search
Back to results

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

Primary Purpose

Obesity, Childhood

Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Intensive lifestyle consultations
Sponsored by
Sheba Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity, Childhood

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesDoes not accept 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)

Sites / Locations

  • Sheba Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Telemedicine

On-site

Arm 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.

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.

Outcomes

Primary Outcome Measures

Weight status
BMI z-score change
Weight status
BMI z-score change

Secondary Outcome Measures

Body-fat percent changes
Body-fat percent changes
Daily step counts
Daily step counts
Weight-related quality of life
Scores on the Impact of Weight on Quality of Life (IWQOL)-Kids questionnaire OR "Sizing me up" questionnaire
Weight-related quality of life
Scores on the Impact of Weight on Quality of Life (IWQOL)-Kids questionnaire OR "Sizing me up" questionnaire
Weight-related quality of life
Scores on the Impact of Weight on Quality of Life (IWQOL)-Kids questionnaire OR "Sizing me up" questionnaire
Visit cancellation rates
Retention in program
Duration of participation in the program
Satisfaction of allocated treatment
Generic PROM questionnaire used in our hopital

Full Information

First Posted
January 8, 2023
Last Updated
January 17, 2023
Sponsor
Sheba Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT05700409
Brief Title
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

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sheba Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Childhood

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Telemedicine
Arm Type
Experimental
Arm 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.
Arm Title
On-site
Arm Type
Active Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Intensive lifestyle consultations
Intervention Description
detailed above
Primary Outcome Measure Information:
Title
Weight status
Description
BMI z-score change
Time Frame
From baseline to 3 months
Title
Weight status
Description
BMI z-score change
Time Frame
From baseline to 6 months
Secondary Outcome Measure Information:
Title
Body-fat percent changes
Time Frame
From baseline to 3 months
Title
Body-fat percent changes
Time Frame
From baseline to 6 months
Title
Daily step counts
Time Frame
At 3 months
Title
Daily step counts
Time Frame
At 6 months
Title
Weight-related quality of life
Description
Scores on the Impact of Weight on Quality of Life (IWQOL)-Kids questionnaire OR "Sizing me up" questionnaire
Time Frame
Basline
Title
Weight-related quality of life
Description
Scores on the Impact of Weight on Quality of Life (IWQOL)-Kids questionnaire OR "Sizing me up" questionnaire
Time Frame
3 months
Title
Weight-related quality of life
Description
Scores on the Impact of Weight on Quality of Life (IWQOL)-Kids questionnaire OR "Sizing me up" questionnaire
Time Frame
6 months
Title
Visit cancellation rates
Time Frame
6 months
Title
Retention in program
Description
Duration of participation in the program
Time Frame
6 months
Title
Satisfaction of allocated treatment
Description
Generic PROM questionnaire used in our hopital
Time Frame
6 months

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Participants will decide if they are randomized based on the sub-group of males or of females
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gal Dubnov-Raz, MD
Phone
+9720544570250
Email
gal.dubnov-raz@sheba.gov.il
Facility Information:
Facility Name
Sheba Medical Center
City
Ramat Gan
State/Province
State/Province
ZIP/Postal Code
52621
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gal Dubnov-Raz, MD
Phone
+9720544570250
Email
gal.dubnov-raz@sheba.gov.il

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs