SPOON: Sustained Program for Improving Nutrition - Guatemala

Obesity, Childhood Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03399617
• Other study ID #: Inter-AmericanDB Guatemala
• Status: Completed
• Phase: N/A
• Start date: September 15, 2018
• Est. completion date: December 18, 2021

Study information

• Verified date: February 2022
• Source: Inter-American Development Bank
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1280
• Est. completion date: December 18, 2021
• Est. primary completion date: November 18, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 3 Months

Eligibility

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

Related Conditions & MeSH terms

• Exclusive Breast Feeding
• Feeding Patterns
• Growth Disorders
• Obesity
• Obesity, Childhood
• Pediatric Obesity
• Stunting

Intervention

Dietary Supplement:
• Micronutrient Powders
Micronutrient powders (5 nutrient formulation) are currently provided by the Guatemalan Ministry of Health to children between 6-24 months of age.

Behavioral:
• SPOON behavioral change strategy
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.

Dietary Supplement:
• SQ-LNS
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.

Locations

Country	Name	City	State
Guatemala	SPOON Guatemala	Rabinal	Baja Verapaz

Sponsors (3)

Lead Sponsor	Collaborator
Inter-American Development Bank	Fundazúcar, The PepsiCo Foundation

Country where clinical trial is conducted

Guatemala, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 at baseline and after 24 months of intervention
Primary	Height	Height-for-age z score obtained by measuring the height of participant children	Measured at 6 and 24 months of age
Primary	Weight gain rate	Rate of weight gain from 0-24 months of age	Constructed from weight measurements at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, and 24 months of age
Primary	Hemoglobin	Measurement of hemoglobin using a portable photometer	Measured at 6 and 24 months of age
Primary	Prevalence of obesity in children	Population estimation of obesity using Population estimation of obesity using Body Mass Index (BMI)	Measured at 6 and 24 months of age
Primary	Prevalence of stunting	Population estimation of stunting using height-for age <-2 SD	Measured at 6 and 24 months of age
Primary	Prevalence of anemia	Population estimation of anemia using hemoglobin	Measured at 6 and 24 months of age
Secondary	Adherence to Nutritional Supplement Regime	Consumption of the nutritional supplement measured as the number of packets consumed in one month	Measured every months from 6 months of age until the end of the intervention
Secondary	Exclusive Breastfeeding	Measured as an indicator of exclusive breastfeeding, self-reported by the mother of a child	Measured 24 months after the start of the intervention