Malnourished, Undernutrition, Wasting
Conditions
Keywords
Anorexic, Nutrition, Oral Nutritional Supplementation, Children, Digestive Condition, Nutrition Status, Wasting
Brief summary
Evaluating the efficiency of using Oral Nutritional Supplementation toward nutrition status (anthropometric index, the prevalence of wasting), digestive disorders, and anorexic in children aged 24 - 71 months.
Detailed description
Evaluating the efficiency of using Oral Nutritional Supplementation toward the improvement of the anthropometric index (weight, height, weight for age Z-score, height for age Z-score, and weight for height Z-score ), nutrition status (the prevalence of wasting) in children aged 24 - 71 months after 3 months using the nutrient product. Evaluating the efficiency of using Oral Nutritional Supplementation for digestive disorders and anorexic in children aged 24 - 71 months. The research involves a randomized controlled clinical trial (RCT). The plan is expected to conduct from 2022 to 2023 with over 600 children aged 24-71 months. The nutrient product produces a high amount of energy that provides over 472kcal/100g; 15,6g/100g of protein; 20,8g/100 of fat; 55,6g/100g of carbonhydrate; 338mg/100g of alpha-Linolenic acid; 1800mg/100g of Linoleic acid; 19,7mg/100g of 2'FL HMO; 1088mg/100g of MCT; 2700mg/100g of FOS/Inulin; 55mg/100g of GOS; 1000mg/100g of Lysine; 687mg/100g of Calcium; 68mg/100g of Magnesium; 6,5mg/100g of Iron; 3,6/100g of Zinc; 41,9µg/100g of Manganese; 2176IU/100g of Vitamin A; 376 IU/100g of Vitamin D3; 44µg/100g of Vitamin K1; 820µg/100g of Vitamin B1; 900µg/100g of Vitamin B2; 610µg/100g of Vitamin B6; 1,92µg/100g Vitamin B12; 4140µg/100g of Acid Pantothenic; 115µg/100g of Acid Folic; 98,2 grams of the product, which equals 2 packs (230ml x 2 per day) will supply about 36,4% - 48,1% of the required energy for children aged 2-5 years old. Additional components include Alpha-Linolenic Acid, which provides 67% of the recommended dietary allowances (RDAs), Linolenic Acid 60, which provides 90% RDAs, and 25 other micronutrients and minerals that include some essential vitamins such as Calcium 112-114% RDAs, Iron 118-120.4% RDAs, Vitamin A 145-174% RDAs, Zinc 75-87% RDAs, Vitamin D3 62% RDAs, Seleni 53-63% RDAs, Vitamin K 63-73% RDAs, Folic Acid 76-115% RDAs. With other elements such as 2'FL HMO (19,7 mg), FOS/inulin (2700 mg), Choline ( 47 mg, Taurine 20 mg) , multi medium-chain triglyceride (MCT) (1088 mg), Bifidobacterium longum (109 CFU). The study will be conducted at schools and homes: 600 children erratically divided into 2 groups, 1 group will use the product for 3 months ( with the amount of use: twice per day, 49,2 grams each time). The product will be distributed to the students through the schools. Monitoring will be performed carefully by the commune and district Health Department and the Centers for Disease Control and Prevention weekly. The study aims to evaluate the efficiency of nutrient products toward nutrition status ( anthropometric index, the prevalence of wasting), digestive disorders, and anorexic in children aged 24-71 months.
Interventions
DIETARY_SUPPLEMENTKazu Gain Gold
Kazu Gain Gold is an Oral Nutritional Supplementation made by AIWAIDO Food Joint Stock Company. Condition: Powder Color: White to light yellow Scent: The fresh scent of milk, gracious sugary smell. Date of use: 24 months from the manufactured date. User Manual: Mix 6 spoons of Kazu Gain Gold (equal to 49,2 grams) with 180 ml of warm water (The energy density reaches 1kal/ml). Consume 2 glasses per day or follow the directions from the medical staff. The product should consume less than 1 hour. Do not let the child eat the leftovers of the previous meal. Preserve: Store in a clean, dry place, and keep away from direct sunlight. Opened can or package must be closed and used up within 3 weeks.
Sponsors
Tu Nguyen Song
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Investigator)
Masking description
Control Group (311 participants): Children eat their usual dietary(not using Oral Nutritional Supplementation) for 3 months. After that, they will use the product for 3 months. Specific Intervention Group (311 participants): Children eat the usual dietary, with 2 glasses of Oral Nutritional Supplementation as the side meal. The product provides GOS, Calcium, Probiotics, HMO, DHA, and Taurine within 3 months of use.
Intervention model description
Step 1: Investigate the nutrition status of all children aged 24 - 71 months in 10 preschools in 10 selected communes. Expecting 3500 targets in 10 examined preschools Step 2: After the investigative selection, participants that meet the standard will be invited to the study ( the communes selected can be narrowed if the targets are hit). As soon as parents sign the consent paper, the study will move to the next step. Step 3: Groups will be divided to investigate activities. Creating a list for all participants that meet the criteria, with WHZ/BAZ \<-0,5. Randomly selection based on age to ensure that there is no significant difference in the nutritional index or related indicators in the group to assess the effectiveness of the intervention (divided by class/age). Then, randomly divided the target by class into three large groups (300 targets per group)
Eligibility
Sex/Gender
ALL
Age
24 Months to 71 Months
Healthy volunteers
No
Inclusion criteria
* Children between the age of 24 - 71 months old that currently study in 10 preschools in the area of 10 selected communes. * The family volunteered for the child to participate in the study * Currently residing at 10 selected communes (over 1 year of residing) * Z-score WHZ/BAZ \< - 0.5
Exclusion criteria
* Lactose intolerance * Children with a history of allergies, congenital diseases * Intellectual disability or are suffering from acute and chronic infectious diseases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of Height for Age Z-score | over 1 and 3 months | Change of average height for age Z Score using WHO Anthro and WHO AnthroPlus. Moreover, compare the difference between before intervention and after the intervention. A Z-score of 0 represents the population median. The standard deviations above the median represent a better outcome and vice versa. |
| Change of Weight for Height Z-score | over 1 and 3 months | Change of average weight for height Z Score using WHO Anthro and WHO AnthroPlus. Moreover, compare the difference between before intervention and after the intervention. A Z-score of 0 represents the population median. The standard deviations above the median represent a better outcome and vice versa. |
| Change in Height (cm) | over 1 and 3 months | A wooden stadiometer measures height by precisely 0.1cm. Children stand up straight, their eyes look straight, and the top of their head touches the wooden shelf fixed at a 0 cm position. The child's whole body ensures that 9 points touch the surface of the ruler: occipital, shoulder blade, buttocks, calf, and heel. The result is recorded in cm and an odd number after the comma. All data will be measured at the time T0 (at baseline) and T3 (after 3 months) |
| Improvement of Digestive Disorders and Anorexia Nervosa | From date of using the product until the date of first documented improvement, assessed up to 3 months | Children in intervention group will have more improvement in the digestive disorders and anorexic than children control group |
| Change in Weight (kg) | over 1 and 3 months | Weight is measured in kg with one decimal value by the Body composition analyzer TANITA scale. The scale is checked and adjusted before use. Children wear light clothing, remove shoes and sandals, and sit or lie balanced at the centre of the scale. When the balance is stable, read and write the result in kg and an odd number after the comma. All data will be measured at the time T0 (at baseline) and T3 (after 3 months) |
| Change of Weight for Age Z-score | over 1 and 3 months | Change of average weight for age Z Score using the World's Health Organization (WHO) software Anthro and WHO AnthroPlus. Moreover, compare the difference between before intervention and after the intervention. A Z-score of 0 represents the population median. The standard deviations above the median represent a better outcome and vice versa. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in the Rate of Malnutrition and Risk of Underweight, Stunting and Wasting | over 1 and 3 months | Changes in the rate of malnutrition and risk of underweight, wasting and stunting after 1, 2 and 3 months of intervention |
| Changes in the Rate of Children Have Gastrointestinal Diseases | over 1 and 3 months | Changes in the percentage of anorexia, the incidence of gastrointestinal diseases (diarrhea, constipation) after intervention |
Countries
Vietnam
Participant flow
Recruitment details
Location: Yen Bai Provincial Children's Hospital Recruitment time: August 1st, 2022
Pre-assignment details
Subjects of the initial survey: 600 24-71-month-old children from 5 preschools of 5 communes meeting the criteria of WHZ/BAZ \< -0.5 and other criteria. Organize training for staff on methods of collecting data, interview techniques, and nutritional status. Data collection implementation: The data collection schedule is notified to the District Hospital, the Provincial Center for Disease Control, and the health department of each school. Information collection sites are located at 5 schools.
Participants by arm
| Arm | Count |
|---|---|
| Control Group (n=300): Children eat usual dietary (not using Oral Nutritional Supplementation) for 3 months. After that, they will use the product in 3 months | 299 |
| Specific Intervention Group (n=300): Children eat the usual dietary and use 2 glasses (49.2 gr powdered milk x 180 ml boil water/time x 2 times/day) of the Oral Nutritional Supplementation as the side meals. The product provides GOS, Calcium, Probiotics, HMO, DHA, and Taurine within 3 months of use.
The product will be provided for subjects at school 5 days per week (From Monday to Friday) and at home on weekends.
Kazu Gain Gold: Kazu Gain Gold is an Oral Nutritional Supplement made by AIWAIDO Food Joint Stock Company.
Condition: Powder
Color: White to light yellow
Scent: The fresh scent of milk, gracious sugary smell.
Date of use: 24 months from the manufactured date.
User Manual: Mix 6 spoons of Kazu Gain Gold (equal to 49.2 grams) with 180 ml of warm water (The energy density reaches 1kal/ml). Consume 2 glasses per day or follow the directions from the medical staff. The product should consume less than 1 hour. Do not let the child eat the leftovers of the previous meal.
Preserve: Store in a clean, dry place, and avoid direct sunlight. Opened can or package must be closed and used up within 3 weeks. | 293 |
| Total | 592 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lack of Efficacy | 0 | 6 |
| Overall Study | Lost to Follow-up | 1 | 1 |
Baseline characteristics
| Characteristic | Control Group | Specific Intervention Group | Total |
|---|---|---|---|
| Age, Customized Age group (by months old) 24 - 35.9 months | 52 Participants | 40 Participants | 92 Participants |
| Age, Customized Age group (by months old) 36 - 47.9 months | 68 Participants | 82 Participants | 150 Participants |
| Age, Customized Age group (by months old) 48 - 59.9 months | 97 Participants | 104 Participants | 201 Participants |
| Age, Customized Age group (by months old) 60 - 71.9 months | 82 Participants | 67 Participants | 149 Participants |
| Anthropometric characteristics of the subjects at the time of initial investigation Z-Score Height for age | -1.31 Z-score STANDARD_DEVIATION 0.86 | -1.36 Z-score STANDARD_DEVIATION 0.79 | -1.33 Z-score STANDARD_DEVIATION 0.82 |
| Anthropometric characteristics of the subjects at the time of initial investigation Z-Score Weight for age | -1.66 Z-score STANDARD_DEVIATION 0.69 | -1.67 Z-score STANDARD_DEVIATION 0.67 | -1.66 Z-score STANDARD_DEVIATION 0.68 |
| Anthropometric characteristics of the subjects at the time of initial investigation Z-Score Weight for height | -1.32 Z-score STANDARD_DEVIATION 0.58 | -1.30 Z-score STANDARD_DEVIATION 0.6 | -1.31 Z-score STANDARD_DEVIATION 0.59 |
| Height | 98.34 centimeters STANDARD_DEVIATION 7.86 | 98.13 centimeters STANDARD_DEVIATION 7.48 | 98.2 centimeters STANDARD_DEVIATION 7.67 |
| Months of age | 50.4 months STANDARD_DEVIATION 12.3 | 50.3 months STANDARD_DEVIATION 11.5 | 50.35 months STANDARD_DEVIATION 11.9 |
| Race/Ethnicity, Customized Schools Cam Nhan | 61 Participants | 67 Participants | 128 Participants |
| Race/Ethnicity, Customized Schools Tan Nguyen | 43 Participants | 65 Participants | 108 Participants |
| Race/Ethnicity, Customized Schools Vinh Kien | 55 Participants | 44 Participants | 99 Participants |
| Race/Ethnicity, Customized Schools Vu Linh | 63 Participants | 59 Participants | 122 Participants |
| Race/Ethnicity, Customized Schools Yen Thanh | 77 Participants | 58 Participants | 135 Participants |
| Sex: Female, Male Female | 150 Participants | 141 Participants | 291 Participants |
| Sex: Female, Male Male | 149 Participants | 152 Participants | 301 Participants |
| Weight | 13.43 kilograms STANDARD_DEVIATION 1.99 | 13.42 kilograms STANDARD_DEVIATION 2.05 | 13.425 kilograms STANDARD_DEVIATION 2.02 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 299 | 0 / 293 |
| other Total, other adverse events | 0 / 299 | 0 / 293 |
| serious Total, serious adverse events | 0 / 299 | 0 / 293 |
Outcome results
Primary
Change in Height (cm)
A wooden stadiometer measures height by precisely 0.1cm. Children stand up straight, their eyes look straight, and the top of their head touches the wooden shelf fixed at a 0 cm position. The child's whole body ensures that 9 points touch the surface of the ruler: occipital, shoulder blade, buttocks, calf, and heel. The result is recorded in cm and an odd number after the comma. All data will be measured at the time T0 (at baseline) and T3 (after 3 months)
Time frame: over 1 and 3 months
Population: The classified population contains children who had consumed more than 75% of the amount of assigned milk and participated 90% during study time, with enough data on height and weight and interview forms from both assessments to be included in the analysis of the results.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Change in Height (cm) | After 2 months (T2) | 99.68 centimeters | Standard Deviation 7.72 |
| Control Group | Change in Height (cm) | Difference between T1 - T0 | 0.54 centimeters | Standard Deviation 0.72 |
| Control Group | Change in Height (cm) | After 1 month (T1) | 98.88 centimeters | Standard Deviation 7.89 |
| Control Group | Change in Height (cm) | Difference between T2 - T0 | 1.32 centimeters | Standard Deviation 0.82 |
| Control Group | Change in Height (cm) | After 3 months (T3) | 99.95 centimeters | Standard Deviation 7.77 |
| Control Group | Change in Height (cm) | Difference between T3 - T0 | 1.61 centimeters | Standard Deviation 0.84 |
| Control Group | Change in Height (cm) | Before intervention (T0) | 98.34 centimeters | Standard Deviation 7.86 |
| Specific Intervention Group | Change in Height (cm) | Difference between T3 - T0 | 1.73 centimeters | Standard Deviation 0.85 |
| Specific Intervention Group | Change in Height (cm) | Before intervention (T0) | 98.62 centimeters | Standard Deviation 7.86 |
| Specific Intervention Group | Change in Height (cm) | After 1 month (T1) | 99.14 centimeters | Standard Deviation 7.88 |
| Specific Intervention Group | Change in Height (cm) | After 2 months (T2) | 99.96 centimeters | Standard Deviation 7.92 |
| Specific Intervention Group | Change in Height (cm) | After 3 months (T3) | 100.35 centimeters | Standard Deviation 7.88 |
| Specific Intervention Group | Change in Height (cm) | Difference between T1 - T0 | 0.52 centimeters | Standard Deviation 0.69 |
| Specific Intervention Group | Change in Height (cm) | Difference between T2 - T0 | 1.34 centimeters | Standard Deviation 0.75 |
Primary
Change in Weight (kg)
Weight is measured in kg with one decimal value by the Body composition analyzer TANITA scale. The scale is checked and adjusted before use. Children wear light clothing, remove shoes and sandals, and sit or lie balanced at the centre of the scale. When the balance is stable, read and write the result in kg and an odd number after the comma. All data will be measured at the time T0 (at baseline) and T3 (after 3 months)
Time frame: over 1 and 3 months
Population: The classified population contains children who had consumed more than 75% of the amount of assigned milk and participated 90% during study time, with enough data on height and weight and interview forms from both assessments to be included in the analysis of the results.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Change in Weight (kg) | After 2 months (T2) | 14.09 kilograms | Standard Deviation 2.03 |
| Control Group | Change in Weight (kg) | Difference between T1 - T0 | 0.35 kilograms | Standard Deviation 0.46 |
| Control Group | Change in Weight (kg) | After 1 month (T1) | 13.77 kilograms | Standard Deviation 2.06 |
| Control Group | Change in Weight (kg) | Difference between T2 - T0 | 0.66 kilograms | Standard Deviation 0.54 |
| Control Group | Change in Weight (kg) | After 3 months (T3) | 14.24 kilograms | Standard Deviation 2.03 |
| Control Group | Change in Weight (kg) | Difference between T3 - T0 | 0.81 kilograms | Standard Deviation 0.53 |
| Control Group | Change in Weight (kg) | Before intervention (T0) | 13.43 kilograms | Standard Deviation 1.99 |
| Specific Intervention Group | Change in Weight (kg) | Difference between T3 - T0 | 1.01 kilograms | Standard Deviation 0.65 |
| Specific Intervention Group | Change in Weight (kg) | Before intervention (T0) | 13.5 kilograms | Standard Deviation 2.08 |
| Specific Intervention Group | Change in Weight (kg) | After 1 month (T1) | 14.04 kilograms | Standard Deviation 2.19 |
| Specific Intervention Group | Change in Weight (kg) | After 2 months (T2) | 14.35 kilograms | Standard Deviation 2.2 |
| Specific Intervention Group | Change in Weight (kg) | After 3 months (T3) | 14.52 kilograms | Standard Deviation 2.23 |
| Specific Intervention Group | Change in Weight (kg) | Difference between T1 - T0 | 0.54 kilograms | Standard Deviation 0.52 |
| Specific Intervention Group | Change in Weight (kg) | Difference between T2 - T0 | 0.85 kilograms | Standard Deviation 0.59 |
Primary
Change of Height for Age Z-score
Change of average height for age Z Score using WHO Anthro and WHO AnthroPlus. Moreover, compare the difference between before intervention and after the intervention. A Z-score of 0 represents the population median. The standard deviations above the median represent a better outcome and vice versa.
Time frame: over 1 and 3 months
Population: Change of average weight for age Z Score and the difference between before intervention and after the intervention
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Change of Height for Age Z-score | After 2 months (T2) | -1.30 Z-score | Standard Deviation 0.84 |
| Control Group | Change of Height for Age Z-score | Difference between T1 - T0 | -0.07 Z-score | Standard Deviation 0.18 |
| Control Group | Change of Height for Age Z-score | After 1 month (T1) | -1.38 Z-score | Standard Deviation 0.85 |
| Control Group | Change of Height for Age Z-score | Difference between T2 - T0 | 0.01 Z-score | Standard Deviation 0.19 |
| Control Group | Change of Height for Age Z-score | After 3 months (T3) | -1.36 Z-score | Standard Deviation 0.85 |
| Control Group | Change of Height for Age Z-score | Difference between T3 - T0 | -0.05 Z-score | Standard Deviation 0.2 |
| Control Group | Change of Height for Age Z-score | Before intervention (T0) | -1.31 Z-score | Standard Deviation 0.86 |
| Specific Intervention Group | Change of Height for Age Z-score | Difference between T3 - T0 | -0.03 Z-score | Standard Deviation 0.21 |
| Specific Intervention Group | Change of Height for Age Z-score | Before intervention (T0) | -1.24 Z-score | Standard Deviation 0.94 |
| Specific Intervention Group | Change of Height for Age Z-score | After 1 month (T1) | -1.32 Z-score | Standard Deviation 0.93 |
| Specific Intervention Group | Change of Height for Age Z-score | After 2 months (T2) | -1.24 Z-score | Standard Deviation 0.93 |
| Specific Intervention Group | Change of Height for Age Z-score | After 3 months (T3) | -1.27 Z-score | Standard Deviation 0.94 |
| Specific Intervention Group | Change of Height for Age Z-score | Difference between T1 - T0 | -0.07 Z-score | Standard Deviation 0.17 |
| Specific Intervention Group | Change of Height for Age Z-score | Difference between T2 - T0 | 0.00 Z-score | Standard Deviation 0.19 |
Primary
Change of Weight for Age Z-score
Change of average weight for age Z Score using the World's Health Organization (WHO) software Anthro and WHO AnthroPlus. Moreover, compare the difference between before intervention and after the intervention. A Z-score of 0 represents the population median. The standard deviations above the median represent a better outcome and vice versa.
Time frame: over 1 and 3 months
Population: The classified population contains children who had consumed more than 75% of the amount of assigned milk and participated 90% during study time, with enough data on height and weight and interview forms from both assessments to be included in the analysis of the results.
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Change of Weight for Age Z-score | After 2 months (T2) | -1.47 Z-score | Standard Deviation 0.7 |
| Control Group | Change of Weight for Age Z-score | Difference between T1 - T0 | 0.07 Z-score | Standard Deviation 0.27 |
| Control Group | Change of Weight for Age Z-score | After 1 month (T1) | -1.58 Z-score | Standard Deviation 0.7 |
| Control Group | Change of Weight for Age Z-score | Difference between T2 - T0 | 0.18 Z-score | Standard Deviation 0.31 |
| Control Group | Change of Weight for Age Z-score | After 3 months (T3) | -1.47 Z-score | Standard Deviation 0.71 |
| Control Group | Change of Weight for Age Z-score | Difference between T3 - T0 | 0.19 Z-score | Standard Deviation 0.31 |
| Control Group | Change of Weight for Age Z-score | Before intervention (T0) | -1.66 Z-score | Standard Deviation 0.7 |
| Specific Intervention Group | Change of Weight for Age Z-score | Difference between T3 - T0 | 0.29 Z-score | Standard Deviation 0.35 |
| Specific Intervention Group | Change of Weight for Age Z-score | Before intervention (T0) | -1.62 Z-score | Standard Deviation 0.73 |
| Specific Intervention Group | Change of Weight for Age Z-score | After 1 month (T1) | -1.44 Z-score | Standard Deviation 0.79 |
| Specific Intervention Group | Change of Weight for Age Z-score | After 2 months (T2) | -1.34 Z-score | Standard Deviation 0.77 |
| Specific Intervention Group | Change of Weight for Age Z-score | After 3 months (T3) | -1.33 Z-score | Standard Deviation 0.79 |
| Specific Intervention Group | Change of Weight for Age Z-score | Difference between T1 - T0 | 0.18 Z-score | Standard Deviation 0.31 |
| Specific Intervention Group | Change of Weight for Age Z-score | Difference between T2 - T0 | 0.28 Z-score | Standard Deviation 0.33 |
Primary
Change of Weight for Height Z-score
Change of average weight for height Z Score using WHO Anthro and WHO AnthroPlus. Moreover, compare the difference between before intervention and after the intervention. A Z-score of 0 represents the population median. The standard deviations above the median represent a better outcome and vice versa.
Time frame: over 1 and 3 months
Population: Change of average weight for height Z Score and the difference between before intervention and after the intervention
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Change of Weight for Height Z-score | After 2 months (T2) | -1.03 Z-score | Standard Deviation 0.62 |
| Control Group | Change of Weight for Height Z-score | Difference between T1 - T0 | 0.19 Z-score | Standard Deviation 0.4 |
| Control Group | Change of Weight for Height Z-score | After 1 month (T1) | -1.13 Z-score | Standard Deviation 0.61 |
| Control Group | Change of Weight for Height Z-score | Difference between T2 - T0 | 0.29 Z-score | Standard Deviation 0.45 |
| Control Group | Change of Weight for Height Z-score | After 3 months (T3) | -0.96 Z-score | Standard Deviation 0.6 |
| Control Group | Change of Weight for Height Z-score | Difference between T3 - T0 | 0.36 Z-score | Standard Deviation 0.46 |
| Control Group | Change of Weight for Height Z-score | Before intervention (T0) | -1.32 Z-score | Standard Deviation 0.58 |
| Specific Intervention Group | Change of Weight for Height Z-score | Difference between T3 - T0 | 0.48 Z-score | Standard Deviation 0.53 |
| Specific Intervention Group | Change of Weight for Height Z-score | Before intervention (T0) | -1.32 Z-score | Standard Deviation 0.6 |
| Specific Intervention Group | Change of Weight for Height Z-score | After 1 month (T1) | -0.98 Z-score | Standard Deviation 0.68 |
| Specific Intervention Group | Change of Weight for Height Z-score | After 2 months (T2) | -0.89 Z-score | Standard Deviation 0.66 |
| Specific Intervention Group | Change of Weight for Height Z-score | After 3 months (T3) | -0.84 Z-score | Standard Deviation 0.66 |
| Specific Intervention Group | Change of Weight for Height Z-score | Difference between T1 - T0 | 0.35 Z-score | Standard Deviation 0.47 |
| Specific Intervention Group | Change of Weight for Height Z-score | Difference between T2 - T0 | 0.43 Z-score | Standard Deviation 0.51 |
Primary
Improvement of Digestive Disorders and Anorexia Nervosa
Children in intervention group will have more improvement in the digestive disorders and anorexic than children control group
Time frame: From date of using the product until the date of first documented improvement, assessed up to 3 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control Group | Improvement of Digestive Disorders and Anorexia Nervosa | After 3 months | 175 participants |
| Control Group | Improvement of Digestive Disorders and Anorexia Nervosa | Before intervention (T0) | 219 participants |
| Specific Intervention Group | Improvement of Digestive Disorders and Anorexia Nervosa | Before intervention (T0) | 212 participants |
| Specific Intervention Group | Improvement of Digestive Disorders and Anorexia Nervosa | After 3 months | 155 participants |
Secondary
Changes in the Rate of Children Have Gastrointestinal Diseases
Changes in the percentage of anorexia, the incidence of gastrointestinal diseases (diarrhea, constipation) after intervention
Time frame: over 1 and 3 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control Group | Changes in the Rate of Children Have Gastrointestinal Diseases | Have diarrhea: During the first month of intervention (T1) | 3 participants |
| Control Group | Changes in the Rate of Children Have Gastrointestinal Diseases | Have diarrhea: During the second month of intervention (T2) | 5 participants |
| Control Group | Changes in the Rate of Children Have Gastrointestinal Diseases | Have diarrhea: During the third month of intervention (T3) | 4 participants |
| Control Group | Changes in the Rate of Children Have Gastrointestinal Diseases | Have constipation: During the first month of intervention (T1) | 0 participants |
| Control Group | Changes in the Rate of Children Have Gastrointestinal Diseases | Have constipation: During the second month of intervention (T2) | 0 participants |
| Control Group | Changes in the Rate of Children Have Gastrointestinal Diseases | Have constipation: During the third month of intervention (T3) | 1 participants |
| Specific Intervention Group | Changes in the Rate of Children Have Gastrointestinal Diseases | Have constipation: During the second month of intervention (T2) | 0 participants |
| Specific Intervention Group | Changes in the Rate of Children Have Gastrointestinal Diseases | Have diarrhea: During the first month of intervention (T1) | 11 participants |
| Specific Intervention Group | Changes in the Rate of Children Have Gastrointestinal Diseases | Have constipation: During the first month of intervention (T1) | 0 participants |
| Specific Intervention Group | Changes in the Rate of Children Have Gastrointestinal Diseases | Have diarrhea: During the second month of intervention (T2) | 3 participants |
| Specific Intervention Group | Changes in the Rate of Children Have Gastrointestinal Diseases | Have constipation: During the third month of intervention (T3) | 0 participants |
| Specific Intervention Group | Changes in the Rate of Children Have Gastrointestinal Diseases | Have diarrhea: During the third month of intervention (T3) | 1 participants |
Secondary
Changes in the Rate of Malnutrition and Risk of Underweight, Stunting and Wasting
Changes in the rate of malnutrition and risk of underweight, wasting and stunting after 1, 2 and 3 months of intervention
Time frame: over 1 and 3 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control Group | Changes in the Rate of Malnutrition and Risk of Underweight, Stunting and Wasting | Malnutrition and risk of underweight : Before intervention (T0) | 246 participants |
| Control Group | Changes in the Rate of Malnutrition and Risk of Underweight, Stunting and Wasting | Malnutrition and risk of underweight : After 1 month (T1) | 240 participants |
| Control Group | Changes in the Rate of Malnutrition and Risk of Underweight, Stunting and Wasting | Malnutrition and risk of underweight : After 2 months (T2) | 221 participants |
| Control Group | Changes in the Rate of Malnutrition and Risk of Underweight, Stunting and Wasting | Malnutrition and risk of underweight : After 3 months (T3) | 220 participants |
| Control Group | Changes in the Rate of Malnutrition and Risk of Underweight, Stunting and Wasting | Malnutrition and risk of stunting : Before intervention (T0) | 187 participants |
| Control Group | Changes in the Rate of Malnutrition and Risk of Underweight, Stunting and Wasting | Malnutrition and risk of stunting : After 1 month (T1) | 196 participants |
| Control Group | Changes in the Rate of Malnutrition and Risk of Underweight, Stunting and Wasting | Malnutrition and risk of stunting : After 2 months (T2) | 184 participants |
| Control Group | Changes in the Rate of Malnutrition and Risk of Underweight, Stunting and Wasting | Malnutrition and risk of stunting : After 3 months (T3) | 191 participants |
| Control Group | Changes in the Rate of Malnutrition and Risk of Underweight, Stunting and Wasting | Malnutrition and risk of wasting : Before intervention (T0) | 197 participants |
| Control Group | Changes in the Rate of Malnutrition and Risk of Underweight, Stunting and Wasting | Malnutrition and risk of wasting : After 1 month (T1) | 169 participants |
| Control Group | Changes in the Rate of Malnutrition and Risk of Underweight, Stunting and Wasting | Malnutrition and risk of wasting : After 2 months (T2) | 148 participants |
| Control Group | Changes in the Rate of Malnutrition and Risk of Underweight, Stunting and Wasting | Malnutrition and risk of wasting : After 3 months (T3) | 129 participants |
| Specific Intervention Group | Changes in the Rate of Malnutrition and Risk of Underweight, Stunting and Wasting | Malnutrition and risk of wasting : After 2 months (T2) | 127 participants |
| Specific Intervention Group | Changes in the Rate of Malnutrition and Risk of Underweight, Stunting and Wasting | Malnutrition and risk of underweight : Before intervention (T0) | 244 participants |
| Specific Intervention Group | Changes in the Rate of Malnutrition and Risk of Underweight, Stunting and Wasting | Malnutrition and risk of stunting : After 2 months (T2) | 206 participants |
| Specific Intervention Group | Changes in the Rate of Malnutrition and Risk of Underweight, Stunting and Wasting | Malnutrition and risk of underweight : After 1 month (T1) | 226 participants |
| Specific Intervention Group | Changes in the Rate of Malnutrition and Risk of Underweight, Stunting and Wasting | Malnutrition and risk of wasting : After 1 month (T1) | 146 participants |
| Specific Intervention Group | Changes in the Rate of Malnutrition and Risk of Underweight, Stunting and Wasting | Malnutrition and risk of underweight : After 2 months (T2) | 207 participants |
| Specific Intervention Group | Changes in the Rate of Malnutrition and Risk of Underweight, Stunting and Wasting | Malnutrition and risk of stunting : After 3 months (T3) | 204 participants |
| Specific Intervention Group | Changes in the Rate of Malnutrition and Risk of Underweight, Stunting and Wasting | Malnutrition and risk of underweight : After 3 months (T3) | 209 participants |
| Specific Intervention Group | Changes in the Rate of Malnutrition and Risk of Underweight, Stunting and Wasting | Malnutrition and risk of wasting : After 3 months (T3) | 118 participants |
| Specific Intervention Group | Changes in the Rate of Malnutrition and Risk of Underweight, Stunting and Wasting | Malnutrition and risk of stunting : Before intervention (T0) | 205 participants |
| Specific Intervention Group | Changes in the Rate of Malnutrition and Risk of Underweight, Stunting and Wasting | Malnutrition and risk of wasting : Before intervention (T0) | 187 participants |
| Specific Intervention Group | Changes in the Rate of Malnutrition and Risk of Underweight, Stunting and Wasting | Malnutrition and risk of stunting : After 1 month (T1) | 208 participants |