Clinical trial NCT02720302: Treatment of Overweight in Children on Distance
Official title: Treatment of Overweight in Children on Distance. A Comparison Between Consultations on the Hospital With Video-Consultations on Distance
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Overweight
Keywords: Overweight
Children
Treatment
Prevention
Lifestyle intervention
Lead sponsor: Skane University Hospital
Sponsor class: OTHER
Collaborators: name: Lund University
First posted: 2016-03-25
Enrollment: 94
Sex: ALL
Minimum age (years): 9
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Body mass index standard deviation score (BMI Z-score) during treatment of overweight
timeFrame: Change from Baseline in body weight at an average of 12 months
Secondary outcomes:
measure: Change in fat percent measured by TANITA
timeFrame: Change from Baseline in fat percent at an average of 12 months
measure: Change in fat distribution measured by abdominal height (F-indicator)
timeFrame: Change from Baseline in fat distribution at an average of 12 months
measure: Change in fat distribution measured by waist circumference
timeFrame: Change from Baseline in waist circumference at an average of 12 months
measure: Change in KIDSCREEN-index
timeFrame: Change from Baseline in Kidscreen index at an average of 12 months
measure: Change in physical activity measured by Moves application to smartphone
timeFrame: Change from Baseline in physical activity at an average of 2, 4, 6, 8, 12 months
measure: Change child's metabolic health (Blood pressure)
timeFrame: Change from Baseline in metabolic health at an average of 12 months
measure: Change child's metabolic health (LDL-cholesterol)
timeFrame: Change from Baseline in metabolic health at an average of 12 months
measure: Change child's metabolic health (HDL-cholesterol)
timeFrame: Change from Baseline in metabolic health at an average of 12 months
measure: Change child's metabolic health (triglycerides)
timeFrame: Change from Baseline in metabolic health at an average of 12 months
measure: Change child's metabolic health (HbA1c)
timeFrame: Change from Baseline in metabolic health at an average of 12 months
measure: Change child's metabolic health (F-blood glucose)
timeFrame: Change from Baseline in metabolic health at an average of 12 months
measure: Change child's metabolic health (f-insulin)
timeFrame: Change from Baseline in metabolic health at an average of 12 months
measure: Change child's metabolic health (ccK-18)
timeFrame: Change from Baseline in metabolic health at an average of 12 months
measure: Change child's metabolic health (ALAT)
timeFrame: Change from Baseline in metabolic health at an average of 12 months
measure: Change in dietary habits
timeFrame: Change from Baseline in dietary habits at an average of 12 months
measure: Change in Outcome Rating Scale and Session Rating Scale
timeFrame: Change from Baseline in Outcome Rating Scale at an average of 2, 4, 6, 8, 12 months
measure: Change in Session Rating Scale
timeFrame: Change from Baseline in Session Rating scale at an average of 2, 4, 6, 8, 12 months
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: Barnmedicin
state: Scania
Study officials:
affiliation: Skane University Hospital
name: Daniel Agardh, Professor
role: STUDY_CHAIR
References:
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.
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.
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.
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.