Lifestyle Intervention of Obese Teenagers (LITE) Program

NCT03458637 | Completed

• 1 other identifier: 2014441E
• Study Type: interventional
• Target: 61
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Body fat percentage

  3 and 6 months

• Waist height ratio

  3 and 6 months

• Improvement in positive parenting behaviour

  3 and 6 months

Study Arms (2)

LITE Program with usual care.

EXPERIMENTAL

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; Behavioral: Usual Care

Usual Care

ACTIVE COMPARATOR

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

Interventions

LITE Program and Usual Care BEHAVIORAL

Family based lifestyle Intervention

LITE Program with usual care.

Usual Care BEHAVIORAL

Usual care consisting of 3 visits to weight management clinic

LITE Program with usual care.; Usual Care

Eligibility Criteria

• Age: 10 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• All adolescents aged 10-16 years old who are currently enrolled in the Weight Management Programme

You may not qualify if:

• 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

Sponsors & Collaborators

• KK Women's and Children's Hospital: lead
• Ronald McDonald House Charities Singapore: collaborator

Related 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.

  PMID: 23166346 BACKGROUND

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Elaine Chu Shan Chew, MBBS

  KK Women's and Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Staff involved in anthropometric measurements will be masked to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: One arm will be randomised to usual care The experimental arm group will be randomised to usual care and LITE program

Study Record Dates

• First Submitted: October 25, 2017
• First Posted: March 8, 2018
• Study Start: November 6, 2014
• Primary Completion: March 29, 2016
• Study Completion: March 29, 2016
• Last Updated: March 8, 2018

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share