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临床试验/NCT02809196
NCT02809196已完成不适用

A Digital Messaging Education Program for Dietary Behavior Modification Towards Healthier Lifestyle Among Danish Adolescents

Centre for Fetal Programming, Denmark2 个研究点 分布在 1 个国家目标入组 7,890 人开始时间: 2016年6月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
7,890
试验地点
2
主要终点
Change from baseline in BMI z-score

研究概览

简要总结

The overall objective is to examine if participating in an SMS-transmitted health educational program targeting a cluster of dietary factors over a period of weeks during the years of adolescence can induce durable changes towards more healthful dietary habits and body weight trajectories. The investigators will examine if impact is reinforced by asking a friend of the participant to also participate; if impact is reinforced by asking the mother of the participant to also participate; and if impact is reinforced when the SMS-transmitted health promotion program is designed to target a specific dietary factor only - decided upon from participants' reporting of their dietary habits at the beginning of the program - rather than to simultaneously target a cluster of dietary issues uniform for all participants.

详细描述

Groups of adolescents from the Danish National Birth Cohort (DNBC) will be offered to participate in the health educational programs. At 14 years and 14 years plus 3 months all children DNBC are invited to report comprehensively on their dietary and physical activity habits by means of a web-based questionnaire (FFQ). Eligible DNBC adolescents for the SMS-educational program will be invited among those who have completed the FFQ. Thus, once they have completed the DNBC FFQ, they may be invited to participate in the SMS-based educational programs, either addressing only one of the three target factors: sugar sweetened beverages, fruit & vegetables, or fish (SSB, F&V, or Fish) or addressing all three factors (cluster). The adolescents may also potentially be invited to include a friend, their mother or both.

Trial Organization:

  • Sjurdur F Olsen, MD PhD, Lead Principal Investigator (Responsible Party), Statens Serum Institut, Copenhagen, Denmark;
  • Eric Ding, ScD, Co-PI, Harvard TH Chan School of Public Health;
  • Daniel Zoughbie, Co-PI, Epidemic Health Inc.

Design for Inviting Adolescents to Educational Program: The study will be conducted corresponding to a '2x2x2 factorial plus 1' design, with 9 arms. In addition to allowing testing of the effect of participating in an SMS based educational program as compared to not participating in such program, this will allow for additional testing of effect of implicating a friend v. not implicating friend; of implicating the mother v. not implicating the mother; and of delivering tailored messaging targeting only one of the three dietary factors (SSB, F&V, or Fish) v. delivering uniform messaging targeting all three factors.

In the tailored program, the participants will receive messages distributed over 4 weeks, whereas in the FULL program (addressing all three clusters) messages are distributed over 12 weeks. Messages can be divided into five categories: Information, quizzes, tips, challenges, and reminders.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Other
盲法
None

入排标准

年龄范围
14 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Adolescents participating in the Danish National Birth Cohort

排除标准

  • Lacking information from maternal interviews 1 and 2

结局指标

主要结局

Change from baseline in BMI z-score

时间窗: 6 months and 18 months after allocation

Based on reported height and weight in online questionnaires

Change from baseline in an index reflecting overall dietary quality

时间窗: 6 months and 18 months after allocation

Based on reported intake in online questionnaires

次要结局

  • Change from baseline in intake of fruits and vegetables(6 months and 18 months after allocation)
  • Change from baseline in intake of fish(6 months and 18 months after allocation)
  • Change from baseline in intake of sugar sweetened beverages(6 months and 18 months after allocation)

研究者

发起方
Centre for Fetal Programming, Denmark
申办方类型
Other
责任方
Sponsor

研究点 (2)

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