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Clinical Trials/NCT03458637
NCT03458637
Completed
Not Applicable

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

KK Women's and Children's Hospital0 sites61 target enrollmentNovember 6, 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Adolescent Obesity
Sponsor
KK Women's and Children's Hospital
Enrollment
61
Primary Endpoint
BMI z-score
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 6, 2014
End Date
March 29, 2016
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
KK Women's and Children's Hospital
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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 Outcomes

  • Improvement in positive parenting behaviour(3 and 6 months)
  • Body fat percentage(3 and 6 months)
  • Waist height ratio(3 and 6 months)

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