Overweight
Conditions
Keywords
Overweight, Children, Treatment, Prevention, Lifestyle intervention
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.
Interventions
BEHAVIORALSOFT
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.
BEHAVIORALTeleSOFT
The therapists communicate with the overweight child and his/her family by the SOFT method on distance by use of video.
Sponsors
Skane University Hospital
Lund University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
9 Years to 12 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body mass index standard deviation score (BMI Z-score) during treatment of overweight | Change from Baseline in body weight at an average of 12 months | Body weight measured by Tanita device |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in fat percent measured by TANITA | Change from Baseline in fat percent at an average of 12 months | TANITA measures fat percent via bioimpedance |
| Change in fat distribution measured by abdominal height (F-indicator) | Change from Baseline in fat distribution at an average of 12 months | F-indicator uses a laser beam to measure the abdominal height |
| Change in fat distribution measured by waist circumference | Change from Baseline in waist circumference at an average of 12 months | Measured using a measurement tape |
| Change in KIDSCREEN-index | Change from Baseline in Kidscreen index at an average of 12 months | Use a validated questionnaire |
| 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 | Measured through an app on a smart phone. |
| Change child's metabolic health (Blood pressure) | Change from Baseline in metabolic health at an average of 12 months | Standardized laboratory tests will be performed |
| Change child's metabolic health (LDL-cholesterol) | Change from Baseline in metabolic health at an average of 12 months | Standardized laboratory tests will be performed |
| Change child's metabolic health (HDL-cholesterol) | Change from Baseline in metabolic health at an average of 12 months | Standardized laboratory tests will be performed |
| Change child's metabolic health (triglycerides) | Change from Baseline in metabolic health at an average of 12 months | Standardized laboratory tests will be performed |
| Change child's metabolic health (HbA1c) | Change from Baseline in metabolic health at an average of 12 months | Standardized laboratory tests will be performed |
| Change child's metabolic health (F-blood glucose) | Change from Baseline in metabolic health at an average of 12 months | Standardized laboratory tests will be performed |
| Change child's metabolic health (f-insulin) | Change from Baseline in metabolic health at an average of 12 months | Standardized laboratory tests will be performed |
| Change child's metabolic health (ccK-18) | Change from Baseline in metabolic health at an average of 12 months | Standardized laboratory tests will be performed |
| Change child's metabolic health (ALAT) | Change from Baseline in metabolic health at an average of 12 months | Standardized laboratory tests will be performed |
| Change in dietary habits | Change from Baseline in dietary habits at an average of 12 months | Normal procedure at The Child Obesity Unit using a questionnaire |
| Change in Outcome Rating Scale and Session Rating Scale | Change from Baseline in Outcome Rating Scale at an average of 2, 4, 6, 8, 12 months | Measured psychological Health in general by four questions combined to a general score on a Visual analogue scale |
| Change in Session Rating Scale | Change from Baseline in Session Rating scale at an average of 2, 4, 6, 8, 12 months | Measured assessment of the consultation by visual analogue scale |
Countries
Sweden
Contacts
STUDY_CHAIRDaniel Agardh, Professor
Skane University Hospital
Outcome results
None listed