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临床试验/NCT07489365
NCT07489365已完成不适用

Evaluability and Feasibility of the eHOOD: A Multi-Component Intervention to Promote Well-being, Healthy Weight, and Lifestyle Habits Among Adolescents in Vulnerable Positions Through Gaming, Physical and Social Activities, and Education

Center for Clinical Research and Prevention2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2022年10月1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
22
试验地点
2
主要终点
Proportion of fully completed questionnaires.

研究概览

简要总结

The goal of this feasibility study is to learn how to best evaluate the eHOOD intervention of-fered to adolescents in lower secondary education with psycho-social challenges. The main questions it aims to answer are:

  1. What is an appropriate evaluation design for testing the eHOOD intervention?
  2. Is the evaluation design feasible in terms of outcomes, measurements, instruments, data collection procedures, and participant acceptability?
  3. Is the eHOOD intervention feasible and acceptable in terms of recruitment, retention of participants, and participant satisfaction and engagement? Participants will meet once a week in 25 weeks and take part in physical activity, communal cooking and dining, education in healthy lifestyle, and online gaming with instruction in a social community with peers. They will answer questionnaires and participate in interviews at the beginning and end of the intervention and their development will be assessed by the eHOOD coach.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
12 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Adolescents in 7th to 10th grade (corresponding to lower secondary education) with psycho-social challenges such as anxiety, loneliness, school refusal, being a victim of bullying, and developmental disorders such as Attention Deficit Hyperactivity Disorder (ADHD), Autism Spectrum Disorders (ASD).

排除标准

  • Inability to take part in a social community

结局指标

主要结局

Proportion of fully completed questionnaires.

时间窗: Baseline to end of intervention at 25 weeks.

Feasibility of evaluation design - data completeness.

Proportion of participants who participate in full interviews.

时间窗: Baseline to end of intervention at 25 weeks.

Feasibility of evaluation design - data completeness.

Proportion of participants for whom complete accelerometer data are collected.

时间窗: Baseline to end of intervention at 25 weeks.

Feasibility of evaluation design - data completeness.

Participants' experiences with instruments and data collection procedures.

时间窗: End of intervention at 25 weeks

Acceptability of evaluation design. Assessed via qualitative interviews at end of intervention.

Number of weeks from recruitment start to enough participants are recruited.

时间窗: Start of recruitment to baseline.

Feasibility of intervention - recruitment rate.

Percentage of participants who attend each meeting.

时间窗: End of intervention at 25 weeks.

Feasibility of intervention - retention of participants. Assessed via registration of par-ticipants' weekly attendance in Impactly platform.

Participants' expectations and motivation for participating in eHOOD.

时间窗: Baseline

Acceptability of intervention. Assessed via qualitative interviews at intervention start.

Participants' satisfaction with and self-rated benefits of eHOOD.

时间窗: End of intervention at 25 weeks.

Acceptability of intervention. Assessed via qualitative interviews at end of intervention.

次要结局

  • Change in mental wellbeing measured with the 5-item World Health Organization Well-Being Index (WHO-5) from intervention start to end of intervention(Baseline to end of intervention at 25 weeks)
  • Change in loneliness measured with the Three-Item Loneliness Scale (T-ILS) from intervention start to end of intervention(Baseline to end of intervention at 25 weeks)
  • Change in level of physical activity and sleep length and quality from intervention start to end of intervention measured with SENS Motion accelerometers mounted on participants' thighs for seven consecutive days at baseline and end of intervention(Baseline to end of intervention at 25 weeks.)
  • Change in number of days per week eating breakfast from intervention start to end of intervention.(Baseline to end of intervention at 25 weeks.)
  • Change in number of days per week eating fast-food from intervention start to end of intervention.(Baseline to end of intervention at 25 weeks.)
  • Change in number of days per week eating fruits and/or vegetables from intervention start to end of intervention.(Baseline to end of intervention at 25 weeks.)
  • Change in number of days per week having meals together with one's family from intervention start to end of intervention.(Time frame: Baseline to end of intervention at 25 weeks.)
  • Change in number of days per week with morning sleepiness from intervention start to end of intervention.(Baseline to end of intervention at 25 weeks.)
  • Change in number of days per week with use of cigarettes/e-cigarettes from intervention start to end of intervention.(Baseline to end of intervention at 25 weeks.)
  • Change in number of days per week with use of other nicotine products from intervention start to end of intervention.(Baseline to end of intervention at 25 weeks.)
  • Change in number of days per week with alcohol intake from intervention start to end of intervention.(Baseline to end of intervention at 25 weeks.)
  • Change in self-rated collaboration skills from intervention start to end of intervention.(Baseline to end of intervention at 25 weeks.)
  • Change in self-rated communication skills from intervention start to end of intervention.(Baseline to end of intervention at 25 weeks.)
  • New friendships at end of the intervention.(End of intervention at 25 weeks)
  • Change in participation in organized leisure sports from intervention start to end of intervention.(Baseline to end of intervention at 25 weeks.)
  • Change in collaboration skills assessed by coach from intervention start to end of intervention.(Baseline to end of intervention at 25 weeks.)
  • Change in communication skills assessed by coach from intervention start to end of intervention.(Baseline to end of intervention at 25 weeks.)

研究者

发起方
Center for Clinical Research and Prevention
申办方类型
Network
责任方
Sponsor

研究点 (2)

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