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

Karolinska Institute

Status: Completed

Conditions: Childhood Obesity

Treatments: Behavioral: CLOSS; Behavioral: Usual care

Study type: Interventional

Funder types: Other

Identifiers

NCT03566771

CLOSS200

Details and patient eligibility

About

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).

Full 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.

Enrollment: 82 patients

Sex: All

Ages: 5 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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82 participants in 2 patient groups

Usual care

Active Comparator group

Description:

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

Treatment:

Behavioral: Usual care

CLOSS

Active Comparator group

Description:

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

Treatment:

Behavioral: CLOSS