Obesity, ChildhoodNCT05700409
Evaluating a Telemedicine-based Intensive Treatment Program for Children and Adolescents With Obesity
A study testing Intensive lifestyle consultations in people with Obesity, Childhood, run by Sheba Medical Center at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Obesity, Childhood
- What is being tested?
- Intensive lifestyle consultations
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jan 2023to 23 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Being tested
- Intensive lifestyle consultations
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive lifestyle consultationsBehavioural
detailed above
| Study group | Role | What they receive |
|---|---|---|
| Telemedicine | Experimental | 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. Receives: Behavioral: Intensive lifestyle consultations |
| On-site | Active comparator | 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. Receives: Behavioral: Intensive lifestyle consultations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight status
BMI z-score change
Measured: From baseline to 3 months
Weight status
BMI z-score change
Measured: From baseline to 6 months
Secondary outcomes (10)
Body-fat percent changes
Measured: From baseline to 3 months
Body-fat percent changes
Measured: From baseline to 6 months
Daily step counts
Measured: At 3 months
Daily step counts
Measured: At 6 months
Weight-related quality of life
Scores on the Impact of Weight on Quality of Life (IWQOL)-Kids questionnaire OR "Sizing me up" questionnaire
Measured: Basline
Weight-related quality of life
Scores on the Impact of Weight on Quality of Life (IWQOL)-Kids questionnaire OR "Sizing me up" questionnaire
Measured: 3 months
Weight-related quality of life
Scores on the Impact of Weight on Quality of Life (IWQOL)-Kids questionnaire OR "Sizing me up" questionnaire
Measured: 6 months
Visit cancellation rates
Measured: 6 months
Retention in program
Duration of participation in the program
Measured: 6 months
Satisfaction of allocated treatment
Generic PROM questionnaire used in our hopital
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start1 Jan 2023
- Primary completion29 Jul 2024
- Study completion23 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obesity, ChildhoodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gal Raz-Dubnov MD, MSc, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05700409
- Sponsor's protocol ID
- SMC-21-8876
- Status last verified
- May 2026
- First submitted
- 8 Jan 2023
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Friedman L, Gil TI, Yaniv A, Ziv-Av E, Manhart A, Gepner Y, Dubnov-Raz G. Telehealth Vs. Face-to-Face Treatment for Children and Adolescents With Obesity: A Randomized Controlled Trial. Pediatr Obes. 2026 Jul;21(7):e70136. doi: 10.1111/ijpo.70136.
PubMed 42444327
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating a Telemedicine-based Intensive Treatment Program for Children and Adolescents With Obesity
- ClinicalTrials.gov ID
- NCT05700409
- Acronym / sponsor ID
- SMC-21-8876
- Conditions
- Obesity, Childhood
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 29 Jul 2024 (actual)
- Study completion
- 23 Jan 2025 (actual)
- First posted
- 26 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telemedicine | Experimental | Behavioral: Intensive lifestyle consultationsThe 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. |
| On-site | Active comparator | Behavioral: Intensive lifestyle consultationsThe 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. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensive lifestyle consultationsdetailed above | Behavioural | On-site, Telemedicine |
Primary outcome
Weight status
Time frame: From baseline to 3 months
BMI z-score change
Weight status
Time frame: From baseline to 6 months
BMI z-score change
10 secondary outcomes
Body-fat percent changes
Time frame: From baseline to 3 months
Body-fat percent changes
Time frame: From baseline to 6 months
Daily step counts
Time frame: At 3 months
Daily step counts
Time frame: At 6 months
Weight-related quality of life
Time frame: Basline
Weight-related quality of life
Time frame: 3 months
Weight-related quality of life
Time frame: 6 months
Visit cancellation rates
Time frame: 6 months
Retention in program
Time frame: 6 months
Satisfaction of allocated treatment
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Derived from this study: PubMed 42444327Friedman L, Gil TI, Yaniv A, Ziv-Av E, Manhart A, Gepner Y, Dubnov-Raz G. Telehealth Vs. Face-to-Face Treatment for Children and Adolescents With Obesity: A Randomized Controlled Trial. Pediatr Obes. 2026 Jul;21(7):e70136. doi: 10.1111/ijpo.70136.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive lifestyle consultations in people with Obesity, Childhood, run by Sheba Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight status (time frame: From baseline to 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05700409, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.