Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Exclusive Breast Feeding
  • Feeding Patterns
  • Obesity, Childhood
  • Stunting
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Outcomes Assessor)Primary Purpose: Prevention

Participation Requirements

Age
Younger than 3 years
Gender
Both males and females

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-fortifica...

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.

Tracking Information

NCT #
NCT03399617
Collaborators
  • The PepsiCo Foundation
  • JPO-JSF Poverty Reduction Program
  • Fundazúcar
Investigators
Study Director: Sebastian Martinez IDB Evaluation Specialist