SPOON: Sustained Program for Improving Nutrition - Mexico
NCT ID: NCT03752762
Last Updated: 2022-03-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2018-12-01
2020-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Standard Care
Participants will receive standard health care services provided by the Health Secretary
No interventions assigned to this group
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.
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.
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.
Interventions
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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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
6 Months
ALL
Yes
Sponsors
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Hospital Infantil de Mexico Federico Gomez
OTHER
The PepsiCo Foundation
OTHER
Inter-American Development Bank
OTHER
Responsible Party
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Principal Investigators
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Sebastian Martinez
Role: STUDY_DIRECTOR
Inter-American Development Bank
Locations
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SPOON Mexico
Tepic, Nayarit, Mexico
Countries
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Other Identifiers
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Inter-AmericanDB Mexico
Identifier Type: -
Identifier Source: org_study_id
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