Effectiveness of a Mobile Health Intervention for the Prevention of Overweight and Obesity in Adolescents on Sport and Nutrition Knowledge, Eating Habits and Physical Activity: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 305
- 试验地点
- 2
- 主要终点
- Eating habits
研究概览
简要总结
The prevention of overweight and obesity in adolescents is a public health priority given the impact of obesity on both short- and long-term health. Scientific evidence has shown that interventions in diet and physical exercise can reduce the risk of obesity in children and young people since adolescence is an ideal stage for educating on a healthy lifestyle and correcting the habits that may have been acquired in childhood. Smartphone applications (apps) can provide a useful alternative to overweight and obesity prevention measures.
The objective of this study was to evaluate, through a randomized controlled clinical trial, the effect of an intervention based on a mobile health application (m-Health) on improving the degree of sport and nutrition knowledge, eating habits, and level of physical activity of adolescents.
The sample consists of 305 adolescents, 154 in the intervention group and 151 in the control group that are evaluated at the beginning and 6 months later regarding sociodemographic, eating habits, food knowledge, level of physical activity, body mass index, and waist circumference. The educational intervention was carried out using an m-Health tool, a mobile phone application. The outcomes were changes in the mentioned variables to a six-month follow-up between the two groups.
详细描述
Design: A randomized parallel-group, controlled clinical trial was performed on adolescents from public secondary schools in the province of Cadiz, Spain.
Randomization and Blinding: The randomization and allocation to each group (1:1, intervention, and usual care) are based on computer-generated random numbers stratified in the three courses of secondary education. The researchers responsible for the study do not participate in the allocation of the participants. Due to the kind of intervention, blinding is not possible when the participants are allocated to groups. To minimize any bias, objective clinical variables are measured during the evaluation visit and the analyses are performed by blinded researchers.
Study Sample: The estimated sample size to detect a mean difference of at least one point in the level of healthy eating habits, measured by the KidMed questionnaire, with a standard deviation of the values in the questionnaire known from previous studies of 2.5 points, a level of confidence of 95% and statistical power of 90%, it was 126 participants in each group, intervention, and control. Assuming a 20% loss to follow-up, 305 participants were recruited, 154 in the intervention group and 151 in the control group.
Recruitment: All participants, in the intervention and control groups, received an Intervention on healthy habits consisting of four sessions developed by a nurse over two months. Adolescents who voluntarily decided to participate in the mobile Health educational intervention were recruited by a nurse. Both the adolescents and their parents signed the informed consent.
Intervention: The nurse installs the application on the mobile phone of the participants in the intervention group. It is a friendly, easy-to-use application for smartphones and tablets that favors the process of learning while playing.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 11 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adolescents who were studying the 1st to 3rd grades of secondary education in public institutes
- •Have a smartphone or tablet with an Android operating system and internet access
排除标准
- •Adolescents with barriers that prevented them from understanding the characteristics of the study: Comprehension, visual or auditory problems
- •Adolescents with disease or treatment that affect the variables studied (diagnosed diseases that affect body weight such as liver or kidney disease or regular treatment with drugs such as corticosteroids)
结局指标
主要结局
Eating habits
时间窗: 6 months
KidMed: A 16-item Questionnaire of Mediterranean diet adherence (unit of measure: points. Each item is scored 0 or 1. The total Mediterranean diet score ranges from 0 to 12 points. The higher the score, the higher the degree of adherence to the Mediterranean Diet).
Nutrition knowledge
时间窗: 6 months
General and Sport Nutrition knowledge Questionnaire: A questionnaire with 62 items (unit of measure: points. The higher the score, the higher the knowledge level)
Level of physical activity
时间窗: 6 months
Physical Activity Questionnaire for adolescents (PAQ-A) (The overall result of the test is a score from 1 to 5 points that allows to establish a graduation in the level of physical activity made by each adolescent. Do higher values represent a better outcome)
次要结局
- Body mass index(6 months)
- Waist circumference(6 months)