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
Verified date | February 2022 |
Source | Inter-American Development Bank |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Guatemala | SPOON Guatemala | Rabinal | Baja Verapaz |
Lead Sponsor | Collaborator |
---|---|
Inter-American Development Bank | Fundazúcar, The PepsiCo Foundation |
Guatemala,
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 |
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