Evaluating a Telemedicine-based Intensive Treatment Program for Children and Adolescents With Obesity
Study Details
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:
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Body-fat percent changes, assessed by bioimpedance analysis in physical clinic visits.
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Daily step counts, measured by smartphone data/ wearable activity tracker, if available.
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Weight-related quality of life
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Retention and visit cancellation rates.
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Satisfaction of both parent and child from their allocated treatment.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Telemedicine 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. |
Behavioral: Intensive lifestyle consultations
detailed above
|
| Active Comparator: On-site 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. |
Behavioral: Intensive lifestyle consultations
detailed above
|
Outcome Measures
Primary Outcome Measures
- Weight status [From baseline to 3 months]
BMI z-score change
- Weight status [From baseline to 6 months]
BMI z-score change
Secondary Outcome Measures
- Body-fat percent changes [From baseline to 3 months]
- Body-fat percent changes [From baseline to 6 months]
- Daily step counts [At 3 months]
- Daily step counts [At 6 months]
- Weight-related quality of life [Basline]
Scores on the Impact of Weight on Quality of Life (IWQOL)-Kids questionnaire OR "Sizing me up" questionnaire
- Weight-related quality of life [3 months]
Scores on the Impact of Weight on Quality of Life (IWQOL)-Kids questionnaire OR "Sizing me up" questionnaire
- Weight-related quality of life [6 months]
Scores on the Impact of Weight on Quality of Life (IWQOL)-Kids questionnaire OR "Sizing me up" questionnaire
- Visit cancellation rates [6 months]
- Retention in program [6 months]
Duration of participation in the program
- Satisfaction of allocated treatment [6 months]
Generic PROM questionnaire used in our hopital
Eligibility Criteria
Criteria
Inclusion Criteria:
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Obesity, defined as a BMI at or above 2 standard deviations SDs according to the WHO growth reference
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Owning a smartphone, needed for video conversations, step counting and the gamification app
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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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sheba Medical Center | Ramat Gan | State/Province | Israel | 52621 |
Sponsors and Collaborators
- Sheba Medical Center
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SMC-21-8876