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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Iron-deficiency
• Intervention / Treatment: Combination product: Nutrition Education and Growing Up Milk for 1 - 3 years old; Behavioral: Nutrition Education

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.

• Study Type: Interventional
• Enrollment (Anticipated): 196
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Dr. dr. Dian N Chandra, M.Gizi; Phone Number: +62 815-9113-542; Email: diannovitach@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 2 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Apparently healthy Indonesian children
• Age 12 - 32 months at baseline visit
• Willing to take min 2 serving of study product per day
• Daily Iron intake less than 80% of Indonesian RDA (<5.6 mg/day)
• Planning to reside in the study area during the next 4 months
• Written informed consent by parent(s) or legally acceptable representative (in ICF there is statement that both are agree that child participate in the study)

Exclusion Criteria:

• Having Hb <8 g/dL using Hemocue
• Having cow's milk allergy, galactosemia, conditions needing a special diet, like major renal and hepatic dysfunction, major gastrointestinal intolerance (e.g., severe vomiting, severe diarrhea), investigator's uncertainty about the willingness or ability of the child/carer to comply with the protocol requirements, participation in any other study within two weeks prior to entry into the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention Group; First group will be given nutrition education and iron intake from growing up milk approximately 2 - 3 servings/day for four months intervention period	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
Placebo Comparator: Control Group; Second group will be given nutrition education only for four months intervention period	Behavioral: Nutrition Education; Nutrition education is a basic information related balanced nutrition for 1 - 3 children including the details of food types and calories.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impact of milk provision on change from baseline of daily iron intake at 4 month in intervention group vs control group	To know the impact of milk provision on change of daily iron intake using 24h recall and semi quantitative food frequency questionnaire in intervention group vs control group	at baseline and at 4 months after baseline (visit4)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impact of milk provision on the adequacy of iron intake based on percentage of recommended daily allowance	To know the adequacy of iron intake based on percentage of recommended daily allowance at baseline in intervention group vs control group	baseline
Impact of milk provision on the adequacy of iron intake based on percentage of recommended daily allowance	To know the adequacy of iron intake based on percentage of recommended daily allowance at 1 month in intervention group vs control group	1 month after baseline (visit1)
Impact of milk provision on the adequacy of iron intake based on percentage of recommended daily allowance	To know the adequacy of iron intake based on percentage of recommended daily allowance at 2 months in intervention group vs control group	2 months after baseline (visit2)
Impact of milk provision on the adequacy of iron intake based on percentage of recommended daily allowance	To know the adequacy of iron intake based on percentage of recommended daily allowance at 3 months in intervention group vs control group	3 months after baseline (visit3)
Impact of milk provision on the adequacy of iron intake based on percentage of recommended daily allowance	To know the adequacy of iron intake based on percentage of recommended daily allowance at 4 months in intervention group vs control group	4 months after baseline (visit4)
Impact of milk provision on the average daily nutrients intake (Energy in kcal)	To know the average daily nutrients intake (Energy in kcal) at baseline in intervention group vs control group	baseline
Impact of milk provision on the average daily nutrients intake (Protein, Carbohydrate, Fat, Fiber & DHA in g)	To know the average daily nutrients intake (Protein, Carbohydrate, Fat, Fiber & DHA in g) at baseline in intervention group vs control group	baseline
Impact of milk provision on the average daily nutrients intake (Fe, Ca, P, Zn, Mg, Vit B6 & Vit E in mg)	To know the average daily nutrients intake (Fe, Ca, P, Zn, Mg, Vit B6 & Vit E in mg) at baseline in intervention group vs control group	baseline
Impact of milk provision on the average daily nutrients intake (Folic Acid, Vit A, Vit C, Vit D & Vit B12 in μg)	To know the average daily nutrients intake (Folic Acid, Vit A, Vit C, Vit D & Vit B12 in μg) at baseline in intervention group vs control group	baseline
Impact of milk provision on the average daily nutrients intake (Energy in kcal)	To know the average daily nutrients intake (Energy in kcal) at 1 month in intervention group vs control group	1 month after baseline (visit1)
Impact of milk provision on the average daily nutrients intake (Protein, Carbohydrate, Fat, Fiber & DHA in g)	To know the average daily nutrients intake (Protein, Carbohydrate, Fat, Fiber & DHA in g) at 1 month in intervention group vs control group	1 month after baseline (visit1)
Impact of milk provision on the average daily nutrients intake (Fe, Ca, P, Zn, Mg, Vit B6 & Vit E in mg)	To know the average daily nutrients intake (Fe, Ca, P, Zn, Mg, Vit B6 & Vit E in mg) at 1 month in intervention group vs control group	1 month after baseline (visit1)
Impact of milk provision on the average daily nutrients intake (Folic Acid, Vit A, Vit C, Vit D & Vit B12 in μg)	To know the average daily nutrients intake (Folic Acid, Vit A, Vit C, Vit D & Vit B12 in μg) at 1 month in intervention group vs control group	1 month after baseline (visit1)
Impact of milk provision on the average daily nutrients intake (Energy in kcal)	To know the average daily nutrients intake (Energy in kcal) at 2 months in intervention group vs control group	2 months after baseline (visit2)
Impact of milk provision on the average daily nutrients intake (Protein, Carbohydrate, Fat, Fiber & DHA in g)	To know the average daily nutrients intake (Protein, Carbohydrate, Fat, Fiber & DHA in g) at 2 months in intervention group vs control group	2 months after baseline (visit2)
Impact of milk provision on the average daily nutrients intake (Fe, Ca, P, Zn, Mg, Vit B6 & Vit E in mg)	To know the average daily nutrients intake (Fe, Ca, P, Zn, Mg, Vit B6 & Vit E in mg) at 2 months in intervention group vs control group	2 months after baseline (visit2)
Impact of milk provision on the average daily nutrients intake (Folic Acid, Vit A, Vit C, Vit D & Vit B12 in μg)	To know the average daily nutrients intake (Folic Acid, Vit A, Vit C, Vit D & Vit B12 in μg) at 2 months in intervention group vs control group	2 months after baseline (visit2)
Impact of milk provision on the average daily nutrients intake (Energy in kcal)	To know the average daily nutrients intake (Energy in kcal) at 3 months in intervention group vs control group	3 months after baseline (visit3)
Impact of milk provision on the average daily nutrients intake (Protein, Carbohydrate, Fat, Fiber & DHA in g)	To know the average daily nutrients intake (Protein, Carbohydrate, Fat, Fiber & DHA in g) at 3 months in intervention group vs control group	3 months after baseline (visit3)
Impact of milk provision on the average daily nutrients intake (Fe, Ca, P, Zn, Mg, Vit B6 & Vit E in mg)	To know the average daily nutrients intake (Fe, Ca, P, Zn, Mg, Vit B6 & Vit E in mg) at 3 months in intervention group vs control group	3 months after baseline (visit3)
Impact of milk provision on the average daily nutrients intake (Folic Acid, Vit A, Vit C, Vit D & Vit B12 in μg)	To know the average daily nutrients intake (Folic Acid, Vit A, Vit C, Vit D & Vit B12 in μg) at 3 months in intervention group vs control group	3 months after baseline (visit3)
Impact of milk provision on the average daily nutrients intake (Energy in kcal)	To know the average daily nutrients intake (Energy in kcal) at 4 months in intervention group vs control group	4 months after baseline (visit4)
Impact of milk provision on the average daily nutrients intake (Protein, Carbohydrate, Fat, Fiber & DHA in g)	To know the average daily nutrients intake (Protein, Carbohydrate, Fat, Fiber & DHA in g) at 4 months in intervention group vs control group	4 months after baseline (visit4)
Impact of milk provision on the average daily nutrients intake (Fe, Ca, P, Zn, Mg, Vit B6 & Vit E in mg)	To know the average daily nutrients intake (Fe, Ca, P, Zn, Mg, Vit B6 & Vit E in mg) at 4 months in intervention group vs control group	4 months after baseline (visit4)
Impact of milk provision on the average daily nutrients intake (Folic Acid, Vit A, Vit C, Vit D & Vit B12 in μg)	To know the average daily nutrients intake (Folic Acid, Vit A, Vit C, Vit D & Vit B12 in μg) at 4 months in intervention group vs control group	4 months after baseline (visit4)
Impact of milk provision on Total hemoglobin Level (SpHb) level using Masimo device	To know the hemoglobin level at baseline in intervention group vs control group	baseline
Impact of milk provision on Total hemoglobin Level (SpHb) level using Masimo device	To know the hemoglobin level at 4 months in intervention group vs control group	4 months after baseline (visit4)
Impact of milk provision on nutritional status (weight, height - WAZ, HAZ, and WHZ)	To know the nutritional status (weight, height - WAZ, HAZ, and WHZ) at baseline in intervention group vs control group	baseline
Impact of milk provision on nutritional status (weight, height - WAZ, HAZ, and WHZ)	To know the nutritional status (weight, height - WAZ, HAZ, and WHZ) at 1 month in intervention group vs control group	1 month after baseline (visit1)
Impact of milk provision on nutritional status (weight, height - WAZ, HAZ, and WHZ)	To know the nutritional status (weight, height - WAZ, HAZ, and WHZ) at 2 months in intervention group vs control group	2 months after baseline (visit1)
Impact of milk provision on nutritional status (weight, height - WAZ, HAZ, and WHZ)	To know the nutritional status (weight, height - WAZ, HAZ, and WHZ) at 3 months in intervention group vs control group	3 months after baseline (visit1)
Impact of milk provision on nutritional status (weight, height - WAZ, HAZ, and WHZ)	To know the nutritional status (weight, height - WAZ, HAZ, and WHZ) at 4 months in intervention group vs control group	4 months after baseline (visit1)

Collaborators and Investigators

• Sponsor: Danone Specialized Nutrition Indonesia
• Collaborators: Indonesian Nutrition Association
• Investigators: Principal Investigator: Dr. dr. Dian N Chandra, M.Gizi, Indonesian Nutrition Association (INA)

Study record dates

Study Major Dates

• Study Start (Anticipated): August 31, 2022
• Primary Completion (Anticipated): February 28, 2023
• Study Completion (Anticipated): February 28, 2023

Study Registration Dates

• First Submitted: July 26, 2022
• First Submitted That Met QC Criteria: August 3, 2022
• First Posted (Actual): August 5, 2022

Study Record Updates

• Last Update Posted (Actual): August 15, 2022
• Last Update Submitted That Met QC Criteria: August 12, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Hematologic Diseases; Anemia, Hypochromic; Anemia; Iron Metabolism Disorders; Anemia, Iron-Deficiency
• Other Study ID Numbers: 270422

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No