NCT05700409

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Sheba Medical Center · Other Government
• Sex: All
• Age: 10 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obesity, Childhood

Interventions

Type	Name	Description
BEHAVIORAL	Intensive lifestyle consultations	detailed above

Timeline

• Start date: 2023-01-01
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2023-01-26
• Last updated: 2024-04-17

Locations

1 site across 1 country: Israel