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NCT Number: NCT05493449

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

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.

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Key information

Age range

4 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Veterinary and Animal Sciences, Lahore

Lahore, 54000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

UHT Milk

Combination Product

In this group of participants, UHT milk, 180 mL was provided and results were compared with control and flavored milk group

Flavored Milk

Combination Product

In this group of participants, flavored milk, 180 mL was provided and results were compared with control and UHT group

Primary outcomes

  1. Weight

    Time frame: change from baseline to 3 months

    Weight of the study participants was measured by using weighing balance.

  2. Height

    Time frame: change from baseline to 3 months

    Height of the study participants was measured by using stadiometer.

  3. Total Body Water (TBW)

    Time frame: change from baseline to 3 months

    TBW of the study participants was measured by using body composition analyzer Inbody J-270.

  4. Body Protein

    Time frame: change from baseline to 3 months

    Body protein of the study participants was measured by using body composition analyzer Inbody J-270.

  5. Minerals

    Time frame: change from baseline to 3 months

    Body minerals of the study participants was measured by using body composition analyzer Inbody J-270.

  6. Body Fat Mass (BFM)

    Time frame: change from baseline to 3 months

    Body fat mass of the study participants was measured by using body composition analyzer Inbody J-270.

  7. Skeletal Muscle Mass (SMM)

    Time frame: change from baseline to 3 months

    SMM of the study participants was measured by using body composition analyzer Inbody J-270.

  8. Percentage Body Fat (PBF)

    Time frame: change from baseline to 3 months

    PBF of the study participants was measured by using body composition analyzer Inbody J-270.

  9. Inbody Score

    Time frame: change from baseline to 3 months

    Inbody Score of the study participants was measured by using body composition analyzer Inbody J-270.

  10. Visceral Fat Level (VFL)

    Time frame: change from baseline to 3 months

    VFL of the study participants was measured by using body composition analyzer Inbody J-270.

  11. Waist to Hip ratio (WHR)

    Time frame: change from baseline to 3 months

    WHR of the study participants was measured by using body composition analyzer Inbody J-270.

Secondary outcomes

  1. Attendance percentage

    Time frame: change from baseline to 3 months

    Student attendance from school records was evaluated for documenting their involvement and performance.

  2. Nutritional deficiency Assessment

    Time frame: change from baseline to 3 months

    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.

Sponsors and collaborators

Lead sponsor

University of Veterinary and Animal Sciences, Lahore - Pakistan

Other

Collaborators

  • Friesland campina Engro Pakistan
  • University of Lahore

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 9, 2022
Registry last updated
Mar 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.