OverweightTeleSOFTNCT02720302
Treatment of Overweight in Children on Distance
A study testing SOFT and TeleSOFT in people with Overweight, run by Skane University Hospital at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 9 to 12 years
- Conditions the study is for
- Overweight
- What is being tested?
- SOFT and TeleSOFT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteSweden
- Study dates
- Mar 2016to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Overweight in Children on Distance. A Comparison Between Consultations on the Hospital With Video-Consultations on Distance
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.
Read the 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.
- Conditions
- Overweight
- Being tested
- SOFT, TeleSOFT
- Keywords
- Overweight, Children, Treatment, Prevention, Lifestyle intervention
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOFTBehavioural
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.
TeleSOFTBehavioural
The therapists communicate with the overweight child and his/her family by the SOFT method on distance by use of video.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Behavioral: TeleSOFT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body mass index standard deviation score (BMI Z-score) during treatment of overweight
Body weight measured by Tanita device
Measured: Change from Baseline in body weight at an average of 12 months
Secondary outcomes (17)
Change in fat percent measured by TANITA
TANITA measures fat percent via bioimpedance
Measured: Change from Baseline in fat percent at an average of 12 months
Change in fat distribution measured by abdominal height (F-indicator)
F-indicator uses a laser beam to measure the abdominal height
Measured: Change from Baseline in fat distribution at an average of 12 months
Change in fat distribution measured by waist circumference
Measured using a measurement tape
Measured: Change from Baseline in waist circumference at an average of 12 months
Change in KIDSCREEN-index
Use a validated questionnaire
Measured: Change from Baseline in Kidscreen index at an average of 12 months
Change in physical activity measured by Moves application to smartphone
Measured through an app on a smart phone.
Measured: Change from Baseline in physical activity at an average of 2, 4, 6, 8, 12 months
Change child's metabolic health (Blood pressure)
Standardized laboratory tests will be performed
Measured: Change from Baseline in metabolic health at an average of 12 months
Change child's metabolic health (LDL-cholesterol)
Standardized laboratory tests will be performed
Measured: Change from Baseline in metabolic health at an average of 12 months
Change child's metabolic health (HDL-cholesterol)
Standardized laboratory tests will be performed
Measured: Change from Baseline in metabolic health at an average of 12 months
Change child's metabolic health (triglycerides)
Standardized laboratory tests will be performed
Measured: Change from Baseline in metabolic health at an average of 12 months
Change child's metabolic health (HbA1c)
Standardized laboratory tests will be performed
Measured: Change from Baseline in metabolic health at an average of 12 months
Change child's metabolic health (F-blood glucose)
Standardized laboratory tests will be performed
Measured: Change from Baseline in metabolic health at an average of 12 months
Change child's metabolic health (f-insulin)
Standardized laboratory tests will be performed
Measured: Change from Baseline in metabolic health at an average of 12 months
Change child's metabolic health (ccK-18)
Standardized laboratory tests will be performed
Measured: Change from Baseline in metabolic health at an average of 12 months
Change child's metabolic health (ALAT)
Standardized laboratory tests will be performed
Measured: Change from Baseline in metabolic health at an average of 12 months
Change in dietary habits
Normal procedure at The Child Obesity Unit using a questionnaire
Measured: Change from Baseline in dietary habits at an average of 12 months
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
Measured: Change from Baseline in Outcome Rating Scale at an average of 2, 4, 6, 8, 12 months
Change in Session Rating Scale
Measured assessment of the consultation by visual analogue scale
Measured: Change from Baseline in Session Rating scale at an average of 2, 4, 6, 8, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2016 (estimated)
- Study startMar 2016
- Primary completion20 Dec 2017
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Skane University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Lund University
- Responsible party
- Principal investigator, Carl-Erik Flodmark, Skane University Hospital
- Investigators
- Daniel Agardh, Professor, Study chair, Skane University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02720302
- Sponsor's protocol ID
- 2015/141
- Acronym
- TeleSOFT
- Status last verified
- May 2025
- First submitted
- 23 Nov 2015
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 17852553Flodmark 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.
PubMed 8474806Nowicka 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.
PubMed 20650975Cole 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.
PubMed 10797032
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Overweight in Children on Distance. A Comparison Between Consultations on the Hospital With Video-Consultations on Distance
- ClinicalTrials.gov ID
- NCT02720302
- Acronym / sponsor ID
- TeleSOFT / 2015/141
- Conditions
- Overweight
- Keywords
- Overweight, Children, Treatment, Prevention, Lifestyle intervention
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Skane University HospitalUniversity, hospital or other
- Collaborators
- Lund University
- Study start
- Mar 2016 (actual)
- Primary completion
- 20 Dec 2017 (actual)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 25 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SOFT | Experimental | Behavioral: SOFTAll 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. |
| TeleSOFT | Experimental | Behavioral: TeleSOFTThe 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). |
Who may qualify
- Ages
- 9 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SOFTSOFT 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. | Behavioural | SOFT |
| TeleSOFTThe therapists communicate with the overweight child and his/her family by the SOFT method on distance by use of video. | Behavioural | TeleSOFT |
Primary outcome
Body mass index standard deviation score (BMI Z-score) during treatment of overweight
Time frame: Change from Baseline in body weight at an average of 12 months
Body weight measured by Tanita device
17 secondary outcomes
Change in fat percent measured by TANITA
Time frame: Change from Baseline in fat percent at an average of 12 months
Change in fat distribution measured by abdominal height (F-indicator)
Time frame: Change from Baseline in fat distribution at an average of 12 months
Change in fat distribution measured by waist circumference
Time frame: Change from Baseline in waist circumference at an average of 12 months
Change in KIDSCREEN-index
Time frame: Change from Baseline in Kidscreen index at an average of 12 months
Change in physical activity measured by Moves application to smartphone
Time frame: Change from Baseline in physical activity at an average of 2, 4, 6, 8, 12 months
Change child's metabolic health (Blood pressure)
Time frame: Change from Baseline in metabolic health at an average of 12 months
Change child's metabolic health (LDL-cholesterol)
Time frame: Change from Baseline in metabolic health at an average of 12 months
Change child's metabolic health (HDL-cholesterol)
Time frame: Change from Baseline in metabolic health at an average of 12 months
Change child's metabolic health (triglycerides)
Time frame: Change from Baseline in metabolic health at an average of 12 months
Change child's metabolic health (HbA1c)
Time frame: Change from Baseline in metabolic health at an average of 12 months
Change child's metabolic health (F-blood glucose)
Time frame: Change from Baseline in metabolic health at an average of 12 months
Change child's metabolic health (f-insulin)
Time frame: Change from Baseline in metabolic health at an average of 12 months
Change child's metabolic health (ccK-18)
Time frame: Change from Baseline in metabolic health at an average of 12 months
Change child's metabolic health (ALAT)
Time frame: Change from Baseline in metabolic health at an average of 12 months
Change in dietary habits
Time frame: Change from Baseline in dietary habits at an average of 12 months
Change in Outcome Rating Scale and Session Rating Scale
Time frame: Change from Baseline in Outcome Rating Scale at an average of 2, 4, 6, 8, 12 months
Change in Session Rating Scale
Time frame: Change from Baseline in Session Rating scale at an average of 2, 4, 6, 8, 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Background: PubMed 17852553Nowicka 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.
- Background: PubMed 8474806Flodmark 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.
- Background: PubMed 20650975Nowicka 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.
- Background: PubMed 10797032Cole 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.
- Individual participant dataSharing planned: No
Related trials for Overweight
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Agardh, Professor study chair
Skane University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SOFT and TeleSOFT in people with Overweight, run by Skane University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body mass index standard deviation score (BMI Z-score) during treatment of overweight (time frame: Change from Baseline in body weight at an average of 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02720302, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.