Clinical trial NCT03458637: 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
Overall status: COMPLETED
Phase: NA
Conditions: Adolescent Obesity
Lifestyle Intervention
Lead sponsor: KK Women's and Children's Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Ronald McDonald House Charities Singapore
First posted: 2018-03-08
Enrollment: 61
Sex: ALL
Minimum age (years): 10
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: One arm will be randomised to usual care The experimental arm group will be randomised to usual care and LITE program
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: BMI z-score
timeFrame: 3 months and 6 months
Secondary outcomes:
measure: Body fat percentage
timeFrame: 3 and 6 months
measure: Waist height ratio
timeFrame: 3 and 6 months
measure: Improvement in positive parenting behaviour
timeFrame: 3 and 6 months
Other outcomes:
Locations:
Study officials:
affiliation: KK Women's and Children's Hospital
name: Elaine Chu Shan Chew, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
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.