Lifestyle Intervention of Obese Teenagers (LITE) Program

NCT ID: NCT03458637

Last Updated: 2018-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-06
• Study Completion Date: 2016-03-29

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.

Conditions

Adolescent Obesity; Lifestyle Intervention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

LITE Program and Usual Care

Intervention Type: BEHAVIORAL

Family based lifestyle Intervention

Usual Care

Intervention Type: BEHAVIORAL

Usual care consisting of 3 visits to weight management clinic

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.

Group Type: ACTIVE_COMPARATOR

Usual Care

Intervention Type: BEHAVIORAL

Usual care consisting of 3 visits to weight management clinic

Interventions

LITE Program and Usual Care

Family based lifestyle Intervention

Intervention Type: BEHAVIORAL

Usual Care

Usual care consisting of 3 visits to weight management clinic

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ronald McDonald House Charities Singapore

UNKNOWN

Sponsor Role: collaborator

KK Women's and Children's Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elaine Chu Shan Chew, MBBS

Role: PRINCIPAL_INVESTIGATOR

KK Women's and Children's Hospital

References

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.

Reference Type: BACKGROUND

PMID: 23166346 (View on PubMed)

Other Identifiers

2014441E

Identifier Type: -

Identifier Source: org_study_id