SPOON: Sustained Program for Improving Nutrition - Guatemala

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 Baja Verapaz, Guatemala

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 Guatemala. 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 Baja Verapaz, Guatemala in conjunction with Fundazucar, Guatemala.

Study Overview

Detailed Description

SPOON Guatemala is an innovative strategy to prevent undernutrition and obesity in children aged 0-24 months living in high-poverty areas of Guatemala. SPOON focuses on improving feeding practices for infant and young children, 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 3 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 24 months. Participants will be randomly assigned at the community 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 in addition to a supply of micronutrient powders from 6-24 months of age, according to the national protocol. Participants in the treatment group will be randomly assigned at an individual level to receive two different interventions:

Treatment 1: This group 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, group sessions, and community mobilization activities.

Treatment 2. This group will receive micronutrient powders 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, group sessions, and community mobilization activities.

A sample size of 500 children per group has been calculate to detect a minimum effect size of 0.2 with 95% level of significance and a 80% power for use of SQ-LNS. Additionally, a sample size of 40 communities and 500 children per group has been calculated to detect a minimum detectable effect size of 0.32 for communication.

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

Interventional

Enrollment (Actual)

1280

Phase

  • 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

    • Baja Verapaz
      • Rabinal, Baja Verapaz, Guatemala
        • SPOON Guatemala

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

Ages Eligible for Study

No older than 3 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Pregnant women in the third trimester or children 3 months of age
  • Living in the defined intervention areas
  • Children with no chronic diseases or congenital malformations
  • Not planning on moving far from the intervention area in the next 24 months

Exclusion Criteria:

  • Children with any chronic disease or congenital malformation
  • Caretakers of the children plan on moving in the next 24 months
  • Children with severe acute malnutrition

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 Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard Care+MNPs
Participants will receive standard health care services provided by the Ministry of Health, including micronutrient powders (MNPs). Children 6 months old will receive 1 gram of powdered micronutrients for 60 days every 6 months until 24 months of age.
Micronutrient powders (5 nutrient formulation) are currently provided by the Guatemalan Ministry of Health to children between 6-24 months of age.
Other Names:
  • MNPs
Experimental: SPOON behavioral change strategy+SQ-LNS
Participants will receive Small Quantity Lipid-based Supplements (SQ-LNS) 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, group sessions, and community mobilization activities. 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.
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, group sessions, and community mobilization activities.
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 does not include sugar.
Other Names:
  • Smal Quantity Lipid-base Nutrient Supplements
Experimental: SPOON behavioral change strategy+MNPs
Participants will receive micronutrient powders (MNPs) from 6-24 months and a behavioral change to promote adequate infant and young child feeding practices and the use of MNPs will be delivered to mothers or caregivers. The behavioral change strategy includes individual home-visits, group sessions, and community mobilization activities.
Micronutrient powders (5 nutrient formulation) are currently provided by the Guatemalan Ministry of Health to children between 6-24 months of age.
Other Names:
  • MNPs
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, group sessions, and community mobilization activities.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infant and young child feeding practices
Time Frame: Measured at baseline and after 24 months of intervention
Set of indicators of infant and young child feeding practices obtained by interview to participant mothers or caregivers
Measured at baseline and after 24 months of intervention
Height
Time Frame: Measured at 6 and 24 months of age
Height-for-age z score obtained by measuring the height of participant children
Measured at 6 and 24 months of age
Weight gain rate
Time Frame: Constructed from weight measurements at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, and 24 months of age
Rate of weight gain from 0-24 months of age
Constructed from weight measurements at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, and 24 months of age
Hemoglobin
Time Frame: Measured at 6 and 24 months of age
Measurement of hemoglobin using a portable photometer
Measured at 6 and 24 months of age
Prevalence of obesity in children
Time Frame: Measured at 6 and 24 months of age
Population estimation of obesity using Population estimation of obesity using Body Mass Index (BMI)
Measured at 6 and 24 months of age
Prevalence of stunting
Time Frame: Measured at 6 and 24 months of age
Population estimation of stunting using height-for age <-2 SD
Measured at 6 and 24 months of age
Prevalence of anemia
Time Frame: Measured at 6 and 24 months of age
Population estimation of anemia using hemoglobin
Measured at 6 and 24 months of age

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to Nutritional Supplement Regime
Time Frame: Measured every months from 6 months of age until the end of the intervention
Consumption of the nutritional supplement measured as the number of packets consumed in one month
Measured every months from 6 months of age until the end of the intervention
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

Collaborators and Investigators

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

Investigators

  • Study Director: Sebastian Martinez, IDB Evaluation Specialist

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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 (Actual)

September 15, 2018

Primary Completion (Actual)

November 18, 2021

Study Completion (Actual)

December 18, 2021

Study Registration Dates

First Submitted

January 8, 2018

First Submitted That Met QC Criteria

January 8, 2018

First Posted (Actual)

January 16, 2018

Study Record Updates

Last Update Posted (Actual)

March 9, 2022

Last Update Submitted That Met QC Criteria

February 22, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

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

IPD Sharing Time Frame

2 years after finalizing the study

IPD Sharing Access Criteria

Public

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Analytic Code

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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