SPOON: Sustained Program for Improving Nutrition - Colombia

Study Overview
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Brief Summary
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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
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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.

Official Title
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SPOON: Sustained Program for Improving Nutrition - Colombia

Conditions
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Child Obesity, Exclusive Breast Feeding, Malnutrition, Child

Intervention / Treatment
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* Dietary Supplement: Micronutrients
* Behavioral: SPOON Group Counseling
* Behavioral: Interpersonal Counseling
* Dietary Supplement: SQ-LNS
* Behavioral: Standard Counseling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 3 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standard Counseling and Micronutrients<br>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. | Dietary Supplement: Micronutrients<br>* 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.<br>Behavioral: Standard Counseling<br>* Standard counseling refers to the counseling currently provided by health personnel to women and children in the selected intervention area of Colombia<br>|
| Experimental: SPOON Group Counseling with SQ-LNS<br>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. | Behavioral: SPOON Group Counseling<br>* 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.<br>* Other names: Group;Dietary Supplement: SQ-LNS<br>* SQ-LNS is a peanut-based dietary supplement that has been shown to increase children's height and weight in several studies in Africa.<br>* Other names: Small Quantity Lipid Nutrient Supplements;|
| Experimental: Group, Interpersonal Counseling, SQ-LNS<br>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. | Behavioral: SPOON Group Counseling<br>* 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.<br>* Other names: Group;Behavioral: Interpersonal Counseling<br>* SPOON interpersonal counseling is an innovative behavior change strategy in which participants will learn information via one-on-one sessions with the instructor.<br>* Other names: SPOON Interpersonal Counseling;Dietary Supplement: SQ-LNS<br>* SQ-LNS is a peanut-based dietary supplement that has been shown to increase children's height and weight in several studies in Africa.<br>* Other names: Small Quantity Lipid Nutrient Supplements;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Height and Weight from Baseline to 8 months old | Prevalence 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 | Measured when child is 6 months old at baseline and when child is 8 months old | 
| Change in Height and Weight from 8 months old to 10 months old | Prevalence 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 | Measured when child is 8 months old and when child is 10 months old | 
| Change in Height and Weight from 10 months old to 12 months old | Prevalence 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 | Measured when child is 10 months old and when child is 12 months old | 
| Change in Height and Weight from 12 months old to 14 months old | Prevalence 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 | Measured when child is 12 months old and when child is 14 months old | 
| Change in Height and Weight from 14 months old to 16 months old | Prevalence 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 | Measured when child is 14 months old and when child is 16 months old | 
| Change in Height and Weight from 16 months old to 18 months old | Prevalence 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 | Measured when child is 16 months old and when child is 18 months old | 
| Change in Height and Weight from 18 months old to 20 months old | Prevalence 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 | Measured when child is 18 months old and when child is 20 months old | 
| Change in Height and Weight from 20 months old to 22 months old | Prevalence 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 | Measured when child is 20 months old and when child is 22 months old | 
| Change in Height and Weight from 22 months old to 24 months old | Prevalence 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 | Measured when child is 22 months old and when child is 24 months old | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Cephalic Circumference from Baseline | An indicator often used as a proxy for child growth and development | Measured when child is 6 months old and when child is 2 years old | 
| Change in Eating Habits from Baseline | Include what kinds, quantity, and frequency of food was consumed | Measured when child is 6 months old and when child is 2 years old | 
| Change in Health Status from Baseline | General health status includes frequency and intensity of diarrhea | Measured when child is 6 months old and when child is 2 years old | 
| Change in Measures of Caregiver Knowledge from Baseline | Caregiver knowledge in nutrition, hygiene and exclusive breastfeeding will be measured | Measured when child is 6 months old and when child is 2 years old | 
| Change in Prevalence of Anemia from Baseline | The prevalence of anemia will be measured by reviewing hemoglobin and hematocrit levels | Measured when child is 6 months old and when child is 2 years old | 
| Weight Gain Rate | Defined as rate of weight gain of the participating children | Measured every 2 months when child is between 6 and 24 months old |