Milk Intervention on Body Composition and School AttendanceNCT05493449
Impact of School Milk Program on Nutritional Status of Primary School Children
A study testing UHT Milk and Flavored Milk in people with Milk Intervention on Body Composition and School Attendance, run by University of Veterinary and Animal Sciences, Lahore - Pakistan at 1 site in Pakistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 4 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Milk Intervention on Body Composition and School Attendance
- What is being tested?
- UHT Milk and Flavored Milk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,799 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Dec 2021to 16 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Participants aged 4-16 years of age enrolled under University of Education, Lahore who are having no symptoms of Lactose Intolerance
Who cannot join
- Participants having symptoms of Lactose Intolerance
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
University of Veterinary and Animal Sciences, Lahore
Lahore, 54000
About this study
Official title: 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.
Read the 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.
- Being tested
- UHT Milk, Flavored Milk
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UHT MilkCombination product
In this group of participants, UHT milk, 180 mL was provided and results were compared with control and flavored milk group
Flavored MilkCombination product
In this group of participants, flavored milk, 180 mL was provided and results were compared with control and UHT group
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | In this group, no milk (intervention) was provided |
| UHT Milk | Experimental | In this group, UHT Milk intervention was provided Receives: Combination Product: UHT Milk |
| Flavored Milk | Experimental | In this group, flavored milk was provided to participants Receives: Combination Product: Flavored Milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
Weight of the study participants was measured by using weighing balance.
Measured: change from baseline to 3 months
Height
Height of the study participants was measured by using stadiometer.
Measured: 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.
Measured: change from baseline to 3 months
Body Protein
Body protein of the study participants was measured by using body composition analyzer Inbody J-270.
Measured: change from baseline to 3 months
Minerals
Body minerals of the study participants was measured by using body composition analyzer Inbody J-270.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: change from baseline to 3 months
Inbody Score
Inbody Score of the study participants was measured by using body composition analyzer Inbody J-270.
Measured: 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.
Measured: 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.
Measured: change from baseline to 3 months
Secondary outcomes (2)
Attendance percentage
Student attendance from school records was evaluated for documenting their involvement and performance.
Measured: 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.
Measured: change from baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2022
- Study start1 Dec 2021
- Primary completion15 Nov 2022
- Study completion16 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Milk Intervention on Body Composition and School AttendanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Model description
- There were three groups in study. Group A is the one which received UHT Milk, Group B received Flavored Milk and Group C was a control group.
- Masking
- None (open label)
- Enrolment
- 7,799 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Veterinary and Animal Sciences, Lahore - Pakistan
- Sponsor type
- University, hospital or other
- Collaborators
- University of Lahore, Friesland campina Engro Pakistan
- Responsible party
- Principal investigator, Sanaullah Iqbal, University of Veterinary and Animal Sciences, Lahore - Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05493449
- Sponsor's protocol ID
- School Milk Program
- Status last verified
- Mar 2023
- First submitted
- 20 Jun 2022
- Last updated
- 6 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of School Milk Program on Nutritional, Body Composition and School Performance of Primary School Children in Attock and Sheikhupura
- ClinicalTrials.gov ID
- NCT05493449
- Acronym / sponsor ID
- School Milk Program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7,799 participants (actual)
- Lead sponsor
- University of Veterinary and Animal Sciences, Lahore - PakistanUniversity, hospital or other
- Collaborators
- University of Lahore, Friesland campina Engro Pakistan
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 15 Nov 2022 (actual)
- Study completion
- 16 Dec 2022 (actual)
- First posted
- 9 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- There were three groups in study. Group A is the one which received UHT Milk, Group B received Flavored Milk and Group C was a control group.
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –In this group, no milk (intervention) was provided |
| UHT Milk | Experimental | Combination Product: UHT MilkIn this group, UHT Milk intervention was provided |
| Flavored Milk | Experimental | Combination Product: Flavored MilkIn this group, flavored milk was provided to participants |
Who may qualify
- Ages
- 4 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Participants aged 4-16 years of age enrolled under University of Education, Lahore who are having no symptoms of Lactose Intolerance
Key exclusion criteria (1 listed)
- Participants having symptoms of Lactose Intolerance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UHT MilkIn this group of participants, UHT milk, 180 mL was provided and results were compared with control and flavored milk group | Combination product | UHT Milk |
| Flavored MilkIn this group of participants, flavored milk, 180 mL was provided and results were compared with control and UHT group | Combination product | Flavored Milk |
Primary outcome
Weight
Time frame: change from baseline to 3 months
Weight of the study participants was measured by using weighing balance.
Height
Time frame: change from baseline to 3 months
Height of the study participants was measured by using stadiometer.
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.
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.
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.
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.
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.
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.
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.
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.
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.
2 secondary outcomes
Attendance percentage
Time frame: change from baseline to 3 months
Nutritional deficiency Assessment
Time frame: change from baseline to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UHT Milk and Flavored Milk in people with Milk Intervention on Body Composition and School Attendance, run by University of Veterinary and Animal Sciences, Lahore - Pakistan at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight (time frame: change from baseline to 3 months). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2023.