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Treatment of Overweight in Children on Distance (TeleSOFT)

Primary Purpose

Overweight

Status
Active
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
SOFT
TeleSOFT
Sponsored by
Skane University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight focused on measuring Overweight, Children, Treatment, Prevention, Lifestyle intervention

Eligibility Criteria

9 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

- Children with overweight and not obese according to the definitions developed by Cole et al (4). It implies that we include children with the following age specific BMI Inclusion criteria

  • 9 years = AGE < 9 years, 6 months AND 19,0< BMI<23,0
  • 9 years, 6 months => AGE < 10 Years AND 19,5 <BMI<23,5
  • 10 years = AGE < 10 years, 6 months AND 20,0<BMI<24,0
  • 10 years, 6 months=>AGE< 11 years AND 20,5<BMI<24,5
  • 11 years = AGE < 11 years, 6 months AND 21,0<BMI<25,5
  • 11 years, 6 months =>AGE<12 years AND 21,5<BMI<25,5

Exclusion Criteria:

  • Children and his/her parents not able to communicate in Swedish.
  • Children with monogenic obesity
  • Present less than 80% at school in the latest school year.
  • No foster care for the child or his/her brothers or sisters

Sites / Locations

  • Barnmedicin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

SOFT

TeleSOFT

Arm Description

All Children have their first and their last consultation at The Child Obesity Unit. The investigators use Standardized Obesity Family Therapy "SOFT" as described by Nowicka & Flodmark (1-3). The intervention use psychological techniques developed in systemic family therapy applied on advice regarding exercise and diet as well as behavioural Life style Changes. At each consultation with the overweight child and his/her biological parents there are two therapists present.

The same method Lifestyle intervention "SOFT" is used. The only difference is that the communication in the second, third (and fourth) visit is made by use of video on distance. The investigators use Standardized Obesity Family Therapy "SOFT" as described by Nowicka & Flodmark (1-3).

Outcomes

Primary Outcome Measures

Body mass index standard deviation score (BMI Z-score) during treatment of overweight
Body weight measured by Tanita device

Secondary Outcome Measures

Change in fat percent measured by TANITA
TANITA measures fat percent via bioimpedance
Change in fat distribution measured by abdominal height (F-indicator)
F-indicator uses a laser beam to measure the abdominal height
Change in fat distribution measured by waist circumference
Measured using a measurement tape
Change in KIDSCREEN-index
Use a validated questionnaire
Change in physical activity measured by Moves application to smartphone
Measured through an app on a smart phone.
Change child's metabolic health (Blood pressure)
Standardized laboratory tests will be performed
Change child's metabolic health (LDL-cholesterol)
Standardized laboratory tests will be performed
Change child's metabolic health (HDL-cholesterol)
Standardized laboratory tests will be performed
Change child's metabolic health (triglycerides)
Standardized laboratory tests will be performed
Change child's metabolic health (HbA1c)
Standardized laboratory tests will be performed
Change child's metabolic health (F-blood glucose)
Standardized laboratory tests will be performed
Change child's metabolic health (f-insulin)
Standardized laboratory tests will be performed
Change child's metabolic health (ccK-18)
Standardized laboratory tests will be performed
Change child's metabolic health (ALAT)
Standardized laboratory tests will be performed
Change in dietary habits
Normal procedure at The Child Obesity Unit using a questionnaire
Change in Outcome Rating Scale and Session Rating Scale
Measured psychological Health in general by four questions combined to a general score on a Visual analogue scale
Change in Session Rating Scale
Measured assessment of the consultation by visual analogue scale

Full Information

First Posted
November 23, 2015
Last Updated
October 24, 2022
Sponsor
Skane University Hospital
Collaborators
Lund University
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1. Study Identification

Unique Protocol Identification Number
NCT02720302
Brief Title
Treatment of Overweight in Children on Distance
Acronym
TeleSOFT
Official Title
Treatment of Overweight in Children on Distance. A Comparison Between Consultations on the Hospital With Video-Consultations on Distance
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 2016 (Actual)
Primary Completion Date
December 20, 2017 (Actual)
Study Completion Date
January 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Skane University Hospital
Collaborators
Lund University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The present study is a public health project with the aim to treat overweight in children 9-11 years of age. After the first consultation the children are randomized to either continue the treatment at The Child Obesity Clinic, Child Department or to have the following 2-3 consultations on distance with Lync. Last visit for all children is on the Child Obesity Clinic after approximately 12 months. Follow up after at least 1 years will be performed.
Detailed Description
This superiority study is a randomized trial with two independent treatment arms. The target for the enrollment is 50% in each of the two treatment groups. With 60 patients in each group, the study has 80% statistical power at 5% significance level to detect an average difference between the treatment groups in the intra-individual change in the BMI Z-score that is 0.51 x the standard deviation in the intra-individual change. Previous data from the investigators own group suggest that a reasonable estimate of the standard deviation in the intra-individual change in the BMI Z-score following intervention is 0.42. Thus, the study has 80% statistical power at 5% significance level to detect a difference in the intra-individual change in the BMI Z-score that is 0.51 x 0.42 = 0.21 on average. The study will with the present funding end its follow up in June 2017.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight
Keywords
Overweight, Children, Treatment, Prevention, Lifestyle intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
94 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SOFT
Arm Type
Experimental
Arm Description
All Children have their first and their last consultation at The Child Obesity Unit. The investigators use Standardized Obesity Family Therapy "SOFT" as described by Nowicka & Flodmark (1-3). The intervention use psychological techniques developed in systemic family therapy applied on advice regarding exercise and diet as well as behavioural Life style Changes. At each consultation with the overweight child and his/her biological parents there are two therapists present.
Arm Title
TeleSOFT
Arm Type
Experimental
Arm Description
The same method Lifestyle intervention "SOFT" is used. The only difference is that the communication in the second, third (and fourth) visit is made by use of video on distance. The investigators use Standardized Obesity Family Therapy "SOFT" as described by Nowicka & Flodmark (1-3).
Intervention Type
Behavioral
Intervention Name(s)
SOFT
Intervention Description
SOFT is based on systemic and solution-focused theories to change lifestyle and has shown positive effects on children with respect to the degree of obesity, physical fitness, self-esteem and family functioning.
Intervention Type
Behavioral
Intervention Name(s)
TeleSOFT
Intervention Description
The therapists communicate with the overweight child and his/her family by the SOFT method on distance by use of video.
Primary Outcome Measure Information:
Title
Body mass index standard deviation score (BMI Z-score) during treatment of overweight
Description
Body weight measured by Tanita device
Time Frame
Change from Baseline in body weight at an average of 12 months
Secondary Outcome Measure Information:
Title
Change in fat percent measured by TANITA
Description
TANITA measures fat percent via bioimpedance
Time Frame
Change from Baseline in fat percent at an average of 12 months
Title
Change in fat distribution measured by abdominal height (F-indicator)
Description
F-indicator uses a laser beam to measure the abdominal height
Time Frame
Change from Baseline in fat distribution at an average of 12 months
Title
Change in fat distribution measured by waist circumference
Description
Measured using a measurement tape
Time Frame
Change from Baseline in waist circumference at an average of 12 months
Title
Change in KIDSCREEN-index
Description
Use a validated questionnaire
Time Frame
Change from Baseline in Kidscreen index at an average of 12 months
Title
Change in physical activity measured by Moves application to smartphone
Description
Measured through an app on a smart phone.
Time Frame
Change from Baseline in physical activity at an average of 2, 4, 6, 8, 12 months
Title
Change child's metabolic health (Blood pressure)
Description
Standardized laboratory tests will be performed
Time Frame
Change from Baseline in metabolic health at an average of 12 months
Title
Change child's metabolic health (LDL-cholesterol)
Description
Standardized laboratory tests will be performed
Time Frame
Change from Baseline in metabolic health at an average of 12 months
Title
Change child's metabolic health (HDL-cholesterol)
Description
Standardized laboratory tests will be performed
Time Frame
Change from Baseline in metabolic health at an average of 12 months
Title
Change child's metabolic health (triglycerides)
Description
Standardized laboratory tests will be performed
Time Frame
Change from Baseline in metabolic health at an average of 12 months
Title
Change child's metabolic health (HbA1c)
Description
Standardized laboratory tests will be performed
Time Frame
Change from Baseline in metabolic health at an average of 12 months
Title
Change child's metabolic health (F-blood glucose)
Description
Standardized laboratory tests will be performed
Time Frame
Change from Baseline in metabolic health at an average of 12 months
Title
Change child's metabolic health (f-insulin)
Description
Standardized laboratory tests will be performed
Time Frame
Change from Baseline in metabolic health at an average of 12 months
Title
Change child's metabolic health (ccK-18)
Description
Standardized laboratory tests will be performed
Time Frame
Change from Baseline in metabolic health at an average of 12 months
Title
Change child's metabolic health (ALAT)
Description
Standardized laboratory tests will be performed
Time Frame
Change from Baseline in metabolic health at an average of 12 months
Title
Change in dietary habits
Description
Normal procedure at The Child Obesity Unit using a questionnaire
Time Frame
Change from Baseline in dietary habits at an average of 12 months
Title
Change in Outcome Rating Scale and Session Rating Scale
Description
Measured psychological Health in general by four questions combined to a general score on a Visual analogue scale
Time Frame
Change from Baseline in Outcome Rating Scale at an average of 2, 4, 6, 8, 12 months
Title
Change in Session Rating Scale
Description
Measured assessment of the consultation by visual analogue scale
Time Frame
Change from Baseline in Session Rating scale at an average of 2, 4, 6, 8, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - Children with overweight and not obese according to the definitions developed by Cole et al (4). It implies that we include children with the following age specific BMI Inclusion criteria 9 years = AGE < 9 years, 6 months AND 19,0< BMI<23,0 9 years, 6 months => AGE < 10 Years AND 19,5 <BMI<23,5 10 years = AGE < 10 years, 6 months AND 20,0<BMI<24,0 10 years, 6 months=>AGE< 11 years AND 20,5<BMI<24,5 11 years = AGE < 11 years, 6 months AND 21,0<BMI<25,5 11 years, 6 months =>AGE<12 years AND 21,5<BMI<25,5 Exclusion Criteria: Children and his/her parents not able to communicate in Swedish. Children with monogenic obesity Present less than 80% at school in the latest school year. No foster care for the child or his/her brothers or sisters
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Agardh, Professor
Organizational Affiliation
Skane University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Barnmedicin
City
Malmö
State/Province
Scania
ZIP/Postal Code
20502
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
17852553
Citation
Nowicka P, Pietrobelli A, Flodmark CE. Low-intensity family therapy intervention is useful in a clinical setting to treat obese and extremely obese children. Int J Pediatr Obes. 2007;2(4):211-7. doi: 10.1080/17477160701379810.
Results Reference
background
PubMed Identifier
8474806
Citation
Flodmark CE, Ohlsson T, Ryden O, Sveger T. Prevention of progression to severe obesity in a group of obese schoolchildren treated with family therapy. Pediatrics. 1993 May;91(5):880-4.
Results Reference
background
PubMed Identifier
20650975
Citation
Nowicka P, Flodmark CE. Family therapy as a model for treating childhood obesity: useful tools for clinicians. Clin Child Psychol Psychiatry. 2011 Jan;16(1):129-45. doi: 10.1177/1359104509355020. Epub 2010 Jul 22.
Results Reference
background
PubMed Identifier
10797032
Citation
Cole TJ, Bellizzi MC, Flegal KM, Dietz WH. Establishing a standard definition for child overweight and obesity worldwide: international survey. BMJ. 2000 May 6;320(7244):1240-3. doi: 10.1136/bmj.320.7244.1240.
Results Reference
background

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Treatment of Overweight in Children on Distance

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