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Completed

NCT Number: NCT05700409

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

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.

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Key information

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sheba Medical Center

Ramat Gan, State/Province, 52621, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Intensive lifestyle consultations

Behavioral

detailed above

Primary outcomes

  1. Weight status

    Time frame: From baseline to 3 months

    BMI z-score change

  2. Weight status

    Time frame: From baseline to 6 months

    BMI z-score change

Secondary outcomes

  1. Body-fat percent changes

    Time frame: From baseline to 3 months

  2. Body-fat percent changes

    Time frame: From baseline to 6 months

  3. Daily step counts

    Time frame: At 3 months

  4. Daily step counts

    Time frame: At 6 months

  5. Weight-related quality of life

    Time frame: Basline

    Scores on the Impact of Weight on Quality of Life (IWQOL)-Kids questionnaire OR "Sizing me up" questionnaire

  6. Weight-related quality of life

    Time frame: 3 months

    Scores on the Impact of Weight on Quality of Life (IWQOL)-Kids questionnaire OR "Sizing me up" questionnaire

  7. Weight-related quality of life

    Time frame: 6 months

    Scores on the Impact of Weight on Quality of Life (IWQOL)-Kids questionnaire OR "Sizing me up" questionnaire

  8. Visit cancellation rates

    Time frame: 6 months

  9. Retention in program

    Time frame: 6 months

    Duration of participation in the program

  10. Satisfaction of allocated treatment

    Time frame: 6 months

    Generic PROM questionnaire used in our hopital

Sponsors and collaborators

Lead sponsor

Sheba Medical Center

Other Gov

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Jan 26, 2023
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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