MINISTOP Plus Program for Pre-school Children With Overweight and Obesity: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Body mass index
研究概览
简要总结
The Mobile-based intervention intended to stop obesity in preschoolers (MINISTOP) program has been developed to be a comprehensive digital support program for all children irrespective of weight status. However, a one size fits all approach may not be sufficient as some families may require extra support through in-person activities to achieve the required lifestyle behaviour change in order to attain and maintain a healthy weight. Therefore, the aims of this pilot randomized controlled trial are to evaluate the efficacy and feasibility of the MINISTOP Plus Program in pre-school children with overweight and obesity on: (i) children's BMI z-scores; (ii) intake of fruit and vegetables, sweet and savoury snacks, and sweet drinks; (iii) time spent in different physical activity intensities; (iv) screen time; and (v) parental self-efficacy.
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
- Single (Investigator)
入排标准
- 年龄范围
- 2 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •2 to 5 year old children with overweight and obesity residing in the municipality of Kungsbacka.
排除标准
- •If a child has a disease or disorder that affects body size or feeding.
- •Children who have a parent suffering from a serious physical or psychological disease making the study too demanding for the family.
- •Children from families who will not be able to understand the app content, i.e., those who do not speak Swedish, English, Arabic, or Somali
结局指标
主要结局
Body mass index
时间窗: At the end of the intervention which is 12-months after baseline
Body weight divided by height squared
次要结局
- Physical activity assessed using an accelerometer(At the end of the intervention which is 12-months after baseline)
- Self-efficacy self-efficacy for promoting healthy dietary and physical activity behaviours in their children's(At the end of the intervention which is 12-months after baseline)
- Screen time as assessed by a questionnaire(At the end of the intervention which is 12-months after baseline)
- Intake of key dietary indicators as assessed by a questionnaire.(At the end of the intervention which is 12-months after baseline.)
研究者
Christine Delisle Nyström
Principal investigator
Karolinska Institutet