Treatment of Overweight in Children on Distance

Overweight Clinical Trial

— TeleSOFT  

Official title:

Treatment of Overweight in Children on Distance. A Comparison Between Consultations on the Hospital With Video-Consultations on Distance

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02720302
• Other study ID #: 2015/141
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 2016
• Est. completion date: January 31, 2025

Study information

• Verified date: April 2024
• Source: Skane University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 94
• Est. completion date: January 31, 2025
• Est. primary completion date: December 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Overweight

Intervention

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

Locations

Country	Name	City	State
Sweden	Barnmedicin	Malmö	Scania

Sponsors (2)

Lead Sponsor	Collaborator
Skane University Hospital	Lund University

Country where clinical trial is conducted

Sweden, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in fat percent measured by TANITA	TANITA measures fat percent via bioimpedance	Change from Baseline in fat percent at an average of 12 months
Secondary	Change in fat distribution measured by abdominal height (F-indicator)	F-indicator uses a laser beam to measure the abdominal height	Change from Baseline in fat distribution at an average of 12 months
Secondary	Change in fat distribution measured by waist circumference	Measured using a measurement tape	Change from Baseline in waist circumference at an average of 12 months
Secondary	Change in KIDSCREEN-index	Use a validated questionnaire	Change from Baseline in Kidscreen index at an average of 12 months
Secondary	Change in physical activity measured by Moves application to smartphone	Measured through an app on a smart phone.	Change from Baseline in physical activity at an average of 2, 4, 6, 8, 12 months
Secondary	Change child's metabolic health (Blood pressure)	Standardized laboratory tests will be performed	Change from Baseline in metabolic health at an average of 12 months
Secondary	Change child's metabolic health (LDL-cholesterol)	Standardized laboratory tests will be performed	Change from Baseline in metabolic health at an average of 12 months
Secondary	Change child's metabolic health (HDL-cholesterol)	Standardized laboratory tests will be performed	Change from Baseline in metabolic health at an average of 12 months
Secondary	Change child's metabolic health (triglycerides)	Standardized laboratory tests will be performed	Change from Baseline in metabolic health at an average of 12 months
Secondary	Change child's metabolic health (HbA1c)	Standardized laboratory tests will be performed	Change from Baseline in metabolic health at an average of 12 months
Secondary	Change child's metabolic health (F-blood glucose)	Standardized laboratory tests will be performed	Change from Baseline in metabolic health at an average of 12 months
Secondary	Change child's metabolic health (f-insulin)	Standardized laboratory tests will be performed	Change from Baseline in metabolic health at an average of 12 months
Secondary	Change child's metabolic health (ccK-18)	Standardized laboratory tests will be performed	Change from Baseline in metabolic health at an average of 12 months
Secondary	Change child's metabolic health (ALAT)	Standardized laboratory tests will be performed	Change from Baseline in metabolic health at an average of 12 months
Secondary	Change in dietary habits	Normal procedure at The Child Obesity Unit using a questionnaire	Change from Baseline in dietary habits at an average of 12 months
Secondary	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 from Baseline in Outcome Rating Scale at an average of 2, 4, 6, 8, 12 months
Secondary	Change in Session Rating Scale	Measured assessment of the consultation by visual analogue scale	Change from Baseline in Session Rating scale at an average of 2, 4, 6, 8, 12 months