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

November 24, 2024 updated by: KK Women's and Children's Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 12 years (Child)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Delayed Intervention Control Group
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

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.
Experimental: Intervention Group
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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Body Mass Index (BMI)
Time Frame: 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
Baseline, 6 months and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in waist circumference
Time Frame: Baseline, 6 months and 12 months
Measure change in waist circumference at baseline, 6 months and 12 months. Waist circumference is measured at the narrowest point between the lower costal (rib) border and the iliac crest using a non-extensible steel tape.
Baseline, 6 months and 12 months
Change in blood pressure
Time Frame: Baseline, 6 months and 12 months
Measure change in blood pressure at baseline, 6 months and 12 months. Blood pressure will be measured in mmHg via an electronic sphygmomanometer. Both systolic and diastolic blood pressure will be measured.
Baseline, 6 months and 12 months
Change in servings of fruits and vegetables
Time Frame: Baseline, 6 months and 12 months
Measure change in number of servings of fruits and vegetables using food frequency questionnaire at baseline, 6 months and 12 months .
Baseline, 6 months and 12 months
Change in physical activity
Time Frame: Baseline, 6 months and 12 months
Measure change in physical activity using results from accelerometer to assess time spent on sedentary and moderate to vigorous physical activity at baseline, 6 months and 12 months.
Baseline, 6 months and 12 months
Change in quality of life
Time Frame: Baseline, 6 months and 12 months
Measure change in quality of life at baseline, 6 months and 12 months using the Pediatric Quality of Life Inventory (PedsQL; Singapore version 4). PedsQL is a comprehensive and multi-dimensional construct that includes physical, emotional, and social functioning to assess quality of life in the children. It uses a 5-point Likert scale where 0= never, 1 = almost never, 2 = sometimes, 3 = often, 4 = almost always. Items will be reverse scored and linearly transformed to a 0-100 scale so that higher scores indicate better quality of life.
Baseline, 6 months and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

KK Women's and Children's Hospital

Collaborators

Duke University
Duke-NUS Graduate Medical School
Health Promotion Board, Singapore
Sport Singapore

Investigators

  • Principal Investigator: Elaine Chu Shan Chew, MBBS, KK Women's and Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 22, 2022

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

March 6, 2022

First Submitted That Met QC Criteria

March 6, 2022

First Posted (Actual)

March 15, 2022

Study Record Updates

Last Update Posted (Estimated)

November 27, 2024

Last Update Submitted That Met QC Criteria

November 24, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20210006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No plan to make IPD available to other researchers based on the informed consent form

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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