NCT05700409Completed
Evaluating a Telemedicine-based Intensive Treatment Program for Children and Adolescents With Obesity
Source: ClinicalTrials.gov · Last updated 1 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 100 (actual)
- First submitted
- 8 Jan 2023
- Start date
- 1 Jan 2023
- Primary completion date
- 29 Jul 2024
- Lead sponsor
- Sheba Medical Center
- Diseases
- Obesity
- NCT number
- NCT05700409
What you commit to
- Study type: Interventional
- Participants enrolled: 100
- From 1 Jan 2023 to the primary completion date, 29 Jul 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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)
Who the study is looking for
- 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
Age in the registry: 10 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sheba medical center Coordinator of this site? Confirm its status | Ramat Gan | Israel | Unknown status |
Related publications
- Telehealth Vs. Face-to-Face Treatment for Children and Adolescents With Obesity: A Randomized Controlled Trial.Pediatr Obes · 2026 · PMID 42444327
This page is information, not medical advice. Discuss any trial with your doctor.