SPOON: Sustained Program for Improving Nutrition - Mexico

• ClinicalTrials.gov Identifier: NCT03752762
• Recruitment Status: Withdrawn
• First Posted: November 26, 2018
• Last Update Posted: March 9, 2022
• Sponsor: Inter-American Development Bank
• Collaborators: Hospital Infantil de Mexico Federico Gomez; The PepsiCo Foundation
• Information provided by (Responsible Party): Inter-American Development Bank

Study Description

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 Mexico. 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 peri-urban areas of Tepic, Nayarit in Mexico in conjunction with the Hospital Infantil de México Federico Gómez and the Nayarit Secretariat of Health.

Condition or disease	Intervention/treatment	Phase
Exclusive Breastfeeding; Feeding Patterns; Stunting; Obesity, Childhood	Dietary Supplement: SQ-LNS; Behavioral: SPOON behavioral change strategy	Not Applicable

Detailed Description:

SPOON Mexico is an innovative strategy to prevent undernutrition and obesity in children aged 0-24 months living in marginalized areas of Tepic City, Nayarit. The SPOON program aims to improve infant and young children feeding practices, 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 6 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 up to 24 months. Participants will be randomly assigned at the household 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 according to the national protocol. Participants in Treatment Group 1 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 and group sessions.

A sample size of 600 children per group has been calculated to detect a minimum effect size of 0.18 with 95% level of significance and a 80% power. Additionally, a 20% attrition has been included in the sample size calculation.

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Effect of an Innovative Behavioral Change Strategy and SQ-LNS on Stunting and Obesity in Children Living in Tepic, Mexico
• Estimated Study Start Date: December 1, 2018
• Estimated Primary Completion Date: December 2020
• Estimated Study Completion Date: December 2020

Arms and Interventions

Arm	Intervention/treatment
No Intervention: Standard Care; Participants will receive standard health care services provided by the Health Secretary
Experimental: SPOON behavioral change strategy+SQ-LNS; Participants will receive SQ-LNS supplement 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 and group sessions. 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.	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 will not include sugar.; Other Name: Small Quantity Lipid Nutrient Supplements; 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 and group sessions.

Outcome Measures

Primary Outcome Measures :

1. Infant and young child feeding practices at 6 months [ Time Frame: Measured at 6 months of age ]
   Set of indicators of infant and young child feeding practices obtained by interview to participant mothers or caregivers
2. Infant and young child feeding practices at 9 months [ Time Frame: Measured at 9 months of age ]
   Set of indicators of infant and young child feeding practices obtained by interview to participant mothers or caregivers
3. Infant and young child feeding practices at 12 months [ Time Frame: Measured at 12 months of age ]
   Set of indicators of infant and young child feeding practices obtained by interview to participant mothers or caregivers
4. Infant and young child feeding practices 15 months [ Time Frame: Measured 15 months of age ]
   Set of indicators of infant and young child feeding practices obtained by interview to participant mothers or caregivers
5. Infant and young child feeding practices at 18 months [ Time Frame: Measured at 18 months of age ]
   Set of indicators of infant and young child feeding practices obtained by interview to participant mothers or caregivers
6. Infant and young child feeding practices at 21 months [ Time Frame: Measured at 21 months of age ]
   Set of indicators of infant and young child feeding practices obtained by interview to participant mothers or caregivers
7. Infant and young child feeding practices at 24 months [ Time Frame: Measured at 24 months of age ]
   Set of indicators of infant and young child feeding practices obtained by interview to participant mothers or caregivers
8. Height at 6 months [ Time Frame: Measured at 6 months of age ]
   Height-for-age z score obtained by measuring the height of participant children using a fixed infantometer
9. Height at 9 months [ Time Frame: Measured at 9 months of age ]
   Height-for-age z score obtained by measuring the height of participant children using a fixed infantometer
10. Height at 12 months [ Time Frame: Measured at 12 months of age ]
    Height-for-age z score obtained by measuring the height of participant children using a fixed infantometer
11. Height at 15 months [ Time Frame: Measured at 15 months of age ]
    Height-for-age z score obtained by measuring the height of participant children using a fixed infantometer
12. Height at 18 months [ Time Frame: Measured at 18 months of age ]
    Height-for-age z score obtained by measuring the height of participant children using a fixed infantometer
13. Height at 21 months [ Time Frame: Measured at 21 months of age ]
    Height-for-age z score obtained by measuring the height of participant children using a fixed infantometer
14. Height at 24 months [ Time Frame: Measured at 24 months of age ]
    Height-for-age z score obtained by measuring the height of participant children using a fixed infantometer
15. Weight gain rate at 6 months [ Time Frame: Constructed from weight measurements at 6 months of age ]
    Rate of weight gain from 0-24 months of age obtained by measuring the weight of participant children using a fixed electronic scale
16. Weight gain rate at 9 months [ Time Frame: Constructed from weight measurements at 9 months of age ]
    Rate of weight gain from 0-24 months of age obtained by measuring the weight of participant children using a fixed electronic scale
17. Weight gain rate at 12 months [ Time Frame: Constructed from weight measurements at 12 months of age ]
    Rate of weight gain from 0-24 months of age obtained by measuring the weight of participant children using a fixed electronic scale
18. Weight gain rate at 15 months [ Time Frame: Constructed from weight measurements at 15 months of age ]
    Rate of weight gain from 0-24 months of age obtained by measuring the weight of participant children using a fixed electronic scale
19. Weight gain rate at 18 months [ Time Frame: Constructed from weight measurements at 18 months of age ]
    Rate of weight gain from 0-24 months of age obtained by measuring the weight of participant children using a fixed electronic scale
20. Weight gain rate at 21 months [ Time Frame: Constructed from weight measurements at 21 months of age ]
    Rate of weight gain from 0-24 months of age obtained by measuring the weight of participant children using a fixed electronic scale
21. Weight gain rate at 24 months [ Time Frame: Constructed from weight measurements at 24 months of age ]
    Rate of weight gain from 0-24 months of age obtained by measuring the weight of participant children using a fixed electronic scale
22. Hemoglobin at 6 months [ Time Frame: Measured at 6 months of age ]
    Measurement of hemoglobin concentration in blood using blood biometry
23. Hemoglobin at 12 months [ Time Frame: Measured at 12 months of age ]
    Measurement of hemoglobin concentration in blood using blood biometry
24. Hemoglobin at 18 months [ Time Frame: Measured at 18 months of age ]
    Measurement of hemoglobin concentration in blood using blood biometry
25. Hemoglobin at 24 months [ Time Frame: Measured at 24 months of age ]
    Measurement of hemoglobin concentration in blood using blood biometry
26. Prevalence of obesity in children at 6 months [ Time Frame: Measured at 6 months of age ]
    Population estimation of obesity using Body Mass Index (BMI)
27. Prevalence of obesity in children at 9 months [ Time Frame: Measured at 9 months of age ]
    Population estimation of obesity using Body Mass Index (BMI)
28. Prevalence of obesity in children at 12 months [ Time Frame: Measured at 12 months of age ]
    Population estimation of obesity using Body Mass Index (BMI)
29. Prevalence of obesity in children at 15 months [ Time Frame: Measured at 15 months of age ]
    Population estimation of obesity using Body Mass Index (BMI)
30. Prevalence of obesity in children at 18 months [ Time Frame: Measured at 18 months of age ]
    Population estimation of obesity using Body Mass Index (BMI)
31. Prevalence of obesity in children at 21 months [ Time Frame: Measured at 21 months of age ]
    Population estimation of obesity using Body Mass Index (BMI)
32. Prevalence of obesity in children at 24 months [ Time Frame: Measured at 24 months of age ]
    Population estimation of obesity using Body Mass Index (BMI)
33. Prevalence of stunting at 6 months [ Time Frame: Measured at 6 months of age ]
    Population estimation of stunting using height-for age <-2 SD
34. Prevalence of stunting at 9 months [ Time Frame: Measured at 9 months of age ]
    Population estimation of stunting using height-for age <-2 SD
35. Prevalence of stunting at 12 months [ Time Frame: Measured at 12 months of age ]
    Population estimation of stunting using height-for age <-2 SD
36. Prevalence of stunting at 15 months [ Time Frame: Measured at 15 months of age ]
    Population estimation of stunting using height-for age <-2 SD
37. Prevalence of stunting at 18 months [ Time Frame: Measured at 18 months of age ]
    Population estimation of stunting using height-for age <-2 SD
38. Prevalence of stunting at 21 months [ Time Frame: Measured at 21 months of age ]
    Population estimation of stunting using height-for age <-2 SD
39. Prevalence of stunting at 24 months [ Time Frame: Measured at 24 months of age ]
    Population estimation of stunting using height-for age <-2 SD
40. Prevalence of anemia at 6 months [ Time Frame: Measured at 6 months of age ]
    Population estimation of anemia using hemoglobin concentration in blood
41. Prevalence of anemia at 12 months [ Time Frame: Measured at 12 months of age ]
    Population estimation of anemia using hemoglobin concentration in blood
42. Prevalence of anemia at 18 months [ Time Frame: Measured at 18 months of age ]
    Population estimation of anemia using hemoglobin concentration in blood
43. Prevalence of anemia at 24 months [ Time Frame: Measured at 24 months of age ]
    Population estimation of anemia using hemoglobin concentration in blood

Secondary Outcome Measures :

1. Adherence to Nutritional Supplement Regime [ Time Frame: Measured every month from 6 months of age until 24 months of age ]
   Consumption of the nutritional supplement measured as the number of packets consumed in one month
2. Exclusive Breastfeeding [ Time Frame: Measured 24 months after the start of the intervention ]
   Measured as an indicator of exclusive breastfeeding, self-reported by the mother of a child

Eligibility Criteria

• Ages Eligible for Study: up to 6 Months (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Pregnant women in the third trimester and children up to 6 months of age at the moment of recruitment (or children with a maximum age of 6 months at the beginning of the first visit of the program)
• Children with no chronic diseases or congenital malformations
• Resident population from Tepic and the adjacent areas of Xalisco, Lomas Verdes, and Cerro Blanco
• The residents have no plans to move away from Tepic in the following 24 months

Exclusion Criteria:

• Population belonging to the PROSPERA program
• Children with chronic diseases or congenital malformations
• Children with severe acute malnutrition
• Planning on moving far from the intervention area in the next 24 months

Contacts and Locations

Locations

Mexico

SPOON Mexico

Tepic, Nayarit, Mexico

Sponsors and Collaborators

Inter-American Development Bank

Hospital Infantil de Mexico Federico Gomez

The PepsiCo Foundation

Investigators

• Study Director: Sebastian Martinez; Inter-American Development Bank

More Information

• Responsible Party: Inter-American Development Bank
• ClinicalTrials.gov Identifier: NCT03752762
• Other Study ID Numbers: Inter-AmericanDB Mexico
• First Posted: November 26, 2018
• Last Update Posted: March 9, 2022
• Last Verified: February 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Unidentified individual data will be shared among participating research institutions and made public 2 years after finalizing the study

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Inter-American Development Bank:

Stunting; Obesity; Lipid-based Nutrient Supplements (LNS); Latin America; Child nutrition; Feeding practices

Additional relevant MeSH terms:

Obesity; Pediatric Obesity; Growth Disorders; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Pathologic Processes