SPOON: Sustained Program for Improving Nutrition - Colombia

Inter-American Development Bank

Status: Unknown

Conditions: Malnutrition, Child; Exclusive Breast Feeding; Child Obesity

Treatments: Dietary Supplement: SQ-LNS; Dietary Supplement: Micronutrients; Behavioral: Standard Counseling; Behavioral: SPOON Group Counseling; Behavioral: Interpersonal Counseling

Study type: Interventional

Funder types: Other

Identifiers

NCT03378726

Inter-AmericanDB Colombia

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,000 estimated patients

Sex: All

Ages: Under 3 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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3,000 participants in 3 patient groups

Standard Counseling and Micronutrients

Experimental group

Description:

Participants will receive standard services provided by the Ministry of Health, including powder micronutrients. Children receive 1 gram of powdered micronutrientes for 60 days between 6 and 12 months of age, and 60 daily packets per year from the time they are 1 year old until 5 years old.

Treatment:

Behavioral: Standard Counseling

Dietary Supplement: Micronutrients

SPOON Group Counseling with SQ-LNS

Experimental group

Description:

Participants will receive the supplement SQ-LNS in addition to SPOON group counseling, which is a new form of social communication in which participants will learn relevant lessons in a group format. SQ-LNS consists of a 20g nutrient supplement package that is to be consumed daily between 6 and 24 months of age.

Treatment:

Behavioral: SPOON Group Counseling

Dietary Supplement: SQ-LNS

Group, Interpersonal Counseling, SQ-LNS

Experimental group

Description:

Participants will receive the supplement SQ-LNS in addition to SPOON group and interpersonal counseling, which will consist of both participants learning relevant lessons in group format as well as in formats in which participants will work one-on-one with an instructor. SQ-LNS consists of a 20g nutrient supplement package that is to be consumed daily between 6 and 24 months of age.

Treatment:

Behavioral: Interpersonal Counseling

Behavioral: SPOON Group Counseling

Dietary Supplement: SQ-LNS