Treatment of Overweight in Children on Distance

NCT02720302 | Active Not Recruiting

• 1 other identifier: 2015/141
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight

Keywords

Overweight; Children; Treatment; Prevention; Lifestyle intervention

Outcome Measures

Primary Outcomes (1)

• Body mass index standard deviation score (BMI Z-score) during treatment of overweight

  Body weight measured by Tanita device

  Change from Baseline in body weight at an average of 12 months

Secondary Outcomes (17)

• Change in fat percent measured by TANITA

  Change from Baseline in fat percent at an average of 12 months

• Change in fat distribution measured by abdominal height (F-indicator)

  Change from Baseline in fat distribution at an average of 12 months

• Change in fat distribution measured by waist circumference

  Change from Baseline in waist circumference at an average of 12 months

• Change in KIDSCREEN-index

  Change from Baseline in Kidscreen index at an average of 12 months

• Change in physical activity measured by Moves application to smartphone

  Change from Baseline in physical activity at an average of 2, 4, 6, 8, 12 months

Study Arms (2)

SOFT

EXPERIMENTAL

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.

Behavioral: SOFT

TeleSOFT

EXPERIMENTAL

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).

Behavioral: TeleSOFT

Interventions

SOFT 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.

SOFT

TeleSOFT BEHAVIORAL

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

TeleSOFT

Eligibility Criteria

• Age: 9 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Skane University Hospital: lead
• Lund University: collaborator

Study Sites (1)

Barnmedicin

Malmö, Skåne County, 20502, Sweden

Location

Related Publications (4)

• 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.

  PMID: 17852553 BACKGROUND

• 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.

  PMID: 8474806 BACKGROUND

• 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.

  PMID: 20650975 BACKGROUND

• 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.

  PMID: 10797032 BACKGROUND

MeSH Terms

Conditions

Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Daniel Agardh, Professor

  Skane University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Docent

Study Record Dates

• First Submitted: November 23, 2015
• First Posted: March 25, 2016
• Study Start: March 1, 2016
• Primary Completion: December 20, 2017
• Study Completion (Estimated): January 31, 2027
• Last Updated: May 4, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)