SPOON: Sustained Program for Improving Nutrition - Guatemala

NCT03399617 | Completed

• 1 other identifier: Inter-AmericanDB Guatemala
• Study Type: interventional
• Target: 1,280
• 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 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.

Conditions

Exclusive Breast Feeding; Feeding Patterns; Stunting; Obesity, Childhood

Keywords

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

Outcome Measures

Primary Outcomes (7)

• Infant and young child feeding practices

  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

  Height-for-age z score obtained by measuring the height of participant children

  Measured at 6 and 24 months of age

• Weight gain rate

  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

  Measurement of hemoglobin using a portable photometer

  Measured at 6 and 24 months of age

• Prevalence of obesity in children

  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

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

  Measured at 6 and 24 months of age

• Prevalence of anemia

  Population estimation of anemia using hemoglobin

  Measured at 6 and 24 months of age

Secondary Outcomes (2)

• Adherence to Nutritional Supplement Regime

  Measured every months from 6 months of age until the end of the intervention

• Exclusive Breastfeeding

  Measured 24 months after the start of the intervention

Study Arms (3)

Standard Care+MNPs

ACTIVE COMPARATOR

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.

Dietary Supplement: Micronutrient Powders

SPOON behavioral change strategy+SQ-LNS

EXPERIMENTAL

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.

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

SPOON behavioral change strategy+MNPs

EXPERIMENTAL

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.

Dietary Supplement: Micronutrient Powders; Behavioral: SPOON behavioral change strategy

Interventions

Micronutrient Powders DIETARY_SUPPLEMENT

Micronutrient powders (5 nutrient formulation) are currently provided by the Guatemalan Ministry of Health to children between 6-24 months of age.

Also known as: MNPs

SPOON behavioral change strategy+MNPs; Standard Care+MNPs

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, group sessions, and community mobilization activities.

SPOON behavioral change strategy+MNPs; SPOON behavioral change strategy+SQ-LNS

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 does not include sugar.

Also known as: Smal Quantity Lipid-base Nutrient Supplements

SPOON behavioral change strategy+SQ-LNS

Eligibility Criteria

• Age: Up to 3 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Inter-American Development Bank: lead
• The PepsiCo Foundation: collaborator
• Fundazúcar: collaborator

Study Sites (1)

SPOON Guatemala

Rabinal, Departamento de Baja Verapaz, Guatemala

Location

Related Publications (1)

• 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.

  PMID: 32690508 DERIVED

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

  IDB Evaluation Specialist

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2018
• First Posted: January 16, 2018
• Study Start: September 15, 2018
• Primary Completion: November 18, 2021
• Study Completion: December 18, 2021
• Last Updated: March 9, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: 2 years after finalizing the study
• Access Criteria: Public

Locations

GU (1)