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SPOON: Sustained Program for Improving Nutrition - Guatemala

Effect of an Innovative Behavioral Change Strategy and SQ-LNS on Stunting and Obesity in Children Living in Baja Verapaz, Guatemala

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03399617
Enrollment
1280
Registered
2018-01-16
Start date
2018-09-15
Completion date
2021-12-18
Last updated
2022-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Interventions

DIETARY_SUPPLEMENTMicronutrient Powders

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

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.

DIETARY_SUPPLEMENTSQ-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 does not include sugar.

Sponsors

The PepsiCo Foundation
CollaboratorOTHER
Fundazúcar
CollaboratorUNKNOWN
Inter-American Development Bank
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
No minimum to 3 Months
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of anemiaMeasured at 6 and 24 months of agePopulation estimation of anemia using hemoglobin
Prevalence of obesity in childrenMeasured at 6 and 24 months of agePopulation estimation of obesity using Population estimation of obesity using Body Mass Index (BMI)
Prevalence of stuntingMeasured at 6 and 24 months of agePopulation estimation of stunting using height-for age \<-2 SD
Infant and young child feeding practicesMeasured at baseline and after 24 months of interventionSet of indicators of infant and young child feeding practices obtained by interview to participant mothers or caregivers
HeightMeasured at 6 and 24 months of ageHeight-for-age z score obtained by measuring the height of participant children
Weight gain rateConstructed from weight measurements at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, and 24 months of ageRate of weight gain from 0-24 months of age
HemoglobinMeasured at 6 and 24 months of ageMeasurement of hemoglobin using a portable photometer

Secondary

MeasureTime frameDescription
Exclusive BreastfeedingMeasured 24 months after the start of the interventionMeasured as an indicator of exclusive breastfeeding, self-reported by the mother of a child
Adherence to Nutritional Supplement RegimeMeasured every months from 6 months of age until the end of the interventionConsumption of the nutritional supplement measured as the number of packets consumed in one month

Countries

Guatemala

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026