Obesity, Childhood
Conditions
Brief summary
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.
Interventions
BEHAVIORALIntensive lifestyle consultations
detailed above
Sponsors
Sheba Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to 18 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight status | From baseline to 3 months | BMI z-score change |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body-fat percent changes | From baseline to 3 months | — |
| Daily step counts | At 3 months | — |
| Weight-related quality of life | Basline | Scores on the Impact of Weight on Quality of Life (IWQOL)-Kids questionnaire OR "Sizing me up" questionnaire |
| Visit cancellation rates | 6 months | — |
| Retention in program | 6 months | Duration of participation in the program |
| Satisfaction of allocated treatment | 6 months | Generic PROM questionnaire used in our hopital |
Countries
Israel
Outcome results
None listed