Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT03303287 |
| Other study ID # |
HEC_4553 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
September 27, 2017 |
| Last updated |
October 9, 2017 |
| Start date |
September 15, 2017 |
| Est. completion date |
April 30, 2019 |
Study information
| Verified date |
October 2017 |
| Source |
Aga Khan University |
| Contact |
Aysha Almas, FCPS |
| Phone |
9221-34930051 |
| Email |
aysha.almas[@]aku.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
1.1.Interventions to reduce childhood obesity School based programs have also been introduced
as interventions to assess the impact on blood pressure ant weight. In effectiveness trial
done by Yin et al on the impact of 8 months after school physical activity programme
demonstrated a reduction in percentage body fat, but no effect on blood pressure.(52) Schools
have been unable to provide sufficient time and resources for students to meet all the
objectives of standard physical education, the concept of "health-related
PE".(13)Traditionally, the role of schools in providing and promoting physical activity has
been during the school day (eg, PE, recess) and/or on the school campus immediately after
school. Trial of Activity for Adolescent Girls (TAAG) is a large-scale randomized trial
involving 36 schools at 6 study sites across the United States and sponsored by the National
Heart, Lung, and Blood Institute. This large-scale study is examining the effects of a
school-community linked intervention on overall physical activity in middle school girls.(53)
Physical activity and behavior of change theory The effectiveness of physical activity
interventions would benefit from a better understanding of this behavior. (54) Theory of
planned behavior has demonstrated usefulness in studies of health-related behavior.(55) Only
children's intention and self-identity as a result of their cognition is related to
participation in physical activity to some extent(56). This suggests that educational
strategies aimed at increasing children's motivation remainan important strategy to promote
physical activity. Physical activity interventions have been done focusing on designing
interventions to overcome cultural, socioeconomic barriers in performing physical activity
based on psychosocial cognitive theory.(57)
A number of carefully designed studies incorporating health-related PE concepts and physical
activity in PE classes have been conducted. Dietary or physical activity behavior produce a
significant and clinically meaningful reduction in body mass index status of children and
adolescents in preventing obesity (58, 59) Alternatively behavioral prevention and
situational prevention elements have been combined to increase physical activity, decrease
the consumption of sugar-sweetened beverages, and decrease time spent with screen media(60).
Studies reporting positive outcomes implemented physical activity sessions that lasted at
least 30 min d(-1)?. Several studies showed that children are most active in the first 10-15
min. The existence or installation of playground markings or fixed play equipment had no
effect, whereas the presence or addition of portable play equipment was positively correlated
with moderate-to-vigorous physical activity.
Role of Parents and Teachers One of the interventions in promoting healthy lifestyle in
children is focusing on children, parents and teachers simultaneously by introducing learning
sessions and materials for healthy lifestyle.(32, 61)Teacher training may be a key element
for successful interventions. To overcome time constraints, a suggested solution is to
integrate physical activity into daily routines and other areas of the preschool
curriculum.(62)Additionally parental barriers are associated with the time that children
spend in both active and sedentary pursuits.(63) Knowledge about risk factors for obesity and
myocardial infarction is suboptimal in Pakistani adults(64).Only 42% adult students had a
good level of knowledge of modifiable risk factors of heart disease among patients with acute
myocardial infarction in Karachi.(65)Health education on physical activity and healthy diet
using multiple level intervention is essential to be given at schools.
1.2 Rationale Dietary behaviors, physical activity and sedentary lifestyle are independent
predictors of overweight and higher BMI among Pakistani primary school children.(66) Your
study does not focus on preschool children so it is better to write about school children.
Children skipping breakfast (8%), eating fast food and snacks ≥once a week (43%) and being
involved in sedentary lifestyle>one hour a day (49%) were significantly more likely to be
overweight and obese while those participating in physical activity>twice a week (53%) were
significantly less likely to be overweight and obese.(67) Approximately 85% of the students
had a predominantly sedentary life style, due to tuitions, television viewing or internet
surfing or indoor games like play stations in affluent schools of Karachi.(68)Most public
sector schools do not have designated physical trainers to encourage physical activity in
school children. Additionally unhealthy food including fast food, sugar sweetened beverages
are commonly available in the school canteens. Furthermore the television watching and
computers have added to physical inactivity making the children more sedentary. Most schools
do not have any health education curriculum which could be taught to children and no such
trial has been conducted in Pakistan A feasibility study using a similar design was done
including 276 children, in which 60 % spent > 3 hours daily in watching TV or working on
computer. It was conducted in four public sector schools in Karachi. However due to limited
length of intervention of 20 weeks, clear benefits on cardiovascular outcomes like blood
pressure could not be observed (unpublished data).Additionally incorporating 30 min physical
activity was a challenging task and was not sustainable. Maybe this is something for the
summary since you already have said it :Schools are probably the most pragmatic place where
such shifts in lifestyle can be incorporated in adolescents.( figure 1) Strategies for
promoting physical activity at school level have been tested worldwide , however not at large
in Pakistan. Strategies need to be built in on large scale in adolescents, which can be
incorporated within their school boundry and time limitations. A multipronged approach
involving children, parents and teachers simultaneously is needed in school setup to make it
more successful. Using a multilevel approach to childhood obesity prevention including staff,
parents, and community partners is beneficial.(69) )
1.3.Main aim The main aim of the study is to incorporate a healthy lifestyle in children in
terms of increased physical activity, healthier dietary habits, and basic health education.
The hypothesis is that the programme will increase the level of physical activity not only at
school time but also at leisure time, increase the healthy dietary habits and have an effect
on cardiovascular outcomes.
1.4 Research Questions 1.4a. Research question I
- What is the effect of a 10 months school health education program in Pakistan(SHEPP): vs
routine physical activity levels (in school, out of school, moderate to vigorous
physical activity and sedentary time) in school children ? 1.4b. Research questions II
- What is the effect of a 10 months school health education program in Pakistan(SHEPP): vs
routine on intake of fruits and vegetable, sugar sweetened beverages and snacks
taken/day in school children ? 1.4c.Research question III
- What is the effect of a 10 months school health education program in Pakistan(SHEPP)vs
routine on cardio metabolic risk factors; systolic blood pressure, diastolic blood
pressure, body mass index and waist circumference and body fat percentage in school
children?
1.5. Objectives 1.5a. Objective I
- To compare the effect of a 10 months school health education program in Pakistan(SHEPP):
vs routine on physical activity levels (in school, out of school, moderate to vigorous
physical activity and sedentary time) in school children 1.5b. Objective II
- To compare the effect of a 10 months school health education program in Pakistan(SHEPP):
vs routine on intake of fruits and vegetable, sugar sweetened beverage and snacks
taken/day in school children 1.5c.Objective III
- To compare the effect of a 10 months school health education program in
Pakistan(SHEPP)vs routine on cardio metabolic risk factors; systolic blood pressure,
diastolic blood pressure, body mass index and waist circumference and body fat
percentage in school children
2. Methods 2.1 Study Design Study design and participants: 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. This would
comprise of data on sociodemographic factors, FFQ for diet, youth physical activity
questionnaire for physical activity, blood pressure ,weight, height and waist
circumference, body fat percentage measurements using validated instruments. Each school
will then be assigned to intervention or control (intervention in one school , and
control in 2 schools). All children aged 8-11 years enrolled in these schools will be
included. The rationale for this is that it is the period 8-11 years age where physical
activity starts to decline mainly in girls.(70) Follow up will be done after 10 months
of intervention. Ten months cutoff has been chosen as benefits on cardiovascular risk
factors are more pronounced at 10 month follow-up.(39)
2.2 Study Setting
Schools under the Aga Khan Education Service will be selected since they are all part of Aga
Khan Development network. These are:
1. Aga Khan School, Kharadhar
2. Aga Khan School, Garden
3. Sultan Mohamed Shah Aga Khan School, Karachi The reason for selection of these school is
that they follow a uniform curriculum across the school system. Additionally since they
are apart of the Aga Khan Development network, it would be more practical to work with
them. All schools are located in urban Karachi and Hyderabad. They have ample space to
conduct physical activity sessions, auditoriums and discussion room. Each school has
approximately 2000 students, both boys and girls. Each school comprises of 10 levels of
classes with 3-4 sections. The study is expected to be completed in 18 months to 20
months.
Intervention School health education program in Pakistan(SHEPP): The health education program
will be directed towards children, parents and teachers. The basis of designing such
intervention is to overcome cultural, socioeconomic barriers in performing physical activity
and is based on psychosocial cognitive theory.(57)The primary focus will be the
children.(figure II) Children 4. Programmed physical activity 140 minutes / week will be
targeted. i. 30 minutes twice a week will be delivered by teachers trained by expert physical
trainers. It would comprise of warm up, moderate to vigorous physical activity and cool
down(71).(30*2=60 min/week). These sessions will be lead by the school physical trainer under
supervision of an expert physical trainer (trained in aerobics) Different exercises is
introduced every month and discussions with students will be done by the research team as
well. A manual will be built to keep uniformity in the interventions. This has been
previously tested(71) ii. 10 minutes physical activity daily during assembly(10*5=50
minutes/week) iii. 1 minute between class warm up. (1*6*5=30 minutes/week) Children will be
encouraged to perform brake time physical activity by selecting leaders within a class
group(who will facilitate such PA in brake time)
- Perform such PA in leisure time 4 times a week(atleast half an hour)
- Before class exercises(2 minutes between periods)
- Decrease levels of sedentary behavior(not more than hour) 5. Healthy diet teaching will
be given to children by a trained nutritionist. Healthy diet is based on food
pyramid.(72)There would be three sessions in all of one hour duration i. Encouragement
to increase fruits and vegetables intake serving in a day ii. Encouragement to avoid
sugar sweetened beverages iii. Encouragement to avoid fast food items 6. Healthy heart
teaching will be given by a trained physician. This would comprise of total 7 sessions
(one hour each). The study material for the children will be adapted from "my heart"
(www.bookgroup.org.pk, Children health fund). This material has been pilot tested
earlier in schools. It has basic information about heart. (AppendixA)
- Heart
- Blockage of arteries
- Riskfactors for blockage
- Diet
- Physical activity
- Smoking and smokeless tobacco
- Hand and dental Hygiene
- Anger mangement Parents Group health education to parents-will be done by the team of
trained nutritionist, physician and teachers. Teachers will be trained to teach parents.
This will be done on weekends in large class format. It would comprise of one hour each.
1. Health problems in Pakistan
2. Physical activity as a preventive measure
3. Healthy diet as a preventive measure Parents will then reinforce these habits in
their children and will ask them atleast twice a week.(Did ypu do physical activity
at school and home?Did you have atleast one fruit or vegetable today?) Teachers The
teachers will be trained by a team of experts including a physician, a nutritionist
and a physical activity expert. A teachers guide will be developed.(Appendix B)This
comprises of
- Heart
- Blockage of arteries
- Risk factors for blockage
- Diet
- Physical activity
- Smoking and smokeless tobacco
- Hand and dental Hygiene
- Anger management The teachers will then reinforce about healthy physical activity and
diet in class once /week (did you do physical activity at home and school?How many times
did you take fruits and vegatables?).
