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
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.
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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT03994419 -
PErioperAtive CHildhood ObesitY
|
||
Active, not recruiting |
NCT06259539 -
A YouTube Curriculum for Children With Autism and Obesity
|
N/A | |
Completed |
NCT03533621 -
Gut Microbiome, Adiposity, and Probiotics (GMAP)
|
N/A | |
Completed |
NCT03641521 -
A Trial to Increase Child Vegetable Intake Through Behavioral Strategies
|
N/A | |
Completed |
NCT04009304 -
Effective Training Models for Implementing Health-Promoting Practices Afterschool
|
N/A | |
Completed |
NCT05563311 -
Functional Assessment and Sleep Apnea in Obese Children and Adolescents
|
N/A | |
Completed |
NCT03575884 -
Fit 5 Kids Screen Time Reduction Curriculum for Latino Preschoolers
|
N/A | |
Terminated |
NCT03586544 -
Reducing Exercise-induced Bronchoconstriction in Children With Asthma and Obesity
|
Phase 4 | |
Completed |
NCT04628897 -
Physical Activity and the Home Environment in Preschool-aged Children in Urban Bangladesh
|
||
Enrolling by invitation |
NCT06265597 -
The Effect of Healthy Nutrition and Yoga Program on Obese Children
|
N/A | |
Active, not recruiting |
NCT03843424 -
Treatment Efforts Addressing Child Weight Management by Unifying Patients, Parents & Providers
|
N/A | |
Completed |
NCT03170700 -
Online Videos and New Feeding Content to Enhance a Current EFNEP Program
|
N/A | |
Not yet recruiting |
NCT06464497 -
Whole Foods for Teens: A Pilot Dietary Intervention to Reduce Body Adiposity in Adolescents With Obesity
|
N/A | |
Enrolling by invitation |
NCT05551650 -
El Sendero: Pathways to Health Study
|
||
Completed |
NCT04346433 -
Sleep and Stigma: Novel Moderators in the Relationship Between Weight Status and Cognitive Function
|
N/A | |
Recruiting |
NCT03963557 -
Cognitive Function and Body Mass Index in Children and Adolescents
|
||
Completed |
NCT03495310 -
Effect of Mindfulness on Stress, Appetite Hormones and Body Weight of Obese Schoolchildren. Controlled Clinical Trial
|
N/A | |
Recruiting |
NCT06028113 -
A Novel Obesity Prevention Program for High-Risk Infants in Primary Care
|
Phase 2 | |
Active, not recruiting |
NCT05465057 -
"HIIT Med Kiloene".
|
N/A | |
Completed |
NCT03069274 -
Sugar-sweetened Beverage Intake Substitution by Water to Prevent Overweight in Mexican Children
|
N/A |