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SPOON: Sustained Program for Improving Nutrition - Guatemala

Primary Purpose

Exclusive Breast Feeding, Feeding Patterns, Stunting

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

About this trial

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

Eligibility Criteria

undefined - 3 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • SPOON Guatemala

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Standard Care+MNPs

SPOON behavioral change strategy+SQ-LNS

SPOON behavioral change strategy+MNPs

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Infant and young child feeding practices
Set of indicators of infant and young child feeding practices obtained by interview to participant mothers or caregivers
Height
Height-for-age z score obtained by measuring the height of participant children
Weight gain rate
Rate of weight gain from 0-24 months of age
Hemoglobin
Measurement of hemoglobin using a portable photometer
Prevalence of obesity in children
Population estimation of obesity using Population estimation of obesity using Body Mass Index (BMI)
Prevalence of stunting
Population estimation of stunting using height-for age <-2 SD
Prevalence of anemia
Population estimation of anemia using hemoglobin

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
The PepsiCo Foundation, Fundazúcar
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1. Study Identification

Unique Protocol Identification Number
NCT03399617
Brief Title
SPOON: Sustained Program for Improving Nutrition - Guatemala
Official Title
Effect of an Innovative Behavioral Change Strategy and SQ-LNS on Stunting and Obesity in Children Living in Baja Verapaz, Guatemala
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
September 15, 2018 (Actual)
Primary Completion Date
November 18, 2021 (Actual)
Study Completion Date
December 18, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Inter-American Development Bank
Collaborators
The PepsiCo Foundation, Fundazúcar

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 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exclusive Breast Feeding, 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
Outcomes Assessor
Allocation
Randomized
Enrollment
1280 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Care+MNPs
Arm Type
Active Comparator
Arm Description
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.
Arm Title
SPOON behavioral change strategy+SQ-LNS
Arm Type
Experimental
Arm Description
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.
Arm Title
SPOON behavioral change strategy+MNPs
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Micronutrient Powders
Other Intervention Name(s)
MNPs
Intervention Description
Micronutrient powders (5 nutrient formulation) are currently provided by the Guatemalan Ministry of Health to children between 6-24 months of age.
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, group sessions, and community mobilization activities.
Intervention Type
Dietary Supplement
Intervention Name(s)
SQ-LNS
Other Intervention Name(s)
Smal Quantity Lipid-base 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 does not include sugar.
Primary Outcome Measure Information:
Title
Infant and young child feeding practices
Description
Set of indicators of infant and young child feeding practices obtained by interview to participant mothers or caregivers
Time Frame
Measured at baseline and after 24 months of intervention
Title
Height
Description
Height-for-age z score obtained by measuring the height of participant children
Time Frame
Measured at 6 and 24 months of age
Title
Weight gain rate
Description
Rate of weight gain from 0-24 months of age
Time Frame
Constructed from weight measurements at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, and 24 months of age
Title
Hemoglobin
Description
Measurement of hemoglobin using a portable photometer
Time Frame
Measured at 6 and 24 months of age
Title
Prevalence of obesity in children
Description
Population estimation of obesity using Population estimation of obesity using Body Mass Index (BMI)
Time Frame
Measured at 6 and 24 months of age
Title
Prevalence of stunting
Description
Population estimation of stunting using height-for age <-2 SD
Time Frame
Measured at 6 and 24 months of age
Title
Prevalence of anemia
Description
Population estimation of anemia using hemoglobin
Time Frame
Measured at 6 and 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 months from 6 months of age until the end of the intervention
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
3 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sebastian Martinez
Organizational Affiliation
IDB Evaluation Specialist
Official's Role
Study Director
Facility Information:
Facility Name
SPOON Guatemala
City
Rabinal
State/Province
Baja Verapaz
Country
Guatemala

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
IPD Sharing Time Frame
2 years after finalizing the study
IPD Sharing Access Criteria
Public
Citations:
PubMed Identifier
32690508
Citation
Gonzalez Acero C, Martinez S, Perez-Exposito A, Winters S. Effect of an innovative behavioural change strategy and small-quantity lipid-based nutrient supplements on stunting and obesity in children in Baja Verapaz, Guatemala: protocol for a randomised control trial. BMJ Open. 2020 Jul 19;10(7):e035528. doi: 10.1136/bmjopen-2019-035528. Erratum In: BMJ Open. 2022 May 24;12(5):e035528corr1.
Results Reference
derived

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SPOON: Sustained Program for Improving Nutrition - Guatemala

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