Pediatric ObesityNCT04395430
A Novel School-clinic-community Online Model of Child Obesity Treatment in Singapore During COVID-19
A study of Pediatric Obesity and Clinical Trial, run by KK Women's and Children's Hospital at 1 site in Singapore.
Trial summary
Background: The Coronavirus 2019 (COVID-19) is an infectious disease, which was first identified in December 2019 and has then spread rapidly around the world. COVID-19 spreads mainly through respiratory droplets and causes people to experience mild to moderate respiratory illness. Read more about this study
- Who is it for?
- Ages 4 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Obesity, Clinical Trial
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSingapore
- Study dates
- 18 Sep 2020to 12 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 4 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Subject must meet all of the inclusion criteria to participate in this study.
- Overweight as defined by BMI percentile of above 90th percentile
- Age 4-7 years old in the year of referral
- Ability to provide informed consent
Who cannot join
- Patients with secondary causes of obesity especially genetic syndromes e.g. Trisomy 21, Prader-Willi
- Currently participating in a weight management program
- Unable to understand and speak English sufficiently to give informed consent and complete the research assessments.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adapting the US-based Clinic-community Model of Child Obesity Treatment Into an Online Intervention Model in Singapore During COVID-19
Background: The Coronavirus 2019 (COVID-19) is an infectious disease, which was first identified in December 2019 and has then spread rapidly around the world. COVID-19 spreads mainly through respiratory droplets and causes people to experience mild to moderate respiratory illness. On 11 March 2020, the World Health Organisation (WHO) declared COVID-19 a pandemic. With the surge in cases and to contain the spread of this disease, Singapore implemented a circuit breaker to reduce movements and interactions in public and private places. People are advised to stay at home and practise social distancing. With restrictions in movements, parents and children are likely to be more sedentary in this pandemic. There is an urgent need to move face-to-face interventions to online interventions as it is important to be active in this period.
Childhood obesity threatens the health of US and Singapore populations. In the US, 30% of children are overweight, 17% have obesity, and 8% have severe obesity. In Singapore, 13% of children have obesity, and approximately half of all overweight children live in Asia. In both countries the prevalence is increasing, especially amongst the lower income populations, and is associated with future cardiovascular and metabolic disease. In US, obesity is most prevalent in Black and Hispanic populations and in Singapore, obesity affects Malays and Indians disproportionately. The underlying drivers and potential solutions thus share many common factors. The current evidence shows a clear dose-response effect with increasing number of hours of treatment, with a threshold for effectiveness at > 25 hours over a 6-month period. A key gap in delivering this recommendation is meeting the intensity, and delivering comprehensive treatment that is culturally relevant, engaging to families, and integrated within the community context.
Read more
The study is an online pilot randomised controlled trial among children aged 4-7 with obesity, in Singapore, to test a novel school-clinic-community online intervention, the KK Hospital (KKH) Sports Singapore program, for child obesity treatment with usual care. The primary outcome is intensity of treatment as measured by hours of exposure to intervention.
The online KKH Sports Singapore program involves 4-6 weekly online sessions of physical activity and nutrition lessons for children and parents.
Read the detailed description
Through this trial, the investigators will address the following aims:
- To demonstrate implementation feasibility and fidelity of the Duke community-based intervention model into an online model. The investigators hypothesise that the evidence-based implementation strategy tested in the US with Parks and Recreation will be adaptable for use at Duke-National University Singapore (NUS) with Singapore Sport, leading to online implementation within a 3-month period, and children in the intervention will receive up to 60 minutes of moderate-to-vigorous physical activity per session.
- To meet current recommendations for intensity of obesity treatment. As compared with usual care, the investigators hypothesise that children in the online intervention will be more likely to receive >25 hours over 6 months of treatment.
- To estimate the effectiveness of the online intervention. Children who participate in the online intervention, as compared with usual care, will demonstrate improvements in health outcomes at 6-months, including cardiorespiratory fitness, weight-related quality of life and stabilisation or reduction in BMI at 6 months.
- Conditions
- Pediatric Obesity, Clinical Trial
- Being tested
- Usual Care, online KKH Sports Singapore Program with Usual Care
- Keywords
- Exercise, Child Health, Child, Preschool, Body Mass Index, Healthy Lifestyle, Community Networks, internet-based intervention
- Medical subject headings
- Pediatric Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual CareBehavioural
Participants will receive standard care which consist of the following:
- a lifestyle counseling visit
- educational materials
- goal-setting by a healthcare professional, and
- information about general weight management resources.
- weighing scale and measuring tape with instructions to use
- fitness tracker
online KKH Sports Singapore Program with Usual CareBehavioural
Participants will receive standard care and basic sports equipment and cooking materials for the online programme.
The online programme will be available up to 4 days per week (Weekdays evenings and Weekends mornings or early afternoons) and all household family members are invited to participate. The majority of the programming will be run by trained research coordinator and volunteers from KKH and Sports Singapore coaches. A regular rotation of comprehensive programming is provided, which includes online fitness, cooking, nutrition, and peer support classes. Every session includes up to 60 minutes of exercise and/or active play, and each session has an additional special 'theme.' For example, one to two sessions per week includes nutrition related programming (e.g., cooking classes), parent specific activities (e.g., a yoga class), peer support sessions (e.g., small group discussions around issues such as weight stigmatization), and fitness classes (e.g., soccer classes).
| Study group | Role | What they receive |
|---|---|---|
| Information Group | Active comparator | Subjects randomized to the Information Group will receive standard care and age appropriate reading books. Receives: Behavioral: Usual Care |
| Intervention Group | Experimental | Subjects randomized to the Intervention Group will receive standard care plus invitation to participate in the online KKH Sports Singapore programme. Receives: Behavioral: Usual Care; Behavioral: online KKH Sports Singapore Program with Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensity of intervention
Measure intensity of intervention from baseline to 6 months. Intensity is measured using the number of hours of exposure to intervention.
Measured: 6 months
Secondary outcomes (11)
Change in cardiorespiratory fitness
Measure change in cardiorespiratory fitness at baseline, 3 months and 6 months using the 3 minute step test.
Measured: Baseline, 3 months and 6 months
Change in quality of life
Measure change in quality of life at baseline, 3 months and 6 months using the Paediatric Quality of Life Inventory (PedsQL; US 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, 3 months and 6 months
Change in BMI
Measure the stabilisation or change in BMI at baseline, 3 months and 6 months. Body mass index (BMI) will be calculated as kg/m2.
Measured: Baseline, 3 months and 6 months
Change in self-esteem
Measure change in self-esteem at baseline, 3 months and 6 months. Self-esteem is measured using the Behavioural Rating Scale of Presented Self-Esteem questionnaire. The first category of items consists of active displays of confidence, curiosity, initiative, exploration and independence while the second category consists of adaptive reactions to change or stress. It uses a four-point scale from 1-4 where higher scores indicate higher self-esteem.
Measured: Baseline, 3 months and 6 months
Change in eating behaviour
Measure change in eating behaviour at baseline, 3 months and 6 months. Eating behaviour is measured using the Child Eating Behaviour Questionnaire (CEBQ). The questionnaire consists of 35 items and measures food responsiveness, emotional over-eating, enjoyment of food, desire to drink, satiety responsiveness, slowness in eating, emotional under-eating and food fussiness using a 5-point Likert scale (1= never, 2 = rarely, 3 = sometimes, 4 = often, 5 = always). Higher scores indicate higher level of behaviour in the respective dimensions.
Measured: Baseline, 3 months and 6 months
Change in gross motor skills
Measure change in gross motor skills at baseline, 3 months and 6 months. Gross motor skills is measured using the Test of Gross Motor Development (Ver. 3.0). The first subtest, Locomotor, measures the gross motor skills that require fluid coordinated movements of the body as the child moves in one direction or another. The second subtest, Ball Skills, measure the gross motor skills that demonstrate efficient throwing, striking, and catching movements.
Measured: Baseline, 3 months and 6 months
Change in caloric intake
Measure change in caloric intake using a three day food diary at baseline, 3 months and 6 months.
Measured: Baseline, 3 months and 6 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, 3 months and 6 months.
Measured: Baseline, 3 months and 6 months
Change in blood pressure
Measure change in blood pressure at baseline, 3 months and 6 months. Blood pressure will be measured in mmHg via an electronic sphygmomanometer. Both systolic and diastolic blood pressure will be measured.
Measured: Baseline, 3 months and 6 months
Change in waist circumference
Measure change in waist circumference at baseline, 3 months and 6 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, 3 months and 6 months
Change in servings of fruits and vegetables
Measure change in number of servings of fruits and vegetables using a three day food diary at baseline, 3 months and 6 months .
Measured: Baseline, 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2020
- Study start18 Sep 2020
- Primary completion12 May 2022
- Study completion12 May 2022
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.
- More trials run by KK Women's and Children's HospitalThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- KK Women's and Children's Hospital
- Sponsor type
- Other government
- Collaborators
- Duke University, Duke-NUS Graduate Medical School, Sport Singapore, Health Promotion Board, Singapore
- 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
- NCT04395430
- Sponsor's protocol ID
- 20190049
- Status last verified
- Mar 2023
- First submitted
- 3 Feb 2020
- Last updated
- 14 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapting the US-based Clinic-community Model of Child Obesity Treatment Into an Online Intervention Model in Singapore During COVID-19
- ClinicalTrials.gov ID
- NCT04395430
- Acronym / sponsor ID
- 20190049
- Conditions
- Pediatric Obesity, Clinical Trial
- Keywords
- Exercise, Child Health, Child, Preschool, Body Mass Index, Healthy Lifestyle, Community Networks, internet-based intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- KK Women's and Children's HospitalOther government
- Collaborators
- Duke University, Duke-NUS Graduate Medical School, Sport Singapore, Health Promotion Board, Singapore
- Study start
- 18 Sep 2020 (actual)
- Primary completion
- 12 May 2022 (actual)
- Study completion
- 12 May 2022 (actual)
- First posted
- 20 May 2020 (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.
Background: The Coronavirus 2019 (COVID-19) is an infectious disease, which was first identified in December 2019 and has then spread rapidly around the world. COVID-19 spreads mainly through respiratory droplets and causes people to experience mild to moderate respiratory illness. On 11 March 2020, the World Health Organisation (WHO) declared COVID-19 a pandemic. With the surge in cases and to contain the spread of this disease, Singapore implemented a circuit breaker to reduce movements and interactions in public and private places. People are advised to stay at home and practise social distancing. With restrictions in movements, parents and children are likely to be more sedentary in this pandemic. There is an urgent need to move face-to-face interventions to online interventions as it is important to be active in this period.
Childhood obesity threatens the health of US and Singapore populations. In the US, 30% of children are overweight, 17% have obesity, and 8% have severe obesity. In Singapore, 13% of children have obesity, and approximately half of all overweight children live in Asia. In both countries the prevalence is increasing, especially amongst the lower income populations, and is associated with future cardiovascular and metabolic disease. In US, obesity is most prevalent in Black and Hispanic populations and in Singapore, obesity affects Malays and Indians disproportionately. The underlying drivers and potential solutions thus share many common factors. The current evidence shows a clear dose-response effect with increasing number of hours of treatment, with a threshold for effectiveness at > 25 hours over a 6-month period. A key gap in delivering this recommendation is meeting the intensity, and delivering comprehensive treatment that is culturally relevant, engaging to families, and integrated within the community context.
The study is an online pilot randomised controlled trial among children aged 4-7 with obesity, in Singapore, to test a novel school-clinic-community online intervention, the KK Hospital (KKH) Sports Singapore program, for child obesity treatment with usual care. The primary outcome is intensity of treatment as measured by hours of exposure to intervention.
The online KKH Sports Singapore program involves 4-6 weekly online sessions of physical activity and nutrition lessons for children and parents.
Detailed description
Through this trial, the investigators will address the following aims:
- To demonstrate implementation feasibility and fidelity of the Duke community-based intervention model into an online model. The investigators hypothesise that the evidence-based implementation strategy tested in the US with Parks and Recreation will be adaptable for use at Duke-National University Singapore (NUS) with Singapore Sport, leading to online implementation within a 3-month period, and children in the intervention will receive up to 60 minutes of moderate-to-vigorous physical activity per session.
- To meet current recommendations for intensity of obesity treatment. As compared with usual care, the investigators hypothesise that children in the online intervention will be more likely to receive >25 hours over 6 months of treatment.
- To estimate the effectiveness of the online intervention. Children who participate in the online intervention, as compared with usual care, will demonstrate improvements in health outcomes at 6-months, including cardiorespiratory fitness, weight-related quality of life and stabilisation or reduction in BMI at 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Information Group | Active comparator | Behavioral: Usual CareSubjects randomized to the Information Group will receive standard care and age appropriate reading books. |
| Intervention Group | Experimental | Behavioral: Usual Care, Behavioral: online KKH Sports Singapore Program with Usual CareSubjects randomized to the Intervention Group will receive standard care plus invitation to participate in the online KKH Sports Singapore programme. |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Subject must meet all of the inclusion criteria to participate in this study.
- Overweight as defined by BMI percentile of above 90th percentile
- Age 4-7 years old in the year of referral
- Ability to provide informed consent
Key exclusion criteria (3 listed)
- Patients with secondary causes of obesity especially genetic syndromes e.g. Trisomy 21, Prader-Willi
- Currently participating in a weight management program
- Unable to understand and speak English sufficiently to give informed consent and complete the research assessments.
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 receive standard care which consist of the following: * a lifestyle counseling visit * educational materials * goal-setting by a healthcare professional, and * information about general weight management resources. * weighing scale and measuring tape with instructions to use * fitness tracker | Behavioural | Information Group, Intervention Group |
| online KKH Sports Singapore Program with Usual CareParticipants will receive standard care and basic sports equipment and cooking materials for the online programme. The online programme will be available up to 4 days per week (Weekdays evenings and Weekends mornings or early afternoons) and all household family members are invited to participate. The majority of the programming will be run by trained research coordinator and volunteers from KKH and Sports Singapore coaches. A regular rotation of comprehensive programming is provided, which includes online fitness, cooking, nutrition, and peer support classes. Every session includes up to 60 minutes of exercise and/or active play, and each session has an additional special 'theme.' For example, one to two sessions per week includes nutrition related programming (e.g., cooking classes), parent specific activities (e.g., a yoga class), peer support sessions (e.g., small group discussions around issues such as weight stigmatization), and fitness classes (e.g., soccer classes). | Behavioural | Intervention Group |
Primary outcome
Intensity of intervention
Time frame: 6 months
Measure intensity of intervention from baseline to 6 months. Intensity is measured using the number of hours of exposure to intervention.
11 secondary outcomes
Change in cardiorespiratory fitness
Time frame: Baseline, 3 months and 6 months
Change in quality of life
Time frame: Baseline, 3 months and 6 months
Change in BMI
Time frame: Baseline, 3 months and 6 months
Change in self-esteem
Time frame: Baseline, 3 months and 6 months
Change in eating behaviour
Time frame: Baseline, 3 months and 6 months
Change in gross motor skills
Time frame: Baseline, 3 months and 6 months
Change in caloric intake
Time frame: Baseline, 3 months and 6 months
Change in physical activity
Time frame: Baseline, 3 months and 6 months
Change in blood pressure
Time frame: Baseline, 3 months and 6 months
Change in waist circumference
Time frame: Baseline, 3 months and 6 months
Change in servings of fruits and vegetables
Time frame: Baseline, 3 months and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
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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. This study is not recruiting at the moment.
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 of Pediatric Obesity and Clinical Trial, 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 14 Mar 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intensity of intervention (time frame: 6 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 14 Mar 2023.