Large-scale Implementation of a mHealth Obesity Prevention Program Within Swedish Primary Child Healthcare: MINISTOP 3.0 Study Protocol
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change in acceptability of MINISTOP 3.0
研究概览
简要总结
MINISTOP is an evidence-based app for parents of preschool aged children with the overall aim to promote healthy lifestyle behaviors and prevent the development of overweight and obesity. MINISTOP has been previously been evaluated in two previous trials (MINISTOP 1.0 and 2.0) with promising results. Therefore, the overall aim of this trial is to evaluate the large scale implementation of MINISTOP within Swedish primary child healthcare. The specific aims are to:
(i) To compare two different implementation strategies for MINISTOP 3.0 (i.e., Basic vs.
Enhanced) on: a) acceptability, appropriateness, feasibility as well as organizational readiness to implement MINISTOP 3.0 within primary child healthcare (primary outcomes) and b) reach, costs, adoption, and sustainability of MINISTOP 3.0 within primary child healthcare (secondary outcomes).
(ii) To compare two different implementation strategies of MINISTOP 3.0 within primary child healthcare on children's key dietary indicators, physical activity, and screen time (secondary outcomes).
(iii) To compare the cost-effectiveness of two different implementation strategies for MINISTOP 3.0.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None (Participant, Outcomes Assessor)
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
- •Child healthcare nurse at participating child healthcare centers
排除标准
- 未提供
研究组 & 干预措施
Basic
The MINISTOP app will be offered to all parents of children at the 2.5/3-year routine visit at primary child healthcare. The child healthcare centers randomly allocated to the basic group will receive the basic implementation strategy package.
干预措施: MINISTOP 3.0 (Behavioral)
Enhanced
The MINISTOP app will be offered to all parents of children at the 2.5/3-year routine visit at primary child healthcare. The child healthcare centers randomly allocated to the enhanced group will receive the enhanced implementation strategy package.
干预措施: MINISTOP 3.0 (Behavioral)
结局指标
主要结局
Change in acceptability of MINISTOP 3.0
时间窗: Baseline, 3 &12 months after implementation
Acceptability of MINISTOP 3.0 by child healthcare nurses (assessed by the questionnaire by Weiner et al.). It includes four questions assessed on a five point likert scale ranging from completely disagree to completely agree.
Change in appropriateness of MINISTOP 3.0
时间窗: Baseline, 3 & 12 months after implementation
Appropriateness of MINISTOP 3.0 by child healthcare nurses (assessed by the questionnaire by Weiner et al.). It includes four questions assessed on a five point likert scale ranging from completely disagree to completely agree.
Change in feasibility of MINISTOP 3.0
时间窗: Baseline, 3 &12 months after implementation
Feasibility of MINISTOP 3.0 by child healthcare nurses (assessed by the questionnaire by Weiner et al.). It includes four questions assessed on a five point likert scale ranging from completely disagree to completely agree.
Change in organizational readiness for implementing MINISTOP 3.0
时间窗: Baseline 3 and 12 months after implementation
Organizational readiness as perceived by child healthcare nurses, which will be measured using the E-READY questionnaire. This questionnaire consists of 32 questions rated on a 4-point likert scale.
次要结局
- Adoption of MINISTOP 3.0(3, 8, and 12 months after implementation)
- Costs of the implementation of MINISTOP 3.0(Baseline and 2, 4, 6, 8, 10, and 12 months after implementation.)
- Sustainability(12 months after implementation)
- Parental usage of MINISTOP 3.0 using objectively measured activity in the app(6 months after the families start using the MINISTOP app)
- Children's intake of key dietary indicators as assess by a questionnaire.(Baseline and 6 months after receiving MINISTOP 3.0)
- Children's physical activity as assessed by a questionnaire(Baseline and 6 months after receiving MINISTOP 3.0)
- Children's screen time as assessed by a questionnaire(Baseline and 6 months after receiving MINISTOP 3.0)
研究者
Christine Delisle Nyström
Docent
Karolinska Institutet