Clinical trial NCT05281016: Integrating Community LITE Programme as an Online Family-based Intervention to Combat Childhood Obesity
Official title: Integrating Community LITE Programme Into a School-clinic-community Partnership as an Online Family-based Intervention to Combat Childhood Obesity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pediatric Obesity
Keywords: child health
Body Mass Index
Healthy Lifestyle
Community Networks
internet-based intervention
Diet, Food, and Nutrition
Parenting
Lead sponsor: KK Women's and Children's Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Duke University
name: Sport Singapore
name: Health Promotion Board, Singapore
name: Duke-NUS Graduate Medical School
First posted: 2022-03-15
Enrollment: 100
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

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

Primary outcomes:
measure: Change in Body Mass Index (BMI)
timeFrame: Baseline, 6 months and 12 months
Secondary outcomes:
measure: Change in waist circumference
timeFrame: Baseline, 6 months and 12 months
measure: Change in blood pressure
timeFrame: Baseline, 6 months and 12 months
measure: Change in servings of fruits and vegetables
timeFrame: Baseline, 6 months and 12 months
measure: Change in physical activity
timeFrame: Baseline, 6 months and 12 months
measure: Change in quality of life
timeFrame: Baseline, 6 months and 12 months
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: KK Women's and Children's Hospital
Study officials:
affiliation: KK Women's and Children's Hospital
name: Elaine Chu Shan Chew, MBBS
role: PRINCIPAL_INVESTIGATOR
References: