Back to resultsChildhood Obesity Treatment - Telephone Coaching vc Usual Care
Primary Purpose
Childhood Obesity
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Usual care, individual visits
Telephone coaching
Sponsored by
About this trial
This is an interventional treatment trial for Childhood Obesity focused on measuring Behavioral treatment, Telephone coaching, Outpatient clinic
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Usual care, individual visits
Telephone coaching
Arm Description
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.
Intervention: Telephone consultation each months except for summer holidays during 18 months. The treating nurse communicated with one of the parents.
Outcomes
Primary Outcome Measures
Change in BMI Standard Deviation Score (units)
BMI Standard Deviation Score units using the Swedish reference by Karlberg et al 2001.
Secondary Outcome Measures
Working time required for the Health care personnel
Mean time for each group measured in minutes
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
Full Information
NCT ID
NCT02794090
First Posted
May 31, 2016
Last Updated
June 8, 2016
Sponsor
Sodertalje Hospital
Collaborators
Karolinska Institutet
1. Study Identification
Unique Protocol Identification Number
NCT02794090
Brief Title
Childhood Obesity Treatment - Telephone Coaching vc Usual Care
Official Title
Exclusive Telephone Coaching in Maintaining Weight Loss - An Randomized Controlled Trial of Childhood Obesity Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sodertalje Hospital
Collaborators
Karolinska Institutet
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity
Keywords
Behavioral treatment, Telephone coaching, Outpatient clinic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Usual care, individual visits
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Telephone coaching
Arm Type
Active Comparator
Arm Description
Intervention: Telephone consultation each months except for summer holidays during 18 months. The treating nurse communicated with one of the parents.
Intervention Type
Behavioral
Intervention Name(s)
Usual care, individual visits
Intervention Description
Randomized controlled study of two types of delivering behavioral treatment to Children suffering from obesity.
Intervention Type
Behavioral
Intervention Name(s)
Telephone coaching
Intervention Description
Randomized controlled study of two types of delivering behavioral treatment to Children suffering from obesity.
Primary Outcome Measure Information:
Title
Change in BMI Standard Deviation Score (units)
Description
BMI Standard Deviation Score units using the Swedish reference by Karlberg et al 2001.
Time Frame
From start of treatment, during intervention and follow-up. In total mean 3,7 years
Secondary Outcome Measure Information:
Title
Working time required for the Health care personnel
Description
Mean time for each group measured in minutes
Time Frame
During the intervention 18 months
Title
Families experience of the treatment
Description
Experience for both the Telephone consultation and usual care by not validated anonymous questionnaires constructed by the researchers in this project
Time Frame
During the intervention 18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pernilla Danielsson, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Childhood Obesity Treatment - Telephone Coaching vc Usual Care
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