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临床试验/NCT03050840
NCT03050840已完成不适用

Gamification and Energetic Behavior Changes in Adolescent-Parent Dyads With Obesity

Children's Hospital of Philadelphia2 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2017年2月13日最近更新:
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
76
试验地点
2
主要终点
Difference in the total number of steps per day

研究概览

简要总结

Obesity [Body mass index (BMI kg/m2 ≥ 95th percentile)] affects 1 in 5 adolescents in the United States, with 13 million suffering from severe obesity (BMI ≥ 120% > 95th percentile or ≥ 35 mg/kg2). Adolescents are able to lose weight with behavioral changes in diet and physical activity, but change in these behaviors requires self-monitoring and support, and weight loss is not always successful.

Parent involvement and parent weight-loss can help their children to lose weight and successfully change their behavior. Guidance from pediatricians can also help to facilitate weight loss among obese adolescents. That said, treatment of obesity through behavior change within the time constraints of a Pediatric practice visit is limited by treatment adherence and clinic visit attendance. Therefore, finding cost-effective, timely, methods to keep adolescents with severe obesity engaged in therapy outside of standard practice is a critical need.

The effects of monetary incentives through games (gamification), and a comprehensive remote digital monitoring system on sleep, physical activity, and dietary intake, has been successful in adults, but has not been tested in adolescents with obesity.

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 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Child Subjects age 10 - 16
  • Obese as defined by body mass index (BMI)
  • Computer access and data plan with text messaging
  • SSB intake of 2 or more servings per day (1 serving=12oz)

排除标准

  • Active substance abuse.
  • Syndromic or secondary obesity.
  • Any developmental disorder.
  • Eating disorder (with the exception of binge eating disorder).
  • Psychosis.
  • Untreated depression.
  • Use of medications (prescription or otherwise) known to effect body weight.
  • Weight loss of more than 5% body weight in the past 3 months.
  • History of bariatric surgery.

研究组 & 干预措施

Self-monitoring

Other

Participants will wear a Fitbit, to self-monitor steps per day, and will report sugar sweetened beverage (SSB) consumption via text messaging. The Way to Health platform will record data.

干预措施: Way to Health (Behavioral)

Self-monitoring plus gamification

Experimental

Participants will wear a Fitbit, to self-monitor steps per day, and will report sugar sweetened beverage consumption via text messaging. Participants will be awarded medals and points based on meeting step per day and SSB consumption goals The Way to Health platform will be used to record data.

干预措施: Way to Health (Behavioral)

结局指标

主要结局

Difference in the total number of steps per day

时间窗: 12 weeks

Fitbit estimated steps per day will be compared between the two treatment groups at the end of the treatment period

次要结局

  • Difference in the total number of sugar sweetened beverages consumed per day(12 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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