Skip to main content
Clinical Trials/NCT03399617
NCT03399617
Completed
Not Applicable

Effect of an Innovative Behavioral Change Strategy and SQ-LNS on Stunting and Obesity in Children Living in Baja Verapaz, Guatemala

Inter-American Development Bank1 site in 1 country1,280 target enrollmentSeptember 15, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Exclusive Breast Feeding
Sponsor
Inter-American Development Bank
Enrollment
1280
Locations
1
Primary Endpoint
Prevalence of anemia
Status
Completed
Last Updated
4 years ago

Overview

Brief 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 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.

Registry
clinicaltrials.gov
Start Date
September 15, 2018
End Date
December 18, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Prevalence of anemia

Time Frame: Measured at 6 and 24 months of age

Population estimation of anemia using hemoglobin

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

Secondary Outcomes

  • Adherence to Nutritional Supplement Regime(Measured every months from 6 months of age until the end of the intervention)
  • Exclusive Breastfeeding(Measured 24 months after the start of the intervention)

Study Sites (1)

Loading locations...

Similar Trials