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Completed

NCT Number: NCT06434259

Evaluation of Long-term 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

4 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Childrens Hospital Martina

Stockholm, 114 28, 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 present study is a continuation of the investigators previous one-year study, Clinicaltrials.gov ID: NCT04323215. In this follow-up study, the investigators aim to assess the treatment outcomes over a three-year period.

The evaluation will be carried out on 107 children who underwent digi-physical treatment for three years. The results will be compared with a matched control group (n=321) from the Swedish childhood obesity treatment register, BORIS.

Who can participate

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

Inclusion criteria

  • Obesity according to International Obesity Task Force (IOTF)

Exclusion criteria

  • None

Treatment and study plan

Digi-physical support system

Device

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

Primary outcomes

  1. Change in degree of obesity

    Time frame: From start of treatment to three years follow-up

    Measured by BMI standard deviation score. Digi-physical group vs. control group

Secondary outcomes

  1. The use of the support system - weighings

    Time frame: From start of treatment to three years follow-up

    Number of weighings/week

  2. The use of the support system - text messages

    Time frame: From start of treatment to three years follow-up

    Number text messages/week

  3. Number of physical visits

    Time frame: From start of treatment to three years follow-up

    Visits to the clinic. Digi-physical group vs. control group

  4. Number of cancelation of physical visits

    Time frame: From start of treatment to three years follow-up

    Visits to the clinic. Digi-physical group vs. control group

  5. Number of patients not showing up to physical visit

    Time frame: From start of treatment to three years follow-up

    Visits to the clinic. Digi-physical group vs. control group

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

Long-term Results of an Interactive Mobile Health Support System and Daily Home-weighing as an add-on to Pediatric Obesity Lifestyle Treatment: A 3-year Pragmatic Clinical Trial

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
May 30, 2024
Registry last updated
May 31, 2024

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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