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Completed

NCT Number: NCT03380598

An Evaluation of a Web-based System for Optimization of Behavioral Childhood Obesity Treatment

This study evaluates the families' and health care professional's experience from using a web based support system including mobile applications for self-monitoring weight and physical activity. Changes in BMI standard deviation score are compared between usual care (control) and usual care with complementary web-based support system (intervention).

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Key information

Conditions

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

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Childhood Obesity Center, Karolinska University hospital, Huddinge, Sweden

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About this study

In this study children with obesity were randomized to either usual care according to regular routine (control group) or to usual care plus a web-based support system (intervention group). The system is based on a smartphone application connected to a scale and an activity measuring wrist-band. Data is automatically transferred from the accessories to the smartphone, where data is presented graphically. The data is transferred to the clinic for support. The system is developed for communication between the clinic and family. The randomization was done at the start of individual treatment and lasted for 6 months. Investigators studied the families and health care professional's experience of using the web-based support system as well as changes in BMI standard deviation score in the control and intervention group.

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
  • No pharmacological treatment that could intervene the obesity treatment

Exclusion criteria

  • Diagnosed with or undergoing assessment of neuropsychiatric disorder
  • Structured obesity treatment the past 6 months
  • Hypothalamic obesity

Treatment and study plan

CLOSS

Behavioral

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

Usual Care

Behavioral

Usual care. The child and parent(s) at regular visits to the nurse at the clinic

Primary outcomes

  1. Familie's experience and feasibility of the treatment

    Time frame: 6 months after baseline

    CLOSS specific questionnaire, control vs intervention

Secondary outcomes

  1. Health care professional's required working time for control vs intervention

    Time frame: During the intervention 6 months

    Time report

  2. Health care professional's experience using the web based support system

    Time frame: During the intervention 3 and 6 months

    CLOSS specific questions regarding the application

Other outcomes

  1. Change in BMI Standard Deviation Score

    Time frame: During the intervention 3 and 6 months

    Control vs intervention

  2. Familie's compliance

    Time frame: During the intervention 6 months

    Control - visits to the clinic Intervention - daily weighing, daily usage of accelerometer, and visits to the clinic

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

An Evaluation of a Web-based CLinical Obesity Support System (CLOSS) - A Randomized Trial of Childhood Obesity Treatment

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 21, 2017
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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