after baseline
Change in Percentage of Children Meeting Recommended Infant and Young Child Feeding (IYCF) Practices Indicators
The change in percentage of children being fed according to the recommended IYCF practices between baseline and endline. The WHO/UNICEF IYCF indicators will be used to assess feeding practices. Mothers will be asked about feeding practices as part of the household surveys. The indicators include: ever breastfed, early initiation of breastfeeding, exclusively breastfed for the first two days after birth, bottle feeding 0-23 months, continued breastfeeding 12-23 months, introduction of solid, semi-solid or soft foods 6-8 months, egg and/or flesh food consumption, sweet beverage consumption, unhealthy food consumption, and zero vegetable or fruit.
Measured: Between baseline and study completion, an average of 4 months after baseline
Change in Percentage of Children Meeting Minimum Meal Frequency Indicator
The change in the percentage of children meeting the minimum meal frequency (MMF) indicator between baseline and endline will be assessed. Minimum meal frequency of (semi) solid or soft foods is assessed by examining the proportion of young children consuming foods: 2x/day for breastfed infants 6-8 months; 3x/day for breastfed children 9-23 months; 4x/day for non-breastfed children 6-23 months.
Measured: Between baseline and study completion, an average of 4 months after baseline
Change in Percentage of Children Meeting Minimum Dietary Diversity
The change in the percentage of young children consuming 5 or more of 8 food groups (breast milk; grains, roots, tubers and plantains; pulses (beans, peas, lentils), nuts and seeds; dairy products (milk, infant formula, yogurt, cheese); flesh foods (meat, fish, poultry, organ meats); eggs; vitamin A rich fruits and vegetables; other fruit and vegetables) between baseline and endline.
Measured: Between baseline and study completion, an average of 4 months after baseline
Change in Percentage of Mothers and Fathers Infant and Young Child Feeding (IYCF) Knowledge, Attitudes, Norms and Intentions
The change in percentage of mothers/fathers with specific IYCF knowledge, attitudes, norms and intentions between baseline and endline will be assessed using survey questions based on the components of the intervention. Mothers will be asked the survey questions as part of the household survey. The questions are grounded in the theory of planned behavior and based on previously published IYCF knowledge, attitudes, norms and intentions questions.
Measured: Between baseline and study completion, an average of 4 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2022
- Study start10 Jun 2022
- Primary completion15 Dec 2022
- Study completion15 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diet, HealthyStudies 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
- Parallel groups
- Model description
- Cluster-randomized control trial. Please note that enrollment number reflects the number of triads included in the study.
- Masking
- None (open label)
- Enrolment
- 488 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Shauna Downs, PhD MS, Rutgers, The State University of New Jersey
- Investigators
- Shauna Downs, Principal investigator, Rutgers School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05374837
- Sponsor's protocol ID
- Pro2021000819
- Other IDs
- 1R21HD105067-01
- Acronym
- IIMAANJE
- Status last verified
- Dec 2024
- First submitted
- 27 Apr 2022
- Last updated
- 30 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Access to the study database will be available for educational, research and non-profit purposes. All data to be shared will be stripped of any potentially identifying information. Data will be made available through written request to the PIs. A brief analysis plan and data request will be required and reviewed by the PI for approval of data sharing. When requests are approved data will be sent electronically in password protected files. The final dataset will be available in a cvs file.
Publications
Downs SM, Gueye D, Sall M, Ndoye B, Sarr NN, Sarr M, Mboup S, Alam NA, Diouf A, Merchant EV, Sackey J. The impact and implementation of an mHealth intervention to improve infant and young child feeding in Senegal: IIMAANJE protocol for a cluster randomized control trial. Front Public Health. 2023 Sep 25;11:1258963. doi: 10.3389/fpubh.2023.1258963. eCollection 2023.
PubMed 37818304
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact and Implementation of a Mobile Messaging Intervention to Improve Infant and Young Child Nutrition in Senegal
- ClinicalTrials.gov ID
- NCT05374837
- Acronym / sponsor ID
- IIMAANJE / Pro2021000819
- Conditions
- Diet, Healthy, Anemia
- Keywords
- Senegal, Infant and young child feeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 488 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 10 Jun 2022 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 16 May 2022 (actual)
- Results
- Posted 30 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project will examine the impact of an infant and young child feeding (IYCF) voice messaging intervention delivered to mothers and fathers in Senegal on the consumption of a minimum acceptable diet and anemia prevalence in their children.
Detailed description
This is a cluster-randomized control trial (cRCT) conducted with 488 mother, father, and child triads in 104 villages in three regions in Senegal: Thies, Diourbel and Fatick. Mothers and fathers in the experimental group will receive 16 voice and text messages over the course of 16 weeks. One voice and 1 text message with the same content will be sent per week over the 16 week period. We will include eight scripted messages which have previously been piloted. We will also include eight unscripted messages from positive deviants from communities similar to our study population that were included in our pilot study. A text message with the same content as the voice message will be sent to each triad mother and father to increase the reach of the intervention. We will conduct baseline and endline assessments of infant and young child feeding practices in both the experimental and control groups. Primary outcomes will include the prevalence of anemia and minimum acceptable diet in children. Minimum acceptable diet is an indicator of dietary diversity and a proxy for nutrient adequacy. Secondary outcomes include the frequency of consuming key foods targeted in the intervention over the previous 7 days and infant and young child feeding indicators of complementary feeding of the child. In addition, infant and young child feeding knowledge, beliefs, and norms (of mothers and fathers in triads) and intentions (of mothers in triads) will be included as secondary outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster-randomized control trial. Please note that enrollment number reflects the number of triads included in the study.
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –The control group will not receive any intervention. After the endline data collection is completed, the intervention will be delivered to the control group. |
| Infant and young child feeding (IYCF) voice messaging intervention | Experimental | Behavioral: Infant and young child feeding voice messaging interventionThe voice messaging intervention group will receive voice/text messages for a period of 16 weeks. |
Who may qualify
- Ages
- 6 to 23 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Residing in Thies, Diourbel or Fatick regions of Senegal
- Household is member of village farming group
- Mothers and fathers (or caregivers) that have a child 6-19 months at baseline
- Mothers and fathers (or caregivers) that are 18 years or older
- Mothers and fathers (or caregivers) have the ability and mental capacity to consent to their participation
Key exclusion criteria (1 listed)
- -Does not meet study inclusion criteria
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 |
|---|---|---|
| Infant and young child feeding voice messaging interventionA mobile voice and text messaging intervention aimed at improving IYCF practices will be delivered to mothers and fathers with young children (6-23 months). A total of 16 voice and text message, with the same content, will be sent over a 16-week period (1 voice + 1 text messages (with same content) per week x 16 weeks). Two types of messages will be included: 1) eight scripted and 2) eight unscripted messages from positive deviants. The content of the messages include: breastfeeding until two years of age, consuming a variety of foods within a given meal, the consistency of porridge (thick rather than thin), limiting sweets and fried foods, the importance of animal source foods, consuming vitamin A rich fruits and vegetables, consuming leafy greens, handwashing and feeding infants and young children fruits and vegetables produced by the household. | Behavioural | Infant and young child feeding (IYCF) voice messaging intervention |
Primary outcome
Number of Children Who Consume a Minimum Acceptable Diet
Time frame: At study completion, an average of 4 months after baseline
The minimum acceptable diet indicator will be used to assess diet quality in children. A list-based recall will be used to assess dietary intake over the previous day. The 24-hour recall will be used to calculate minimum dietary diversity (MDD) (consuming 5 or more of 8 food groups (breast milk; grains, roots, tubers and plantains; pulses (beans, peas, lentils), nuts and seeds; dairy products (milk, infant formula, yogurt, cheese); flesh foods (meat, fish, poultry, organ meats); eggs; vitamin A rich fruits and vegetables; other fruit and vegetables) and minimum meal frequency (MMF) (2x/day for breastfed infants 6-8 months; 3x/day for breastfed children 9-23 months; 4x/day for non-breastfed children 6-23 months). Children who meet the thresholds for both MDD and MMF are defined as consuming a MAD, based on the WHO/UNICEF IYCF indicator.
Anemia Prevalence of Children
Time frame: At study completion, an average of 4 months after baseline
Hemocue Hb301 machines to measure hemoglobin levels in children in order to determine anemia prevalence using the WHO cut-offs: mild 10 ≤ hb < 11 g/dl; moderate 7 ≤ hb < 10 d/dl and severe hb < 7 g/dl. A finger prick will be used to obtain a drop of capillary blood that is placed on a cuvette and inserted in the Hemocue machine to obtain an on-the-spot assessment of hemoglobin levels.
Change in Percentage of Children Consuming a Minimum Acceptable Diet Between Baseline and Endline
Time frame: Between baseline and study completion, an average of 4 months after baseline
The change in percentage of children meeting the minimum acceptable diet indicator between baseline and endline will be used to assess diet quality in children. A list-based recall will be used to assess dietary intake over the previous day. The 24-hour recall will be used to calculate minimum dietary diversity (MDD) (consuming 5 or more of 8 food groups (breast milk; grains, roots, tubers and plantains; pulses (beans, peas, lentils), nuts and seeds; dairy products (milk, infant formula, yogurt, cheese); flesh foods (meat, fish, poultry, organ meats); eggs; vitamin A rich fruits and vegetables; other fruit and vegetables) and minimum meal frequency (MMF) (2x/day for breastfed infants 6-8 months; 3x/day for breastfed children 9-23 months; 4x/day for non-breastfed children 6-23 months). Children who meet the thresholds for both MDD and MMF are defined as consuming a MAD, based on the WHO/UNICEF IYCF indicator.
Change in Percentage of Children With Anemia Between Baseline and Endline
Time frame: Between baseline and study completion, an average of 4 months after baseline
We will use Hemocue Hb301 machines to measure hemoglobin levels in children in order to determine anemia prevalence using the WHO cut-offs: mild 10 ≤ hb < 11 g/dl; moderate 7 ≤ hb < 10 d/dl and severe hb < 7 g/dl. A finger prick will be used to obtain a drop of capillary blood that is placed on a cuvette and inserted in the Hemocue machine to obtain an on-the-spot assessment of hemoglobin levels. The change in child anemia prevalence between baseline and endline will be examined (calculated as endline-baseline/baseline*100).
10 secondary outcomes
Frequency of Child Consuming Key Foods in the Past 7 Days
Time frame: At study completion, an average of 4 months after baseline
Infant and Young Child Feeding (IYCF) Practices Indicators
Time frame: At study completion, an average of 4 months after baseline
Mothers and Fathers Infant and Young Child Feeding (IYCF) Knowledge, Attitudes, Norms and Intentions
Time frame: At study completion, an average of 4 months after baseline
Number of Children Consuming Minimum Meal Frequency
Time frame: At study completion, an average of 4 months after baseline
Number of Children Consuming Minimum Dietary Diversity
Time frame: At study completion, an average of 4 months after baseline
Percent Change in Frequency of Consuming Key Foods in the Past 7 Days
Time frame: Between baseline and study completion, an average of 4 months after baseline
Change in Percentage of Children Meeting Recommended Infant and Young Child Feeding (IYCF) Practices Indicators
Time frame: Between baseline and study completion, an average of 4 months after baseline
Change in Percentage of Children Meeting Minimum Meal Frequency Indicator
Time frame: Between baseline and study completion, an average of 4 months after baseline
Change in Percentage of Children Meeting Minimum Dietary Diversity
Time frame: Between baseline and study completion, an average of 4 months after baseline
Change in Percentage of Mothers and Fathers Infant and Young Child Feeding (IYCF) Knowledge, Attitudes, Norms and Intentions
Time frame: Between baseline and study completion, an average of 4 months after baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37818304Downs SM, Gueye D, Sall M, Ndoye B, Sarr NN, Sarr M, Mboup S, Alam NA, Diouf A, Merchant EV, Sackey J. The impact and implementation of an mHealth intervention to improve infant and young child feeding in Senegal: IIMAANJE protocol for a cluster randomized control trial. Front Public Health. 2023 Sep 25;11:1258963. doi: 10.3389/fpubh.2023.1258963. eCollection 2023.
- Individual participant dataSharing planned: No. Access to the study database will be available for educational, research and non-profit purposes. All data to be shared will be stripped of any potentially identifying information. Data will be made available through written request to the PIs. A brief analysis plan and data request will be required and reviewed by the PI for approval of data sharing. When requests are approved data will be sent electronically in password protected files. The final dataset will be available in a cvs file.
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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.
Shauna Downs principal investigator
Rutgers School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infant and young child feeding voice messaging intervention in people with Diet, Healthy and Anemia, run by Rutgers, The State University of New Jersey at 1 site in Senegal.
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 7 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 30 Dec 2024. 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 Senegal. 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?
Yes. Results are posted in the registry (first posted 30 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Children Who Consume a Minimum Acceptable Diet (time frame: At study completion, an average of 4 months after baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05374837, which also lists 1 linked publication.
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 30 Dec 2024.