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

NCT05281016 | Recruiting

• 1 other identifier: 20210006
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Obesity

Keywords

child health; Body Mass Index; Healthy Lifestyle; Community Networks; internet-based intervention; Diet, Food, and Nutrition; Parenting

Outcome Measures

Primary Outcomes (1)

• Change in Body Mass Index (BMI)

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

  Baseline, 6 months and 12 months

Secondary Outcomes (5)

• Change in waist circumference

  Baseline, 6 months and 12 months

• Change in blood pressure

  Baseline, 6 months and 12 months

• Change in servings of fruits and vegetables

  Baseline, 6 months and 12 months

• Change in physical activity

  Baseline, 6 months and 12 months

• Change in quality of life

  Baseline, 6 months and 12 months

Study Arms (2)

Delayed Intervention Control Group

EXPERIMENTAL

Participants randomised to the Control Group will be offered standard care and will be introduced to 6 month delayed intervention which consists of the online community LITE programme.

Behavioral: Usual Care; Behavioral: Online community LITE programme

Intervention Group

EXPERIMENTAL

Participants randomised to the Intervention Group will receive standard care plus invitation to participate in the online community LITE programme for 4-5 months.

Behavioral: Usual Care; Behavioral: Online community LITE programme

Interventions

Usual Care BEHAVIORAL

Participants will be offered standard care which consists of the following: * Clinic consultation with physician and dietician, * pamphlets on weight management principles.

Delayed Intervention Control Group; Intervention Group

Online community LITE programme BEHAVIORAL

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.

Delayed Intervention Control Group; Intervention Group

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• KK Women's and Children's Hospital: lead
• Duke University: collaborator
• Sport Singapore: collaborator
• Health Promotion Board, Singapore: collaborator
• Duke-NUS Graduate Medical School: collaborator

Study Sites (1)

KK Women's and Children's Hospital

Singapore, 229899, Singapore

RECRUITING

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Elaine Chu Shan Chew, MBBS

  KK Women's and Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Khairunisa Bte Khaider

CONTACT

+6581986365; khairunisa.khaider@kkh.com.sg

Elaine Chu Shan Chew, MBBS

CONTACT

+6598281745; elaine.chew.c.s@singhealth.com.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2022
• First Posted: March 15, 2022
• Study Start: April 22, 2022
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 27, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)