Exclusive Breast FeedingNCT03378726
SPOON: Sustained Program for Improving Nutrition - Colombia
A study testing Micronutrients, SPOON Group Counseling and Interpersonal Counseling in people with Exclusive Breast Feeding and Child Obesity, run by Inter-American Development Bank.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 3 monthsHealthy volunteers can take part
- Conditions the study is for
- Exclusive Breast Feeding, Child Obesity, Malnutrition, Child
- What is being tested?
- Micronutrients, SPOON Group Counseling and Interpersonal Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,000 participants
- Where
- No sites listed yet
- Study dates
- Feb 2018to Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 3 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Participants must live in the defined intervention areas
Who cannot join
- Any chronic disease or malformation
- Caretakers of the children plan on moving in the next 24 months
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Exclusive Breast Feeding, Child Obesity, Malnutrition, Child
- Being tested
- Micronutrients, SPOON Group Counseling, Interpersonal Counseling, SQ-LNS, Standard Counseling
- Medical subject headings
- Breast Feeding, Pediatric Obesity, Child Nutrition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicronutrientsDietary 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.
SPOON Group CounselingBehavioural
Also called Group
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.
Interpersonal CounselingBehavioural
Also called SPOON 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.
SQ-LNSDietary supplement
Also called Small Quantity Lipid Nutrient Supplements
SQ-LNS is a peanut-based dietary supplement that has been shown to increase children's height and weight in several studies in Africa.
Standard CounselingBehavioural
Standard counseling refers to the counseling currently provided by health personnel to women and children in the selected intervention area of Colombia
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: SPOON Group Counseling; Behavioral: Interpersonal Counseling; Dietary Supplement: SQ-LNS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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: 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: 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: 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: 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: 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: 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: 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: Measured when child is 22 months old and when child is 24 months old
Secondary outcomes (6)
Change in Cephalic Circumference from Baseline
An indicator often used as a proxy for child growth and development
Measured: 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: 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: 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: 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: 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: Measured every 2 months when child is between 6 and 24 months old
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2017
- Study startFeb 2018 (estimated)
- Primary completionJan 2020 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exclusive Breast FeedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inter-American Development Bank
- Sponsor type
- University, hospital or other
- Collaborators
- Fundación Saldarriaga Concha, Instituto Departamental de Salud de Nariño, Ministerio de Salud y Protección Social de Colombia
- Responsible party
- Sponsor
- Investigators
- Sebastian Martinez, Study director, Inter-American Development Bank
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03378726
- Sponsor's protocol ID
- Inter-AmericanDB Colombia
- Status last verified
- Feb 2017
- First submitted
- 14 Dec 2017
- Last updated
- 20 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Unidentified individual data will be shared among participating research institutions and made public 2 years after finalizing the study
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SPOON: Sustained Program for Improving Nutrition - Colombia
- ClinicalTrials.gov ID
- NCT03378726
- Acronym / sponsor ID
- Inter-AmericanDB Colombia
- Conditions
- Exclusive Breast Feeding, Child Obesity, Malnutrition, Child
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Inter-American Development BankUniversity, hospital or other
- Collaborators
- Fundación Saldarriaga Concha, Instituto Departamental de Salud de Nariño, Ministerio de Salud y Protección Social de Colombia
- Study start
- Feb 2018 (estimated)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 20 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard Counseling and Micronutrients | Experimental | Dietary Supplement: Micronutrients, Behavioral: Standard CounselingParticipants 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. |
| SPOON Group Counseling with SQ-LNS | Experimental | Behavioral: SPOON Group Counseling, Dietary Supplement: SQ-LNSParticipants 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. |
| Group, Interpersonal Counseling, SQ-LNS | Experimental | Behavioral: SPOON Group Counseling, Behavioral: Interpersonal Counseling, Dietary Supplement: SQ-LNSParticipants 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. |
Who may qualify
- Ages
- Up to 3 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Participants must live in the defined intervention areas
Key exclusion criteria (2 listed)
- Any chronic disease or malformation
- Caretakers of the children plan on moving in the next 24 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MicronutrientsMicronutrient powder is the current supplement provided by the Colombian Ministry of Health and Social Protection to children between 1 and 5 years of age. | Dietary supplement | Standard Counseling and Micronutrients |
| SPOON Group CounselingAlso: GroupSPOON group counseling is an innovative behavior change strategy in which participants will learn information related to child health and nutrition in a group format. | Behavioural | Group, Interpersonal Counseling, SQ-LNS, SPOON Group Counseling with SQ-LNS |
| Interpersonal CounselingAlso: SPOON Interpersonal CounselingSPOON interpersonal counseling is an innovative behavior change strategy in which participants will learn information via one-on-one sessions with the instructor. | Behavioural | Group, Interpersonal Counseling, SQ-LNS |
| SQ-LNSAlso: Small Quantity Lipid Nutrient SupplementsSQ-LNS is a peanut-based dietary supplement that has been shown to increase children's height and weight in several studies in Africa. | Dietary supplement | Group, Interpersonal Counseling, SQ-LNS, SPOON Group Counseling with SQ-LNS |
| Standard CounselingStandard counseling refers to the counseling currently provided by health personnel to women and children in the selected intervention area of Colombia | Behavioural | Standard Counseling and Micronutrients |
Primary outcome
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
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
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
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
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
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
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
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
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
6 secondary outcomes
Change in Cephalic Circumference from Baseline
Time frame: Measured when child is 6 months old and when child is 2 years old
Change in Eating Habits from Baseline
Time frame: Measured when child is 6 months old and when child is 2 years old
Change in Health Status from Baseline
Time frame: Measured when child is 6 months old and when child is 2 years old
Change in Measures of Caregiver Knowledge from Baseline
Time frame: Measured when child is 6 months old and when child is 2 years old
Change in Prevalence of Anemia from Baseline
Time frame: Measured when child is 6 months old and when child is 2 years old
Weight Gain Rate
Time frame: Measured every 2 months when child is between 6 and 24 months old
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2017.
- Individual participant dataSharing planned: Yes. Unidentified individual data will be shared among participating research institutions and made public 2 years after finalizing the study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sebastian Martinez study director
Inter-American Development Bank
Questions about this trial
What is this clinical trial studying?
A study testing Micronutrients, SPOON Group Counseling and Interpersonal Counseling in people with Exclusive Breast Feeding and Child Obesity, run by Inter-American Development Bank.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carolina González Acero ((809) 784-6405, cgonzalez@iadb.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2017.