Impact of School Milk Program on Nutritional Status of Primary School Children

Impact of School Milk Program on Nutritional, Body Composition and School Performance of Primary School Children in Attock and Sheikhupura

Malnutrition is very common in Pakistan, especially in children of under developed areas due to lack of resources and access to nutritious food. It can disturb the normal physical and mental development as well as functioning in children which can put economic burden on country level.

Therefore, school meal programs can play an important role in providing school children with healthy and nutritious food which can improve their nutritional status as well as overall health.

Study Overview

• Status: Completed
• Conditions: Milk Intervention on Body Composition and School Attendance
• Intervention / Treatment: Combination product: UHT Milk; Combination product: Flavored Milk

Detailed Description

The proposed intervention study was conducted in the primary school going children of age 4-16 years old in two districts of Punjab namely Attock and Sheikhpura with collaboration of University of Veterinary and Animal Sciences, Lahore, University of Education, Lahore and Friesland Campina (Engro Foods Pvt. Ltd.), Pakistan. The participants of study was students studying in classes nursery to 5, out of study population of 90 Schools of different tehsils of two districts (Attock city and Sheikupura city), Punjab-Pakistan that are being run by the administration of University of Education, Lahore.

The study participants for research are 8.9 % of 7799 total population involved in school milk program children i.e. total 693 (380 Attock city and 313 Sheikhupura). A total of 18 schools (9 from each district) was selected as a sample of the study population, since there were three groups (A-Group to receive Full Cream Milk; B-Group to receive Flavored Milk; C-Group is control) and three schools in each districts form each group. In addition, the selected schools have been selected in each district in a way in both selected districts to have a uniform population of around 160±5.

At initiation of the study, baseline data was collected from the study participants. Data regarding socio-demographic factors, 24-hrs dietary recall, anthropometric, school attendance, body composition, dietary deficiency signs and symptoms was collected from study population i.e. 693 students. After baseline findings, for dietary intervention, the sample population based on schools was divided into 3 clusters/group including control, Ultra High Temperature (UHT) and flavored milk as intervention groups (i.e., UHT and flavored milk groups, were given milk (180 mL/participants/day; on alternate days basis and/or daily basis as the case may be owing to Covid situation) for 3 months. The data was collected from study participants at different intervals initiation (baseline) and termination (3 months), whereas, data after 2 months of termination will be collected to estimate washout period differences of the intervention on the study parameters. After the completion of study, the control group will also receive milk for same duration on humanitarian basis.

Inclusion Criteria: Children having no symptoms of Lactose Intolerance Exclusion Criteria: Children having symptoms of Lactose Intolerance

Informed Consent and other considerations:

All the protocols of study were explained to study participants/teachers and informed consent was obtained prior to enrollment in the study. The data was considered as relevant and reliable, if 70% of the sample (compared to start of the study) completes the study with minimum of 80% of allocated milk consumption. If any student(s) wants to quit during the course of the study, he/she do it on his/her will and was not forced to complete the study.

Data Analysis:

Descriptive analysis was carried out by using SPSS version 25 (SPSS for windows version 25; SPSS Inc., Chicago, IL, USA), Microsoft excel and World Health Organization Anthroplus (Software) was used to calculate height for age and BMI for age z scores. The data was analyzed by using independent sample t-test, paired sample t-test and one-way ANOVA, statistical significance was at p > 0.05.

• Study Type: Interventional
• Enrollment (Actual): 7799
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Lahore, Pakistan, 54000
    • University of veterinary and animal sciences, Lahore

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 16 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Participants aged 4-16 years of age enrolled under University of Education, Lahore who are having no symptoms of Lactose Intolerance

Exclusion Criteria:

• Participants having symptoms of Lactose Intolerance

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; In this group, no milk (intervention) was provided
Experimental: UHT Milk; In this group, UHT Milk intervention was provided	Combination product: UHT Milk; In this group of participants, UHT milk, 180 mL was provided and results were compared with control and flavored milk group
Experimental: Flavored Milk; In this group, flavored milk was provided to participants	Combination product: Flavored Milk; In this group of participants, flavored milk, 180 mL was provided and results were compared with control and UHT group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight	Weight of the study participants was measured by using weighing balance.	change from baseline to 3 months
Height	Height of the study participants was measured by using stadiometer.	change from baseline to 3 months
Total Body Water (TBW)	TBW of the study participants was measured by using body composition analyzer Inbody J-270.	change from baseline to 3 months
Body Protein	Body protein of the study participants was measured by using body composition analyzer Inbody J-270.	change from baseline to 3 months
Minerals	Body minerals of the study participants was measured by using body composition analyzer Inbody J-270.	change from baseline to 3 months
Body Fat Mass (BFM)	Body fat mass of the study participants was measured by using body composition analyzer Inbody J-270.	change from baseline to 3 months
Skeletal Muscle Mass (SMM)	SMM of the study participants was measured by using body composition analyzer Inbody J-270.	change from baseline to 3 months
Percentage Body Fat (PBF)	PBF of the study participants was measured by using body composition analyzer Inbody J-270.	change from baseline to 3 months
Inbody Score	Inbody Score of the study participants was measured by using body composition analyzer Inbody J-270.	change from baseline to 3 months
Visceral Fat Level (VFL)	VFL of the study participants was measured by using body composition analyzer Inbody J-270.	change from baseline to 3 months
Waist to Hip ratio (WHR)	WHR of the study participants was measured by using body composition analyzer Inbody J-270.	change from baseline to 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Attendance percentage	Student attendance from school records was evaluated for documenting their involvement and performance.	change from baseline to 3 months
Nutritional deficiency Assessment	The study participants were examined physically to check nutritional deficiencies along with signs & symptoms including hair, mouth, lips, eyes, gums, teeth, tongue, face, skin, nails, musculoskeletal and neck etc. Deficiencies related to various macro and micronutrients were also examined i.e., energy, proteins, vitamin A, D, calcium, riboflavin, Vitamin B12 etc.	change from baseline to 3 months

Collaborators and Investigators

• Sponsor: University of Veterinary and Animal Sciences, Lahore - Pakistan
• Collaborators: University of Education, Lahore; Friesland campina Engro Pakistan

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Actual): November 15, 2022
• Study Completion (Actual): December 16, 2022

Study Registration Dates

• First Submitted: June 20, 2022
• First Submitted That Met QC Criteria: August 2, 2022
• First Posted (Actual): August 9, 2022

Study Record Updates

• Last Update Posted (Estimate): March 6, 2023
• Last Update Submitted That Met QC Criteria: March 3, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: School Milk Program

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
• product manufactured in and exported from the U.S.: No