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Completed

NCT Number: NCT03566771

Treatment Results and Health Care Consumption From a Web-based Support System in Behavioural Childhood Obesity Treatment

This study aims to evaluate if a web-based support system with daily self-monitoring of weight, use of an activity measuring wrist-band, and communication between the clinic and the parents gives better results on degree of obesity compared with usual care. Changes in BMI standard deviation score (SDS) are compared between usual care (control) and usual care with complementary web-based support system (intervention).

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Key information

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Outpatient pediatric clinic at Hisingen, Gothenburg, Sweden

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About this study

In this study children with obesity will be randomized to either usual care according to regular routine (control) or to usual care plus a web-based support system (intervention). Based on previous reviews on mobile health and obesity in combination with the investigators' experiences of childhood obesity treatment components were identified which the researchers hypothesize are of major importance for a web-based system for childhood obesity treatment: Frequent self-monitoring of weight and physical activity, goals for weight loss, and feedback from the treatment team. The system is based on a smart phone application connected to a scale and an activity measuring wrist-band. Data is automatically transferred from the accessories to the smart phone, where data is presented graphically. The data is further transferred to the clinic for support and communication between the clinic and the parents. The randomization will be done at the start of individual treatment and will last for 12 months. The main aim is to evaluate if use of the web-based support system will give better results on degree of obesity compared with usual care.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Obesity according to International Obesity Task Force (IOTF)
  • Swedish speaking parents
  • Parents able to use a smart phone
  • Patients new in treatment or in treatment during the past 9-15 months with a decrease of BMI SDS with ≤0.25

Exclusion criteria

  • Diagnosed with or undergoing assessment of neuropsychiatric disorder
  • Hypothalamic obesity
  • Pharmacological treatment that could intervene the obesity treatment

Treatment and study plan

Usual Care

Behavioral

The child and parent(s) at regular visits to the pediatric clinic for childhood obesity treatment

CLOSS

Behavioral

Usual care plus using mobile applications to register weight and physical activity as well as for communication with the clinic. A web-based support system enables health care professionals to follow the patient's daily objectively measured weight and physical activity online.

Primary outcomes

  1. Changes in degree of obesity

    Time frame: 6 and 12 months after baseline

    Measured by BMI standard deviation score control vs intervention

Secondary outcomes

  1. Number of physical visits

    Time frame: During the intervention 12 months

    Control vs intervention

  2. Cancelation of physical visits

    Time frame: During the intervention 12 months

    Control vs intervention

  3. Time consumption for the health care professionals

    Time frame: During the intervention 12 months

    Time for physical visits, communication and documentation reported by health care professionals. Control vs intervention

  4. Parental experience of treatment

    Time frame: During the intervention 3, 6 and 12 months

    Measured by web-based CLOSS specific questions. Control vs intervention

  5. Health care professional's experiences using the web-based support system

    Time frame: During the intervention 3, 6 and 12 months

    CLOSS specific questions regarding the application

  6. Physical activity level

    Time frame: During the intervention 12 months

    Measured by time and intensity through the activity measuring wrist-band. Only intervention

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

Treatment Results and Health Care Consumption From a Web-based CLinical Obesity Support System (CLOSS) - A Randomized Multicentre Trial of Childhood Obesity Treatment

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 25, 2018
Registry last updated
Apr 8, 2020

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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