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SPOON: Sustained Program for Improving Nutrition - Mexico

Primary Purpose

Exclusive Breastfeeding, Feeding Patterns, Stunting

Status
Withdrawn
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
SQ-LNS
SPOON behavioral change strategy
Sponsored by
Inter-American Development Bank
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Exclusive Breastfeeding focused on measuring Stunting, Obesity, Lipid-based Nutrient Supplements (LNS), Latin America, Child nutrition, Feeding practices

Eligibility Criteria

undefined - 6 Months (Child)All SexesAccepts 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

Sites / Locations

  • SPOON Mexico

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard Care

SPOON behavioral change strategy+SQ-LNS

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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
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
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
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
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
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
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
Height at 6 months
Height-for-age z score obtained by measuring the height of participant children using a fixed infantometer
Height at 9 months
Height-for-age z score obtained by measuring the height of participant children using a fixed infantometer
Height at 12 months
Height-for-age z score obtained by measuring the height of participant children using a fixed infantometer
Height at 15 months
Height-for-age z score obtained by measuring the height of participant children using a fixed infantometer
Height at 18 months
Height-for-age z score obtained by measuring the height of participant children using a fixed infantometer
Height at 21 months
Height-for-age z score obtained by measuring the height of participant children using a fixed infantometer
Height at 24 months
Height-for-age z score obtained by measuring the height of participant children using a fixed infantometer
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
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
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
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
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
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
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
Hemoglobin at 6 months
Measurement of hemoglobin concentration in blood using blood biometry
Hemoglobin at 12 months
Measurement of hemoglobin concentration in blood using blood biometry
Hemoglobin at 18 months
Measurement of hemoglobin concentration in blood using blood biometry
Hemoglobin at 24 months
Measurement of hemoglobin concentration in blood using blood biometry
Prevalence of obesity in children at 6 months
Population estimation of obesity using Body Mass Index (BMI)
Prevalence of obesity in children at 9 months
Population estimation of obesity using Body Mass Index (BMI)
Prevalence of obesity in children at 12 months
Population estimation of obesity using Body Mass Index (BMI)
Prevalence of obesity in children at 15 months
Population estimation of obesity using Body Mass Index (BMI)
Prevalence of obesity in children at 18 months
Population estimation of obesity using Body Mass Index (BMI)
Prevalence of obesity in children at 21 months
Population estimation of obesity using Body Mass Index (BMI)
Prevalence of obesity in children at 24 months
Population estimation of obesity using Body Mass Index (BMI)
Prevalence of stunting at 6 months
Population estimation of stunting using height-for age <-2 SD
Prevalence of stunting at 9 months
Population estimation of stunting using height-for age <-2 SD
Prevalence of stunting at 12 months
Population estimation of stunting using height-for age <-2 SD
Prevalence of stunting at 15 months
Population estimation of stunting using height-for age <-2 SD
Prevalence of stunting at 18 months
Population estimation of stunting using height-for age <-2 SD
Prevalence of stunting at 21 months
Population estimation of stunting using height-for age <-2 SD
Prevalence of stunting at 24 months
Population estimation of stunting using height-for age <-2 SD
Prevalence of anemia at 6 months
Population estimation of anemia using hemoglobin concentration in blood
Prevalence of anemia at 12 months
Population estimation of anemia using hemoglobin concentration in blood
Prevalence of anemia at 18 months
Population estimation of anemia using hemoglobin concentration in blood
Prevalence of anemia at 24 months
Population estimation of anemia using hemoglobin concentration in blood

Secondary Outcome Measures

Adherence to Nutritional Supplement Regime
Consumption of the nutritional supplement measured as the number of packets consumed in one month
Exclusive Breastfeeding
Measured as an indicator of exclusive breastfeeding, self-reported by the mother of a child

Full Information

First Posted
January 8, 2018
Last Updated
February 22, 2022
Sponsor
Inter-American Development Bank
Collaborators
Hospital Infantil de Mexico Federico Gomez, The PepsiCo Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT03752762
Brief Title
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

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Funding cancelled
Study Start Date
December 1, 2018 (Anticipated)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Inter-American Development Bank
Collaborators
Hospital Infantil de Mexico Federico Gomez, The PepsiCo Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exclusive Breastfeeding, Feeding Patterns, Stunting, Obesity, Childhood
Keywords
Stunting, Obesity, Lipid-based Nutrient Supplements (LNS), Latin America, Child nutrition, Feeding practices

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Care
Arm Type
No Intervention
Arm Description
Participants will receive standard health care services provided by the Health Secretary
Arm Title
SPOON behavioral change strategy+SQ-LNS
Arm Type
Experimental
Arm 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.
Intervention Type
Dietary Supplement
Intervention Name(s)
SQ-LNS
Other Intervention Name(s)
Small Quantity Lipid Nutrient Supplements
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
SPOON behavioral change strategy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Infant and young child feeding practices at 6 months
Description
Set of indicators of infant and young child feeding practices obtained by interview to participant mothers or caregivers
Time Frame
Measured at 6 months of age
Title
Infant and young child feeding practices at 9 months
Description
Set of indicators of infant and young child feeding practices obtained by interview to participant mothers or caregivers
Time Frame
Measured at 9 months of age
Title
Infant and young child feeding practices at 12 months
Description
Set of indicators of infant and young child feeding practices obtained by interview to participant mothers or caregivers
Time Frame
Measured at 12 months of age
Title
Infant and young child feeding practices 15 months
Description
Set of indicators of infant and young child feeding practices obtained by interview to participant mothers or caregivers
Time Frame
Measured 15 months of age
Title
Infant and young child feeding practices at 18 months
Description
Set of indicators of infant and young child feeding practices obtained by interview to participant mothers or caregivers
Time Frame
Measured at 18 months of age
Title
Infant and young child feeding practices at 21 months
Description
Set of indicators of infant and young child feeding practices obtained by interview to participant mothers or caregivers
Time Frame
Measured at 21 months of age
Title
Infant and young child feeding practices at 24 months
Description
Set of indicators of infant and young child feeding practices obtained by interview to participant mothers or caregivers
Time Frame
Measured at 24 months of age
Title
Height at 6 months
Description
Height-for-age z score obtained by measuring the height of participant children using a fixed infantometer
Time Frame
Measured at 6 months of age
Title
Height at 9 months
Description
Height-for-age z score obtained by measuring the height of participant children using a fixed infantometer
Time Frame
Measured at 9 months of age
Title
Height at 12 months
Description
Height-for-age z score obtained by measuring the height of participant children using a fixed infantometer
Time Frame
Measured at 12 months of age
Title
Height at 15 months
Description
Height-for-age z score obtained by measuring the height of participant children using a fixed infantometer
Time Frame
Measured at 15 months of age
Title
Height at 18 months
Description
Height-for-age z score obtained by measuring the height of participant children using a fixed infantometer
Time Frame
Measured at 18 months of age
Title
Height at 21 months
Description
Height-for-age z score obtained by measuring the height of participant children using a fixed infantometer
Time Frame
Measured at 21 months of age
Title
Height at 24 months
Description
Height-for-age z score obtained by measuring the height of participant children using a fixed infantometer
Time Frame
Measured at 24 months of age
Title
Weight gain rate at 6 months
Description
Rate of weight gain from 0-24 months of age obtained by measuring the weight of participant children using a fixed electronic scale
Time Frame
Constructed from weight measurements at 6 months of age
Title
Weight gain rate at 9 months
Description
Rate of weight gain from 0-24 months of age obtained by measuring the weight of participant children using a fixed electronic scale
Time Frame
Constructed from weight measurements at 9 months of age
Title
Weight gain rate at 12 months
Description
Rate of weight gain from 0-24 months of age obtained by measuring the weight of participant children using a fixed electronic scale
Time Frame
Constructed from weight measurements at 12 months of age
Title
Weight gain rate at 15 months
Description
Rate of weight gain from 0-24 months of age obtained by measuring the weight of participant children using a fixed electronic scale
Time Frame
Constructed from weight measurements at 15 months of age
Title
Weight gain rate at 18 months
Description
Rate of weight gain from 0-24 months of age obtained by measuring the weight of participant children using a fixed electronic scale
Time Frame
Constructed from weight measurements at 18 months of age
Title
Weight gain rate at 21 months
Description
Rate of weight gain from 0-24 months of age obtained by measuring the weight of participant children using a fixed electronic scale
Time Frame
Constructed from weight measurements at 21 months of age
Title
Weight gain rate at 24 months
Description
Rate of weight gain from 0-24 months of age obtained by measuring the weight of participant children using a fixed electronic scale
Time Frame
Constructed from weight measurements at 24 months of age
Title
Hemoglobin at 6 months
Description
Measurement of hemoglobin concentration in blood using blood biometry
Time Frame
Measured at 6 months of age
Title
Hemoglobin at 12 months
Description
Measurement of hemoglobin concentration in blood using blood biometry
Time Frame
Measured at 12 months of age
Title
Hemoglobin at 18 months
Description
Measurement of hemoglobin concentration in blood using blood biometry
Time Frame
Measured at 18 months of age
Title
Hemoglobin at 24 months
Description
Measurement of hemoglobin concentration in blood using blood biometry
Time Frame
Measured at 24 months of age
Title
Prevalence of obesity in children at 6 months
Description
Population estimation of obesity using Body Mass Index (BMI)
Time Frame
Measured at 6 months of age
Title
Prevalence of obesity in children at 9 months
Description
Population estimation of obesity using Body Mass Index (BMI)
Time Frame
Measured at 9 months of age
Title
Prevalence of obesity in children at 12 months
Description
Population estimation of obesity using Body Mass Index (BMI)
Time Frame
Measured at 12 months of age
Title
Prevalence of obesity in children at 15 months
Description
Population estimation of obesity using Body Mass Index (BMI)
Time Frame
Measured at 15 months of age
Title
Prevalence of obesity in children at 18 months
Description
Population estimation of obesity using Body Mass Index (BMI)
Time Frame
Measured at 18 months of age
Title
Prevalence of obesity in children at 21 months
Description
Population estimation of obesity using Body Mass Index (BMI)
Time Frame
Measured at 21 months of age
Title
Prevalence of obesity in children at 24 months
Description
Population estimation of obesity using Body Mass Index (BMI)
Time Frame
Measured at 24 months of age
Title
Prevalence of stunting at 6 months
Description
Population estimation of stunting using height-for age <-2 SD
Time Frame
Measured at 6 months of age
Title
Prevalence of stunting at 9 months
Description
Population estimation of stunting using height-for age <-2 SD
Time Frame
Measured at 9 months of age
Title
Prevalence of stunting at 12 months
Description
Population estimation of stunting using height-for age <-2 SD
Time Frame
Measured at 12 months of age
Title
Prevalence of stunting at 15 months
Description
Population estimation of stunting using height-for age <-2 SD
Time Frame
Measured at 15 months of age
Title
Prevalence of stunting at 18 months
Description
Population estimation of stunting using height-for age <-2 SD
Time Frame
Measured at 18 months of age
Title
Prevalence of stunting at 21 months
Description
Population estimation of stunting using height-for age <-2 SD
Time Frame
Measured at 21 months of age
Title
Prevalence of stunting at 24 months
Description
Population estimation of stunting using height-for age <-2 SD
Time Frame
Measured at 24 months of age
Title
Prevalence of anemia at 6 months
Description
Population estimation of anemia using hemoglobin concentration in blood
Time Frame
Measured at 6 months of age
Title
Prevalence of anemia at 12 months
Description
Population estimation of anemia using hemoglobin concentration in blood
Time Frame
Measured at 12 months of age
Title
Prevalence of anemia at 18 months
Description
Population estimation of anemia using hemoglobin concentration in blood
Time Frame
Measured at 18 months of age
Title
Prevalence of anemia at 24 months
Description
Population estimation of anemia using hemoglobin concentration in blood
Time Frame
Measured at 24 months of age
Secondary Outcome Measure Information:
Title
Adherence to Nutritional Supplement Regime
Description
Consumption of the nutritional supplement measured as the number of packets consumed in one month
Time Frame
Measured every month from 6 months of age until 24 months of age
Title
Exclusive Breastfeeding
Description
Measured as an indicator of exclusive breastfeeding, self-reported by the mother of a child
Time Frame
Measured 24 months after the start of the intervention

10. Eligibility

Sex
All
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sebastian Martinez
Organizational Affiliation
Inter-American Development Bank
Official's Role
Study Director
Facility Information:
Facility Name
SPOON Mexico
City
Tepic
State/Province
Nayarit
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Unidentified individual data will be shared among participating research institutions and made public 2 years after finalizing the study

Learn more about this trial

SPOON: Sustained Program for Improving Nutrition - Mexico

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