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SPOON: Sustained Program for Improving Nutrition - Colombia

Primary Purpose

Exclusive Breast Feeding, Child Obesity, Malnutrition, Child

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Micronutrients
SPOON Group Counseling
Interpersonal Counseling
SQ-LNS
Standard Counseling
Sponsored by
Inter-American Development Bank
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Exclusive Breast Feeding

Eligibility Criteria

undefined - 3 Months (Child)All SexesAccepts 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    Standard Counseling and Micronutrients

    SPOON Group Counseling with SQ-LNS

    Group, Interpersonal Counseling, SQ-LNS

    Arm 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.

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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
    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
    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
    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
    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
    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
    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
    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
    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

    Secondary Outcome Measures

    Change in Cephalic Circumference from Baseline
    An indicator often used as a proxy for child growth and development
    Change in Eating Habits from Baseline
    Include what kinds, quantity, and frequency of food was consumed
    Change in Health Status from Baseline
    General health status includes frequency and intensity of diarrhea
    Change in Measures of Caregiver Knowledge from Baseline
    Caregiver knowledge in nutrition, hygiene and exclusive breastfeeding will be measured
    Change in Prevalence of Anemia from Baseline
    The prevalence of anemia will be measured by reviewing hemoglobin and hematocrit levels
    Weight Gain Rate
    Defined as rate of weight gain of the participating children

    Full Information

    First Posted
    December 14, 2017
    Last Updated
    December 14, 2017
    Sponsor
    Inter-American Development Bank
    Collaborators
    Fundación Saldarriaga Concha, Instituto Departamental de Salud de Nariño, Ministerio de Salud y Protección Social de Colombia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03378726
    Brief Title
    SPOON: Sustained Program for Improving Nutrition - Colombia
    Official Title
    SPOON: Sustained Program for Improving Nutrition - Colombia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 2018 (Anticipated)
    Primary Completion Date
    January 2020 (Anticipated)
    Study Completion Date
    January 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Inter-American Development Bank
    Collaborators
    Fundación Saldarriaga Concha, Instituto Departamental de Salud de Nariño, Ministerio de Salud y Protección Social de Colombia

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Exclusive Breast Feeding, Child Obesity, Malnutrition, Child

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    3000 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Standard Counseling and Micronutrients
    Arm Type
    Experimental
    Arm 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.
    Arm Title
    SPOON Group Counseling with SQ-LNS
    Arm Type
    Experimental
    Arm 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.
    Arm Title
    Group, Interpersonal Counseling, SQ-LNS
    Arm Type
    Experimental
    Arm 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.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Micronutrients
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    SPOON Group Counseling
    Other Intervention Name(s)
    Group
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Interpersonal Counseling
    Other Intervention Name(s)
    SPOON Interpersonal Counseling
    Intervention Description
    SPOON interpersonal counseling is an innovative behavior change strategy in which participants will learn information via one-on-one sessions with the instructor.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    SQ-LNS
    Other Intervention Name(s)
    Small Quantity Lipid Nutrient Supplements
    Intervention Description
    SQ-LNS is a peanut-based dietary supplement that has been shown to increase children's height and weight in several studies in Africa.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Standard Counseling
    Intervention Description
    Standard counseling refers to the counseling currently provided by health personnel to women and children in the selected intervention area of Colombia
    Primary Outcome Measure Information:
    Title
    Change in Height and Weight from Baseline to 8 months old
    Description
    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
    Title
    Change in Height and Weight from 8 months old to 10 months old
    Description
    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
    Title
    Change in Height and Weight from 10 months old to 12 months old
    Description
    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
    Title
    Change in Height and Weight from 12 months old to 14 months old
    Description
    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
    Title
    Change in Height and Weight from 14 months old to 16 months old
    Description
    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
    Title
    Change in Height and Weight from 16 months old to 18 months old
    Description
    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
    Title
    Change in Height and Weight from 18 months old to 20 months old
    Description
    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
    Title
    Change in Height and Weight from 20 months old to 22 months old
    Description
    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
    Title
    Change in Height and Weight from 22 months old to 24 months old
    Description
    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
    Secondary Outcome Measure Information:
    Title
    Change in Cephalic Circumference from Baseline
    Description
    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
    Title
    Change in Eating Habits from Baseline
    Description
    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
    Title
    Change in Health Status from Baseline
    Description
    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
    Title
    Change in Measures of Caregiver Knowledge from Baseline
    Description
    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
    Title
    Change in Prevalence of Anemia from Baseline
    Description
    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
    Title
    Weight Gain Rate
    Description
    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

    10. Eligibility

    Sex
    All
    Maximum Age & Unit of Time
    3 Months
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Carolina González Acero
    Phone
    (809) 784-6405
    Email
    cgonzalez@iadb.org
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sebastian Martinez
    Organizational Affiliation
    Inter-American Development Bank
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Unidentified individual data will be shared among participating research institutions and made public 2 years after finalizing the study

    Learn more about this trial

    SPOON: Sustained Program for Improving Nutrition - Colombia

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