SPOON: Sustained Program for Improving Nutrition - Mexico

NCT03752762 | Withdrawn

• 1 other identifier: Inter-AmericanDB Mexico
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Exclusive Breastfeeding; Feeding Patterns; Stunting; Obesity, Childhood

Keywords

Stunting; Obesity; Lipid-based Nutrient Supplements (LNS); Latin America; Child nutrition; Feeding practices

Outcome Measures

Primary Outcomes (43)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• Hemoglobin at 6 months

  Measurement of hemoglobin concentration in blood using blood biometry

  Measured at 6 months of age

• Hemoglobin at 12 months

  Measurement of hemoglobin concentration in blood using blood biometry

  Measured at 12 months of age

• Hemoglobin at 18 months

  Measurement of hemoglobin concentration in blood using blood biometry

  Measured at 18 months of age

• Hemoglobin at 24 months

  Measurement of hemoglobin concentration in blood using blood biometry

  Measured at 24 months of age

• Prevalence of obesity in children at 6 months

  Population estimation of obesity using Body Mass Index (BMI)

  Measured at 6 months of age

• Prevalence of obesity in children at 9 months

  Population estimation of obesity using Body Mass Index (BMI)

  Measured at 9 months of age

• Prevalence of obesity in children at 12 months

  Population estimation of obesity using Body Mass Index (BMI)

  Measured at 12 months of age

• Prevalence of obesity in children at 15 months

  Population estimation of obesity using Body Mass Index (BMI)

  Measured at 15 months of age

• Prevalence of obesity in children at 18 months

  Population estimation of obesity using Body Mass Index (BMI)

  Measured at 18 months of age

• Prevalence of obesity in children at 21 months

  Population estimation of obesity using Body Mass Index (BMI)

  Measured at 21 months of age

• Prevalence of obesity in children at 24 months

  Population estimation of obesity using Body Mass Index (BMI)

  Measured at 24 months of age

• Prevalence of stunting at 6 months

  Population estimation of stunting using height-for age \<-2 SD

  Measured at 6 months of age

• Prevalence of stunting at 9 months

  Population estimation of stunting using height-for age \<-2 SD

  Measured at 9 months of age

• Prevalence of stunting at 12 months

  Population estimation of stunting using height-for age \<-2 SD

  Measured at 12 months of age

• Prevalence of stunting at 15 months

  Population estimation of stunting using height-for age \<-2 SD

  Measured at 15 months of age

• Prevalence of stunting at 18 months

  Population estimation of stunting using height-for age \<-2 SD

  Measured at 18 months of age

• Prevalence of stunting at 21 months

  Population estimation of stunting using height-for age \<-2 SD

  Measured at 21 months of age

• Prevalence of stunting at 24 months

  Population estimation of stunting using height-for age \<-2 SD

  Measured at 24 months of age

• Prevalence of anemia at 6 months

  Population estimation of anemia using hemoglobin concentration in blood

  Measured at 6 months of age

• Prevalence of anemia at 12 months

  Population estimation of anemia using hemoglobin concentration in blood

  Measured at 12 months of age

• Prevalence of anemia at 18 months

  Population estimation of anemia using hemoglobin concentration in blood

  Measured at 18 months of age

• Prevalence of anemia at 24 months

  Population estimation of anemia using hemoglobin concentration in blood

  Measured at 24 months of age

Secondary Outcomes (2)

• Adherence to Nutritional Supplement Regime

  Measured every month from 6 months of age until 24 months of age

• Exclusive Breastfeeding

  Measured 24 months after the start of the intervention

Study Arms (2)

Standard Care

NO INTERVENTION

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

SPOON behavioral change strategy+SQ-LNS

EXPERIMENTAL

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.

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

Interventions

SQ-LNS DIETARY_SUPPLEMENT

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.

Also known as: Small Quantity Lipid Nutrient Supplements

SPOON behavioral change strategy+SQ-LNS

SPOON behavioral change strategy BEHAVIORAL

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 behavioral change strategy+SQ-LNS

Eligibility Criteria

• Age: Up to 6 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Inter-American Development Bank: lead
• Hospital Infantil de Mexico Federico Gomez: collaborator
• The PepsiCo Foundation: collaborator

Study Sites (1)

SPOON Mexico

Tepic, Nayarit, Mexico

Location

MeSH Terms

Conditions

Breast Feeding; Feeding Behavior; Growth Disorders; Pediatric Obesity; Obesity

Condition Hierarchy (Ancestors)

Behavior; Behavior, Animal; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms

Study Officials

• Sebastian Martinez

  Inter-American Development Bank

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2018
• First Posted: November 26, 2018
• Study Start: December 1, 2018
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: March 9, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share

Locations

ME (1)