Clinical trial NCT05700409: Evaluating a Telemedicine-based Intensive Treatment Program for Children and Adolescents With Obesity
Official title: Evaluating a Telemedicine-based Intensive Treatment Program for Children and Adolescents With Obesity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity, Childhood
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2023-01-26
Enrollment: 100
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Weight status
timeFrame: From baseline to 3 months
measure: Weight status
timeFrame: From baseline to 6 months
Secondary outcomes:
measure: Body-fat percent changes
timeFrame: From baseline to 3 months
measure: Body-fat percent changes
timeFrame: From baseline to 6 months
measure: Daily step counts
timeFrame: At 3 months
measure: Daily step counts
timeFrame: At 6 months
measure: Weight-related quality of life
timeFrame: Basline
measure: Weight-related quality of life
timeFrame: 3 months
measure: Weight-related quality of life
timeFrame: 6 months
measure: Visit cancellation rates
timeFrame: 6 months
measure: Retention in program
timeFrame: 6 months
measure: Satisfaction of allocated treatment
timeFrame: 6 months
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
state: State/Province
Study officials:
References: