Exclusive BreastfeedingNCT03752762
SPOON: Sustained Program for Improving Nutrition - Mexico
A study testing SQ-LNS and SPOON behavioral change strategy in people with Exclusive Breastfeeding and Feeding Patterns, run by Inter-American Development Bank at 1 site in Mexico.
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 Mexico. 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… Read more about this study
- Who is it for?
- Ages Up to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Exclusive Breastfeeding, Feeding Patterns, Stunting
- What is being tested?
- SQ-LNS and SPOON behavioral change strategy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteMexico
- Study dates
- 1 Dec 2018to Dec 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 6 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Pregnant women in the third trimester and children up to 6 months of age at the moment of recruitment (or children with a maximum age of 6 months at the beginning of the first visit of the program)
- Children with no chronic diseases or congenital malformations
- Resident population from Tepic and the adjacent areas of Xalisco, Lomas Verdes, and Cerro Blanco
- The residents have no plans to move away from Tepic in the following 24 months
Who cannot join
- Population belonging to the PROSPERA program
- Children with chronic diseases or congenital malformations
- Children with severe acute malnutrition
- Planning on moving far from the intervention area in the next 24 months
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 Tepic, Mexico
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 Mexico. 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 peri-urban areas of Tepic, Nayarit in Mexico in conjunction with the Hospital Infantil de México Federico Gómez and the Nayarit Secretariat of Health.
Read the detailed description
SPOON Mexico is an innovative strategy to prevent undernutrition and obesity in children aged 0-24 months living in marginalized areas of Tepic City, Nayarit. The SPOON program aims to improve infant and young children feeding practices, 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 6 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 up to 24 months. Participants will be randomly assigned at the household 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 according to the national protocol. Participants in Treatment Group 1 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 and group sessions.
A sample size of 600 children per group has been calculated to detect a minimum effect size of 0.18 with 95% level of significance and a 80% power. Additionally, a 20% attrition has been included in the sample size calculation.
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
- SQ-LNS, SPOON behavioral change strategy
- 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.
SQ-LNSDietary supplement
Also called Small Quantity Lipid 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 will not include sugar.
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 and group sessions.
| Study group | Role | What they receive |
|---|---|---|
| Standard Care | No intervention | Participants will receive standard health care services provided by the Health Secretary |
| SPOON behavioral change strategy+SQ-LNS | Experimental | Participants will receive SQ-LNS supplement 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 and group sessions. 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: Dietary Supplement: SQ-LNS; 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 at 6 months
Set of indicators of infant and young child feeding practices obtained by interview to participant mothers or caregivers
Measured: Measured at 6 months of age
Infant and young child feeding practices at 9 months
Set of indicators of infant and young child feeding practices obtained by interview to participant mothers or caregivers
Measured: Measured at 9 months of age
Infant and young child feeding practices at 12 months
Set of indicators of infant and young child feeding practices obtained by interview to participant mothers or caregivers
Measured: Measured at 12 months of age
Infant and young child feeding practices 15 months
Set of indicators of infant and young child feeding practices obtained by interview to participant mothers or caregivers
Measured: Measured 15 months of age
Infant and young child feeding practices at 18 months
Set of indicators of infant and young child feeding practices obtained by interview to participant mothers or caregivers
Measured: Measured at 18 months of age
Infant and young child feeding practices at 21 months
Set of indicators of infant and young child feeding practices obtained by interview to participant mothers or caregivers
Measured: Measured at 21 months of age
Infant and young child feeding practices at 24 months
Set of indicators of infant and young child feeding practices obtained by interview to participant mothers or caregivers
Measured: Measured at 24 months of age
Height at 6 months
Height-for-age z score obtained by measuring the height of participant children using a fixed infantometer
Measured: Measured at 6 months of age
Height at 9 months
Height-for-age z score obtained by measuring the height of participant children using a fixed infantometer
Measured: Measured at 9 months of age
Height at 12 months
Height-for-age z score obtained by measuring the height of participant children using a fixed infantometer
Measured: Measured at 12 months of age
Height at 15 months
Height-for-age z score obtained by measuring the height of participant children using a fixed infantometer
Measured: Measured at 15 months of age
Height at 18 months
Height-for-age z score obtained by measuring the height of participant children using a fixed infantometer
Measured: Measured at 18 months of age
Height at 21 months
Height-for-age z score obtained by measuring the height of participant children using a fixed infantometer
Measured: Measured at 21 months of age
Height at 24 months
Height-for-age z score obtained by measuring the height of participant children using a fixed infantometer
Measured: Measured at 24 months of age
Weight gain rate at 6 months
Rate of weight gain from 0-24 months of age obtained by measuring the weight of participant children using a fixed electronic scale
Measured: Constructed from weight measurements at 6 months of age
Weight gain rate at 9 months
Rate of weight gain from 0-24 months of age obtained by measuring the weight of participant children using a fixed electronic scale
Measured: Constructed from weight measurements at 9 months of age
Weight gain rate at 12 months
Rate of weight gain from 0-24 months of age obtained by measuring the weight of participant children using a fixed electronic scale
Measured: Constructed from weight measurements at 12 months of age
Weight gain rate at 15 months
Rate of weight gain from 0-24 months of age obtained by measuring the weight of participant children using a fixed electronic scale
Measured: Constructed from weight measurements at 15 months of age
Weight gain rate at 18 months
Rate of weight gain from 0-24 months of age obtained by measuring the weight of participant children using a fixed electronic scale
Measured: Constructed from weight measurements at 18 months of age
Weight gain rate at 21 months
Rate of weight gain from 0-24 months of age obtained by measuring the weight of participant children using a fixed electronic scale
Measured: Constructed from weight measurements at 21 months of age
Weight gain rate at 24 months
Rate of weight gain from 0-24 months of age obtained by measuring the weight of participant children using a fixed electronic scale
Measured: Constructed from weight measurements at 24 months of age
Hemoglobin at 6 months
Measurement of hemoglobin concentration in blood using blood biometry
Measured: Measured at 6 months of age
Hemoglobin at 12 months
Measurement of hemoglobin concentration in blood using blood biometry
Measured: Measured at 12 months of age
Hemoglobin at 18 months
Measurement of hemoglobin concentration in blood using blood biometry
Measured: Measured at 18 months of age
Hemoglobin at 24 months
Measurement of hemoglobin concentration in blood using blood biometry
Measured: Measured at 24 months of age
Prevalence of obesity in children at 6 months
Population estimation of obesity using Body Mass Index (BMI)
Measured: Measured at 6 months of age
Prevalence of obesity in children at 9 months
Population estimation of obesity using Body Mass Index (BMI)
Measured: Measured at 9 months of age
Prevalence of obesity in children at 12 months
Population estimation of obesity using Body Mass Index (BMI)
Measured: Measured at 12 months of age
Prevalence of obesity in children at 15 months
Population estimation of obesity using Body Mass Index (BMI)
Measured: Measured at 15 months of age
Prevalence of obesity in children at 18 months
Population estimation of obesity using Body Mass Index (BMI)
Measured: Measured at 18 months of age
Prevalence of obesity in children at 21 months
Population estimation of obesity using Body Mass Index (BMI)
Measured: Measured at 21 months of age
Prevalence of obesity in children at 24 months
Population estimation of obesity using Body Mass Index (BMI)
Measured: Measured at 24 months of age
Prevalence of stunting at 6 months
Population estimation of stunting using height-for age <-2 SD
Measured: Measured at 6 months of age
Prevalence of stunting at 9 months
Population estimation of stunting using height-for age <-2 SD
Measured: Measured at 9 months of age
Prevalence of stunting at 12 months
Population estimation of stunting using height-for age <-2 SD
Measured: Measured at 12 months of age
Prevalence of stunting at 15 months
Population estimation of stunting using height-for age <-2 SD
Measured: Measured at 15 months of age
Prevalence of stunting at 18 months
Population estimation of stunting using height-for age <-2 SD
Measured: Measured at 18 months of age
Prevalence of stunting at 21 months
Population estimation of stunting using height-for age <-2 SD
Measured: Measured at 21 months of age
Prevalence of stunting at 24 months
Population estimation of stunting using height-for age <-2 SD
Measured: Measured at 24 months of age
Prevalence of anemia at 6 months
Population estimation of anemia using hemoglobin concentration in blood
Measured: Measured at 6 months of age
Prevalence of anemia at 12 months
Population estimation of anemia using hemoglobin concentration in blood
Measured: Measured at 12 months of age
Prevalence of anemia at 18 months
Population estimation of anemia using hemoglobin concentration in blood
Measured: Measured at 18 months of age
Prevalence of anemia at 24 months
Population estimation of anemia using hemoglobin concentration in blood
Measured: Measured at 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 month from 6 months of age until 24 months of age
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 posted26 Nov 2018
- Study start1 Dec 2018 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Why it stopped: Funding cancelled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exclusive BreastfeedingStudies 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
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inter-American Development Bank
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Infantil de Mexico Federico Gomez, The PepsiCo Foundation
- Responsible party
- Sponsor
- Investigators
- Sebastian Martinez, Study director, Inter-American Development Bank
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03752762
- Sponsor's protocol ID
- Inter-AmericanDB Mexico
- 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
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 Tepic, Mexico
- ClinicalTrials.gov ID
- NCT03752762
- Acronym / sponsor ID
- Inter-AmericanDB Mexico
- Keywords
- Stunting, Obesity, Lipid-based Nutrient Supplements (LNS), Latin America, Child nutrition, Feeding practices
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding cancelled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Inter-American Development BankUniversity, hospital or other
- Collaborators
- Hospital Infantil de Mexico Federico Gomez, The PepsiCo Foundation
- Study start
- 1 Dec 2018 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 26 Nov 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 Mexico. 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 peri-urban areas of Tepic, Nayarit in Mexico in conjunction with the Hospital Infantil de México Federico Gómez and the Nayarit Secretariat of Health.
Detailed description
SPOON Mexico is an innovative strategy to prevent undernutrition and obesity in children aged 0-24 months living in marginalized areas of Tepic City, Nayarit. The SPOON program aims to improve infant and young children feeding practices, 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 6 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 up to 24 months. Participants will be randomly assigned at the household 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 according to the national protocol. Participants in Treatment Group 1 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 and group sessions.
A sample size of 600 children per group has been calculated to detect a minimum effect size of 0.18 with 95% level of significance and a 80% power. Additionally, a 20% attrition has been included in the sample size calculation.
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
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care | No intervention | –Participants will receive standard health care services provided by the Health Secretary |
| SPOON behavioral change strategy+SQ-LNS | Experimental | Dietary Supplement: SQ-LNS, Behavioral: SPOON behavioral change strategyParticipants will receive SQ-LNS supplement 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 and group sessions. 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. |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Pregnant women in the third trimester and children up to 6 months of age at the moment of recruitment (or children with a maximum age of 6 months at the beginning of the first visit of the program)
- Children with no chronic diseases or congenital malformations
- Resident population from Tepic and the adjacent areas of Xalisco, Lomas Verdes, and Cerro Blanco
- The residents have no plans to move away from Tepic in the following 24 months
Key exclusion criteria (4 listed)
- Population belonging to the PROSPERA program
- Children with chronic diseases or congenital malformations
- Children with severe acute malnutrition
- Planning on moving far from the intervention area 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 |
|---|---|---|
| SQ-LNSAlso: Small Quantity Lipid 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 will not include sugar. | Dietary supplement | SPOON behavioral change strategy+SQ-LNS |
| 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 and group sessions. | Behavioural | SPOON behavioral change strategy+SQ-LNS |
Primary outcome
Infant and young child feeding practices at 6 months
Time frame: Measured at 6 months of age
Set of indicators of infant and young child feeding practices obtained by interview to participant mothers or caregivers
Infant and young child feeding practices at 9 months
Time frame: Measured at 9 months of age
Set of indicators of infant and young child feeding practices obtained by interview to participant mothers or caregivers
Infant and young child feeding practices at 12 months
Time frame: Measured at 12 months of age
Set of indicators of infant and young child feeding practices obtained by interview to participant mothers or caregivers
Infant and young child feeding practices 15 months
Time frame: Measured 15 months of age
Set of indicators of infant and young child feeding practices obtained by interview to participant mothers or caregivers
Infant and young child feeding practices at 18 months
Time frame: Measured at 18 months of age
Set of indicators of infant and young child feeding practices obtained by interview to participant mothers or caregivers
Infant and young child feeding practices at 21 months
Time frame: Measured at 21 months of age
Set of indicators of infant and young child feeding practices obtained by interview to participant mothers or caregivers
Infant and young child feeding practices at 24 months
Time frame: Measured at 24 months of age
Set of indicators of infant and young child feeding practices obtained by interview to participant mothers or caregivers
Height at 6 months
Time frame: Measured at 6 months of age
Height-for-age z score obtained by measuring the height of participant children using a fixed infantometer
Height at 9 months
Time frame: Measured at 9 months of age
Height-for-age z score obtained by measuring the height of participant children using a fixed infantometer
Height at 12 months
Time frame: Measured at 12 months of age
Height-for-age z score obtained by measuring the height of participant children using a fixed infantometer
Height at 15 months
Time frame: Measured at 15 months of age
Height-for-age z score obtained by measuring the height of participant children using a fixed infantometer
Height at 18 months
Time frame: Measured at 18 months of age
Height-for-age z score obtained by measuring the height of participant children using a fixed infantometer
Height at 21 months
Time frame: Measured at 21 months of age
Height-for-age z score obtained by measuring the height of participant children using a fixed infantometer
Height at 24 months
Time frame: Measured at 24 months of age
Height-for-age z score obtained by measuring the height of participant children using a fixed infantometer
Weight gain rate at 6 months
Time frame: Constructed from weight measurements at 6 months of age
Rate of weight gain from 0-24 months of age obtained by measuring the weight of participant children using a fixed electronic scale
Weight gain rate at 9 months
Time frame: Constructed from weight measurements at 9 months of age
Rate of weight gain from 0-24 months of age obtained by measuring the weight of participant children using a fixed electronic scale
Weight gain rate at 12 months
Time frame: Constructed from weight measurements at 12 months of age
Rate of weight gain from 0-24 months of age obtained by measuring the weight of participant children using a fixed electronic scale
Weight gain rate at 15 months
Time frame: Constructed from weight measurements at 15 months of age
Rate of weight gain from 0-24 months of age obtained by measuring the weight of participant children using a fixed electronic scale
Weight gain rate at 18 months
Time frame: Constructed from weight measurements at 18 months of age
Rate of weight gain from 0-24 months of age obtained by measuring the weight of participant children using a fixed electronic scale
Weight gain rate at 21 months
Time frame: Constructed from weight measurements at 21 months of age
Rate of weight gain from 0-24 months of age obtained by measuring the weight of participant children using a fixed electronic scale
Weight gain rate at 24 months
Time frame: Constructed from weight measurements at 24 months of age
Rate of weight gain from 0-24 months of age obtained by measuring the weight of participant children using a fixed electronic scale
Hemoglobin at 6 months
Time frame: Measured at 6 months of age
Measurement of hemoglobin concentration in blood using blood biometry
Hemoglobin at 12 months
Time frame: Measured at 12 months of age
Measurement of hemoglobin concentration in blood using blood biometry
Hemoglobin at 18 months
Time frame: Measured at 18 months of age
Measurement of hemoglobin concentration in blood using blood biometry
Hemoglobin at 24 months
Time frame: Measured at 24 months of age
Measurement of hemoglobin concentration in blood using blood biometry
Prevalence of obesity in children at 6 months
Time frame: Measured at 6 months of age
Population estimation of obesity using Body Mass Index (BMI)
Prevalence of obesity in children at 9 months
Time frame: Measured at 9 months of age
Population estimation of obesity using Body Mass Index (BMI)
Prevalence of obesity in children at 12 months
Time frame: Measured at 12 months of age
Population estimation of obesity using Body Mass Index (BMI)
Prevalence of obesity in children at 15 months
Time frame: Measured at 15 months of age
Population estimation of obesity using Body Mass Index (BMI)
Prevalence of obesity in children at 18 months
Time frame: Measured at 18 months of age
Population estimation of obesity using Body Mass Index (BMI)
Prevalence of obesity in children at 21 months
Time frame: Measured at 21 months of age
Population estimation of obesity using Body Mass Index (BMI)
Prevalence of obesity in children at 24 months
Time frame: Measured at 24 months of age
Population estimation of obesity using Body Mass Index (BMI)
Prevalence of stunting at 6 months
Time frame: Measured at 6 months of age
Population estimation of stunting using height-for age <-2 SD
Prevalence of stunting at 9 months
Time frame: Measured at 9 months of age
Population estimation of stunting using height-for age <-2 SD
Prevalence of stunting at 12 months
Time frame: Measured at 12 months of age
Population estimation of stunting using height-for age <-2 SD
Prevalence of stunting at 15 months
Time frame: Measured at 15 months of age
Population estimation of stunting using height-for age <-2 SD
Prevalence of stunting at 18 months
Time frame: Measured at 18 months of age
Population estimation of stunting using height-for age <-2 SD
Prevalence of stunting at 21 months
Time frame: Measured at 21 months of age
Population estimation of stunting using height-for age <-2 SD
Prevalence of stunting at 24 months
Time frame: Measured at 24 months of age
Population estimation of stunting using height-for age <-2 SD
Prevalence of anemia at 6 months
Time frame: Measured at 6 months of age
Population estimation of anemia using hemoglobin concentration in blood
Prevalence of anemia at 12 months
Time frame: Measured at 12 months of age
Population estimation of anemia using hemoglobin concentration in blood
Prevalence of anemia at 18 months
Time frame: Measured at 18 months of age
Population estimation of anemia using hemoglobin concentration in blood
Prevalence of anemia at 24 months
Time frame: Measured at 24 months of age
Population estimation of anemia using hemoglobin concentration in blood
2 secondary outcomes
Adherence to Nutritional Supplement Regime
Time frame: Measured every month from 6 months of age until 24 months of age
Exclusive Breastfeeding
Time frame: Measured 24 months after the start of the intervention
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2022.
- 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SQ-LNS and SPOON behavioral change strategy in people with Exclusive Breastfeeding and Feeding Patterns, run by Inter-American Development Bank at 1 site in Mexico.
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 4 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: withdrawn, 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 Mexico. 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 was withdrawn before enrolling participants, so there are no results.
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 at 6 months (time frame: Measured at 6 months of age). The study lists 43 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 9 Mar 2022; AzTrials last refreshed its copy on 27 Oct 2026.