A Novel School-clinic-community Online Model of Child Obesity Treatment in Singapore During COVID-19
NCT ID: NCT04395430
Last Updated: 2023-03-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
40 participants
INTERVENTIONAL
2020-09-18
2022-05-12
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Integrating Community LITE Programme as an Online Family-based Intervention to Combat Childhood Obesity
NCT05281016
Reducing Pediatric Obesity Through After-school Programs
NCT01156103
Mobile Health Intervention to Identify Early Responders to Treatment in Adolescent Obesity
NCT03561597
Guided Self-help for Families With an Overweight Child
NCT01145833
Childhood Overweight
NCT00916318
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
1. 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.
2. 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.
3. 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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Information Group
Subjects randomized to the Information Group will receive standard care and age appropriate reading books.
Usual Care
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
Intervention Group
Subjects randomized to the Intervention Group will receive standard care plus invitation to participate in the online KKH Sports Singapore programme.
Usual Care
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 Care
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).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Usual Care
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 Care
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).
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Age 4-7 years old in the year of referral
* Ability to provide informed consent
Exclusion Criteria
* Currently participating in a weight management program
* Unable to understand and speak English sufficiently to give informed consent and complete the research assessments.
4 Years
7 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Duke University
OTHER
Duke-NUS Graduate Medical School
OTHER
Sport Singapore
UNKNOWN
Health Promotion Board, Singapore
OTHER_GOV
KK Women's and Children's Hospital
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Elaine Chu Shan Chew, MBBS
Role: PRINCIPAL_INVESTIGATOR
KK Women's and Children's Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
KK Women's and Children's Hospital
Singapore, , Singapore
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
20190049
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.