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NCT Number: NCT03458637

Lifestyle Intervention of Obese Teenagers (LITE) Program

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.

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Key information

Conditions

Adolescent Obesity Body Weight Lifestyle Intervention Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms

Age range

10 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LITE Program and Usual Care

Behavioral

Family based lifestyle Intervention

Usual Care

Behavioral

Usual care consisting of 3 visits to weight management clinic

Primary outcomes

  1. BMI z-score

    Time frame: 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 outcomes

  1. Body fat percentage

    Time frame: 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

  2. Waist height ratio

    Time frame: 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

  3. Improvement in positive parenting behaviour

    Time frame: 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

Sponsors and collaborators

Lead sponsor

KK Women's and Children's Hospital

Other Gov

Collaborators

  • Ronald McDonald House Charities Singapore

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Mar 8, 2018
Registry last updated
Mar 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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