跳至主要内容
临床试验/NCT05281016
NCT05281016招募中不适用

Integrating Community LITE Programme Into a School-clinic-community Partnership as an Online Family-based Intervention to Combat Childhood Obesity

KK Women's and Children's Hospital2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年4月22日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
2
主要终点
Change in Body Mass Index (BMI)

研究概览

简要总结

Childhood obesity in Singapore is rising with a record prevalence of 13% in 2017 (1). Given that 70% of overweight children remain so into adulthood (2), this will further increase the public health epidemic of diabetes among Singaporeans. Early intervention is thus critical to improve the weight trajectory of overweight children and foster life long healthy lifestyle habits. Family-based interventions combining dietary, physical activity and behavioural interventions are currently recommended as the best practice in the management of childhood obesity in children younger than 12 years old (3-7). Our pilot study on family-based intervention in the tertiary setting demonstrated feasibility and short-term effectiveness. However, its outreach and sustainable results are limited. Currently, school-based screening, weight management clinics and community recreational facilities are operating in silos with limited effectiveness. Here, the investigators will integrate our family-based intervention into a school, clinic and community partnership to achieve an impactful and sustainable outcome for families with overweight children.

The community Lifestyle InTervention for Everyone (LITE) program is a structured, group family-based multicomponent lifestyle intervention. Community LITE program will introduce various exercise programs within the family based online sessions to reduce perceived barrier and promote self-efficacy of community sports facilities to increase physical activity. Children have minimal control over their food and physical activity choices especially in current obesogenic environment (8). Parents are the most important influencers(9) to impose interventions for childhood obesity through parental practices and parenting style(10). Therefore, they are the main focus of the community-based intervention program.

详细描述

The investigators hypothesize that our community LITE program can reduce the prevalence of overweight children aged 6-12 years old in Singapore with sustainable lasting effects by encouraging healthy lifestyle and behaviours. The investigators will test our hypothesis with the following aims:

Primary aim: To investigate whether community LITE programme will lead to a reduction in Body Mass Index (BMI) z-score. Intervention outcome will be compared with that from the usual care at 6 months and 12 months.

Secondary aims:

  1. To demonstrate implementation feasibility and acceptability of the community LITE programme
  2. To estimate cost and cost effectiveness of programme
  3. To estimate the effectiveness of programme. Children will demonstrate improvements in health outcomes at 6-months and 12 months, including waist-height, blood pressure, fruits and vegetables intake and MVPA level at 6 months and 12 months.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
6 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Overweight as defined by BMI percentile of above 90th percentile
  • Age 6- 12 years old
  • Ability to provide informed consent

排除标准

  • Patients with secondary causes of obesity especially genetic syndromes e.g. Trisomy 21, Prader-Willi, and those who are taking medications that can affect weight status.
  • Intellectual disability, poor level of spoken English (including their parent/carer)
  • Significant medical illness that precludes physical activity and significant psychiatric illness
  • Sibling who is already participating in the study

结局指标

主要结局

Change in Body Mass Index (BMI)

时间窗: Baseline, 6 months and 12 months

Measure the change in BMI at baseline, 6 months and 12 months. Body mass index (BMI) will be calculated as kg/m2

次要结局

  • Change in quality of life(Baseline, 6 months and 12 months)
  • Change in waist circumference(Baseline, 6 months and 12 months)
  • Change in servings of fruits and vegetables(Baseline, 6 months and 12 months)
  • Change in blood pressure(Baseline, 6 months and 12 months)
  • Change in physical activity(Baseline, 6 months and 12 months)

研究者

发起方
KK Women's and Children's Hospital
申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验