Skip to content

SPOON: Sustained Program for Improving Nutrition - Colombia

SPOON: Sustained Program for Improving Nutrition - Colombia

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03378726
Enrollment
3000
Registered
2017-12-20
Start date
2018-02-28
Completion date
2020-01-31
Last updated
2017-12-20

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

Conditions

Exclusive Breast Feeding, Child Obesity, Malnutrition, Child

Brief summary

The primary goal of this study is to prevent undernutrition and obesity in peri-urban areas of Colombia. This study is designed to evaluate the impact of promoting adequate 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 Pasto, Colombia in conjunction with Fundación Saldarriaga Concha and the Colombian Ministry of Health and Social Protection.

Detailed description

SPOON Colombia is an innovative strategy to prevent undernutrition and obesity in children aged 0-24 months living in high-poverty areas of Colombia. The SPOON program aims to improve infant and young children feeding practices, including exclusive breastfeeding during a child's first six months and home-fortification with peanut-based SQ-LNS (small quantity lipid-based nutrient supplements) for children 6 to 24 months of age. The SPOON intervention will randomly assign participants at the household level to one of three groups: a control group, Treatment Group 1, and Treatment Group 2. Participants in the control group will receive the standard services provided by their local health clinics in addition to a supply of micronutrient powder. The powder consists of vitamins and minerals that are added to the child's food to increase his or her consumption of micronutrients. Participants in Treatment Group 1 will receive group counseling and the SQ-LNS supplement instead of micronutrient powder. The group counseling program consists of various lessons for the children's caregivers about the importance of breastfeeding and providing high quality food with the SQ-LNS supplement. Those assigned to Treatment Group 2 will receive all the services that those in Treatment Group 1 receive in addition to individualized counseling, where messages about nutrition and breastfeeding will be reinforced through home visits. Comparing the three treatment arms will identify the marginal impact of the SPOON program. For example, measuring the differences in outcomes between the participants in the control arm and in Treatment Group 1 will identify the impact of the Spoon program package, which includes SQ-LNS and group counseling, compared to current government-provided services. Measuring the differences between Treatment Group 1 and Treatment Group 2 will indicate the marginal impact of individualized counseling, and measuring the difference between the control arm and Treatment Group 2 will determine the combined impact of the SPOON program combined with individualized counseling.

Interventions

DIETARY_SUPPLEMENTMicronutrients

Micronutrient powder is the current supplement provided by the Colombian Ministry of Health and Social Protection to children between 1 and 5 years of age.

BEHAVIORALSPOON Group Counseling

SPOON group counseling is an innovative behavior change strategy in which participants will learn information related to child health and nutrition in a group format.

SPOON interpersonal counseling is an innovative behavior change strategy in which participants will learn information via one-on-one sessions with the instructor.

DIETARY_SUPPLEMENTSQ-LNS

SQ-LNS is a peanut-based dietary supplement that has been shown to increase children's height and weight in several studies in Africa.

Standard counseling refers to the counseling currently provided by health personnel to women and children in the selected intervention area of Colombia

Sponsors

Fundación Saldarriaga Concha
CollaboratorOTHER
Instituto Departamental de Salud de Nariño
CollaboratorUNKNOWN
Ministerio de Salud y Protección Social de Colombia
CollaboratorUNKNOWN
Inter-American Development Bank
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)

Eligibility

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

Inclusion criteria

* Participants must live in the defined intervention areas

Exclusion criteria

* Any chronic disease or malformation * Caretakers of the children plan on moving in the next 24 months

Design outcomes

Primary

MeasureTime frameDescription
Change in Height and Weight from Baseline to 8 months oldMeasured when child is 6 months old at baseline and when child is 8 months oldPrevalence of stunting and being overweight, height for age z-score, body mass index z-score will be determined from measuring the height and weight of the subject
Change in Height and Weight from 8 months old to 10 months oldMeasured when child is 8 months old and when child is 10 months oldPrevalence of stunting and being overweight, height for age z-score, body mass index z-score will be determined from measuring the height and weight of the subject
Change in Height and Weight from 10 months old to 12 months oldMeasured when child is 10 months old and when child is 12 months oldPrevalence of stunting and being overweight, height for age z-score, body mass index z-score will be determined from measuring the height and weight of the subject
Change in Height and Weight from 12 months old to 14 months oldMeasured when child is 12 months old and when child is 14 months oldPrevalence of stunting and being overweight, height for age z-score, body mass index z-score will be determined from measuring the height and weight of the subject
Change in Height and Weight from 14 months old to 16 months oldMeasured when child is 14 months old and when child is 16 months oldPrevalence of stunting and being overweight, height for age z-score, body mass index z-score will be determined from measuring the height and weight of the subject
Change in Height and Weight from 16 months old to 18 months oldMeasured when child is 16 months old and when child is 18 months oldPrevalence of stunting and being overweight, height for age z-score, body mass index z-score will be determined from measuring the height and weight of the subject
Change in Height and Weight from 18 months old to 20 months oldMeasured when child is 18 months old and when child is 20 months oldPrevalence of stunting and being overweight, height for age z-score, body mass index z-score will be determined from measuring the height and weight of the subject
Change in Height and Weight from 20 months old to 22 months oldMeasured when child is 20 months old and when child is 22 months oldPrevalence of stunting and being overweight, height for age z-score, body mass index z-score will be determined from measuring the height and weight of the subject
Change in Height and Weight from 22 months old to 24 months oldMeasured when child is 22 months old and when child is 24 months oldPrevalence of stunting and being overweight, height for age z-score, body mass index z-score will be determined from measuring the height and weight of the subject

Secondary

MeasureTime frameDescription
Change in Cephalic Circumference from BaselineMeasured when child is 6 months old and when child is 2 years oldAn indicator often used as a proxy for child growth and development
Change in Eating Habits from BaselineMeasured when child is 6 months old and when child is 2 years oldInclude what kinds, quantity, and frequency of food was consumed
Change in Health Status from BaselineMeasured when child is 6 months old and when child is 2 years oldGeneral health status includes frequency and intensity of diarrhea
Change in Measures of Caregiver Knowledge from BaselineMeasured when child is 6 months old and when child is 2 years oldCaregiver knowledge in nutrition, hygiene and exclusive breastfeeding will be measured
Change in Prevalence of Anemia from BaselineMeasured when child is 6 months old and when child is 2 years oldThe prevalence of anemia will be measured by reviewing hemoglobin and hematocrit levels
Weight Gain RateMeasured every 2 months when child is between 6 and 24 months oldDefined as rate of weight gain of the participating children

Contacts

Primary ContactCarolina González Acero
cgonzalez@iadb.org(809) 784-6405

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026