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

Obesity, Childhood Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05700409
• Other study ID #: SMC-21-8876
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: Sheba Medical Center
• Contact: Gal Dubnov-Raz, MD
• Phone: +9720544570250
• Email: gal.dubnov-raz[@]sheba.gov.il
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

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)

Related Conditions & MeSH terms

• Obesity
• Obesity, Childhood
• Pediatric Obesity

Intervention

Behavioral:
• Intensive lifestyle consultations
detailed above

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Ramat Gan	State/Province

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight status	BMI z-score change	From baseline to 3 months
Primary	Weight status	BMI z-score change	From baseline to 6 months
Secondary	Body-fat percent changes		From baseline to 3 months
Secondary	Body-fat percent changes		From baseline to 6 months
Secondary	Daily step counts		At 3 months
Secondary	Daily step counts		At 6 months
Secondary	Weight-related quality of life	Scores on the Impact of Weight on Quality of Life (IWQOL)-Kids questionnaire OR "Sizing me up" questionnaire	Basline
Secondary	Weight-related quality of life	Scores on the Impact of Weight on Quality of Life (IWQOL)-Kids questionnaire OR "Sizing me up" questionnaire	3 months
Secondary	Weight-related quality of life	Scores on the Impact of Weight on Quality of Life (IWQOL)-Kids questionnaire OR "Sizing me up" questionnaire	6 months
Secondary	Visit cancellation rates		6 months
Secondary	Retention in program	Duration of participation in the program	6 months
Secondary	Satisfaction of allocated treatment	Generic PROM questionnaire used in our hopital	6 months