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

Sponsor
Karolinska Institutet (Other)
Overall Status
Completed
CT.gov ID
NCT03566771
Collaborator
(none)
82
10
2
19.5
8.2
0.4

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Usual care
  • Behavioral: CLOSS
N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
82 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Treatment Results and Health Care Consumption From a Web-based CLinical Obesity Support System (CLOSS) - A Randomized Multicentre Trial of Childhood Obesity Treatment
Actual Study Start Date :
Apr 11, 2018
Actual Primary Completion Date :
Nov 26, 2019
Actual Study Completion Date :
Nov 26, 2019

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Usual care

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

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

Active Comparator: CLOSS

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

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.

Outcome Measures

Primary Outcome Measures

  1. Changes in degree of obesity [6 and 12 months after baseline]

    Measured by BMI standard deviation score control vs intervention

Secondary Outcome Measures

  1. Number of physical visits [During the intervention 12 months]

    Control vs intervention

  2. Cancelation of physical visits [During the intervention 12 months]

    Control vs intervention

  3. Time consumption for the health care professionals [During the intervention 12 months]

    Time for physical visits, communication and documentation reported by health care professionals. Control vs intervention

  4. Parental experience of treatment [During the intervention 3, 6 and 12 months]

    Measured by web-based CLOSS specific questions. Control vs intervention

  5. Health care professional's experiences using the web-based support system [During the intervention 3, 6 and 12 months]

    CLOSS specific questions regarding the application

  6. Physical activity level [During the intervention 12 months]

    Measured by time and intensity through the activity measuring wrist-band. Only intervention

Eligibility Criteria

Criteria

Ages Eligible for Study:
5 Years to 12 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Outpatient pediatric clinic at Hisingen Göteborg Sweden
2 Outpatient pediatric clinic in Kungshöjd Göteborg Sweden
3 Outpatient pediatric clinic at Helsingborg hospital Helsingborg Sweden
4 Outpatient pediatric clinic at Hässleholm hospital Hässleholm Sweden
5 Outpatient pediatric clinic, Hälsan Barnmottagning Jönköping Sweden
6 Outpatient pediatric clinic at Karlstad hospital Karlstad Sweden
7 Outpatient pediatric clinic at Nacka hospital Stockholm Sweden
8 Pediatric clinic, Umeå University Hospital Umeå Sweden
9 Outpatient pediatric clinic at Västerås central hospital Västerås Sweden
10 Outpatient pediatric clinic at Ystad hospital Ystad Sweden

Sponsors and Collaborators

  • Karolinska Institutet

Investigators

  • Principal Investigator: Pernilla Danielsson, PhD, Karolinska Institutet

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Pernilla Danielsson, Principal Investigator, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT03566771
Other Study ID Numbers:
  • CLOSS200
First Posted:
Jun 25, 2018
Last Update Posted:
Apr 8, 2020
Last Verified:
Apr 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Pernilla Danielsson, Principal Investigator, Karolinska Institutet
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 8, 2020