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

NCT ID: NCT03566771

Last Updated: 2020-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-11

Study Completion Date

2019-11-26

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Childhood Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Usual care

Usual care according to regular treatment routines at the clinic during 12 months

Group Type ACTIVE_COMPARATOR

Usual care

Intervention Type BEHAVIORAL

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

CLOSS

Usual care plus using a web-based support system for self-monitoring weight, physical activity and communication with the clinic during 12 months

Group Type ACTIVE_COMPARATOR

CLOSS

Intervention Type 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.

Interventions

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Usual care

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

Intervention Type BEHAVIORAL

CLOSS

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Pernilla Danielsson

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pernilla Danielsson, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

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Outpatient pediatric clinic at Hisingen

Gothenburg, , Sweden

Site Status

Outpatient pediatric clinic in Kungshöjd

Gothenburg, , Sweden

Site Status

Outpatient pediatric clinic at Hässleholm hospital

Hässleholm, , Sweden

Site Status

Outpatient pediatric clinic at Helsingborg hospital

Helsingborg, , Sweden

Site Status

Outpatient pediatric clinic, Hälsan Barnmottagning

Jönköping, , Sweden

Site Status

Outpatient pediatric clinic at Karlstad hospital

Karlstad, , Sweden

Site Status

Outpatient pediatric clinic at Nacka hospital

Stockholm, , Sweden

Site Status

Pediatric clinic, Umeå University Hospital

Umeå, , Sweden

Site Status

Outpatient pediatric clinic at Västerås central hospital

Västerås, , Sweden

Site Status

Outpatient pediatric clinic at Ystad hospital

Ystad, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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CLOSS200

Identifier Type: -

Identifier Source: org_study_id

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