A Multi-component Physical Activity Intervention for Adolescent Girls: Feasibility Cluster Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 160
- 试验地点
- 4
- 主要终点
- Change in objective physical activity levels
研究概览
简要总结
A four-arm randomised pilot trial involving:
- Physical activity programme only - live exercise sessions, social support, standardised text messages
- Individual behaviour change support only - regular one-to-one video calls with an activity mentor
- Combined - Physical activity provision and individual behaviour change support
- Usual care control All groups will be provided with a menu of physical activities.
Objectives.
To conduct a RE-AIM evaluation of a 6-month multi-component PA intervention for adolescent girls, through investigating:
- Who the intervention reaches, how representative they are for the population (Reach, Adoption) and who is most likely to benefit from the intervention (Reach);
- The extent to which the intervention is delivered as intended (Implementation), and factors that affect this (Adoption);
- Preliminary impact on participants' PA, sedentary behaviour, cardiovascular fitness and psychological wellbeing at 3, 6 and 12 months (Effectiveness, Maintenance);
- The qualitatively examine the acceptability of the intervention for adolescent girls, and identify necessary refinements;
- To gather data to inform a sample size calculation for a main trail
详细描述
Procedures. Following written informed assent of participants and consent of parents/guardians, the researcher will have a short introductory video call with the participant and parent to talk through the next steps, give instructions on how to complete fitness tests and answer any questions. After this introduction, participants can carry out their fitness testing at home remotely under the supervision of the researcher (via Zoom) or their parent. Following written consent, participants will complete all questionnaires online (approximately 15 minutes) - self-reported physical activity, sociodemographic and psychosocial measures (behavioural regulation in exercise questionnaire, body-appreciation scale and self-esteem scale - details of each listed below). Participants will then complete the fitness measures using the Resistance Training for Teens (RTFT) app (30 minutes) - 20m shuttle run tests, long jump and push up test. Participants will wear an Actigraph accelerometer on their don-dominant wrist continuously, as outlined in the study protocol, for 9 days before starting their 12-week physical activity programme. In total, assessments should take approximately one hour and will be conducted at baseline (week 0), post-intervention (week 12) and follow up (week 24).
Randomisation. Participants will be randomly allocated to one of the four intervention arms following baseline measures. 40 participants will be allocated to each arm using block randomisation on Microsoft Excel.
Intervention group - The goals of this physical activity intervention are to 1) increase adolescent girls total physical activity levels and 2) improve adolescent girls health behaviours, including body appreciation and motivation. This study hopes to build on our prior feasibility work to help us to understand which components of the intervention are most effective, i.e. a physical activity programme, individual behaviour change support or a combination. To achieve these goals the following elements will be implemented:
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Menu of physical activity options: Participants in all four groups will be given a booklet with suggestions of ways to be physically active, e.g. YouTube workouts, cycling or jogging, sports, or design their own using a home-based exercise booklet. They are asked to do 3 sessions of 30 minutes per week. Participants are asked to record what activity they did and the duration of the session using a method most convenient for them, e.g. notes on their phone, wall calendar or using an activity log template which the investigators will provide.
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Physical activity programme: Participants in groups 1 and 3 will receive -
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Non Reply SMS: Sent to the participant mobile three times per week by the primary researcher, Emma Cowley PhD candidate, from an online non-reply messaging service. This service is password protected. All messages will be standardised (not personally tailored) and will be focused on behaviour change techniques or reminders.
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Live exercise sessions: The researcher (with personal training and physical education teaching qualifications) will host two online group fitness classes each week which participants are also invited to join. This option is to allow participants the potential to engage with the other participants on the programme from the comfort of their own homes. It is also thought that having a scheduled set time to join a class on line may increase motivation and improve adherence, however the choice to join the class is optional. From previous feasibility work, these sessions were a highlight of the programme and often times parents and siblings would join in too. Participants are invited to turn their cameras on for the intro and warm up, however this is not mandatory.
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Access to a social media group: With participant and parental consent, participants are invited to join a private group community online where they can access additional resources provided by the research team, ask questions in an informal setting and communicate with the other participants in the programme. It is well researched that social connection is a facilitator to adolescent girls participation in physical activity and as participants will be exercising from home the investigators feel giving them access to a social, safe and virtual community can help give them this social connectedness to other adolescent girls of the same age. This is not compulsory and participants are free to join the group, leave the group or decline being added to the group without it affecting their participation in the rest of the programme.
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Individual behaviour change support:
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
盲法说明
Due to the nature of the study, it will not be possible to blind participants to their study condition (as they will know whether they are engaging the physical activity programme or not). As the researchers will be doing the data collection and conducting the behaviour change support calls, it will also not be possible to blind the researcher to the study.
入排标准
- 年龄范围
- 13 Years 至 16 Years（Child）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •13-16 years
- •Living in the UK or Ireland
- •Would like support with becoming more physically active
- •Ability to participate in moderate intensity physical activity according to the Physical Activity Readiness Questionnaire
排除标准
- •Have taken part in previous HERizon study
- •Currently doing more than 1 hour of exercise or sport every day.
- •Currently pregnant
- •Not having access to at least ONE of the following: a smartphone, home computer, or parent smartphone.
结局指标
主要结局
Change in objective physical activity levels
时间窗: Baseline to post-intervention (week 12)
Participants objective PA will be monitored continuously (i.e. 24 h/day) over a nine-day period using an accelerometer (actigraph GT9x software). This device will be worn on their non-dominant wrist and uses the same validated MEMS sensor as the Actigraph GT3X+ model which has been validated (Hanggi et al., 2013) and used extensively with adolescents (Corder et al., 2016). Using the Actigraph, total daily PA, moderate-to-vigorous PA and sedentary time can be assessed.
次要结局
- Change in Physical Activity Motivation(week 0, week 12, week 24)
- Upper body strength(week 0, week 12, week 24)
- Strength/ Power(week 0, week 12, week 24)
- Aerobic capacity(week 0, week 12, week 24)
- Change in Body Appreciation(week 0, week 12, week 24)
- Change in Physical Activity Competence(week 0, week 12, week 24)
- Change in Self-esteeem(week 0, week 12, week 24)
- Change in objective physical activity levels(Baseline to follow-up (week 24))