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Completed

NCT Number: NCT04323215

Evaluation of a Digital Childhood Obesity Treatment

This study aims to evaluate if a web-based digital support system aiming to replacing or complement standardized pediatric behavioural obesity treatment. The hypothesis is that a digital system of communication between the family and the clinic can generate improved treatment results (change in BMI SDS) and reduce the number of missed visits.

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Key information

Conditions

Childhood Obesity Behavior Body Weight Health Behavior Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms Treatment Adherence Treatment Adherence and Compliance

Age range

3 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Childrens hospital Martina

Stockholm, Sweden

About this study

Childhood obesity treatment is time consuming for both the health care system, and for the involved families. There is an association between the intensity and the outcome of treatment.

In this study all children who start treatment for childhood obesity will use a digital support system as a complement to behavioral treatment. The digital support system includes daily weighing on scales that do not show any digits, linked to a mobile app where weight development is shown as a moving average in the form of BMI standard deviation score (SDS). The app also provides an individual target curve visualizing the expected weight journey. Weight in growing children is complex to interpret why BMI SDS is used. Objective data from scale are automatically transferred to the database and the clinic and the family have direct contact with the clinic via the app.

The evaluation will be carried out when approximately 120 children have had the opportunity to be treated with the support system for one year. The results will be compared with a matched control group from the BORIS childhood obesity treatment register.

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)

Exclusion criteria

  • No

Treatment and study plan

Support system

Device

A support system named Provement will be used to provide behavioral treatment.

Primary outcomes

  1. Change in degree of obesity

    Time frame: From start of treatment to one year follow-up

    Measured by BMI standard deviation score. Support system users vs control

Secondary outcomes

  1. The use of the support system - weighings

    Time frame: From start of treatment to one year follow-up

    Number of weighings/week

  2. The use of the support system - text messages

    Time frame: From start of treatment to one year follow-up

    Number text messages/week

  3. Number of physical visits

    Time frame: From start of treatment to one year follow-up

    Visits to the clinic. Support system users vs control

  4. Number of cancelation of physical visits

    Time frame: From start of treatment to one year follow-up

    Visits to the clinic. Support system users vs control

  5. Number of patients not showing up to physical visit

    Time frame: From start of treatment to one year follow-up

    Visits to the clinic. Support system users vs control

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

One Year Evaluation of a Web-based System for Optimization of Behavioural Childhood Obesity Treatment

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Mar 26, 2020
Registry last updated
Nov 23, 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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