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

NCT05700409 | Recruiting

• 1 other identifier: SMC-21-8876
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity, Childhood

Outcome Measures

Primary Outcomes (2)

• Weight status

  BMI z-score change

  From baseline to 3 months

• Weight status

  BMI z-score change

  From baseline to 6 months

Secondary Outcomes (10)

• 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

Study Arms (2)

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.

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.

Behavioral: Intensive lifestyle consultations

Interventions

Intensive lifestyle consultations BEHAVIORAL

detailed above

On-site; Telemedicine

Eligibility Criteria

• Age: 10 Years - 18 Years
• Gender Eligibility Details: Participants will decide if they are randomized based on the sub-group of males or of females
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Sheba Medical Center

Ramat Gan, State/Province, 52621, Israel

RECRUITING

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Gal Dubnov-Raz, MD

CONTACT

+9720544570250; gal.dubnov-raz@sheba.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Pediatric LIfestyle Clinic

Study Record Dates

• First Submitted: January 8, 2023
• First Posted: January 26, 2023
• Study Start: January 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)