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临床试验/NCT02724839
NCT02724839已完成不适用

Innovations in the Management of Obesity and Inactivity in Pediatric Primary Care

Children's Hospital Medical Center, Cincinnati2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2015年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
36
试验地点
2
主要终点
Change From Baseline in Parent-report Child's Daily Servings of Fruits and Vegetables and Time Spent on Screens.

研究概览

简要总结

The purpose of this study is to design, pilot, and tweak a series of peer-led group nutrition sessions for primary care patients aged 6 -12 years who are overweight or obese and who want to eat healthier and be more active.

详细描述

In addition to the group nutrition sessions, the investigators will give a Fitbit to each of a parent and child dyad, which will be used to track and motivate their activity. The investigators hypothesize an improvement pre-post in children's physical activity levels, self-efficacy and intentions for physical activity, self-reported consumption of fruits, vegetables, and child quality of life, and a decrease in consumption of sugar-sweetened beverages and fast and snack-food, and television (TV)/ videos screen time

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
6 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patients whose primary medical home is the Pediatric Primary Care Center (primarily Medicaid or self-pay)
  • BMI is greater than 85th%ile for age and sex
  • English speaking
  • have access to a computer/internet or a smart phone (for uploading Fitbit data)

排除标准

  • Have been seen in a weight management clinic within the last 2 years
  • prescribed an atypical antipsychotic
  • non-ambulatory

结局指标

主要结局

Change From Baseline in Parent-report Child's Daily Servings of Fruits and Vegetables and Time Spent on Screens.

时间窗: Baseline, 3 months

Data were not collected on any participants because we changed the study design based on qualitative participant feedback in pilot phases. Our asking participants about their habits, and showing them their data, was part of the intervention instead of an outcome to assess efficacy of the intervention.

Overall Satisfaction With Group Nutrition Sessions

时间窗: Baseline, 3 months

Participants evaluated their satisfaction with the group sessions using a 5 point scale with a score of 1 being complete dissatisfaction and 5 being the greatest satisfaction.

Attendance

时间窗: Baseline, 3 months

Evaluation of participant attendance in each arm.

次要结局

  • PedsQL (Pediatric Quality of Life Inventory)(Baseline, 3 months)
  • Child Intention to be Active(baseline, 3 months)
  • Change From Baseline in Parent-reported Number of Hours of Screen Time Child Watches Daily(Baseline, 3 months)
  • BMI Z-Score(Baseline, 3 months)
  • Number of Participants Reporting They Were Satisfied With the Group Nutrition Sessions (4 or 5 on 5-point Likert Scale)(baseline, 3 months)
  • Child Self-efficacy Related to Physical Activity(Baseline, 3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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