SPOON: Sustained Program for Improving Nutrition - Colombia
NCT ID: NCT03378726
Last Updated: 2017-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
3000 participants
INTERVENTIONAL
2018-02-28
2020-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
Standard Counseling
Standard counseling refers to the counseling currently provided by health personnel to women and children in the selected intervention area of Colombia
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.
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.
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.
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.
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.
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-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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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.
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-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.
Standard Counseling
Standard counseling refers to the counseling currently provided by health personnel to women and children in the selected intervention area of Colombia
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* Caretakers of the children plan on moving in the next 24 months
3 Months
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fundación Saldarriaga Concha
OTHER
Instituto Departamental de Salud de Nariño
UNKNOWN
Ministerio de Salud y Protección Social de Colombia
UNKNOWN
Inter-American Development Bank
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sebastian Martinez
Role: STUDY_DIRECTOR
Inter-American Development Bank
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Inter-AmericanDB Colombia
Identifier Type: -
Identifier Source: org_study_id