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

Sheba Medical Center

Status: Enrolling

Conditions: Obesity, Childhood

Treatments: Behavioral: Intensive lifestyle consultations

Study type: Interventional

Funder types: Other

Identifiers

NCT05700409

SMC-21-8876

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 10 to 18 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

100 participants in 2 patient groups

Telemedicine

Experimental group

Description:

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.

Treatment:

Behavioral: Intensive lifestyle consultations

On-site

Active Comparator group

Description:

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.

Treatment:

Behavioral: Intensive lifestyle consultations