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Lifestyle Intervention of Obese Teenagers (LITE) Program

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03458637
Recruitment Status : Completed
First Posted : March 8, 2018
Last Update Posted : March 8, 2018
Sponsor:
Collaborator:
Ronald McDonald House Charities Singapore
Information provided by (Responsible Party):
KK Women's and Children's Hospital

Study Description
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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.


Condition or disease Intervention/treatment Phase
Adolescent Obesity Lifestyle Intervention Behavioral: LITE Program and Usual Care Behavioral: Usual Care Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: One arm will be randomised to usual care The experimental arm group will be randomised to usual care and LITE program
Masking: Single (Outcomes Assessor)
Masking Description: Staff involved in anthropometric measurements will be masked to group allocation.
Primary Purpose: Treatment
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
Actual Study Start Date : November 6, 2014
Actual Primary Completion Date : March 29, 2016
Actual Study Completion Date : March 29, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arms and Interventions
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Arm Intervention/treatment
Experimental: LITE Program with usual care.
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.
 Behavioral: LITE Program and Usual Care
Family based lifestyle Intervention

Behavioral: Usual Care
Usual care consisting of 3 visits to weight management clinic
Active Comparator: Usual Care
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.
 Behavioral: Usual Care
Usual care consisting of 3 visits to weight management clinic


Outcome Measures
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Primary Outcome Measures :
  1. BMI z-score [ Time Frame: 3 months and 6 months ]
    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 :
  1. Body fat percentage [ Time Frame: 3 and 6 months ]
    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

  2. Waist height ratio [ Time Frame: 3 and 6 months ]
    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

  3. Improvement in positive parenting behaviour [ Time Frame: 3 and 6 months ]
    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


Eligibility Criteria
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Ages Eligible for Study:   10 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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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): NCT03458637


Sponsors and Collaborators
KK Women's and Children's Hospital
Ronald McDonald House Charities Singapore
Investigators
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Principal Investigator: Elaine Chu Shan Chew, MBBS KK Women's and Children's Hospital
More Information
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Publications:

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Responsible Party: KK Women's and Children's Hospital
ClinicalTrials.gov Identifier: NCT03458637    
Other Study ID Numbers: 2014441E
First Posted: March 8, 2018    Key Record Dates
Last Update Posted: March 8, 2018
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to make IPD available to other researchers based on the informed consent form

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity
Pediatric Obesity
Overnutrition
 Nutrition Disorders
Overweight
Body Weight