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

NCT ID: NCT03380598

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

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-20

Study Completion Date

2018-09-24

Brief Summary

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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).

Detailed Description

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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.

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 6 months.

Group Type ACTIVE_COMPARATOR

Usual care

Intervention Type BEHAVIORAL

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

CLOSS

Usual care plus using a web based support system for self-monitoring weight at physical activity.

Group Type ACTIVE_COMPARATOR

CLOSS

Intervention Type 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.

Interventions

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CLOSS

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.

Intervention Type BEHAVIORAL

Usual care

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

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
* 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
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

PhD Pediatric Nurse

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pernilla Danielsson, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

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National Childhood Obesity Center, Karolinska University hospital

Huddinge, , Sweden

Site Status

Outpatient paediatric clinic at Norrtälje Hospital

Norrtälje, , Sweden

Site Status

Outpatient paediatric clinic at Södertälje Hospital

Södertälje, , Sweden

Site Status

Countries

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Sweden

References

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Johansson L, Hagman E, Danielsson P. A novel interactive mobile health support system for pediatric obesity treatment: a randomized controlled feasibility trial. BMC Pediatr. 2020 Sep 23;20(1):447. doi: 10.1186/s12887-020-02338-9.

Reference Type DERIVED
PMID: 32967638 (View on PubMed)

Other Identifiers

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CLOSS100

Identifier Type: -

Identifier Source: org_study_id

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