SPOON: Sustained Program for Improving Nutrition - Colombia

NCT03378726 | Unknown

• 1 other identifier: Inter-AmericanDB Colombia
• Study Type: interventional
• Target: 3,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Exclusive Breast Feeding; Child Obesity; Malnutrition, Child

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (6)

• Change in Cephalic Circumference from Baseline

  Measured when child is 6 months old and when child is 2 years old

• Change in Eating Habits from Baseline

  Measured when child is 6 months old and when child is 2 years old

• Change in Health Status from Baseline

  Measured when child is 6 months old and when child is 2 years old

• Change in Measures of Caregiver Knowledge from Baseline

  Measured when child is 6 months old and when child is 2 years old

• Change in Prevalence of Anemia from Baseline

  Measured when child is 6 months old and when child is 2 years old

Study Arms (3)

Standard Counseling and Micronutrients

EXPERIMENTAL

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

SPOON Group Counseling with SQ-LNS

EXPERIMENTAL

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

Group, Interpersonal Counseling, SQ-LNS

EXPERIMENTAL

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

Interventions

Micronutrients DIETARY_SUPPLEMENT

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.

Standard Counseling and Micronutrients

SPOON Group Counseling BEHAVIORAL

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

Group, Interpersonal Counseling, SQ-LNS; SPOON Group Counseling with SQ-LNS

Interpersonal Counseling BEHAVIORAL

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

Group, Interpersonal Counseling, SQ-LNS

SQ-LNS DIETARY_SUPPLEMENT

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

Group, Interpersonal Counseling, SQ-LNS; SPOON Group Counseling with SQ-LNS

Standard Counseling BEHAVIORAL

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

Standard Counseling and Micronutrients

Eligibility Criteria

• Age: Up to 3 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Participants must live in the defined intervention areas

You may not qualify if:

• Any chronic disease or malformation
• Caretakers of the children plan on moving in the next 24 months

Sponsors & Collaborators

• Inter-American Development Bank: lead
• Fundación Saldarriaga Concha: collaborator
• Instituto Departamental de Salud de Nariño: collaborator
• Ministerio de Salud y Protección Social de Colombia: collaborator

MeSH Terms

Conditions

Breast Feeding; Pediatric Obesity; Child Nutrition Disorders

Interventions

Micronutrients; Population Groups

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Nutrients; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Demography; Population Characteristics

Study Officials

• Sebastian Martinez

  Inter-American Development Bank

  STUDY DIRECTOR

Central Study Contacts

Carolina González Acero

CONTACT

(809) 784-6405; cgonzalez@iadb.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2017
• First Posted: December 20, 2017
• Study Start: February 1, 2018
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: December 20, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will share