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NCT Number: NCT02720302

Treatment of Overweight in Children 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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

9 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Barnmedicin

Malmö, Skåne County, 20502, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

TeleSOFT

Behavioral

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Change in fat percent measured by TANITA

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

    TANITA measures fat percent via bioimpedance

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

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

    F-indicator uses a laser beam to measure the abdominal height

  3. Change in fat distribution measured by waist circumference

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

    Measured using a measurement tape

  4. Change in KIDSCREEN-index

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

    Use a validated questionnaire

  5. 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

    Measured through an app on a smart phone.

  6. Change child's metabolic health (Blood pressure)

    Time frame: Change from Baseline in metabolic health at an average of 12 months

    Standardized laboratory tests will be performed

  7. Change child's metabolic health (LDL-cholesterol)

    Time frame: Change from Baseline in metabolic health at an average of 12 months

    Standardized laboratory tests will be performed

  8. Change child's metabolic health (HDL-cholesterol)

    Time frame: Change from Baseline in metabolic health at an average of 12 months

    Standardized laboratory tests will be performed

  9. Change child's metabolic health (triglycerides)

    Time frame: Change from Baseline in metabolic health at an average of 12 months

    Standardized laboratory tests will be performed

  10. Change child's metabolic health (HbA1c)

    Time frame: Change from Baseline in metabolic health at an average of 12 months

    Standardized laboratory tests will be performed

  11. Change child's metabolic health (F-blood glucose)

    Time frame: Change from Baseline in metabolic health at an average of 12 months

    Standardized laboratory tests will be performed

  12. Change child's metabolic health (f-insulin)

    Time frame: Change from Baseline in metabolic health at an average of 12 months

    Standardized laboratory tests will be performed

  13. Change child's metabolic health (ccK-18)

    Time frame: Change from Baseline in metabolic health at an average of 12 months

    Standardized laboratory tests will be performed

  14. Change child's metabolic health (ALAT)

    Time frame: Change from Baseline in metabolic health at an average of 12 months

    Standardized laboratory tests will be performed

  15. Change in dietary habits

    Time frame: Change from Baseline in dietary habits at an average of 12 months

    Normal procedure at The Child Obesity Unit using a questionnaire

  16. 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

    Measured psychological Health in general by four questions combined to a general score on a Visual analogue scale

  17. Change in Session Rating Scale

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Skane University Hospital

Other

Collaborators

  • Lund University

Registry information

Official study title

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

Acronym: TeleSOFT

Important dates

Study start
2016
Primary completion
2017
Study completion
2027
First posted
Mar 25, 2016
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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