Pediatric ObesityNCT05281016
Integrating Community LITE Programme as an Online Family-based Intervention to Combat Childhood Obesity
A study testing Online community LITE programme in people with Pediatric Obesity, run by KK Women's and Children's Hospital at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Obesity
- What is being tested?
- Online community LITE programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSingapore
- Study dates
- 22 Apr 2022to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Overweight as defined by BMI percentile of above 90th percentile
- Age 6- 12 years old
- Ability to provide informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore1 site, 1 recruiting
- Recruiting
KK Women's and Children's Hospital
Singapore, 229899
Khairunisa Bte Khaider, +6581986365, khairunisa.khaider@kkh.com.sg
Elaine Chu Shan Chew, MBBS, +6598281745, elaine.chew.c.s@singhealth.com.sg
About this study
Official title: 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.
Read the 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:
- To demonstrate implementation feasibility and acceptability of the community LITE programme
- To estimate cost and cost effectiveness of programme
- 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.
- Conditions
- Pediatric Obesity
- Being tested
- Usual Care, Online community LITE programme
- Keywords
- child health, Body Mass Index, Healthy Lifestyle, Community Networks, internet-based intervention, Diet, Food, and Nutrition, Parenting
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual CareBehavioural
Participants will be offered standard care which consists of the following:
- Clinic consultation with physician and dietician,
- pamphlets on weight management principles.
Online community LITE programmeBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Usual Care; Behavioral: Online community LITE programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, 6 months and 12 months
Secondary outcomes (5)
Change in waist circumference
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.
Measured: Baseline, 6 months and 12 months
Change in blood pressure
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.
Measured: Baseline, 6 months and 12 months
Change in servings of fruits and vegetables
Measure change in number of servings of fruits and vegetables using food frequency questionnaire at baseline, 6 months and 12 months .
Measured: Baseline, 6 months and 12 months
Change in physical activity
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.
Measured: Baseline, 6 months and 12 months
Change in quality of life
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.
Measured: Baseline, 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2022
- Study start22 Apr 2022
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KK Women's and Children's Hospital
- Sponsor type
- Other government
- Collaborators
- Duke University, Sport Singapore, Health Promotion Board, Singapore, Duke-NUS Graduate Medical School
- Responsible party
- Sponsor
- Investigators
- Elaine Chu Shan Chew, MBBS, Principal investigator, KK Women's and Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05281016
- Sponsor's protocol ID
- 20210006
- Status last verified
- Oct 2024
- First submitted
- 6 Mar 2022
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to make IPD available to other researchers based on the informed consent form
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Community LITE Programme Into a School-clinic-community Partnership as an Online Family-based Intervention to Combat Childhood Obesity
- ClinicalTrials.gov ID
- NCT05281016
- Acronym / sponsor ID
- 20210006
- Conditions
- Pediatric Obesity
- Keywords
- child health, Body Mass Index, Healthy Lifestyle, Community Networks, internet-based intervention, Diet, Food, and Nutrition, Parenting
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- KK Women's and Children's HospitalOther government
- Collaborators
- Duke University, Sport Singapore, Health Promotion Board, Singapore, Duke-NUS Graduate Medical School
- Study start
- 22 Apr 2022 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 15 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To demonstrate implementation feasibility and acceptability of the community LITE programme
- To estimate cost and cost effectiveness of programme
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Delayed Intervention Control Group | Experimental | Behavioral: Usual Care, Behavioral: Online community LITE programmeParticipants 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. |
| Intervention Group | Experimental | Behavioral: Usual Care, Behavioral: Online community LITE programmeParticipants randomised to the Intervention Group will receive standard care plus invitation to participate in the online community LITE programme for 4-5 months. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Overweight as defined by BMI percentile of above 90th percentile
- Age 6- 12 years old
- Ability to provide informed consent
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual CareParticipants will be offered standard care which consists of the following: * Clinic consultation with physician and dietician, * pamphlets on weight management principles. | Behavioural | Delayed Intervention Control Group, Intervention Group |
| Online community LITE programmeParticipants 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. | Behavioural | Delayed Intervention Control Group, Intervention Group |
Primary outcome
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
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
- Individual participant dataSharing planned: No. No plan to make IPD available to other researchers based on the informed consent form
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elaine Chu Shan Chew, MBBS principal investigator
KK Women's and Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online community LITE programme in people with Pediatric Obesity, run by KK Women's and Children's Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Khairunisa Bte Khaider (+6581986365, khairunisa.khaider@kkh.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Body Mass Index (BMI) (time frame: Baseline, 6 months and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2024.