NCT03180580

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
831

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2015

Geographic Reach
1 country

1 active site

Status
completed

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

July 1, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2016

Completed
9 months until next milestone

First Posted

Study publicly available on registry

June 8, 2017

Completed
Last Updated

February 11, 2022

Status Verified

June 1, 2017

Enrollment Period

11 months

First QC Date

September 8, 2016

Last Update Submit

February 10, 2022

Conditions

Keywords

Childhood, Overweight, Obesity

Outcome Measures

Primary Outcomes (1)

  • Retention rate

    No of participant attend in the implementation program on healthy eating and active living and use healthy tiffin box * Proportion of children measured for weight * Proportion of children measured for height * Proportion of children selected for intervention * Proportion of children participated in the intervention session * No of targeted parents trained on guideline in each session * Proportion of planned HEAL intervention session that were delivered

    6 months

Secondary Outcomes (2)

  • 2. Number of participant adhere with healthy eating and active living and use healthy tiffin box intervention

    6 months

  • Participants' barrier and facilitators for practicing the implemented intervention program

    6 months

Study Arms (1)

HEAL guideline+ Healthy Tiffin box

EXPERIMENTAL

HEAL guideline+ Healthy Tiffin box intervention arm will receive a culturally appropriate healthy eating and active living messages including a specially designed healthy tiffin box to practice healthy eating. HEAL guideline+ Healthy Tiffin box is a combination of intervention to promote healthy eating and physical activity behavior as well as improve the practice. HEAL guideline-Healthy Eating and Active Living (HEAL) Guideline. A complete intervention guideline for promoting healthy dietary pattern and physical activity. Healthy Tiffin box- A five chamber snack box that will help to contain food stuffs from all 5 major food groups eg; grain, meat/fish foods, vegetables, fruits and milk or milk products. This box will help to practice healthy eating behaviors.

Behavioral: HEAL guideline and healthy tiffin box intervention

Interventions

Healthy Eating and Active Living (HEAL) guideline and healthy tiffin box intervention is a combination of intervention to promote healthy eating behavior and improve physical activity level of school going children. The guideline was developed to deliver healthy lifestyle message encouraging healthy dietary habit and physical activity pattern in order to control childhood overweight and obesity. Investigators was designed a "Healthy Tiffin Box" for children that contained five different compartments of various sizes for stuffing with five different food types in order to ensure healthy balanced diet including low carbohydrate, moderate protein, low fat and high vitamin. We also provided with a recommended physical activity list for children.

HEAL guideline+ Healthy Tiffin box

Eligibility Criteria

Age7 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • English medium school and 2 Bengali medium school
  • Schools situated at Dhaka North City Corporation.
  • Participants both male and female.
  • Must be student of grade 3 to grade 9.
  • Who will agree to give consent.
  • Who have higher than normal BMI, overweight and obese.

You may not qualify if:

  • Who have normal BMI.
  • Who will not agree to give consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Icddr,B

Dhaka, 1000, Bangladesh

Location

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Sonia Pervin, MPH

    International Centre for Diarrhoeal Disease Research, Bangladesh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2016

First Posted

June 8, 2017

Study Start

July 1, 2015

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

February 11, 2022

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations