Lifestyle Intervention of Obese Teenagers (LITE) Program

Adolescent Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03458637
• Other study ID #: 2014441E
• Status: Completed
• Phase: N/A
• First received: October 25, 2017
• Last updated: March 7, 2018
• Start date: November 6, 2014
• Est. completion date: March 29, 2016

Study information

• Verified date: September 2017
• Source: KK Women's and Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: March 29, 2016
• Est. primary completion date: March 29, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Adolescent Obesity
• Lifestyle Intervention
• Obesity
• Pediatric Obesity

Intervention

Behavioral:
• LITE Program and Usual Care
Family based lifestyle Intervention
• Usual Care
Usual care consisting of 3 visits to weight management clinic

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
KK Women's and Children's Hospital	Ronald McDonald House Charities Singapore

References & Publications (1)

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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