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SPOON: Sustained Program for Improving Nutrition - Colombia

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ClinicalTrials.gov Identifier: NCT03378726
Recruitment Status : Not yet recruiting
First Posted : December 20, 2017
Last Update Posted : December 20, 2017
Sponsor:
Collaborators:
Fundación Saldarriaga Concha
Instituto Departamental de Salud de Nariño
Ministerio de Salud y Protección Social de Colombia
Information provided by (Responsible Party):
Inter-American Development Bank

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.

Condition or disease Intervention/treatment Phase
Exclusive Breast Feeding Child Obesity Malnutrition, Child Dietary Supplement: Micronutrients Behavioral: SPOON Group Counseling Behavioral: Interpersonal Counseling Dietary Supplement: SQ-LNS Behavioral: Standard Counseling Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: SPOON: Sustained Program for Improving Nutrition - Colombia
Estimated Study Start Date : February 2018
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Arm Intervention/treatment
Experimental: Standard Counseling and Micronutrients
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
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.

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

Experimental: SPOON Group Counseling with SQ-LNS
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
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.
Other Name: Group

Dietary Supplement: SQ-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.
Other Name: Small Quantity Lipid Nutrient Supplements

Experimental: Group, Interpersonal Counseling, 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
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.
Other Name: Group

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

Dietary Supplement: SQ-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.
Other Name: Small Quantity Lipid Nutrient Supplements




Primary Outcome Measures :
  1. Change in Height and Weight from Baseline to 8 months old [ Time Frame: Measured when child is 6 months old at baseline and when child is 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

  2. Change in Height and Weight from 8 months old to 10 months old [ Time Frame: Measured when child is 8 months old and when child is 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

  3. Change in Height and Weight from 10 months old to 12 months old [ Time Frame: Measured when child is 10 months old and when child is 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

  4. Change in Height and Weight from 12 months old to 14 months old [ Time Frame: Measured when child is 12 months old and when child is 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

  5. Change in Height and Weight from 14 months old to 16 months old [ Time Frame: Measured when child is 14 months old and when child is 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

  6. Change in Height and Weight from 16 months old to 18 months old [ Time Frame: Measured when child is 16 months old and when child is 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

  7. Change in Height and Weight from 18 months old to 20 months old [ Time Frame: Measured when child is 18 months old and when child is 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

  8. Change in Height and Weight from 20 months old to 22 months old [ Time Frame: Measured when child is 20 months old and when child is 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

  9. Change in Height and Weight from 22 months old to 24 months old [ Time Frame: Measured when child is 22 months old and when child is 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


Secondary Outcome Measures :
  1. Change in Cephalic Circumference from Baseline [ Time Frame: Measured when child is 6 months old and when child is 2 years old ]
    An indicator often used as a proxy for child growth and development

  2. Change in Eating Habits from Baseline [ Time Frame: Measured when child is 6 months old and when child is 2 years old ]
    Include what kinds, quantity, and frequency of food was consumed

  3. Change in Health Status from Baseline [ Time Frame: Measured when child is 6 months old and when child is 2 years old ]
    General health status includes frequency and intensity of diarrhea

  4. Change in Measures of Caregiver Knowledge from Baseline [ Time Frame: Measured when child is 6 months old and when child is 2 years old ]
    Caregiver knowledge in nutrition, hygiene and exclusive breastfeeding will be measured

  5. Change in Prevalence of Anemia from Baseline [ Time Frame: Measured when child is 6 months old and when child is 2 years old ]
    The prevalence of anemia will be measured by reviewing hemoglobin and hematocrit levels

  6. Weight Gain Rate [ Time Frame: Measured every 2 months when child is between 6 and 24 months old ]
    Defined as rate of weight gain of the participating children



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Ages Eligible for Study:   up to 3 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03378726


Contacts
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Contact: Carolina González Acero (809) 784-6405 cgonzalez@iadb.org

Sponsors and Collaborators
Inter-American Development Bank
Fundación Saldarriaga Concha
Instituto Departamental de Salud de Nariño
Ministerio de Salud y Protección Social de Colombia
Investigators
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Study Director: Sebastian Martinez Inter-American Development Bank

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Responsible Party: Inter-American Development Bank
ClinicalTrials.gov Identifier: NCT03378726     History of Changes
Other Study ID Numbers: Inter-AmericanDB Colombia
First Posted: December 20, 2017    Key Record Dates
Last Update Posted: December 20, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Unidentified individual data will be shared among participating research institutions and made public 2 years after finalizing the study

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Child Nutrition Disorders
Nutrition Disorders
Malnutrition
Pediatric Obesity
Obesity
Overnutrition
Overweight
Body Weight
Signs and Symptoms
Nutrients
Micronutrients
Trace Elements
Growth Substances
Physiological Effects of Drugs