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临床试验/NCT03180580
NCT03180580已完成不适用

Feasibility and Acceptability of Implementing School Based "Healthy Eating and Active Living" Intervention to Control Overweight and Obesity Among Children in Urban Area in Bangladesh

International Centre for Diarrhoeal Disease Research, Bangladesh2 个研究点 分布在 1 个国家目标入组 831 人开始时间: 2015年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
831
试验地点
2
主要终点
Retention rate

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
7 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 2 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
  • Who will agree to give consent.
  • Who have higher than normal BMI, overweight and obese.

排除标准

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

结局指标

主要结局

Retention rate

时间窗: 6 months

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

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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