Lifestyle Intervention of Obese Teenagers (LITE) Program

Sponsor

KK Women's and Children's Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03458637

Collaborator

Ronald McDonald House Charities Singapore (Other)

Enrollment

Arms

16.7

Actual Duration (Months)

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

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 programOne 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 :

Nov 6, 2014

Actual Primary Completion Date :

Mar 29, 2016

Actual Study Completion Date :

Mar 29, 2016

Arms and Interventions

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

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

Primary Outcome Measures

BMI z-score [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

Body fat percentage [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
Waist height ratio [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
Improvement in positive parenting behaviour [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

Criteria

Ages Eligible for Study:

10 Years to 16 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

Principal Investigator: Elaine Chu Shan Chew, MBBS, KK Women's and Children's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

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.

Responsible Party:

KK Women's and Children's Hospital

ClinicalTrials.gov Identifier:

NCT03458637

Other Study ID Numbers:

2014441E

First Posted:

Mar 8, 2018

Last Update Posted:

Mar 8, 2018

Last Verified:

Sep 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Obesity

Pediatric Obesity

Study Results

No Results Posted as of Mar 8, 2018