Lifestyle Intervention of Obese Teenagers (LITE) Program

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Adolescent Obesity, Lifestyle Intervention

Intervention / Treatment
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* Behavioral: LITE Program and Usual Care
* Behavioral: Usual Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LITE Program with usual care.<br>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<br>* Family based lifestyle Intervention<br>Behavioral: Usual Care<br>* Usual care consisting of 3 visits to weight management clinic<br>|
| Active Comparator: Usual Care<br>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<br>* Usual care consisting of 3 visits to weight management clinic<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 3 months and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 3 and 6 months | 
| 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 | 3 and 6 months | 
| 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 | 3 and 6 months |