Clinical trial NCT03399617: SPOON: Sustained Program for Improving Nutrition - Guatemala
Official title: Effect of an Innovative Behavioral Change Strategy and SQ-LNS on Stunting and Obesity in Children Living in Baja Verapaz, Guatemala
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exclusive Breast Feeding
Feeding Patterns
Stunting
Obesity, Childhood
Keywords: Stunting
Obesity
Lipid-based Nutrient Supplements (LNS)
Latin America
Child nutrition
Feeding practices
Lead sponsor: Inter-American Development Bank
Sponsor class: OTHER
Collaborators: name: The PepsiCo Foundation
name: Fundazúcar
First posted: 2018-01-16
Enrollment: 1280
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Infant and young child feeding practices
timeFrame: Measured at baseline and after 24 months of intervention
measure: Height
timeFrame: Measured at 6 and 24 months of age
measure: Weight gain rate
timeFrame: Constructed from weight measurements at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, and 24 months of age
measure: Hemoglobin
timeFrame: Measured at 6 and 24 months of age
measure: Prevalence of obesity in children
timeFrame: Measured at 6 and 24 months of age
measure: Prevalence of stunting
timeFrame: Measured at 6 and 24 months of age
measure: Prevalence of anemia
timeFrame: Measured at 6 and 24 months of age
Secondary outcomes:
measure: Adherence to Nutritional Supplement Regime
timeFrame: Measured every months from 6 months of age until the end of the intervention
measure: Exclusive Breastfeeding
timeFrame: Measured 24 months after the start of the intervention
Other outcomes:
Locations:
city: Rabinal
country: Guatemala
facility: SPOON Guatemala
state: Baja Verapaz
Study officials:
affiliation: IDB Evaluation Specialist
name: Sebastian Martinez
role: STUDY_DIRECTOR
References:
citation: Gonzalez Acero C, Martinez S, Perez-Exposito A, Winters S. Effect of an innovative behavioural change strategy and small-quantity lipid-based nutrient supplements on stunting and obesity in children in Baja Verapaz, Guatemala: protocol for a randomised control trial. BMJ Open. 2020 Jul 19;10(7):e035528. doi: 10.1136/bmjopen-2019-035528.