An interventional study of Micronutrients and SPOON Group Counseling in Exclusive Breast Feeding, Child Obesity and Malnutrition, Child, sponsored by Inter-American Development Bank. Status unknown. Open to participants aged Up to 3 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-12-20.
Sponsored by Inter-American Development Bank · Not applicable, Interventional, and Diagnostic
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.
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.
1,081 studies on the registry are indexed under Breast Feeding; 217 are open to participants now.
This study's planned enrollment of 3,000 is above the median of 100 across 844 interventional studies indexed under Breast Feeding.
Browse Breast Feeding studies →Inter-American Development Bank is the lead sponsor of 6 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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 · Behavioral: Standard Counseling
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 · Dietary Supplement: SQ-LNS
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 · Behavioral: Interpersonal Counseling · Dietary Supplement: SQ-LNS
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.
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.
Also known as: Group
SPOON interpersonal counseling is an innovative behavior change strategy in which participants will learn information via one-on-one sessions with the instructor.
Also known as: SPOON Interpersonal Counseling
SQ-LNS is a peanut-based dietary supplement that has been shown to increase children's height and weight in several studies in Africa.
Also known as: Small Quantity Lipid Nutrient Supplements
Standard counseling refers to the counseling currently provided by health personnel to women and children in the selected intervention area of Colombia
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Measured when child is 22 months old and when child is 24 months old
Change in Cephalic Circumference from Baseline
An indicator often used as a proxy for child growth and development
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Measured every 2 months when child is between 6 and 24 months old
No study locations are listed for this record.
Plan to share: Yes — Unidentified individual data will be shared among participating research institutions and made public 2 years after finalizing the study
No publications or documents are linked to this record.
Start is estimated for Feb 2018; primary completion for Jan 2020, 23 months later.
Of 502 non-industry interventional studies with no phase under Breast Feeding, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 23. This study's planned 23 months is above that.
Counting every sponsor, half of 510 studies reached it within 12 months; a quarter within 6 and three quarters within 23.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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Inter-American Development Bank