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The study objective is to evaluate whether a novel telemedicine-based intensive treatment program for children with obesity is superior to standard on-site care. This will be a randomized, non-blinded (due to the nature of the intervention) study, where 100 children and adolescents aged 10-18 years with obesity will be divided in a 1:1 ratio to either telemedicine or on-site treatments for 6 months.
The telemedicine arm will include 30, mostly video, consultations for each participant: 3 physician appointments, 7 exercise consultations by our exercise physiologist, 10 dietary consultations by our pediatric dietitian, and 10 psychologist consultations to assist with goal setting and overall well-being. Three visits will be conducted in-office, for physician assessment, smartphone technical assistance and physical measurements (baseline, at 3 months and at the end of the 6-month period). Participants randomized to the telemedicine arm will have a step-counting rewarding app installed on their smartphone by our staff.
The in-office arm will have 6 monthly visits during the study period, with two consultations performed in each visit - one by the physician or exercise physiologist, and one by our pediatric dietitian.
The main outcome of the study is BMI standard deviation (z-score) changes, which will be evaluated after 3 and 6 months of treatment during physical office visits in both study arms.
Secondary outcomes will be:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telemedicine | Experimental | The telemedicine arm will include 30, mostly video, consultations for each participant: 3 physician appointments, 7 exercise consultations by our exercise physiologist, 10 dietary consultations by our pediatric dietitian, and 10 psychologist consultations to assist with goal setting and overall well-being. Three visits will be conducted in-office, for physician assessment, smartphone technical assistance and physical measurements (baseline, at 3 months and at the end of the 6-month period). Participants randomized to the telemedicine arm will have a step-counting rewarding app installed on their smartphone by our staff. |
|
| On-site | Active Comparator | The on-site arm will have 6 monthly visits during the study period, with two consultations performed in each visit - one by the physician or exercise physiologist, and one by our pediatric dietitian. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intensive lifestyle consultations | Behavioral | detailed above |
|
| Measure | Description | Time Frame |
|---|---|---|
| Weight status | BMI z-score change | From baseline to 3 months |
| Weight status | BMI z-score change | From baseline to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Body-fat percent changes | From baseline to 3 months | |
| Body-fat percent changes | From baseline to 6 months | |
| Daily step counts |
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Inclusion Criteria:
Exclusion Criteria:
Participants will decide if they are randomized based on the sub-group of males or of females
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sheba Medical Center | Ramat Gan | State/Province | 52621 | Israel |
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| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| At 3 months |
| Daily step counts | At 6 months |
| Weight-related quality of life | Scores on the Impact of Weight on Quality of Life (IWQOL)-Kids questionnaire OR "Sizing me up" questionnaire | Basline |
| Weight-related quality of life | Scores on the Impact of Weight on Quality of Life (IWQOL)-Kids questionnaire OR "Sizing me up" questionnaire | 3 months |
| Weight-related quality of life | Scores on the Impact of Weight on Quality of Life (IWQOL)-Kids questionnaire OR "Sizing me up" questionnaire | 6 months |
| Visit cancellation rates | 6 months |
| Retention in program | Duration of participation in the program | 6 months |
| Satisfaction of allocated treatment | Generic PROM questionnaire used in our hopital | 6 months |
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |