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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04395430
Recruitment Status : Not yet recruiting
First Posted : May 20, 2020
Last Update Posted : August 5, 2020
Sponsor:
Collaborators:
Duke University
Duke-NUS Graduate Medical School
Sport Singapore
Health Promotion Board, Singapore
Information provided by (Responsible Party):
KK Women's and Children's Hospital

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 4-6 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 3-4 weekly online sessions of physical activity and nutrition lessons for children and parents.


Condition or disease Intervention/treatment Phase
Pediatric Obesity Clinical Trial Behavioral: Usual Care Behavioral: online KKH Sports Singapore Program with Usual Care Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Adapting the US-based Clinic-community Model of Child Obesity Treatment Into an Online Intervention Model in Singapore During COVID-19
Estimated Study Start Date : September 1, 2020
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : October 2021

Arm Intervention/treatment
Active Comparator: Information Group
Subjects randomized to the Information Group will receive standard care and age appropriate reading books.
Behavioral: 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

Experimental: Intervention Group
Subjects randomized to the Intervention Group will receive standard care plus invitation to participate in the online KKH Sports Singapore programme.
Behavioral: 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

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).





Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Change in cardiorespiratory fitness [ Time Frame: Baseline, 3 months and 6 months ]
    Measure change in cardiorespiratory fitness at baseline, 3 months and 6 months using the 3 minute step test.

  2. Change in quality of life [ Time Frame: Baseline, 3 months and 6 months ]
    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.

  3. Change in BMI [ Time Frame: Baseline, 3 months and 6 months ]
    Measure the stabilisation or change in BMI at baseline, 3 months and 6 months. Body mass index (BMI) will be calculated as kg/m2.

  4. Change in self-esteem [ Time Frame: Baseline, 3 months and 6 months ]
    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.

  5. Change in eating behaviour [ Time Frame: Baseline, 3 months and 6 months ]
    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.

  6. Change in gross motor skills [ Time Frame: Baseline, 3 months and 6 months ]
    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.

  7. Change in caloric intake [ Time Frame: Baseline, 3 months and 6 months ]
    Measure change in caloric intake using a three day food diary at baseline, 3 months and 6 months.

  8. Change in physical activity [ Time Frame: Baseline, 3 months and 6 months ]
    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.

  9. Change in blood pressure [ Time Frame: Baseline, 3 months and 6 months ]
    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.

  10. Change in waist circumference [ Time Frame: Baseline, 3 months and 6 months ]
    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.

  11. Change in servings of fruits and vegetables [ Time Frame: Baseline, 3 months and 6 months ]
    Measure change in number of servings of fruits and vegetables using a three day food diary at baseline, 3 months and 6 months .



Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Subject must meet all of the inclusion criteria to participate in this study.

  • Overweight as defined by BMI percentile of above 90th percentile
  • Age 4-6 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04395430


Contacts
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Contact: Khairunisa Bte Khaider +6581986365 khairunisa.khaider@kkh.com.sg
Contact: Elaine Chu Shan Chew, MBBS +6598281745 elaine.chew.c.s@singhealth.com.sg

Sponsors and Collaborators
KK Women's and Children's Hospital
Duke University
Duke-NUS Graduate Medical School
Sport Singapore
Health Promotion Board, Singapore
Investigators
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Principal Investigator: Elaine Chu Shan Chew, MBBS KK Women's and Children's Hospital
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Responsible Party: KK Women's and Children's Hospital
ClinicalTrials.gov Identifier: NCT04395430    
Other Study ID Numbers: 20190049
First Posted: May 20, 2020    Key Record Dates
Last Update Posted: August 5, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by KK Women's and Children's Hospital:
Exercise
Child Health
Child, Preschool
Body Mass Index
Healthy Lifestyle
Community Networks
internet-based intervention
Additional relevant MeSH terms:
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Obesity
Pediatric Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight