Clinical trial NCT03752762: SPOON: Sustained Program for Improving Nutrition - Mexico
Official title: Effect of an Innovative Behavioral Change Strategy and SQ-LNS on Stunting and Obesity in Children Living in Tepic, Mexico
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Exclusive Breastfeeding
Feeding Patterns
Stunting
Obesity, Childhood
Keywords: Stunting
Obesity
Lipid-based Nutrient Supplements (LNS)
Latin America
Child nutrition
Feeding practices
Lead sponsor: Inter-American Development Bank
Sponsor class: OTHER
Collaborators: name: Hospital Infantil de Mexico Federico Gomez
name: The PepsiCo Foundation
First posted: 2018-11-26
Enrollment: 0
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Infant and young child feeding practices at 6 months
timeFrame: Measured at 6 months of age
measure: Infant and young child feeding practices at 9 months
timeFrame: Measured at 9 months of age
measure: Infant and young child feeding practices at 12 months
timeFrame: Measured at 12 months of age
measure: Infant and young child feeding practices 15 months
timeFrame: Measured 15 months of age
measure: Infant and young child feeding practices at 18 months
timeFrame: Measured at 18 months of age
measure: Infant and young child feeding practices at 21 months
timeFrame: Measured at 21 months of age
measure: Infant and young child feeding practices at 24 months
timeFrame: Measured at 24 months of age
measure: Height at 6 months
timeFrame: Measured at 6 months of age
measure: Height at 9 months
timeFrame: Measured at 9 months of age
measure: Height at 12 months
timeFrame: Measured at 12 months of age
measure: Height at 15 months
timeFrame: Measured at 15 months of age
measure: Height at 18 months
timeFrame: Measured at 18 months of age
measure: Height at 21 months
timeFrame: Measured at 21 months of age
measure: Height at 24 months
timeFrame: Measured at 24 months of age
measure: Weight gain rate at 6 months
timeFrame: Constructed from weight measurements at 6 months of age
measure: Weight gain rate at 9 months
timeFrame: Constructed from weight measurements at 9 months of age
measure: Weight gain rate at 12 months
timeFrame: Constructed from weight measurements at 12 months of age
measure: Weight gain rate at 15 months
timeFrame: Constructed from weight measurements at 15 months of age
measure: Weight gain rate at 18 months
timeFrame: Constructed from weight measurements at 18 months of age
measure: Weight gain rate at 21 months
timeFrame: Constructed from weight measurements at 21 months of age
measure: Weight gain rate at 24 months
timeFrame: Constructed from weight measurements at 24 months of age
measure: Hemoglobin at 6 months
timeFrame: Measured at 6 months of age
measure: Hemoglobin at 12 months
timeFrame: Measured at 12 months of age
measure: Hemoglobin at 18 months
timeFrame: Measured at 18 months of age
measure: Hemoglobin at 24 months
timeFrame: Measured at 24 months of age
measure: Prevalence of obesity in children at 6 months
timeFrame: Measured at 6 months of age
measure: Prevalence of obesity in children at 9 months
timeFrame: Measured at 9 months of age
measure: Prevalence of obesity in children at 12 months
timeFrame: Measured at 12 months of age
measure: Prevalence of obesity in children at 15 months
timeFrame: Measured at 15 months of age
measure: Prevalence of obesity in children at 18 months
timeFrame: Measured at 18 months of age
measure: Prevalence of obesity in children at 21 months
timeFrame: Measured at 21 months of age
measure: Prevalence of obesity in children at 24 months
timeFrame: Measured at 24 months of age
measure: Prevalence of stunting at 6 months
timeFrame: Measured at 6 months of age
measure: Prevalence of stunting at 9 months
timeFrame: Measured at 9 months of age
measure: Prevalence of stunting at 12 months
timeFrame: Measured at 12 months of age
measure: Prevalence of stunting at 15 months
timeFrame: Measured at 15 months of age
measure: Prevalence of stunting at 18 months
timeFrame: Measured at 18 months of age
measure: Prevalence of stunting at 21 months
timeFrame: Measured at 21 months of age
measure: Prevalence of stunting at 24 months
timeFrame: Measured at 24 months of age
measure: Prevalence of anemia at 6 months
timeFrame: Measured at 6 months of age
measure: Prevalence of anemia at 12 months
timeFrame: Measured at 12 months of age
measure: Prevalence of anemia at 18 months
timeFrame: Measured at 18 months of age
measure: Prevalence of anemia at 24 months
timeFrame: Measured at 24 months of age
Secondary outcomes:
measure: Adherence to Nutritional Supplement Regime
timeFrame: Measured every month from 6 months of age until 24 months of age
measure: Exclusive Breastfeeding
timeFrame: Measured 24 months after the start of the intervention
Other outcomes:
Locations:
city: Tepic
country: Mexico
facility: SPOON Mexico
state: Nayarit
Study officials:
affiliation: Inter-American Development Bank
name: Sebastian Martinez
role: STUDY_DIRECTOR
References: