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Recruiting NCT05281016

Integrating Community LITE Programme as an Online Family-based Intervention to Combat Childhood Obesity

No phase Interventional Pediatric Obesity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Usual Care, Online community LITE programme.
Who it may be relevant to
Registry conditions: Pediatric Obesity. Basic parameters: 6 years — 12 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Singapore
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Detailed description

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.

Interventions

  • Behavioral Usual Care
    Participants will be offered standard care which consists of the following: * Clinic consultation with physician and dietician, * pamphlets on weight management principles.
  • Behavioral Online community LITE programme
    Participants will be invited to participate in the online community LITE programme. Participants will also receive basic sports equipment for the online programme. The online community LITE programme will consist of 2 sessions a week for 4-5 months. Each session is 1 hour long. The programme will deliver 3 domains: physical activity, nutrition and behaviour. It consists of relatively unstructured sessions comprising of cooking and nutrition classes, games and sports and peer support.

Primary outcome measures

  • Change in Body Mass Index (BMI) [Time frame: Baseline, 6 months and 12 months]
Secondary outcome measures (5)
  • Change in waist circumference [Time frame: Baseline, 6 months and 12 months]
  • Change in blood pressure [Time frame: Baseline, 6 months and 12 months]
  • Change in servings of fruits and vegetables [Time frame: Baseline, 6 months and 12 months]
  • Change in physical activity [Time frame: Baseline, 6 months and 12 months]
  • Change in quality of life [Time frame: Baseline, 6 months and 12 months]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Treatment

Study locations

Singapore · 1 center
  • KK Women's and Children's Hospital — Singapore

Identifiers

NCT: NCT05281016 · 20210006

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗