SPOON: Sustained Program for Improving Nutrition - Mexico

Inter-American Development Bank

Status: Withdrawn

Conditions: Exclusive Breastfeeding; Obesity, Childhood; Stunting; Feeding Patterns

Treatments: Dietary Supplement: SQ-LNS; Behavioral: SPOON behavioral change strategy

Study type: Interventional

Funder types: Other

Identifiers

NCT03752762

Inter-AmericanDB Mexico

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: Under 6 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Standard Care

No Intervention group

Description:

Participants will receive standard health care services provided by the Health Secretary

SPOON behavioral change strategy+SQ-LNS

Experimental group

Description:

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.

Treatment:

Behavioral: SPOON behavioral change strategy

Dietary Supplement: SQ-LNS