Co-creation of Service Innovation - Evaluation of the Efficacy of an App for Parents to Prevent Childhood Obesity and Promote Healthy Life-styles: CoSIE Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 327
- 试验地点
- 2
- 主要终点
- Change in consumption of sugar - sweetened beverages and juice, first year
研究概览
简要总结
The objective of the study is to evaluate the effectiveness of the app in terms of changing lifestyles both related to nutrition and physical activity. The study is also aimed at evaluating the usability and the degree of acceptance of the app among parents.
The primary objective will be assessed in terms of the change in the consumption of sugary drinks and high-calorie food and in terms of time spent in front of a screen.
The secondary objectives are the evaluation of BMI (percentile and z-score) and waist circumference and the evaluation of the usability of the app.
STUDY DESIGN The study is a randomized control trial. Both parents and children are recruited.
- Family paediatricians during the health balance of 3 or 5 years old (children between 3 and 6.5 years old)
- Sport medicine during the visits for sport ability (children between 7 and 11 years old)
- Pediatric Endocrinology and Diabetology of the Santa Maria Hospital during routine visits (children between 5 and 11 years old)
When the study is presented to families, few clinical information are collected on the electronic platform designed for enrollment and randomization:
- Child weight and height
- Child waist circumference
More information about children and parents are collected (through questionnaire).
The families (both treatment and control ) are contacted after 12 month and after 24 months from the recruitment to answer to a questionnaire on lifestyle habits (food and physical activity) of the child and app utilization
During this visit also child weight, height and waist circumference will be collected.
Intervention group The app is explained and installed during the recruitment to the family in the intervention group.
Some families in this group will be selected to take part to the qualitative research.
Control group Every months during the first year of study a newsletter is sent only to the members of the control group.
详细描述
Childhood obesity is a highly prevalent condition and together with the behaviours associated with it, such as improper diet and physical inactivity, it generates a high burden of disease in adulthood.
In recent years, it is increasing the use of mobile devices in support of health prevention and promotion strategies. In a primary care setting these new technologies offer the opportunity to open a two-way communication channel between parents and institutions and can help by adapting the intervention and framing the message according to the needs of each family.
Since 2010, the Reggio Emilia AUSL has started a research and interventions program aimed at preventing childhood obesity. The program has adopted a multilevel and multi-setting strategy for primary prevention (BMInforma Program).
Since 2017, together with the University of Bologna and the regional company Lepida2000, the Local Health Authority is part of the Co-creation of Service Innovation in Europe project (CoSIE Project), a project funded by the European Union with a Horizon 2020 call coordinated by the University of Turku, Finland. The CoSIE project promotes the co-creation of public services through the involvement of citizens and other interested parties in the definition of objectives and delivery methods.
The project is divided into nine pilot projects and the Italian pilot project, carried out in the province of Reggio Emilia, is part of the AUSL program for the prevention of childhood obesity. The aim of the pilot project is to create a network between the services involved in the prevention and treatment of obesity and, at the same time, it aims to create an app that can help promote a healthy lifestyle. The app was designed and created with a co-creation process.
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
- Single (Participant)
盲法说明
Families in the control arm will receive a newsletter
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •parents of children aged 3 to 11 presneting for a new well child visit or for a sport medicin visit or presenting for a childhood obesity visit at the AUSL Reggio Emilia clinics, including family pediatricians clinics.
排除标准
- •Families resident outside the Province of Reggio Emilia
- •Parents with no comprehension of the Italian language
- •Children inside a program for obesity cure or prevention. The program are:
- •the GET program (a program coordinated by the hospital pediatric unit in which obese children follow a group intervention),
- •the BMInforma program (in which overweight girls from 5 to 7 years old follow a counselling proposed by the family paediatrician),
- •the second level medical clinic in which obese children with pathologic condition are cured
- •Children with severe obesity previously diagnosed
结局指标
主要结局
Change in consumption of sugar - sweetened beverages and juice, first year
时间窗: 12 months
Endpoint: number per week Outcome: Delta 12m-baseline Test/analysis: Difference between groups Source: Questionnaire in FU visits
Change of consumption of hypercaloric foods like fried food, salty snacks and sweet snacks/candies, second year
时间窗: 24 months
Endpoint: number per week Outcome: Delta 24m-baseline Test/analysis: Difference between groups Source: Questionnaire in FU visits
Change in consumption of hypercaloric foods like fried food, salty snacks and sweet snacks/candies, first year
时间窗: 12 months
Endpoint: number per week Outcome: Delta 12m-baseline Test/analysis: Difference between groups Source: Questionnaire in FU visits
Change in screen time spent by children, second year
时间窗: 24 months
Endpoint: Minutes of screen time per day Outcome: Delta 24m-baseline Test/analysis: Difference between groups Source: Questionnaire in FU visits
Change in consumption of sugar - sweetened beverages and juice, second year
时间窗: 24 months
Endpoint: number per week Outcome: Delta 24m - baseline Test/analysis: Difference between groups Source: Questionnaire in FU visits
Change in screen time spent by children, first year
时间窗: 12 months
Endpoint: Minutes of screen time per day Outcome: Delta 12m-baseline Test/analysis: Difference between groups Source: Questionnaire in FU visits
次要结局
- BMI centile of children after the first year(12 months)
- Usability(after at 12 months of app utilization)
- Acceptability(after at 12 months of app utilization)
- BMI centile of children after the second year(24 months)