Childhood Obesity Treatment - Telephone Coaching vc Usual Care

Study Overview
=================
Brief Summary
-----------------
This study evaluates if usual physical care visits to an outpatient pediatric clinic can be replaced with more frequent and shorter Telephone coaching Contacts during 18 months.

Detailed Description
-----------------
In this randomized controlled study, patients at age 5 to 14 and enrolled in obesity treatment, were randomized to either usual care according to regular routine or to telephone consultation.The randomization was done at the start of individual treatment and lasted for 18 months. We also studied working time required for the Health care, and the families' experience of the Telephone coaching.

Official Title
-----------------
Exclusive Telephone Coaching in Maintaining Weight Loss - An Randomized Controlled Trial of Childhood Obesity Treatment

Conditions
-----------------
Childhood Obesity

Intervention / Treatment
-----------------
* Behavioral: Usual care, individual visits
* Behavioral: Telephone coaching


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children 5 to 14 years old who were patients at the outpatient pediatric centre All families after that the parents had attended at least 4 of 7 meetings in a parental/education group. Exclusion Criteria: Obesity related syndromes Non-Swedish speaking families

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 14 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual care, individual visits<br>Usual care according to regular treatment routines at the clinic during 18 months. The Child and parent(s) at regular visits to the nurse at the clinic. | Behavioral: Usual care, individual visits<br>* Randomized controlled study of two types of delivering behavioral treatment to Children suffering from obesity.<br>|
| Active Comparator: Telephone coaching<br>Intervention: Telephone consultation each months except for summer holidays during 18 months. The treating nurse communicated with one of the parents. | Behavioral: Telephone coaching<br>* Randomized controlled study of two types of delivering behavioral treatment to Children suffering from obesity.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in BMI Standard Deviation Score (units) | BMI Standard Deviation Score units using the Swedish reference by Karlberg et al 2001. | From start of treatment, during intervention and follow-up. In total mean 3,7 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Working time required for the Health care personnel | Mean time for each group measured in minutes | During the intervention 18 months | 
| Families experience of the treatment | Experience for both the Telephone consultation and usual care by not validated anonymous questionnaires constructed by the researchers in this project | During the intervention 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Behavioral treatment, Telephone coaching, Outpatient clinic