Treatment of Overweight in Children on Distance

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2025-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Overweight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SOFT

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.

Group Type EXPERIMENTAL

SOFT

Intervention Type BEHAVIORAL

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.

TeleSOFT

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).

Group Type EXPERIMENTAL

TeleSOFT

Intervention Type BEHAVIORAL

The therapists communicate with the overweight child and his/her family by the SOFT method on distance by use of video.

Interventions

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SOFT

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

TeleSOFT

The therapists communicate with the overweight child and his/her family by the SOFT method on distance by use of video.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

9 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No