SPOON: Sustained Program for Improving Nutrition - Mexico

February 22, 2022 updated by: Inter-American Development Bank

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Nayarit
      • Tepic, Nayarit, Mexico
        • SPOON Mexico

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

No older than 6 months (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
NO_INTERVENTION: Standard Care
Participants will receive standard health care services provided by the Health Secretary
EXPERIMENTAL: SPOON behavioral change strategy+SQ-LNS
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
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.
Other Names:
  • Small Quantity Lipid Nutrient Supplements
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Infant and young child feeding practices at 6 months
Time Frame: Measured at 6 months of age
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
Time Frame: Measured at 9 months of age
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
Time Frame: Measured at 12 months of age
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
Time Frame: Measured 15 months of age
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
Time Frame: Measured at 18 months of age
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
Time Frame: Measured at 21 months of age
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
Time Frame: Measured at 24 months of age
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
Time Frame: Measured at 6 months of age
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
Time Frame: Measured at 9 months of age
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
Time Frame: Measured at 12 months of age
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
Time Frame: Measured at 15 months of age
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
Time Frame: Measured at 18 months of age
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
Time Frame: Measured at 21 months of age
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
Time Frame: Measured at 24 months of age
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
Time Frame: Constructed from weight measurements at 6 months of age
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
Time Frame: Constructed from weight measurements at 9 months of age
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
Time Frame: Constructed from weight measurements at 12 months of age
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
Time Frame: Constructed from weight measurements at 15 months of age
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
Time Frame: Constructed from weight measurements at 18 months of age
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
Time Frame: Constructed from weight measurements at 21 months of age
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
Time Frame: Constructed from weight measurements at 24 months of age
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
Time Frame: Measured at 6 months of age
Measurement of hemoglobin concentration in blood using blood biometry
Measured at 6 months of age
Hemoglobin at 12 months
Time Frame: Measured at 12 months of age
Measurement of hemoglobin concentration in blood using blood biometry
Measured at 12 months of age
Hemoglobin at 18 months
Time Frame: Measured at 18 months of age
Measurement of hemoglobin concentration in blood using blood biometry
Measured at 18 months of age
Hemoglobin at 24 months
Time Frame: Measured at 24 months of age
Measurement of hemoglobin concentration in blood using blood biometry
Measured at 24 months of age
Prevalence of obesity in children at 6 months
Time Frame: Measured at 6 months of age
Population estimation of obesity using Body Mass Index (BMI)
Measured at 6 months of age
Prevalence of obesity in children at 9 months
Time Frame: Measured at 9 months of age
Population estimation of obesity using Body Mass Index (BMI)
Measured at 9 months of age
Prevalence of obesity in children at 12 months
Time Frame: Measured at 12 months of age
Population estimation of obesity using Body Mass Index (BMI)
Measured at 12 months of age
Prevalence of obesity in children at 15 months
Time Frame: Measured at 15 months of age
Population estimation of obesity using Body Mass Index (BMI)
Measured at 15 months of age
Prevalence of obesity in children at 18 months
Time Frame: Measured at 18 months of age
Population estimation of obesity using Body Mass Index (BMI)
Measured at 18 months of age
Prevalence of obesity in children at 21 months
Time Frame: Measured at 21 months of age
Population estimation of obesity using Body Mass Index (BMI)
Measured at 21 months of age
Prevalence of obesity in children at 24 months
Time Frame: Measured at 24 months of age
Population estimation of obesity using Body Mass Index (BMI)
Measured at 24 months of age
Prevalence of stunting at 6 months
Time Frame: Measured at 6 months of age
Population estimation of stunting using height-for age <-2 SD
Measured at 6 months of age
Prevalence of stunting at 9 months
Time Frame: Measured at 9 months of age
Population estimation of stunting using height-for age <-2 SD
Measured at 9 months of age
Prevalence of stunting at 12 months
Time Frame: Measured at 12 months of age
Population estimation of stunting using height-for age <-2 SD
Measured at 12 months of age
Prevalence of stunting at 15 months
Time Frame: Measured at 15 months of age
Population estimation of stunting using height-for age <-2 SD
Measured at 15 months of age
Prevalence of stunting at 18 months
Time Frame: Measured at 18 months of age
Population estimation of stunting using height-for age <-2 SD
Measured at 18 months of age
Prevalence of stunting at 21 months
Time Frame: Measured at 21 months of age
Population estimation of stunting using height-for age <-2 SD
Measured at 21 months of age
Prevalence of stunting at 24 months
Time Frame: Measured at 24 months of age
Population estimation of stunting using height-for age <-2 SD
Measured at 24 months of age
Prevalence of anemia at 6 months
Time Frame: Measured at 6 months of age
Population estimation of anemia using hemoglobin concentration in blood
Measured at 6 months of age
Prevalence of anemia at 12 months
Time Frame: Measured at 12 months of age
Population estimation of anemia using hemoglobin concentration in blood
Measured at 12 months of age
Prevalence of anemia at 18 months
Time Frame: Measured at 18 months of age
Population estimation of anemia using hemoglobin concentration in blood
Measured at 18 months of age
Prevalence of anemia at 24 months
Time Frame: Measured at 24 months of age
Population estimation of anemia using hemoglobin concentration in blood
Measured at 24 months of age

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Exclusive Breastfeeding
Time Frame: Measured 24 months after the start of the intervention
Measured as an indicator of exclusive breastfeeding, self-reported by the mother of a child
Measured 24 months after the start of the intervention
Adherence to Nutritional Supplement Regime
Time Frame: Measured every month from 6 months of age until 24 months of age
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Inter-American Development Bank

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hospital Infantil de Mexico Federico Gomez
The PepsiCo Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2018

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2020

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 8, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 21, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 26, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 9, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Inter-AmericanDB Mexico

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Unidentified individual data will be shared among participating research institutions and made public 2 years after finalizing the study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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Locations

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