An interventional study of Micronutrient Powders and SPOON behavioral change strategy in Exclusive Breast Feeding, Feeding Patterns and Stunting, sponsored by Inter-American Development Bank. Completed at 1 site in Guatemala. Open to participants aged Up to 3 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-09.
Sponsored by Inter-American Development Bank · Not applicable, Interventional, and Prevention
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.
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.
1,081 studies on the registry are indexed under Breast Feeding; 217 are open to participants now.
This study's enrollment of 1,280 is above the median of 100 across 844 interventional studies indexed under Breast Feeding.
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Exclusion Criteria:
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.
Dietary Supplement: Micronutrient Powders
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.
Behavioral: SPOON behavioral change strategy · Dietary Supplement: SQ-LNS
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.
Dietary Supplement: Micronutrient Powders · Behavioral: SPOON behavioral change strategy
Micronutrient powders (5 nutrient formulation) are currently provided by the Guatemalan Ministry of Health to children between 6-24 months of age.
Also known as: MNPs
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-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.
Also known as: Smal Quantity Lipid-base Nutrient Supplements
Infant and young child feeding practices
Set of indicators of infant and young child feeding practices obtained by interview to participant mothers or caregivers
Time frame: Measured at baseline and after 24 months of intervention
Height
Height-for-age z score obtained by measuring the height of participant children
Time frame: Measured at 6 and 24 months of age
Weight gain rate
Rate of weight gain from 0-24 months of age
Time frame: 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
Time frame: 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)
Time frame: Measured at 6 and 24 months of age
Prevalence of stunting
Population estimation of stunting using height-for age \<-2 SD
Time frame: Measured at 6 and 24 months of age
Prevalence of anemia
Population estimation of anemia using hemoglobin
Time frame: Measured at 6 and 24 months of age
Adherence to Nutritional Supplement Regime
Consumption of the nutritional supplement measured as the number of packets consumed in one month
Time frame: 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
Time frame: Measured 24 months after the start of the intervention
Plan to share: Yes — Unidentified individual data will be shared among participating research institutions and made public 2 years after finalizing the study
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code
Time frame: 2 years after finalizing the study
Access criteria: Public
Ran from Sep 2018 to primary completion in Nov 2021, 38 months.
Of 502 non-industry interventional studies with no phase under Breast Feeding, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 23. This study's 38 months is above that.
Counting every sponsor, half of 510 studies reached it within 12 months; a quarter within 6 and three quarters within 23.
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This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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Inter-American Development Bank