SPOON: Sustained Program for Improving Nutrition - Mexico
- Conditions
- StuntingFeeding PatternsObesity, ChildhoodExclusive Breastfeeding
- Interventions
- Dietary Supplement: SQ-LNSBehavioral: SPOON behavioral change strategy
- Registration Number
- NCT03752762
- Lead Sponsor
- Inter-American Development Bank
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- Pregnant women in the third trimester and children up to 6 months of age at the moment of recruitment (or children with a maximum age of 6 months at the beginning of the first visit of the program)
- Children with no chronic diseases or congenital malformations
- Resident population from Tepic and the adjacent areas of Xalisco, Lomas Verdes, and Cerro Blanco
- The residents have no plans to move away from Tepic in the following 24 months
- Population belonging to the PROSPERA program
- Children with chronic diseases or congenital malformations
- Children with severe acute malnutrition
- Planning on moving far from the intervention area in the next 24 months
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SPOON behavioral change strategy+SQ-LNS SQ-LNS Participants will receive SQ-LNS supplement from 6-24 months and a behavioral change to promote adequate infant and young child feeding practices and the use of SQ-LNS will be delivered to mothers or caregivers. The behavioral change strategy includes individual home-visits and group sessions. SQ-LNS consists of a 20g nutrient supplement package to be consumed daily from 6-24 of age. SQ-LNS formulation does not include sugar. SPOON behavioral change strategy+SQ-LNS SPOON behavioral change strategy Participants will receive SQ-LNS supplement from 6-24 months and a behavioral change to promote adequate infant and young child feeding practices and the use of SQ-LNS will be delivered to mothers or caregivers. The behavioral change strategy includes individual home-visits and group sessions. SQ-LNS consists of a 20g nutrient supplement package to be consumed daily from 6-24 of age. SQ-LNS formulation does not include sugar.
- Primary Outcome Measures
Name Time Method Prevalence of stunting at 18 months Measured at 18 months of age Population estimation of stunting using height-for age \<-2 SD
Prevalence of stunting at 21 months Measured at 21 months of age Population estimation of stunting using height-for age \<-2 SD
Infant and young child feeding practices at 9 months Measured at 9 months of age Set of indicators of infant and young child feeding practices obtained by interview to participant mothers or caregivers
Infant and young child feeding practices at 18 months Measured at 18 months of age Set of indicators of infant and young child feeding practices obtained by interview to participant mothers or caregivers
Height at 12 months Measured at 12 months of age Height-for-age z score obtained by measuring the height of participant children using a fixed infantometer
Height at 21 months Measured at 21 months of age Height-for-age z score obtained by measuring the height of participant children using a fixed infantometer
Height at 24 months Measured at 24 months of age Height-for-age z score obtained by measuring the height of participant children using a fixed infantometer
Hemoglobin at 18 months Measured at 18 months of age Measurement of hemoglobin concentration in blood using blood biometry
Hemoglobin at 24 months Measured at 24 months of age Measurement of hemoglobin concentration in blood using blood biometry
Infant and young child feeding practices 15 months Measured 15 months of age Set of indicators of infant and young child feeding practices obtained by interview to participant mothers or caregivers
Infant and young child feeding practices at 21 months Measured at 21 months of age Set of indicators of infant and young child feeding practices obtained by interview to participant mothers or caregivers
Height at 9 months Measured at 9 months of age Height-for-age z score obtained by measuring the height of participant children using a fixed infantometer
Weight gain rate at 12 months Constructed from weight measurements at 12 months of age Rate of weight gain from 0-24 months of age obtained by measuring the weight of participant children using a fixed electronic scale
Weight gain rate at 18 months Constructed from weight measurements at 18 months of age Rate of weight gain from 0-24 months of age obtained by measuring the weight of participant children using a fixed electronic scale
Weight gain rate at 24 months Constructed from weight measurements at 24 months of age Rate of weight gain from 0-24 months of age obtained by measuring the weight of participant children using a fixed electronic scale
Hemoglobin at 6 months Measured at 6 months of age Measurement of hemoglobin concentration in blood using blood biometry
Hemoglobin at 12 months Measured at 12 months of age Measurement of hemoglobin concentration in blood using blood biometry
Prevalence of obesity in children at 9 months Measured at 9 months of age Population estimation of obesity using Body Mass Index (BMI)
Prevalence of obesity in children at 18 months Measured at 18 months of age Population estimation of obesity using Body Mass Index (BMI)
Prevalence of obesity in children at 24 months Measured at 24 months of age Population estimation of obesity using Body Mass Index (BMI)
Infant and young child feeding practices at 12 months Measured at 12 months of age Set of indicators of infant and young child feeding practices obtained by interview to participant mothers or caregivers
Height at 15 months Measured at 15 months of age Height-for-age z score obtained by measuring the height of participant children using a fixed infantometer
Weight gain rate at 21 months Constructed from weight measurements at 21 months of age Rate of weight gain from 0-24 months of age obtained by measuring the weight of participant children using a fixed electronic scale
Prevalence of obesity in children at 6 months Measured at 6 months of age Population estimation of obesity using Body Mass Index (BMI)
Infant and young child feeding practices at 6 months Measured at 6 months of age Set of indicators of infant and young child feeding practices obtained by interview to participant mothers or caregivers
Height at 6 months Measured at 6 months of age Height-for-age z score obtained by measuring the height of participant children using a fixed infantometer
Weight gain rate at 15 months Constructed from weight measurements at 15 months of age Rate of weight gain from 0-24 months of age obtained by measuring the weight of participant children using a fixed electronic scale
Infant and young child feeding practices at 24 months Measured at 24 months of age Set of indicators of infant and young child feeding practices obtained by interview to participant mothers or caregivers
Height at 18 months Measured at 18 months of age Height-for-age z score obtained by measuring the height of participant children using a fixed infantometer
Weight gain rate at 6 months Constructed from weight measurements at 6 months of age Rate of weight gain from 0-24 months of age obtained by measuring the weight of participant children using a fixed electronic scale
Weight gain rate at 9 months Constructed from weight measurements at 9 months of age Rate of weight gain from 0-24 months of age obtained by measuring the weight of participant children using a fixed electronic scale
Prevalence of obesity in children at 12 months Measured at 12 months of age Population estimation of obesity using Body Mass Index (BMI)
Prevalence of obesity in children at 15 months Measured at 15 months of age Population estimation of obesity using Body Mass Index (BMI)
Prevalence of stunting at 12 months Measured at 12 months of age Population estimation of stunting using height-for age \<-2 SD
Prevalence of stunting at 15 months Measured at 15 months of age Population estimation of stunting using height-for age \<-2 SD
Prevalence of stunting at 24 months Measured at 24 months of age Population estimation of stunting using height-for age \<-2 SD
Prevalence of anemia at 6 months Measured at 6 months of age Population estimation of anemia using hemoglobin concentration in blood
Prevalence of obesity in children at 21 months Measured at 21 months of age Population estimation of obesity using Body Mass Index (BMI)
Prevalence of stunting at 9 months Measured at 9 months of age Population estimation of stunting using height-for age \<-2 SD
Prevalence of anemia at 12 months Measured at 12 months of age Population estimation of anemia using hemoglobin concentration in blood
Prevalence of anemia at 18 months Measured at 18 months of age Population estimation of anemia using hemoglobin concentration in blood
Prevalence of anemia at 24 months Measured at 24 months of age Population estimation of anemia using hemoglobin concentration in blood
Prevalence of stunting at 6 months Measured at 6 months of age Population estimation of stunting using height-for age \<-2 SD
- Secondary Outcome Measures
Name Time Method Adherence to Nutritional Supplement Regime Measured every month from 6 months of age until 24 months of age Consumption of the nutritional supplement measured as the number of packets consumed in one month
Exclusive Breastfeeding Measured 24 months after the start of the intervention Measured as an indicator of exclusive breastfeeding, self-reported by the mother of a child
Trial Locations
- Locations (1)
SPOON Mexico
🇲🇽Tepic, Nayarit, Mexico