NCT05489094

The Impact of Nutrition Education and Milk Provision in Fueling the Progress of 1 - 3 Years Old Children

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 196 (estimated)
• Sponsor: Danone Specialized Nutrition Indonesia · Industry
• Sex: All
• Age: 12 Months – 32 Months
• Healthy volunteers: Not accepted

Summary

The study will be conducted by the Indonesia Nutrition Association that led by a Principle Investigator and supported by the study team consisted of Nutritionists. The aims of the study are to reduce iron deficiency by increasing iron intake in children 1-3 years by providing interventions in the form of increasing iron intake from growing up milk for four months and nutrition education for the intervention group and nutrition education only for the control group.

Detailed description

The study will be conducted by the Indonesia Nutrition Association that led by a Principle Investigator and supported by the study team consisted of Nutritionists. The aim of the study is to reduce iron deficiency by increasing iron intake in children 1-3 years (min 40%) by providing interventions in the form of increasing iron intake from growing up milk and nutrition education for the intervention group and nutrition education only for the control group for four months intervention period. The subject for the study is 2 x 98 children for a cluster randomization control trial study residing in Kampung Melayu, East Jakarta. After signed informed consent had been obtained from parents/caretakers, baseline characteristics (demographics, medical history, pre-existing conditions, weight, and height) were collected and recorded. Children that have passed the requirements to be included and not to be excluded based on inclusion and exclusion criteria will be collected and recorded their data based on the protocol. All children in the intervention group will be receiving nutrition education and growing up milk approximately 2-3 servings/day during the intervention period, whereas those who are in the control group will receive only nutrition education. Their data will be collected and recorded for the study. During the intervention period, in a regular period, children in the study, will be measured on parameters that are stated above. Screening, enrolment, baseline measurements, subsequent assessments at 1, 2, 3, and 4 months of intervention will be done at the community health center in Jakarta. The monitoring to ensure adherent to the intervention will be conducted via home visits by health workers.

Conditions

• Iron-deficiency

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Nutrition Education and Growing Up Milk for 1 - 3 years old	Nutrition education is a basic information related balanced nutrition for 1 - 3 children including the details of food types and calories. while Intervention product is formulated to deliver macro- and micronutrients as part of the dietary intake for children at 1-3 years old with Iron-C formula
BEHAVIORAL	Nutrition Education	Nutrition education is a basic information related balanced nutrition for 1 - 3 children including the details of food types and calories.

Timeline

• Start date: 2022-08-31
• Primary completion: 2023-02-28
• Completion: 2023-02-28
• First posted: 2022-08-05
• Last updated: 2022-08-15