Treatment of Overweight in Children on Distance (TeleSOFT)

Skane University Hospital

Status: Active, not recruiting

Conditions: Overweight

Treatments: Behavioral: SOFT; Behavioral: TeleSOFT

Study type: Interventional

Funder types: Other

Identifiers

NCT02720302

2015/141

Details and patient eligibility

About

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.

Full 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.

Enrollment: 94 patients

Sex: All

Ages: 9 to 12 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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94 participants in 2 patient groups

SOFT

Experimental group

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.

Treatment:

Behavioral: SOFT

TeleSOFT

Experimental group

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).

Treatment:

Behavioral: TeleSOFT