Integrating Community LITE Programme as an Online Family-based Intervention to Combat Childhood Obesity
Primary Purpose
Pediatric Obesity
Status
Recruiting
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Usual Care
Online community LITE programme
Sponsored by
About this trial
This is an interventional treatment trial for Pediatric Obesity focused on measuring child health, Body Mass Index, Healthy Lifestyle, Community Networks, internet-based intervention, Diet, Food, and Nutrition, Parenting
Eligibility Criteria
Inclusion Criteria:
- Overweight as defined by BMI percentile of above 90th percentile
- Age 6- 12 years old
- Ability to provide informed consent
Exclusion Criteria:
- Patients with secondary causes of obesity especially genetic syndromes e.g. Trisomy 21, Prader-Willi, and those who are taking medications that can affect weight status.
- Intellectual disability, poor level of spoken English (including their parent/carer)
- Significant medical illness that precludes physical activity and significant psychiatric illness
- Sibling who is already participating in the study
Sites / Locations
- KK Women's and Children's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Delayed Intervention Control Group
Intervention Group
Arm Description
Participants randomised to the Control Group will be offered standard care and will be introduced to 6 month delayed intervention which consists of the online community LITE programme.
Participants randomised to the Intervention Group will receive standard care plus invitation to participate in the online community LITE programme for 4-5 months.
Outcomes
Primary Outcome Measures
Change in Body Mass Index (BMI)
Measure the change in BMI at baseline, 6 months and 12 months. Body mass index (BMI) will be calculated as kg/m2
Secondary Outcome Measures
Change in waist circumference
Measure change in waist circumference at baseline, 6 months and 12 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.
Change in blood pressure
Measure change in blood pressure at baseline, 6 months and 12 months. Blood pressure will be measured in mmHg via an electronic sphygmomanometer. Both systolic and diastolic blood pressure will be measured.
Change in servings of fruits and vegetables
Measure change in number of servings of fruits and vegetables using food frequency questionnaire at baseline, 6 months and 12 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, 6 months and 12 months.
Change in quality of life
Measure change in quality of life at baseline, 6 months and 12 months using the Pediatric Quality of Life Inventory (PedsQL; Singapore 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.
Full Information
NCT ID
NCT05281016
First Posted
March 6, 2022
Last Updated
September 26, 2023
Sponsor
KK Women's and Children's Hospital
Collaborators
Duke University, Sport Singapore, Health Promotion Board, Singapore, Duke-NUS Graduate Medical School
1. Study Identification
Unique Protocol Identification Number
NCT05281016
Brief Title
Integrating Community LITE Programme as an Online Family-based Intervention to Combat Childhood Obesity
Official Title
Integrating Community LITE Programme Into a School-clinic-community Partnership as an Online Family-based Intervention to Combat Childhood Obesity
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 22, 2022 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
KK Women's and Children's Hospital
Collaborators
Duke University, Sport Singapore, Health Promotion Board, Singapore, Duke-NUS Graduate Medical School
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Childhood obesity in Singapore is rising with a record prevalence of 13% in 2017 (1). Given that 70% of overweight children remain so into adulthood (2), this will further increase the public health epidemic of diabetes among Singaporeans. Early intervention is thus critical to improve the weight trajectory of overweight children and foster life long healthy lifestyle habits. Family-based interventions combining dietary, physical activity and behavioural interventions are currently recommended as the best practice in the management of childhood obesity in children younger than 12 years old (3-7). Our pilot study on family-based intervention in the tertiary setting demonstrated feasibility and short-term effectiveness. However, its outreach and sustainable results are limited. Currently, school-based screening, weight management clinics and community recreational facilities are operating in silos with limited effectiveness. Here, the investigators will integrate our family-based intervention into a school, clinic and community partnership to achieve an impactful and sustainable outcome for families with overweight children.
The community Lifestyle InTervention for Everyone (LITE) program is a structured, group family-based multicomponent lifestyle intervention. Community LITE program will introduce various exercise programs within the family based online sessions to reduce perceived barrier and promote self-efficacy of community sports facilities to increase physical activity. Children have minimal control over their food and physical activity choices especially in current obesogenic environment (8). Parents are the most important influencers(9) to impose interventions for childhood obesity through parental practices and parenting style(10). Therefore, they are the main focus of the community-based intervention program.
Detailed Description
The investigators hypothesize that our community LITE program can reduce the prevalence of overweight children aged 6-12 years old in Singapore with sustainable lasting effects by encouraging healthy lifestyle and behaviours. The investigators will test our hypothesis with the following aims:
Primary aim: To investigate whether community LITE programme will lead to a reduction in Body Mass Index (BMI) z-score. Intervention outcome will be compared with that from the usual care at 6 months and 12 months.
Secondary aims:
To demonstrate implementation feasibility and acceptability of the community LITE programme
To estimate cost and cost effectiveness of programme
To estimate the effectiveness of programme. Children will demonstrate improvements in health outcomes at 6-months and 12 months, including waist-height, blood pressure, fruits and vegetables intake and MVPA level at 6 months and 12 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Obesity
Keywords
child health, Body Mass Index, Healthy Lifestyle, Community Networks, internet-based intervention, Diet, Food, and Nutrition, Parenting
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Delayed Intervention Control Group
Arm Type
Experimental
Arm Description
Participants randomised to the Control Group will be offered standard care and will be introduced to 6 month delayed intervention which consists of the online community LITE programme.
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Participants randomised to the Intervention Group will receive standard care plus invitation to participate in the online community LITE programme for 4-5 months.
Intervention Type
Behavioral
Intervention Name(s)
Usual Care
Intervention Description
Participants will be offered standard care which consists of the following:
Clinic consultation with physician and dietician,
pamphlets on weight management principles.
Intervention Type
Behavioral
Intervention Name(s)
Online community LITE programme
Intervention Description
Participants will be invited to participate in the online community LITE programme. Participants will also receive basic sports equipment for the online programme.
The online community LITE programme will consist of 2 sessions a week for 4-5 months. Each session is 1 hour long. The programme will deliver 3 domains: physical activity, nutrition and behaviour. It consists of relatively unstructured sessions comprising of cooking and nutrition classes, games and sports and peer support.
Primary Outcome Measure Information:
Title
Change in Body Mass Index (BMI)
Description
Measure the change in BMI at baseline, 6 months and 12 months. Body mass index (BMI) will be calculated as kg/m2
Time Frame
Baseline, 6 months and 12 months
Secondary Outcome Measure Information:
Title
Change in waist circumference
Description
Measure change in waist circumference at baseline, 6 months and 12 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.
Time Frame
Baseline, 6 months and 12 months
Title
Change in blood pressure
Description
Measure change in blood pressure at baseline, 6 months and 12 months. Blood pressure will be measured in mmHg via an electronic sphygmomanometer. Both systolic and diastolic blood pressure will be measured.
Time Frame
Baseline, 6 months and 12 months
Title
Change in servings of fruits and vegetables
Description
Measure change in number of servings of fruits and vegetables using food frequency questionnaire at baseline, 6 months and 12 months .
Time Frame
Baseline, 6 months and 12 months
Title
Change in physical activity
Description
Measure change in physical activity using results from accelerometer to assess time spent on sedentary and moderate to vigorous physical activity at baseline, 6 months and 12 months.
Time Frame
Baseline, 6 months and 12 months
Title
Change in quality of life
Description
Measure change in quality of life at baseline, 6 months and 12 months using the Pediatric Quality of Life Inventory (PedsQL; Singapore 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.
Time Frame
Baseline, 6 months and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Overweight as defined by BMI percentile of above 90th percentile
Age 6- 12 years old
Ability to provide informed consent
Exclusion Criteria:
Patients with secondary causes of obesity especially genetic syndromes e.g. Trisomy 21, Prader-Willi, and those who are taking medications that can affect weight status.
Intellectual disability, poor level of spoken English (including their parent/carer)
Significant medical illness that precludes physical activity and significant psychiatric illness
Sibling who is already participating in the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Khairunisa Bte Khaider
Phone
+6581986365
Email
khairunisa.khaider@kkh.com.sg
First Name & Middle Initial & Last Name or Official Title & Degree
Elaine Chu Shan Chew, MBBS
Phone
+6598281745
Email
elaine.chew.c.s@singhealth.com.sg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elaine Chu Shan Chew, MBBS
Organizational Affiliation
KK Women's and Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
KK Women's and Children's Hospital
City
Singapore
ZIP/Postal Code
229899
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Khairunisa Bte Khaider
Phone
+6581986365
Email
khairunisa.khaider@kkh.com.sg
First Name & Middle Initial & Last Name & Degree
Elaine Chu Shan Chew, MBBS
Phone
+6598281745
Email
elaine.chew.c.s@singhealth.com.sg
First Name & Middle Initial & Last Name & Degree
Elaine Chu Shan Chew, MBBS
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No plan to make IPD available to other researchers based on the informed consent form
Learn more about this trial
Integrating Community LITE Programme as an Online Family-based Intervention to Combat Childhood Obesity
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