The primary goal of this study is to assess the impact of an innovative strategy to prevent undernutrition and obesity in early childhood in children 0-24 months in Mexico. This study is designed to evaluate the impact of promoting adequate infant an young child feeding practices and the use of SQ-LNS (Small Quantity Lipid-Based Nutrient Supplements) on the nutritional status of infants and young children. The study will be conducted in peri-urban areas of Tepic, Nayarit in Mexico in conjunction with the Hospital Infantil de México Federico Gómez and the Nayarit Secretariat of Health.
SPOON Mexico is an innovative strategy to prevent undernutrition and obesity in children aged 0-24 months living in marginalized areas of Tepic City, Nayarit. The SPOON program aims to improve infant and young children feeding practices, including exclusive breastfeeding, and promote the use of home-fortification with peanut-based SQ-LNS (small quantity lipid-based nutrient supplements) through a novel behavior change strategy. The study will recruit children between 0 and 6 months of age as well as pregnant women in the third trimester. Mothers or caregivers of eligible children will be invited to participate and a consent form obtain. Participation will start at 0-6 months and the intervention will last until children are up to 24 months. Participants will be randomly assigned at the household level to one of two groups: a control group and a treatment group. Participants in the control group will receive the standard services provided by their local health clinics according to the national protocol. Participants in Treatment Group 1 will receive SQ-LNS supplement from 6-24 months and an innovative behavioral change strategy designed using ethnographic and marketing methods to promote adequate infant and young child feeding practices and the use of SQ-LNS. The strategy will be delivered to mothers or caregivers through individual home-visits and group sessions. A sample size of 600 children per group has been calculated to detect a minimum effect size of 0.18 with 95% level of significance and a 80% power. Additionally, a 20% attrition has been included in the sample size calculation. Main outcomes include infant and young child feeding practices, height, weight, hemoglobin, prevalence of anemia, prevalence of stunting, prevalence of obesity, and weight gain rate. A baseline and final survey will be conducted to collect data for these variables, as well as sociodemographic information. Impact estimation will be done comparing the average results and the distribution of indicators between the treatment and control group. Differences of simple means and regression models including co-variables of the child's age and sex, and characteristics of the primary caregiver and household will be estimated. In addition to potential changes in indicator averages, changes in the distribution of variables will be explored under the hypothesis that the intervention might not only improve average value for a given indicator, but compress the distribution over a range of values closer to an optimal range. Changes to distributions will be checked by applying the Kolmogorov-Smirnov test.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
SQ-LNS is a peanut-based ready to use home fortification product to improve diet quality in children 6-24 months of age. It includes peanuts and other ingredients such as vegetable fat, powdered milk and several micronutrients. The formulation designed for this study will not include sugar.
An innovative behavioral change strategy designed using ethnographic and marketing methods to promote adequate infant and young child feeding practices and the use of SQ-LNS. The strategy will be delivered to mothers or caregivers through individual home-visits and group sessions.
SPOON Mexico
Tepic, Nayarit, Mexico
Infant and young child feeding practices at 6 months
Set of indicators of infant and young child feeding practices obtained by interview to participant mothers or caregivers
Time frame: Measured at 6 months of age
Infant and young child feeding practices at 9 months
Set of indicators of infant and young child feeding practices obtained by interview to participant mothers or caregivers
Time frame: Measured at 9 months of age
Infant and young child feeding practices at 12 months
Set of indicators of infant and young child feeding practices obtained by interview to participant mothers or caregivers
Time frame: Measured at 12 months of age
Infant and young child feeding practices 15 months
Set of indicators of infant and young child feeding practices obtained by interview to participant mothers or caregivers
Time frame: Measured 15 months of age
Infant and young child feeding practices at 18 months
Set of indicators of infant and young child feeding practices obtained by interview to participant mothers or caregivers
Time frame: Measured at 18 months of age
Infant and young child feeding practices at 21 months
Set of indicators of infant and young child feeding practices obtained by interview to participant mothers or caregivers
Time frame: Measured at 21 months of age
Infant and young child feeding practices at 24 months
Set of indicators of infant and young child feeding practices obtained by interview to participant mothers or caregivers
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Measured at 24 months of age
Height at 6 months
Height-for-age z score obtained by measuring the height of participant children using a fixed infantometer
Time frame: Measured at 6 months of age
Height at 9 months
Height-for-age z score obtained by measuring the height of participant children using a fixed infantometer
Time frame: Measured at 9 months of age
Height at 12 months
Height-for-age z score obtained by measuring the height of participant children using a fixed infantometer
Time frame: Measured at 12 months of age
Height at 15 months
Height-for-age z score obtained by measuring the height of participant children using a fixed infantometer
Time frame: Measured at 15 months of age
Height at 18 months
Height-for-age z score obtained by measuring the height of participant children using a fixed infantometer
Time frame: Measured at 18 months of age
Height at 21 months
Height-for-age z score obtained by measuring the height of participant children using a fixed infantometer
Time frame: Measured at 21 months of age
Height at 24 months
Height-for-age z score obtained by measuring the height of participant children using a fixed infantometer
Time frame: Measured at 24 months of age
Weight gain rate at 6 months
Rate of weight gain from 0-24 months of age obtained by measuring the weight of participant children using a fixed electronic scale
Time frame: Constructed from weight measurements at 6 months of age
Weight gain rate at 9 months
Rate of weight gain from 0-24 months of age obtained by measuring the weight of participant children using a fixed electronic scale
Time frame: Constructed from weight measurements at 9 months of age
Weight gain rate at 12 months
Rate of weight gain from 0-24 months of age obtained by measuring the weight of participant children using a fixed electronic scale
Time frame: Constructed from weight measurements at 12 months of age
Weight gain rate at 15 months
Rate of weight gain from 0-24 months of age obtained by measuring the weight of participant children using a fixed electronic scale
Time frame: Constructed from weight measurements at 15 months of age
Weight gain rate at 18 months
Rate of weight gain from 0-24 months of age obtained by measuring the weight of participant children using a fixed electronic scale
Time frame: Constructed from weight measurements at 18 months of age
Weight gain rate at 21 months
Rate of weight gain from 0-24 months of age obtained by measuring the weight of participant children using a fixed electronic scale
Time frame: Constructed from weight measurements at 21 months of age
Weight gain rate at 24 months
Rate of weight gain from 0-24 months of age obtained by measuring the weight of participant children using a fixed electronic scale
Time frame: Constructed from weight measurements at 24 months of age
Hemoglobin at 6 months
Measurement of hemoglobin concentration in blood using blood biometry
Time frame: Measured at 6 months of age
Hemoglobin at 12 months
Measurement of hemoglobin concentration in blood using blood biometry
Time frame: Measured at 12 months of age
Hemoglobin at 18 months
Measurement of hemoglobin concentration in blood using blood biometry
Time frame: Measured at 18 months of age
Hemoglobin at 24 months
Measurement of hemoglobin concentration in blood using blood biometry
Time frame: Measured at 24 months of age
Prevalence of obesity in children at 6 months
Population estimation of obesity using Body Mass Index (BMI)
Time frame: Measured at 6 months of age
Prevalence of obesity in children at 9 months
Population estimation of obesity using Body Mass Index (BMI)
Time frame: Measured at 9 months of age
Prevalence of obesity in children at 12 months
Population estimation of obesity using Body Mass Index (BMI)
Time frame: Measured at 12 months of age
Prevalence of obesity in children at 15 months
Population estimation of obesity using Body Mass Index (BMI)
Time frame: Measured at 15 months of age
Prevalence of obesity in children at 18 months
Population estimation of obesity using Body Mass Index (BMI)
Time frame: Measured at 18 months of age
Prevalence of obesity in children at 21 months
Population estimation of obesity using Body Mass Index (BMI)
Time frame: Measured at 21 months of age
Prevalence of obesity in children at 24 months
Population estimation of obesity using Body Mass Index (BMI)
Time frame: Measured at 24 months of age
Prevalence of stunting at 6 months
Population estimation of stunting using height-for age \<-2 SD
Time frame: Measured at 6 months of age
Prevalence of stunting at 9 months
Population estimation of stunting using height-for age \<-2 SD
Time frame: Measured at 9 months of age
Prevalence of stunting at 12 months
Population estimation of stunting using height-for age \<-2 SD
Time frame: Measured at 12 months of age
Prevalence of stunting at 15 months
Population estimation of stunting using height-for age \<-2 SD
Time frame: Measured at 15 months of age
Prevalence of stunting at 18 months
Population estimation of stunting using height-for age \<-2 SD
Time frame: Measured at 18 months of age
Prevalence of stunting at 21 months
Population estimation of stunting using height-for age \<-2 SD
Time frame: Measured at 21 months of age
Prevalence of stunting at 24 months
Population estimation of stunting using height-for age \<-2 SD
Time frame: Measured at 24 months of age
Prevalence of anemia at 6 months
Population estimation of anemia using hemoglobin concentration in blood
Time frame: Measured at 6 months of age
Prevalence of anemia at 12 months
Population estimation of anemia using hemoglobin concentration in blood
Time frame: Measured at 12 months of age
Prevalence of anemia at 18 months
Population estimation of anemia using hemoglobin concentration in blood
Time frame: Measured at 18 months of age
Prevalence of anemia at 24 months
Population estimation of anemia using hemoglobin concentration in blood
Time frame: Measured at 24 months of age
Adherence to Nutritional Supplement Regime
Consumption of the nutritional supplement measured as the number of packets consumed in one month
Time frame: Measured every month from 6 months of age until 24 months of age
Exclusive Breastfeeding
Measured as an indicator of exclusive breastfeeding, self-reported by the mother of a child
Time frame: Measured 24 months after the start of the intervention