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Lifestyle Intervention of Obese Teenagers (LITE) Program

Primary Purpose

Adolescent Obesity, Lifestyle Intervention

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
LITE Program and Usual Care
Usual Care
Sponsored by
KK Women's and Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adolescent Obesity

Eligibility Criteria

10 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • All adolescents aged 10-16 years old who are currently enrolled in the Weight Management Programme

Exclusion Criteria:

  • Intellectual disability, significant medical illness that precludes physical activity and significant psychiatric illness
  • Secondary cause of obesity
  • Taking of medications that can affect weight status
  • Poor level of spoken English (adolescent/carer)
  • Severe obesity as defined by BMI more than or equal to 40kg/m2
  • Sibling who is already participating in the study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    LITE Program with usual care.

    Usual Care

    Arm Description

    LITE Program with usual care. LITE program involves four x 180 min weekly sessions, followed by three x 90 min monthly sessions, for adolescents and parents. The key aspects covered in the LITE program are in keeping with Health Promotion Board guidelines for the management of overweight and obesity and include healthy food choices and eating patterns, increasing physical activity and reducing sedentary behavior. The parenting aspects aim to support and increase parental capacity to implement and maintain the lifestyle changes.

    Usual care consisting of Weight management clinic consultation at baseline randomization, 3 and 6 months post randomization in a tertiary setting in KK Hospital. Duration of treatment is 6 months. Qualified pediatrician, trained in screening for causes and medical complications of obesity in children, runs the weight management clinic and review the participant at each visit. Optional physical activity, dietary consultation at each weight management clinic visit.

    Outcomes

    Primary Outcome Measures

    BMI z-score
    Investigate the efficacy of LITE + Usual Care in comparison to Usual Care only in reducing BMI-z scores from randomization to 6 months in children 10-16 years of age identified as obese who are referred to the KKH Weight Management Clinic

    Secondary Outcome Measures

    Body fat percentage
    Investigate the efficacy of LITE + Usual Care in comparison to Usual Care only in reducing body fat percentage from randomization to 6 months in children 10-16 years of age identified as obese who are referred to the KKH Weight Management Clinic
    Waist height ratio
    Investigate the efficacy of LITE + Usual Care in comparison to Usual Care only in reducing waist height ratio from randomization to 6 months in children 10-16 years of age identified as obese who are referred to the KKH Weight Management Clinic
    Improvement in positive parenting behaviour
    Investigate the efficacy of LITE + Usual Care in comparison to Usual Care only in improvement in positive parenting behaviour from randomization to 6 months in children 10-16 years of age identified as obese who are referred to the KKH Weight Management Clinic. Improvement in positive parenting behaviour is measured using the Parenting Scale which is a 30 item questionnaire administered to a parent to measure dysfunctional discipline styles

    Full Information

    First Posted
    October 25, 2017
    Last Updated
    March 7, 2018
    Sponsor
    KK Women's and Children's Hospital
    Collaborators
    Ronald McDonald House Charities Singapore
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03458637
    Brief Title
    Lifestyle Intervention of Obese Teenagers (LITE) Program
    Official Title
    Lifestyle Intervention of Obese Teenagers (LITE) Program: A Randomized Controlled Trial of Usual Care + LITE Versus Usual Care to Treat Obesity in Children 10-16 Years Who Are Referred to KKH Weight Management Clinic
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    November 6, 2014 (Actual)
    Primary Completion Date
    March 29, 2016 (Actual)
    Study Completion Date
    March 29, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    KK Women's and Children's Hospital
    Collaborators
    Ronald McDonald House Charities Singapore

    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
    Background: Family-based lifestyle intervention programmes have been known to reduce overweight and improve cardiovascular risk in adolescent obesity [1]. This study was designed to address the gap in service provision of a family based weight management program for overweight and obese adolescents. The LITE (Lifestyle Intervention for obese teenagers) group program is a 6-month, family-based behavioural lifestyle intervention, specifically designed to treat obesity in adolescents 10-16 years referred to the Weight Management Clinic. The main principles underpinning LITE program are that parents are identified as the agents of change responsible for implementing lifestyle change in the family . Methods: The study design is a two-arm randomized controlled trial that recruited 60 overweight and obese adolescents 10-16 year olds that attended Kandang Kerbau Women and Children's Hospital(KKH) weight management clinic. Adolescents with secondary cause for obesity are excluded. Participants are randomized to LITE program with usual care or usual care. Briefly, the LITE program involves four x 180 min weekly sessions, followed by three x 90 min monthly sessions, for adolescents and parents. The key aspects covered in the LITE program are in keeping with Health Promotion Board guidelines for the management of overweight and obesity and include healthy food choices and eating patterns, increasing physical activity and reducing sedentary behavior. The parenting aspects aim to support and increase parental capacity to implement and maintain the lifestyle changes. The program takes a solution focused approach with families identifying small changes that they would like to try each week instead of a child-centric approach. Outcome measurement are assessed at 3 and 6 months post baseline and include anthropometric measurements, physical activity, dietary intake, metabolic profile, improvement in positive parenting behaviour and measurement of family support. Primary outcome is change in body mass index (BMI) z-score at 6 months. Secondary aim is to evaluate the changes in waist-height ratio and fat percentage change and improvement in positive parenting behaviour.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Adolescent Obesity, Lifestyle Intervention

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    One arm will be randomised to usual care The experimental arm group will be randomised to usual care and LITE program
    Masking
    Outcomes Assessor
    Masking Description
    Staff involved in anthropometric measurements will be masked to group allocation.
    Allocation
    Randomized
    Enrollment
    61 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    LITE Program with usual care.
    Arm Type
    Experimental
    Arm Description
    LITE Program with usual care. LITE program involves four x 180 min weekly sessions, followed by three x 90 min monthly sessions, for adolescents and parents. The key aspects covered in the LITE program are in keeping with Health Promotion Board guidelines for the management of overweight and obesity and include healthy food choices and eating patterns, increasing physical activity and reducing sedentary behavior. The parenting aspects aim to support and increase parental capacity to implement and maintain the lifestyle changes.
    Arm Title
    Usual Care
    Arm Type
    Active Comparator
    Arm Description
    Usual care consisting of Weight management clinic consultation at baseline randomization, 3 and 6 months post randomization in a tertiary setting in KK Hospital. Duration of treatment is 6 months. Qualified pediatrician, trained in screening for causes and medical complications of obesity in children, runs the weight management clinic and review the participant at each visit. Optional physical activity, dietary consultation at each weight management clinic visit.
    Intervention Type
    Behavioral
    Intervention Name(s)
    LITE Program and Usual Care
    Intervention Description
    Family based lifestyle Intervention
    Intervention Type
    Behavioral
    Intervention Name(s)
    Usual Care
    Intervention Description
    Usual care consisting of 3 visits to weight management clinic
    Primary Outcome Measure Information:
    Title
    BMI z-score
    Description
    Investigate the efficacy of LITE + Usual Care in comparison to Usual Care only in reducing BMI-z scores from randomization to 6 months in children 10-16 years of age identified as obese who are referred to the KKH Weight Management Clinic
    Time Frame
    3 months and 6 months
    Secondary Outcome Measure Information:
    Title
    Body fat percentage
    Description
    Investigate the efficacy of LITE + Usual Care in comparison to Usual Care only in reducing body fat percentage from randomization to 6 months in children 10-16 years of age identified as obese who are referred to the KKH Weight Management Clinic
    Time Frame
    3 and 6 months
    Title
    Waist height ratio
    Description
    Investigate the efficacy of LITE + Usual Care in comparison to Usual Care only in reducing waist height ratio from randomization to 6 months in children 10-16 years of age identified as obese who are referred to the KKH Weight Management Clinic
    Time Frame
    3 and 6 months
    Title
    Improvement in positive parenting behaviour
    Description
    Investigate the efficacy of LITE + Usual Care in comparison to Usual Care only in improvement in positive parenting behaviour from randomization to 6 months in children 10-16 years of age identified as obese who are referred to the KKH Weight Management Clinic. Improvement in positive parenting behaviour is measured using the Parenting Scale which is a 30 item questionnaire administered to a parent to measure dysfunctional discipline styles
    Time Frame
    3 and 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    10 Years
    Maximum Age & Unit of Time
    16 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: All adolescents aged 10-16 years old who are currently enrolled in the Weight Management Programme Exclusion Criteria: Intellectual disability, significant medical illness that precludes physical activity and significant psychiatric illness Secondary cause of obesity Taking of medications that can affect weight status Poor level of spoken English (adolescent/carer) Severe obesity as defined by BMI more than or equal to 40kg/m2 Sibling who is already participating in the study
    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

    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
    Citations:
    PubMed Identifier
    23166346
    Citation
    Ho M, Garnett SP, Baur L, Burrows T, Stewart L, Neve M, Collins C. Effectiveness of lifestyle interventions in child obesity: systematic review with meta-analysis. Pediatrics. 2012 Dec;130(6):e1647-71. doi: 10.1542/peds.2012-1176. Epub 2012 Nov 19.
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