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

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-18

Study Completion Date

2022-05-12

Brief Summary

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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

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Through this trial, the investigators will address the following aims:

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

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Pediatric Obesity Clinical Trial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Information Group

Subjects randomized to the Information Group will receive standard care and age appropriate reading books.

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type BEHAVIORAL

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.

Group Type EXPERIMENTAL

Usual Care

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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

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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 Type BEHAVIORAL

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).

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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.
Minimum Eligible Age

4 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Duke University

OTHER

Sponsor Role collaborator

Duke-NUS Graduate Medical School

OTHER

Sponsor Role collaborator

Sport Singapore

UNKNOWN

Sponsor Role collaborator

Health Promotion Board, Singapore

OTHER_GOV

Sponsor Role collaborator

KK Women's and Children's Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elaine Chu Shan Chew, MBBS

Role: PRINCIPAL_INVESTIGATOR

KK Women's and Children's Hospital

Locations

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KK Women's and Children's Hospital

Singapore, , Singapore

Site Status

Countries

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Singapore

Other Identifiers

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20190049

Identifier Type: -

Identifier Source: org_study_id

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