A Novel School-clinic-community Online Model of Child Obesity Treatment in Singapore During COVID-19

NCT04395430 | Completed

• 1 other identifier: 20190049
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Pediatric Obesity; Clinical Trial

Keywords

Exercise; Child Health; Child, Preschool; Body Mass Index; Healthy Lifestyle; Community Networks; internet-based intervention

Outcome Measures

Primary Outcomes (1)

• Intensity of intervention

  Measure intensity of intervention from baseline to 6 months. Intensity is measured using the number of hours of exposure to intervention.

  6 months

Secondary Outcomes (11)

• Change in cardiorespiratory fitness

  Baseline, 3 months and 6 months

• Change in quality of life

  Baseline, 3 months and 6 months

• Change in BMI

  Baseline, 3 months and 6 months

• Change in self-esteem

  Baseline, 3 months and 6 months

• Change in eating behaviour

  Baseline, 3 months and 6 months

Study Arms (2)

Information Group

ACTIVE COMPARATOR

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

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.

Behavioral: Usual Care; Behavioral: online KKH Sports Singapore Program with Usual Care

Interventions

Usual Care 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

Information Group; Intervention Group

online KKH Sports Singapore Program with Usual Care 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).

Intervention Group

Eligibility Criteria

• Age: 4 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• KK Women's and Children's Hospital: lead
• Duke University: collaborator
• Duke-NUS Graduate Medical School: collaborator
• Sport Singapore: collaborator
• Health Promotion Board, Singapore: collaborator

Study Sites (1)

KK Women's and Children's Hospital

Singapore, 229899, Singapore

Location

MeSH Terms

Conditions

Pediatric Obesity; Motor Activity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Elaine Chu Shan Chew, MBBS

  KK Women's and Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2020
• First Posted: May 20, 2020
• Study Start: September 18, 2020
• Primary Completion: May 12, 2022
• Study Completion: May 12, 2022
• Last Updated: March 14, 2023

Record last verified: 2023-03

Locations

SG (1)