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临床试验/NCT01693250
NCT01693250已完成不适用

Phase 1 Study of Fitbit and Apps on Healthy Weight Management in Obese Teens in Primary Care Clinics

University of California, San Francisco2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2015年4月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
Body Mass Index (BMI)

研究概览

简要总结

The emerging epidemic of type 2 diabetes mellitus (T2DM) in children is coupled with the increased prevalence of childhood obesity in the last two decades. Obesity during the adolescent years is associated with many adverse health consequences, including T2DM, hyperlipidemia, and psychosocial problems. The first step toward effective obesity management and T2DM prevention is monitoring of physical activity (PA) and dietary intake. With the rapid expansion of cellular networks, and advancements in smartphone technologies, it is now possible to monitor PA and dietary intake and at the same time to transmit data digitally to their primary care providers (PCP). The proposed pilot study will include the collaboration among UCSF, North East Medical Services (NEMS), mHealth teams, and overweight and/or obese adolescents. The study will adapt and implement smartphone-based technologies and integrate these technologies with the Electronic Health Record (EHR) to increase PA and dietary intake. Two specific aims of this proposed study include: (1) adapt fitbit Ultra applications for the smartphone-based technologies and EHR and (2) and assess the feasibility and estimate the effect for patient outcomes (self-efficacy, physical activity, dietary intake, BMI, and lipid profile), at 3 months post intervention between the intervention and control groups. The smartphone app for the intervention group will allow the teens to graphically compare daily PA and dietary intake with the goal, participate in a reward program where they can collect virtual points for achieving the goal, and play interactive games related to PA and diet. A total of 40 overweight and/or obese adolescents at NEMS will be recruited and randomized to the feasibility study (Aim 2).

详细描述

Using evidence to inform the design of clinical practice is a foundational principle of modern health care practice. In the present pilot study, using evidence from research on technology in clinical practice facilitated development of a hybrid intervention that combined lifestyle modification with routine clinical care. Chief among the benefits of this hybrid smartphone technology-based intervention (STB) was the potential to improve health outcomes and reduce obesity in overweight and obese adolescents. The purposes of this study were to (1) measure effects of an innovative smartphone-technology-based (STB) intervention for overweight and obese adolescents and to (2) examine the intervention's feasibility for use in primary care clinics.The STB intervention had 3 components: use of Fitbit Flex, participation in the online educational program, and receipt of bi-weekly text message during the maintenance phase. A randomized control study design was utilized. Data regard to anthropometrics (BMI and waist-hip ratio), blood pressure, levels of physical and sedentary activity, diet, and self-efficacy regarding physical activity and diet were collected at baseline, 3 month and 6 months after the baseline assessment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Care Provider, Outcomes Assessor)

盲法说明

Primary care providers and outcome assessors were blinded to the group assignment.

入排标准

年龄范围
13 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • between 13-18 years old
  • have a BMI at ≥ 85th percentile, based on CDC growth chart
  • own a smartphone;
  • have access to a computer with internet access
  • be able to read and speak English.

排除标准

  • have acute or life-threatening disease
  • not be able to engage in activities of daily living

研究组 & 干预措施

fitbit ultra

Experimental

Adolescents in the intervention group will receive a Fitbit Ultra and will download an app to their smartphone. Participants will be asked to wear the Fitbit device and use the app every day for three months.

干预措施: fitbit Ultra (Behavioral)

Pedometer

Active Comparator

After completion of the baseline assessments, adolescents in the control group will be given an Omron HJ-105 pedometer and a food diary and be asked to use them for three months.

干预措施: Pedometer (Behavioral)

结局指标

主要结局

Body Mass Index (BMI)

时间窗: baseline and 6 months

Participants' BMI was determined by dividing body mass (weight) by height squared (kg/m2). Adolescents' weight and height were measured while the adolescents wore light-weight clothes and no shoes. For BMI, adequate sensitivity and specificity has been reported in children and adolescents, with sensitivity ranging from 29% to 88% and specificity ranging from 94% to 100%.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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