Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03180580 |
Other study ID # |
PR-15057 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
July 2015 |
Est. completion date |
June 2016 |
Study information
Verified date |
June 2017 |
Source |
International Centre for Diarrhoeal Disease Research, Bangladesh |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
In Bangladesh, the prevalence of overweight and obesity among children varies from less than
1% to 17.9% based on different reference standard. In 2014 school based country wide study
has been demonstrated that among children (6-15 years of age), 9.6% were overweight and 3.5%
children were obese. Childhood obesity is getting increasing attention due to its association
with adult obesity and increased risk of co morbidities in adulthood. Childhood obesity is
known to be an independent risk factor for adult obesity and once a child is obese, it is
difficult to reverse through interventions. This suggests an urgent need to address
overweight and obesity levels in childhood. The increasing trend of childhood obesity
suggests urgent solution of the problem. There is no evidence of intervention for childhood
overweight and obesity exists in Bangladesh. This feasibility study will be able to generate
evidence for overcoming this upcoming epidemic in resource poor setting. If the proposed
study will be able to address its objective that will create a possibility for developing a
large cluster randomized trial in low resource setting like Bangladesh. This study will also
give opportunity to our policy makers for advocating to the government of Bangladesh for
adopting an obesity control policy for children.
The aim of the study is to develop a school based healthy eating and active lifestyles module
and assess feasibility and acceptability of the guideline in school setting.
Outcome measures/variables:
Healthy Eating and Active Living intervention material (Guideline, Tiffin box) Perception of
children, parents and policy makers regarding obesogenic behavior Acceptance of children,
parents and policy makers regarding planned intervention.
Facilitators and barriers of Healthy Eating and Active Living.
Description:
Study Setting:
The investigators were purposively selected four wards with the highest prevalence of obesity
out of 30 wards that were surveyed in the previous study (PR-13024) conducted by Centre for
control of chronic diseases (CCCD), icddr,b. Investigators were obtained the list of schools
from city corporation head office for the 4 selected wards. Investigators were randomly
selected 2 English medium and 2 Bengali medium schools from the available list. Investigators
were included only those schools who will give us a letter of supports for their voluntary
participation in the research project. We were followed the available list of both Bengali
and English medium schools collected from City Corporation. If any school disagrees to
participate in the research, we were approached next available school in the list and
selected following a letter of supports.
With supports of the school authority, investigators were assessed BMI of all children in
Grade 3 (aged 7-8 years) up to Grade 9 (aged 13-14 years) in order to make a list of those
children who will have a higher than normal BMI. Investigators were randomly selected 3
children from that list from each grade and obtain parental consent to recruit them.
Investigators were additionally obtained assent for children 11-14 years of age. A written
voluntary consent was provided to parents describing the study purpose, objectives and
methodology prior to obtaining consent of the parents and get permission to recruit their
child participate in the study. Thus investigators were recruited 27 children from one school
and a total of 108 children were selected from 4 schools for inviting to participate in the
intervention.
Study Design:
The study was adopted both of quantitative and qualitative designs. Investigators were
conduct secondary analysis to achieve specific aim 1 using data on diet and physical activity
pattern from previously conducted study by Centre for Control of Chronic Diseases (CCCD) in
2013 in 7 divisional cities in Bangladesh. For achieving aims 2, and 3 we were adopted
qualitative methods.
To achieve specific aim 1, investigators were performed secondary data analysis to determine
the usual dietary and physical activity pattern of the children. Investigators were analyzed
data on childhood dietary pattern following food frequency questionnaire and food preference
were also be calculated. There were 20 food groups for listing food preference that has been
collected through 7 days recall method. These food groups were analyzed for children's food
preference by rating 'preferred' and 'not preferred' as well as frequency of consumption
within 24 hours and last 7 days. Thus we were determined the dietary patterns of children
5-18 years of age with normal BMI, high BMI and low-BMI which has already been defined in the
study by following the International Obesity Task Force (IOTF) guideline. In order to develop
healthy eating guideline, we were developed a dietary guideline that would be suitable for
children with normal weight, and make adjustment in the dietary pattern for underweight and
overweight children. We will determine appropriate portion size of carbohydrates, proteins,
fats, vitamins and minerals required for a balanced nutritional supply for different ages.
The total daily calorie intake should comprise of: Fat - 30-35%, Protein - 15% and
Carbohydrates - 50-55% for the children during their school time. Vitamins and minerals will
come from a range of fruits and vegetables along within these three major food groups,
including 3 serving of vegetable and 2 serving of fruits.
Simultaneously physical activity pattern was analyzed based on data from 24 hour physical
activities by children. There were 17 listed physical activities and games questions to
assess their frequency of activity on a day.
Under aim 1, investigators were designed a "Healthy Tiffin Box" intervention for children. We
were provided a specially designed Tiffin box that will contain five different compartments
of various sizes for stuffing with five different food types in order to ensure healthy
balanced diet. It was recommended to parents to provide food from all food groups and make a
'Healthy Tiffin Box' with an amount adjusted to the recommended size of the designated
compartment. We were suggested a seasonally available and culturally appropriate list of
healthy foods and recipes for children. The use of 'Healthy Tiffin Box' was demonstrated to
parents, children and school authority by study staff and the benefit of the box will be
explained to understand the importance of healthy eating and physical activity practice from
their early life.
To achieve specific aim 2, a healthy Tiffin box (intervention material) and healthy eating
and active living intervention guideline (intervention module) were developed to deliver
healthy lifestyle message encouraging healthy dietary habit and physical activity pattern in
order to control childhood overweight and obesity. The guideline was consisted of detail
description of healthy dietary behaviour and appropriate physical activity within school
environments. There were some pictorial messages and food items in the guideline for clear
understanding. We were delivered messages through one hour interactive group session
consisting of child and parents pair based on guideline.
Investigators were provided specially designated healthy tiffin box to encourage children
healthy eating habit started from their school time. In this feasibility study, children were
selected for tiffin box intervention based on their higher BMI and based on consent from
their parents. For children aged 11-12 years old, we were collected their assent beside their
parent's consent. The tiffin box was designated based on available design of box with
addition compartment from the local market. In order to building a healthy tiffin box, we
were designed additional four compartments with appropriate portion size for whole grain,
snakes, fruits and vegetable. For assessing feasibility of implementing "Healthy Tiffin Box"
intervention we were adopted three steps.
- Step 1: Demonstration sessions on healthy Tiffin box and guidelines for children and
parents
- Step 2: Implementation of intervention and follow-up
- Step 3: Assessment of intervention among children
Step 1: Investigators were demonstrate to parents and children how they will use healthy
Tiffin box for school meal and how healthy eating guideline will guide them to prefer healthy
foods with appropriate portion size for their children through group session. We were
suggested the parents a list of healthy food items for each compartment of the Tiffin box.
Selected parents and children were rigorously trained on healthy eating and active living
guideline. We were conducted session with child and mother in pair and give an overview on
the following topics related to energy intake and expenditure 1) a decrease in the
consumption of unhealthy diets 2) Culturally and seasonally available healthy foods for
children 3) proper method of providing food for school 4) increasing the ratio of healthy to
unhealthy snacks importance of physical activity during childhood 5) Type of indoor and
outdoor activities for children 6) a reduction in screen-based activities.
The training was included interactive lecture on the above topics within children's
appropriate time (during Tiffin period or after school time) and demonstration on the proper
use of healthy Tiffin box. We were involved children and parents prioritizing few photographs
of available healthy and unhealthy foods as first activity; the second activity was involved
sorting few existing photographs of active and sedentary, indoor and outdoor activities, and
discussion around a photograph of an overweight adolescent boy and girl playing basketball
was third activity. Photographs were collected from existing sources through relevant website
to understand and encourage discussion amongst children that previously have been shown to be
an effective method (Curtin, 2001). We were performed an hour session among school teachers
for their understanding about the programme and guideline. As teachers are responsible for
children's school hour's activities, they were also be included in the training session.
Step 2: This step was included implementation of intervention and follow-up. We were set
goals during the training session on Tiffin box and guideline with the parents and
children's. We were asked the parents to provide locally available healthy foods and tasty
recopies for their children from all food groups that they have learnt from their session.
Parents were also being asked to monitor active physical game during their leisure time. For
activities during school, teachers were being requested to reinforce their pupils for
physical activity. Selected participants were followed up each weekly by a staff in order to
ensure compliance to intervention by providing recommended healthy foods and ensure
activities to keep energy balance. Throughout the programme the children and parents were
encouraged to find acceptable activity and dietary replacements from available list to ensure
healthy energy balance. Teachers were asked to follow children's daily eating patterns as
well as physical activity. Our study staffs were followed up each participant weekly up to 4
weeks after the training session and document findings through a check-list.
Step 3: Investigators were assess the feasibility of the intervention among children at the
schools. Parents of the students were asked about the intervention to assess compliance. We
were developed an assessment tool based on guideline in order to understand problem parents
faced while implementing the intervention. This assessment tool (check-list) was used to
understand the feasibility of intervention which was consist of prescribed information on
diet and physical activity that have been given during training session. The assessments of
feasibility of intervention among child and parents pair were conducted in school.
In order to achieve specific aim 3, Investigators were adopted qualitative approach to assess
the feasibility of proposed Healthy Tiffin Box intervention for children with higher than a
normal BMI for promoting healthy eating and active living in school setting.
Focus group discussion of parents Focus group discussion of children and parents were used to
assess the likelihood and acceptance of the proposed future healthy eating and active living
intervention as well as their opportunity and barrier to implement such intervention in
school setting.
All activities were designed to allow spontaneous discussion amongst the children; the one
research officer was act as a facilitator. During focus group discussion, one research
officer was responsible for keeping a written record that was include notation of children's
responses, relevant quotes, and facilitator observations. An observer was also be present
while discussion to observe whether the discussion is continuing according to discussion
guideline.
Key Informant interviews (KII) of teachers and policy makers:
Investigators were perform key informant interviews to collect information from a wide range
of experts-including teacher and policy makers, involve with schools, planner of schools and
parents/guardian- who have detailed knowledge about opportunity of school facilities and
experiencing barriers for school health programs. Through these interviews, with their
particular knowledge and understanding, Investigators would be able to evaluate insight on
nature of the problem and take recommendations for solutions.