Evaluating a Telemedicine-based Intensive Treatment Program for Children and Adolescents With Obesity

Study Overview
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Brief Summary
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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: Body-fat percent changes, assessed by bioimpedance analysis in physical clinic visits. Daily step counts, measured by smartphone data/ wearable activity tracker, if available. Weight-related quality of life Retention and visit cancellation rates. Satisfaction of both parent and child from their allocated treatment.

Official Title
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Evaluating a Telemedicine-based Intensive Treatment Program for Children and Adolescents With Obesity

Conditions
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Obesity, Childhood

Intervention / Treatment
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* Behavioral: Intensive lifestyle consultations


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Obesity, defined as a BMI at or above 2 standard deviations SDs according to the WHO growth reference Owning a smartphone, needed for video conversations, step counting and the gamification app Parent consent and child's assent to participate in the program Exclusion Criteria: Significant physical or mental barriers to physical activity and/or to dietary changes (such as autistic spectrum disorder that precludes dietary changes or sufficient exercise, as assessed by the PI)

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telemedicine<br>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. | Behavioral: Intensive lifestyle consultations<br>* detailed above<br>|
| Active Comparator: On-site<br>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. | Behavioral: Intensive lifestyle consultations<br>* detailed above<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 |