SPOON: Sustained Program for Improving Nutrition - Mexico

Obesity, Childhood Clinical Trial

Official title:

Effect of an Innovative Behavioral Change Strategy and SQ-LNS on Stunting and Obesity in Children Living in Tepic, Mexico

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03752762
• Other study ID #: Inter-AmericanDB Mexico
• Status: Withdrawn
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: December 2020

Study information

• Verified date: February 2022
• Source: Inter-American Development Bank
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 6 Months

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Exclusive Breastfeeding
• Feeding Patterns
• Growth Disorders
• Obesity
• Obesity, Childhood
• Pediatric Obesity
• Stunting

Intervention

Dietary Supplement:
• SQ-LNS
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.

Behavioral:
• SPOON behavioral change strategy
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.

Locations

Country	Name	City	State
Mexico	SPOON Mexico	Tepic	Nayarit

Sponsors (3)

Lead Sponsor	Collaborator
Inter-American Development Bank	Hospital Infantil de Mexico Federico Gomez, The PepsiCo Foundation

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Measured at 6 months of age
Primary	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	Measured at 9 months of age
Primary	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	Measured at 12 months of age
Primary	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	Measured 15 months of age
Primary	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	Measured at 18 months of age
Primary	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	Measured at 21 months of age
Primary	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	Measured at 24 months of age
Primary	Height at 6 months	Height-for-age z score obtained by measuring the height of participant children using a fixed infantometer	Measured at 6 months of age
Primary	Height at 9 months	Height-for-age z score obtained by measuring the height of participant children using a fixed infantometer	Measured at 9 months of age
Primary	Height at 12 months	Height-for-age z score obtained by measuring the height of participant children using a fixed infantometer	Measured at 12 months of age
Primary	Height at 15 months	Height-for-age z score obtained by measuring the height of participant children using a fixed infantometer	Measured at 15 months of age
Primary	Height at 18 months	Height-for-age z score obtained by measuring the height of participant children using a fixed infantometer	Measured at 18 months of age
Primary	Height at 21 months	Height-for-age z score obtained by measuring the height of participant children using a fixed infantometer	Measured at 21 months of age
Primary	Height at 24 months	Height-for-age z score obtained by measuring the height of participant children using a fixed infantometer	Measured at 24 months of age
Primary	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	Constructed from weight measurements at 6 months of age
Primary	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	Constructed from weight measurements at 9 months of age
Primary	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	Constructed from weight measurements at 12 months of age
Primary	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	Constructed from weight measurements at 15 months of age
Primary	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	Constructed from weight measurements at 18 months of age
Primary	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	Constructed from weight measurements at 21 months of age
Primary	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	Constructed from weight measurements at 24 months of age
Primary	Hemoglobin at 6 months	Measurement of hemoglobin concentration in blood using blood biometry	Measured at 6 months of age
Primary	Hemoglobin at 12 months	Measurement of hemoglobin concentration in blood using blood biometry	Measured at 12 months of age
Primary	Hemoglobin at 18 months	Measurement of hemoglobin concentration in blood using blood biometry	Measured at 18 months of age
Primary	Hemoglobin at 24 months	Measurement of hemoglobin concentration in blood using blood biometry	Measured at 24 months of age
Primary	Prevalence of obesity in children at 6 months	Population estimation of obesity using Body Mass Index (BMI)	Measured at 6 months of age
Primary	Prevalence of obesity in children at 9 months	Population estimation of obesity using Body Mass Index (BMI)	Measured at 9 months of age
Primary	Prevalence of obesity in children at 12 months	Population estimation of obesity using Body Mass Index (BMI)	Measured at 12 months of age
Primary	Prevalence of obesity in children at 15 months	Population estimation of obesity using Body Mass Index (BMI)	Measured at 15 months of age
Primary	Prevalence of obesity in children at 18 months	Population estimation of obesity using Body Mass Index (BMI)	Measured at 18 months of age
Primary	Prevalence of obesity in children at 21 months	Population estimation of obesity using Body Mass Index (BMI)	Measured at 21 months of age
Primary	Prevalence of obesity in children at 24 months	Population estimation of obesity using Body Mass Index (BMI)	Measured at 24 months of age
Primary	Prevalence of stunting at 6 months	Population estimation of stunting using height-for age <-2 SD	Measured at 6 months of age
Primary	Prevalence of stunting at 9 months	Population estimation of stunting using height-for age <-2 SD	Measured at 9 months of age
Primary	Prevalence of stunting at 12 months	Population estimation of stunting using height-for age <-2 SD	Measured at 12 months of age
Primary	Prevalence of stunting at 15 months	Population estimation of stunting using height-for age <-2 SD	Measured at 15 months of age
Primary	Prevalence of stunting at 18 months	Population estimation of stunting using height-for age <-2 SD	Measured at 18 months of age
Primary	Prevalence of stunting at 21 months	Population estimation of stunting using height-for age <-2 SD	Measured at 21 months of age
Primary	Prevalence of stunting at 24 months	Population estimation of stunting using height-for age <-2 SD	Measured at 24 months of age
Primary	Prevalence of anemia at 6 months	Population estimation of anemia using hemoglobin concentration in blood	Measured at 6 months of age
Primary	Prevalence of anemia at 12 months	Population estimation of anemia using hemoglobin concentration in blood	Measured at 12 months of age
Primary	Prevalence of anemia at 18 months	Population estimation of anemia using hemoglobin concentration in blood	Measured at 18 months of age
Primary	Prevalence of anemia at 24 months	Population estimation of anemia using hemoglobin concentration in blood	Measured at 24 months of age
Secondary	Adherence to Nutritional Supplement Regime	Consumption of the nutritional supplement measured as the number of packets consumed in one month	Measured every month from 6 months of age until 24 months of age
Secondary	Exclusive Breastfeeding	Measured as an indicator of exclusive breastfeeding, self-reported by the mother of a child	Measured 24 months after the start of the intervention