Evaluating a Telemedicine-based Intensive Treatment Program for Children and Adolescents With Obesity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Weight status
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
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.
干预措施: Intensive lifestyle consultations (Behavioral)
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.
干预措施: Intensive lifestyle consultations (Behavioral)
结局指标
主要结局
Weight status
时间窗: From baseline to 6 months
BMI z-score change
次要结局
- Daily step counts(At 6 months)
- Body-fat percent changes(From baseline to 6 months)
- Weight-related quality of life(6 months)
- Visit cancellation rates(6 months)
- Retention in program(6 months)
- Satisfaction of allocated treatment(6 months)
研究者
Gal Raz-Dubnov MD, MSc
Director, Pediatric LIfestyle Clinic
Sheba Medical Center