Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of a Digital Childhood Obesity Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04323215
Recruitment Status : Recruiting
First Posted : March 26, 2020
Last Update Posted : March 26, 2020
Sponsor:
Information provided by (Responsible Party):
Pernilla Danielsson, Karolinska Institutet

Brief Summary:
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.

Condition or disease Intervention/treatment
Childhood Obesity Treatment Adherence Device: Support system

Detailed Description:

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: One Year Evaluation of a Web-based System for Optimization of Behavioural Childhood Obesity Treatment
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : May 1, 2020

Group/Cohort Intervention/treatment
Support system users
Usual care (behavioral treatment) plus the support system for self-monitoring of weight and communication with the clinic during one year of treatment.
Device: Support system
Behavioral treatment with extra support by a support system, named Provement

Control group
Children treated with usual care according to regular treatment routines registred in BORIS the Swedish childhood obesity treatment register



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All children who start treatment for childhood obesity at Martina children Hospital will use a digital support system as a complement to behavioral treatment. Approximately 120 children 3-18 years will be included in this first evaluation.
Criteria

Inclusion Criteria:

  • Obesity according to International Obesity Task Force (IOTF)

Exclusion Criteria:

  • No

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04323215


Contacts
Layout table for location contacts
Contact: Pernilla Danielsson, PhD +46 708 377734 pernilla.danielsson.liljeqvist@ki.se
Contact: Emilia Hagman, PhD +46 8 58587423 emilia.hagman@ki.se

Locations
Layout table for location information
Sweden
Childrens hospital Martina Recruiting
Stockholm, Sweden
Contact: Karin Kling, RN    +46 70 9269047    karin.kling@bsmartina.se   
Sponsors and Collaborators
Karolinska Institutet
Investigators
Layout table for investigator information
Principal Investigator: Pernilla Danielsson, PhD Karolinska Institutet, CLINTEC, Division of pediatrics

Layout table for additonal information
Responsible Party: Pernilla Danielsson, Principal Investigator, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT04323215    
Other Study ID Numbers: Provement100
First Posted: March 26, 2020    Key Record Dates
Last Update Posted: March 26, 2020
Last Verified: March 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pernilla Danielsson, Karolinska Institutet:
Mobile Health
Support System
Behavioral treatment
Self-Monitoring
Additional relevant MeSH terms:
Layout table for MeSH terms
Obesity
Pediatric Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms