Exclusive Breast FeedingNCT03399617
SPOON: Sustained Program for Improving Nutrition - Guatemala
A study testing Micronutrient Powders, SPOON behavioral change strategy and SQ-LNS in people with Exclusive Breast Feeding and Feeding Patterns, run by Inter-American Development Bank at 1 site in Guatemala.
Trial summary
The primary goal of this study is to assess the impact of an innovative strategy to prevent undernutrition and obesity in early childhood in children 0-24 months in Guatemala. This study is designed to evaluate the impact of promoting adequate infant an young child feeding practices and the use of SQ-LNS (Small… 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, Feeding Patterns, Stunting
- What is being tested?
- Micronutrient Powders, SPOON behavioral change strategy and SQ-LNS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,280 participants
- Where
- 1 siteGuatemala
- Study dates
- 15 Sep 2018to 18 Dec 2021
- 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
- Pregnant women in the third trimester or children 3 months of age
- Living in the defined intervention areas
- Children with no chronic diseases or congenital malformations
- Not planning on moving far from the intervention area in the next 24 months
Who cannot join
- Children with any chronic disease or congenital malformation
- Caretakers of the children plan on moving in the next 24 months
- Children with severe acute malnutrition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of an Innovative Behavioral Change Strategy and SQ-LNS on Stunting and Obesity in Children Living in Baja Verapaz, Guatemala
The primary goal of this study is to assess the impact of an innovative strategy to prevent undernutrition and obesity in early childhood in children 0-24 months in Guatemala. This study is designed to evaluate the impact of promoting adequate infant an young child 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 Baja Verapaz, Guatemala in conjunction with Fundazucar, Guatemala.
Read the detailed description
SPOON Guatemala is an innovative strategy to prevent undernutrition and obesity in children aged 0-24 months living in high-poverty areas of Guatemala. SPOON focuses on improving feeding practices for infant and young children, including exclusive breastfeeding, and promote the use of home-fortification with peanut-based SQ-LNS (small quantity lipid-based nutrient supplements) through a novel behavior change strategy.
The study will recruit children between 0 and 3 months of age as well as pregnant women in the third trimester. Mothers or caregivers of eligible children will be invited to participate and a consent form obtain. Participation will start at 0-6 months and the intervention will last until children are 24 months. Participants will be randomly assigned at the community level to one of two groups: a control group and a treatment group. Participants in the control group will receive the standard services provided by their local health clinics in addition to a supply of micronutrient powders from 6-24 months of age, according to the national protocol. Participants in the treatment group will be randomly assigned at an individual level to receive two different interventions:
Treatment 1: This group will receive SQ-LNS supplement from 6-24 months and an innovative behavioral change strategy designed using ethnographic and marketing methods to promote adequate infant and young child feeding practices and the use of SQ-LNS. The strategy will be delivered to mothers or caregivers through individual home-visits, group sessions, and community mobilization activities.
Treatment 2. This group will receive micronutrient powders from 6-24 months and an innovative behavioral change strategy designed using ethnographic and marketing methods to promote adequate infant and young child feeding practices and the use of SQ-LNS. The strategy will be delivered to mothers or caregivers through individual home-visits, group sessions, and community mobilization activities.
A sample size of 500 children per group has been calculate to detect a minimum effect size of 0.2 with 95% level of significance and a 80% power for use of SQ-LNS. Additionally, a sample size of 40 communities and 500 children per group has been calculated to detect a minimum detectable effect size of 0.32 for communication.
Main outcomes include infant and young child feeding practices, height, weight, hemoglobin, prevalence of anemia, prevalence of stunting, prevalence of obesity, and weight gain rate. A baseline and final survey will be conducted to collect data for these variables, as well as sociodemographic information. Impact estimation will be done comparing the average results and the distribution of indicators between the treatment and control group. Differences of simple means and regression models including co-variables of the child's age and sex, and characteristics of the primary caregiver and household will be estimated. In addition to potential changes in indicator averages, changes in the distribution of variables will be explored under the hypothesis that the intervention might not only improve average value for a given indicator, but compress the distribution over a range of values closer to an optimal range. Changes to distributions will be checked by applying the Kolmogorov-Smirnov test.
- Being tested
- Micronutrient Powders, SPOON behavioral change strategy, SQ-LNS
- Keywords
- Stunting, Obesity, Lipid-based Nutrient Supplements (LNS), Latin America, Child nutrition, Feeding practices
- Medical subject headings
- Breast Feeding, Feeding Behavior, Growth Disorders, Pediatric Obesity, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micronutrient PowdersDietary supplement
Also called MNPs
Micronutrient powders (5 nutrient formulation) are currently provided by the Guatemalan Ministry of Health to children between 6-24 months of age.
SPOON behavioral change strategyBehavioural
An innovative behavioral change strategy designed using ethnographic and marketing methods to promote adequate infant and young child feeding practices and the use of SQ-LNS. The strategy will be delivered to mothers or caregivers through individual home-visits, group sessions, and community mobilization activities.
SQ-LNSDietary supplement
Also called Smal Quantity Lipid-base Nutrient Supplements
SQ-LNS is a peanut-based ready to use home fortification product to improve diet quality in children 6-24 months of age. It includes peanuts and other ingredients such as vegetable fat, powdered milk and several micronutrients. The formulation designed for this study does not include sugar.
| Study group | Role | What they receive |
|---|---|---|
| Standard Care+MNPs | Active comparator | Participants will receive standard health care services provided by the Ministry of Health, including micronutrient powders (MNPs). Children 6 months old will receive 1 gram of powdered micronutrients for 60 days every 6 months until 24 months of age. Receives: Dietary Supplement: Micronutrient Powders |
| SPOON behavioral change strategy+SQ-LNS | Experimental | Participants will receive Small Quantity Lipid-based Supplements (SQ-LNS) from 6-24 months and a behavioral change to promote adequate infant and young child feeding practices and the use of SQ-LNS will be delivered to mothers or caregivers. The behavioral change strategy includes individual home-visits, group sessions, and community mobilization activities. SQ-LNS consists of a 20g nutrient supplement package to be consumed daily from 6-24 of age. SQ-LNS formulation does not include sugar. Receives: Behavioral: SPOON behavioral change strategy; Dietary Supplement: SQ-LNS |
| SPOON behavioral change strategy+MNPs | Experimental | Participants will receive micronutrient powders (MNPs) from 6-24 months and a behavioral change to promote adequate infant and young child feeding practices and the use of MNPs will be delivered to mothers or caregivers. The behavioral change strategy includes individual home-visits, group sessions, and community mobilization activities. Receives: Dietary Supplement: Micronutrient Powders; Behavioral: SPOON behavioral change strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infant and young child feeding practices
Set of indicators of infant and young child feeding practices obtained by interview to participant mothers or caregivers
Measured: Measured at baseline and after 24 months of intervention
Height
Height-for-age z score obtained by measuring the height of participant children
Measured: Measured at 6 and 24 months of age
Weight gain rate
Rate of weight gain from 0-24 months of age
Measured: Constructed from weight measurements at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, and 24 months of age
Hemoglobin
Measurement of hemoglobin using a portable photometer
Measured: Measured at 6 and 24 months of age
Prevalence of obesity in children
Population estimation of obesity using Population estimation of obesity using Body Mass Index (BMI)
Measured: Measured at 6 and 24 months of age
Prevalence of stunting
Population estimation of stunting using height-for age <-2 SD
Measured: Measured at 6 and 24 months of age
Prevalence of anemia
Population estimation of anemia using hemoglobin
Measured: Measured at 6 and 24 months of age
Secondary outcomes (2)
Adherence to Nutritional Supplement Regime
Consumption of the nutritional supplement measured as the number of packets consumed in one month
Measured: Measured every months from 6 months of age until the end of the intervention
Exclusive Breastfeeding
Measured as an indicator of exclusive breastfeeding, self-reported by the mother of a child
Measured: Measured 24 months after the start of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2018
- Study start15 Sep 2018
- Primary completion18 Nov 2021
- Study completion18 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inter-American Development Bank
- Sponsor type
- University, hospital or other
- Collaborators
- The PepsiCo Foundation, Fundazúcar
- Responsible party
- Sponsor
- Investigators
- Sebastian Martinez, Study director, IDB Evaluation Specialist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03399617
- Sponsor's protocol ID
- Inter-AmericanDB Guatemala
- Status last verified
- Feb 2022
- First submitted
- 8 Jan 2018
- Last updated
- 9 Mar 2022
- 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
Publications
Gonzalez Acero C, Martinez S, Perez-Exposito A, Winters S. Effect of an innovative behavioural change strategy and small-quantity lipid-based nutrient supplements on stunting and obesity in children in Baja Verapaz, Guatemala: protocol for a randomised control trial. BMJ Open. 2020 Jul 19;10(7):e035528. doi: 10.1136/bmjopen-2019-035528.
PubMed 32690508
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of an Innovative Behavioral Change Strategy and SQ-LNS on Stunting and Obesity in Children Living in Baja Verapaz, Guatemala
- ClinicalTrials.gov ID
- NCT03399617
- Acronym / sponsor ID
- Inter-AmericanDB Guatemala
- Keywords
- Stunting, Obesity, Lipid-based Nutrient Supplements (LNS), Latin America, Child nutrition, Feeding practices
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,280 participants (actual)
- Lead sponsor
- Inter-American Development BankUniversity, hospital or other
- Collaborators
- The PepsiCo Foundation, Fundazúcar
- Study start
- 15 Sep 2018 (actual)
- Primary completion
- 18 Nov 2021 (actual)
- Study completion
- 18 Dec 2021 (actual)
- First posted
- 16 Jan 2018 (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 assess the impact of an innovative strategy to prevent undernutrition and obesity in early childhood in children 0-24 months in Guatemala. This study is designed to evaluate the impact of promoting adequate infant an young child 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 Baja Verapaz, Guatemala in conjunction with Fundazucar, Guatemala.
Detailed description
SPOON Guatemala is an innovative strategy to prevent undernutrition and obesity in children aged 0-24 months living in high-poverty areas of Guatemala. SPOON focuses on improving feeding practices for infant and young children, including exclusive breastfeeding, and promote the use of home-fortification with peanut-based SQ-LNS (small quantity lipid-based nutrient supplements) through a novel behavior change strategy.
The study will recruit children between 0 and 3 months of age as well as pregnant women in the third trimester. Mothers or caregivers of eligible children will be invited to participate and a consent form obtain. Participation will start at 0-6 months and the intervention will last until children are 24 months. Participants will be randomly assigned at the community level to one of two groups: a control group and a treatment group. Participants in the control group will receive the standard services provided by their local health clinics in addition to a supply of micronutrient powders from 6-24 months of age, according to the national protocol. Participants in the treatment group will be randomly assigned at an individual level to receive two different interventions:
Treatment 1: This group will receive SQ-LNS supplement from 6-24 months and an innovative behavioral change strategy designed using ethnographic and marketing methods to promote adequate infant and young child feeding practices and the use of SQ-LNS. The strategy will be delivered to mothers or caregivers through individual home-visits, group sessions, and community mobilization activities.
Treatment 2. This group will receive micronutrient powders from 6-24 months and an innovative behavioral change strategy designed using ethnographic and marketing methods to promote adequate infant and young child feeding practices and the use of SQ-LNS. The strategy will be delivered to mothers or caregivers through individual home-visits, group sessions, and community mobilization activities.
A sample size of 500 children per group has been calculate to detect a minimum effect size of 0.2 with 95% level of significance and a 80% power for use of SQ-LNS. Additionally, a sample size of 40 communities and 500 children per group has been calculated to detect a minimum detectable effect size of 0.32 for communication.
Main outcomes include infant and young child feeding practices, height, weight, hemoglobin, prevalence of anemia, prevalence of stunting, prevalence of obesity, and weight gain rate. A baseline and final survey will be conducted to collect data for these variables, as well as sociodemographic information. Impact estimation will be done comparing the average results and the distribution of indicators between the treatment and control group. Differences of simple means and regression models including co-variables of the child's age and sex, and characteristics of the primary caregiver and household will be estimated. In addition to potential changes in indicator averages, changes in the distribution of variables will be explored under the hypothesis that the intervention might not only improve average value for a given indicator, but compress the distribution over a range of values closer to an optimal range. Changes to distributions will be checked by applying the Kolmogorov-Smirnov test.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard Care+MNPs | Active comparator | Dietary Supplement: Micronutrient PowdersParticipants will receive standard health care services provided by the Ministry of Health, including micronutrient powders (MNPs). Children 6 months old will receive 1 gram of powdered micronutrients for 60 days every 6 months until 24 months of age. |
| SPOON behavioral change strategy+SQ-LNS | Experimental | Behavioral: SPOON behavioral change strategy, Dietary Supplement: SQ-LNSParticipants will receive Small Quantity Lipid-based Supplements (SQ-LNS) from 6-24 months and a behavioral change to promote adequate infant and young child feeding practices and the use of SQ-LNS will be delivered to mothers or caregivers. The behavioral change strategy includes individual home-visits, group sessions, and community mobilization activities. SQ-LNS consists of a 20g nutrient supplement package to be consumed daily from 6-24 of age. SQ-LNS formulation does not include sugar. |
| SPOON behavioral change strategy+MNPs | Experimental | Dietary Supplement: Micronutrient Powders, Behavioral: SPOON behavioral change strategyParticipants will receive micronutrient powders (MNPs) from 6-24 months and a behavioral change to promote adequate infant and young child feeding practices and the use of MNPs will be delivered to mothers or caregivers. The behavioral change strategy includes individual home-visits, group sessions, and community mobilization activities. |
Who may qualify
- Ages
- Up to 3 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Pregnant women in the third trimester or children 3 months of age
- Living in the defined intervention areas
- Children with no chronic diseases or congenital malformations
- Not planning on moving far from the intervention area in the next 24 months
Key exclusion criteria (3 listed)
- Children with any chronic disease or congenital malformation
- Caretakers of the children plan on moving in the next 24 months
- Children with severe acute malnutrition
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 |
|---|---|---|
| Micronutrient PowdersAlso: MNPsMicronutrient powders (5 nutrient formulation) are currently provided by the Guatemalan Ministry of Health to children between 6-24 months of age. | Dietary supplement | SPOON behavioral change strategy+MNPs, Standard Care+MNPs |
| SPOON behavioral change strategyAn innovative behavioral change strategy designed using ethnographic and marketing methods to promote adequate infant and young child feeding practices and the use of SQ-LNS. The strategy will be delivered to mothers or caregivers through individual home-visits, group sessions, and community mobilization activities. | Behavioural | SPOON behavioral change strategy+MNPs, SPOON behavioral change strategy+SQ-LNS |
| SQ-LNSAlso: Smal Quantity Lipid-base Nutrient SupplementsSQ-LNS is a peanut-based ready to use home fortification product to improve diet quality in children 6-24 months of age. It includes peanuts and other ingredients such as vegetable fat, powdered milk and several micronutrients. The formulation designed for this study does not include sugar. | Dietary supplement | SPOON behavioral change strategy+SQ-LNS |
Primary outcome
Infant and young child feeding practices
Time frame: Measured at baseline and after 24 months of intervention
Set of indicators of infant and young child feeding practices obtained by interview to participant mothers or caregivers
Height
Time frame: Measured at 6 and 24 months of age
Height-for-age z score obtained by measuring the height of participant children
Weight gain rate
Time frame: Constructed from weight measurements at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, and 24 months of age
Rate of weight gain from 0-24 months of age
Hemoglobin
Time frame: Measured at 6 and 24 months of age
Measurement of hemoglobin using a portable photometer
Prevalence of obesity in children
Time frame: Measured at 6 and 24 months of age
Population estimation of obesity using Population estimation of obesity using Body Mass Index (BMI)
Prevalence of stunting
Time frame: Measured at 6 and 24 months of age
Population estimation of stunting using height-for age <-2 SD
Prevalence of anemia
Time frame: Measured at 6 and 24 months of age
Population estimation of anemia using hemoglobin
2 secondary outcomes
Adherence to Nutritional Supplement Regime
Time frame: Measured every months from 6 months of age until the end of the intervention
Exclusive Breastfeeding
Time frame: Measured 24 months after the start of the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2022.
- Derived from this study: PubMed 32690508Gonzalez Acero C, Martinez S, Perez-Exposito A, Winters S. Effect of an innovative behavioural change strategy and small-quantity lipid-based nutrient supplements on stunting and obesity in children in Baja Verapaz, Guatemala: protocol for a randomised control trial. BMJ Open. 2020 Jul 19;10(7):e035528. doi: 10.1136/bmjopen-2019-035528.
- 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
IDB Evaluation Specialist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Micronutrient Powders, SPOON behavioral change strategy and SQ-LNS in people with Exclusive Breast Feeding and Feeding Patterns, run by Inter-American Development Bank at 1 site in Guatemala.
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 9 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Guatemala. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infant and young child feeding practices (time frame: Measured at baseline and after 24 months of intervention). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03399617, which also lists 1 linked publication.
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 9 Mar 2022; AzTrials last refreshed its copy on 27 Oct 2026.