Mobile Messaging for Improved Nutrition

Anemia Clinical Trial

— IIMAANJE  

Official title:

The Impact and Implementation of a Mobile Messaging Intervention to Improve Infant and Young Child Nutrition in Senegal

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05374837
• Other study ID #: Pro2021000819
• Secondary ID: 1R21HD105067-01
• Status: Completed
• Phase: N/A
• Start date: June 10, 2022
• Est. completion date: December 15, 2022

Study information

• Verified date: March 2023
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 492
• Est. completion date: December 15, 2022
• Est. primary completion date: December 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 23 Months

Eligibility

Inclusion Criteria:

• 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 Exclusion Criteria: -Does not meet study inclusion criteria

Related Conditions & MeSH terms

• Anemia
• Diet, Healthy

Intervention

Behavioral:
• Infant and young child feeding voice messaging intervention
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.

Locations

Country	Name	City	State
Senegal	Institut de Recherche en Santé de Surveillance Epidemiologique et de Formation	Dakar

Sponsors (2)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

Senegal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Through study completion, an average of 4 months after baseline data collection
Primary	Anemia prevalence	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.	Through study completion, an average of 4 months after baseline data collection
Primary	Change in Minimum Acceptable Diet prevalence	The change in 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.	Through study completion, an average of 4 months after baseline data collection
Primary	Change in Anemia prevalence	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 changes in anemia prevalence between baseline and endline will be examined.	Through study completion, an average of 4 months after baseline data collection
Secondary	Frequency of consuming key foods in the past 7 days	The frequency of 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.	Through study completion, an average of 4 months after baseline data collection
Secondary	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.	Through study completion, an average of 4 months after baseline data collection
Secondary	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.	Through study completion, an average of 4 months after baseline data collection
Secondary	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)	Through study completion, an average of 4 months after baseline data collection
Secondary	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)	Through study completion, an average of 4 months after baseline data collection
Secondary	Change in prevalence of frequency of consuming key foods in the past 7 days	The change 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.	Through study completion, an average of 4 months after baseline data collection
Secondary	Change in prevalence of 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 change in the prevalence of children being fed according to the detailed descriptions of these indicators will be assessed between baseline and endline based on the WHO/UNICEF IYCF indicator manual.	Through study completion, an average of 4 months after baseline data collection
Secondary	Change in prevalence of children meeting Minimum Meal Frequency indicator	The change in the prevalence 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.	Through study completion, an average of 4 months after baseline data collection
Secondary	Change in prevalence of children meeting Minimum Dietary Diversity	The change in 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) between baseline and endline.	Through study completion, an average of 4 months after baseline data collection
Secondary	Change in proportion of mothers and fathers (or caregivers) Infant and Young Child Feeding (IYCF) knowledge, attitudes, norms and intentions	The change in IYCF knowledge, attitudes, norms and intentions among mothers and fathers (or caregivers) between baseline and endline 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.	Through study completion, an average of 4 months after baseline data collection