NCT03303287

Brief Summary

Pakistan is a developing country and there have been a considerable rise in obesity and hypertension in children in recent years. In this setting a focus on primary prevention of cardiovascular diseases is more cost effective than spending resources on secondary or tertiary prevention,. Primary prevention includes interventions to promote physical activity (\> 30 minutes/day in school), healthy dietary habits (decreased consumption of sweetened beverages and snacks, and increased consumption of fruit and vegetables) and health education focusing on cardiovascular risk factors in school children. This would translate into healthier cardiovascular outcomes (eg. less hypertension, dyslipidemia and diabetes) in adult life. The investigators propose a school health education program for Pakistan (SHEPP) for children aged 9-11 years in 3 schools in Karachi for a period of one year. This program will comprise of 140 minutes physical activity/week (including aerobics):30 minutes aerobic PA(30\*2=60) + 10 minutes (10\*5=50)physical activity in assembly daily+ 1 minute between periods(1\*6\*5=30) and healthy diet and healthy heart teaching. Additionally teaching will also be given to teachers and parents, who will further reinforce these habits in children. We hypothesise that SHEPP will improve physical activity levels, dietary habits and knowledge about healthy heart in children, will decrease blood pressure, body mass index, waist circumference, at the end of the year. If this healthy behavior is carried on to adult life it will serve as an excellent primary prevention measure. The investigators , later on plan to study long term outcomes after implementation of this intervention.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
800

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2017

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

September 27, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 6, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2019

Completed
Last Updated

October 10, 2017

Status Verified

October 1, 2017

Enrollment Period

1.6 years

First QC Date

September 27, 2017

Last Update Submit

October 9, 2017

Conditions

Keywords

health education

Outcome Measures

Primary Outcomes (1)

  • increase in Minutes spent in school, out of school in physical activity

    • Physical activity levels(in school, out of school, moderate to vigorous physical activity and sedentary time) assessed by number of minutes spent in physical activity

    10 months

Secondary Outcomes (4)

  • decrease in blood pressure in mm

    10 months

  • decrease in BMI in kg/m2

    10 months

  • increase in Number of fruits and vegetable/ decrease in sweetened beverages in a day

    10 months

  • Decrease in waist circumference in cm

    10 months

Study Arms (2)

intervention

EXPERIMENTAL

School health education program in Pakistan(SHEPP): The health education program will be directed towards children, parents and teachers

Behavioral: School health education

control

NO INTERVENTION

usual

Interventions

School health education program in Pakistan(SHEPP): The health education program will be directed towards children, parents and teachers

intervention

Eligibility Criteria

Age8 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • All children aged 8-11 years enrolled in the schools.

You may not qualify if:

  • Any child or adolescent suffering from any physical disability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aga Khan Schools

Karachi, Sindh, Pakistan

RECRUITING

Related Publications (2)

  • Almas A, Iqbal R, Ghani A, Samad Z, Sabir S, Kazmi K. School Health Education Program in Pakistan (SHEPP): findings from a feasibility trial in pre-adolescent school children from a lower middle-income country. Pilot Feasibility Stud. 2023 Jul 17;9(1):123. doi: 10.1186/s40814-023-01344-9.

  • Almas A, Iqbal R, Sabir S, Ghani A, Kazmi K. School health education program in Pakistan (SHEPP)-a threefold health education feasibility trial in schoolchildren from a lower-middle-income country. Pilot Feasibility Stud. 2020 Jun 8;6:80. doi: 10.1186/s40814-020-00625-x. eCollection 2020.

MeSH Terms

Conditions

Health Education

Condition Hierarchy (Ancestors)

Adherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Aysha Almas, FCPS

    Aga Khan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Aysha Almas, FCPS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: : Three schools under the Aga Khan Education Service in Karachi will be included in a two-arm parallel cluster intervention trial. All schools belong to lower to middle income class, at different locations, all having the same school curriculum. Baseline data will be collected from all three schools during a three month period by trained research staff
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

September 27, 2017

First Posted

October 6, 2017

Study Start

September 15, 2017

Primary Completion

April 30, 2019

Study Completion

April 30, 2019

Last Updated

October 10, 2017

Record last verified: 2017-10

Locations