Clinical trial NCT03378726: SPOON: Sustained Program for Improving Nutrition - Colombia
Official title: SPOON: Sustained Program for Improving Nutrition - Colombia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Exclusive Breast Feeding
Child Obesity
Malnutrition, Child
Lead sponsor: Inter-American Development Bank
Sponsor class: OTHER
Collaborators: name: Fundación Saldarriaga Concha
name: Instituto Departamental de Salud de Nariño
name: Ministerio de Salud y Protección Social de Colombia
First posted: 2017-12-20
Enrollment: 3000
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Height and Weight from Baseline to 8 months old
timeFrame: Measured when child is 6 months old at baseline and when child is 8 months old
measure: Change in Height and Weight from 8 months old to 10 months old
timeFrame: Measured when child is 8 months old and when child is 10 months old
measure: Change in Height and Weight from 10 months old to 12 months old
timeFrame: Measured when child is 10 months old and when child is 12 months old
measure: Change in Height and Weight from 12 months old to 14 months old
timeFrame: Measured when child is 12 months old and when child is 14 months old
measure: Change in Height and Weight from 14 months old to 16 months old
timeFrame: Measured when child is 14 months old and when child is 16 months old
measure: Change in Height and Weight from 16 months old to 18 months old
timeFrame: Measured when child is 16 months old and when child is 18 months old
measure: Change in Height and Weight from 18 months old to 20 months old
timeFrame: Measured when child is 18 months old and when child is 20 months old
measure: Change in Height and Weight from 20 months old to 22 months old
timeFrame: Measured when child is 20 months old and when child is 22 months old
measure: Change in Height and Weight from 22 months old to 24 months old
timeFrame: Measured when child is 22 months old and when child is 24 months old
Secondary outcomes:
measure: Change in Cephalic Circumference from Baseline
timeFrame: Measured when child is 6 months old and when child is 2 years old
measure: Change in Eating Habits from Baseline
timeFrame: Measured when child is 6 months old and when child is 2 years old
measure: Change in Health Status from Baseline
timeFrame: Measured when child is 6 months old and when child is 2 years old
measure: Change in Measures of Caregiver Knowledge from Baseline
timeFrame: Measured when child is 6 months old and when child is 2 years old
measure: Change in Prevalence of Anemia from Baseline
timeFrame: Measured when child is 6 months old and when child is 2 years old
measure: Weight Gain Rate
timeFrame: Measured every 2 months when child is between 6 and 24 months old
Other outcomes:
Locations:
Study officials:
affiliation: Inter-American Development Bank
name: Sebastian Martinez
role: STUDY_DIRECTOR
References: