scholarly journals Engaging adolescents in changing behaviour (EACH-B): A study protocol for a cluster randomised controlled trial to improve dietary quality and physical activity

2020 ◽  
Author(s):  
Sofia Strömmer ◽  
Millie Barrett ◽  
Kathryn Woods-Townsend ◽  
Janis Baird ◽  
David Farrell ◽  
...  
Keyword(s):  
Physical Activity ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Health Behaviours ◽  
Cluster Randomised Controlled Trial ◽  
Dietary Quality ◽  
School Students ◽  
Cluster Randomised ◽  
Important Time ◽  
Randomised Controlled

Abstract Background Poor diet and lack of physical activity are strongly linked to non-communicable disease risk, but modifying them is challenging. There is increasing recognition that adolescence is an important time to intervene; habits formed during this period tend to last, and physical and psychological changes during adolescence make it an important time to help individuals form healthier habits. Improving adolescents’ health behaviours is important not only for their own health now and in adulthood, but also for the health of any future children. Building on LifeLab - an existing, purpose-built educational facility at the University of Southampton - we have developed a multi-component intervention for secondary school students called Engaging Adolescents in Changing Behaviour (EACH-B) that aims to motivate and support adolescents to eat better and be more physically active.Methods A cluster randomised controlled trial is being conducted to evaluate the effectiveness of the EACH-B intervention. The primary outcomes of the intervention are self-reported dietary quality and objectively measured physical activity (PA) levels, both assessed at baseline and at 12-month follow-up. The EACH-B intervention consists of three linked elements: professional development for teachers including training in communication skills to support health behaviour change; the LifeLab educational module comprising in-school teaching of nine science lessons linked to the English National Curriculum and a practical day visit to the LifeLab facility; and a personalised digital intervention that involves social support and game features that promote eating better and being more active.Both the taught module and the LifeLab day are designed with a focus on the science behind the messages about positive health behaviours, such as diet and PA, for the adolescents now, in adulthood and their future offspring, with the aim of promoting personal plans for change. The EACH-B research trial aims to recruit approximately 2,300 secondary school students aged 12-13 years from 50 schools (the clusters) from Hampshire and neighbouring counties. Participating schools will be randomised to either the control or intervention arm. The intervention will be run during two academic years, with continual recruitment of schools throughout the school year until the sample size is reached. The schools allocated to the control arm will receive normal schooling but will be offered the intervention after data collection for the trial is complete. An economic model will be developed to assess the cost-effectiveness of the EACH-B intervention compared with usual schooling.Discussion Adolescents’ health needs are often ignored and they can be difficult to engage in behaviour change. Building a cheap, sustainable way of engaging them in making healthier choices will benefit their long-term health and that of their future children.Trial registration EACH-B is a cluster randomised controlled trial (ISRCTN 74109264, registered 30th August 2019), funded by the National Institute for Health Research (RP-PG-0216-20004). http://www.isrctn.com/ISRCTN74109264

scholarly journals Engaging adolescents in changing behaviour (EACH-B): a study protocol for a cluster randomised controlled trial to improve dietary quality and physical activity

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Sofia Strömmer ◽  
Millie Barrett ◽  
Kathryn Woods-Townsend ◽  
Janis Baird ◽  
David Farrell ◽  
...  
Keyword(s):  
Physical Activity ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Health Behaviours ◽  
Cluster Randomised Controlled Trial ◽  
Dietary Quality ◽  
School Students ◽  
Cluster Randomised ◽  
Important Time ◽  
Randomised Controlled

Abstract Background Poor diet and lack of physical activity are strongly linked to non-communicable disease risk, but modifying them is challenging. There is increasing recognition that adolescence is an important time to intervene; habits formed during this period tend to last, and physical and psychological changes during adolescence make it an important time to help individuals form healthier habits. Improving adolescents’ health behaviours is important not only for their own health now and in adulthood, but also for the health of any future children. Building on LifeLab—an existing, purpose-built educational facility at the University of Southampton—we have developed a multi-component intervention for secondary school students called Engaging Adolescents in Changing Behaviour (EACH-B) that aims to motivate and support adolescents to eat better and be more physically active. Methods A cluster randomised controlled trial is being conducted to evaluate the effectiveness of the EACH-B intervention. The primary outcomes of the intervention are self-reported dietary quality and objectively measured physical activity (PA) levels, both assessed at baseline and at 12-month follow-up. The EACH-B intervention consists of three linked elements: professional development for teachers including training in communication skills to support health behaviour change; the LifeLab educational module comprising in-school teaching of nine science lessons linked to the English National Curriculum and a practical day visit to the LifeLab facility; and a personalised digital intervention that involves social support and game features that promote eating better and being more active. Both the taught module and the LifeLab day are designed with a focus on the science behind the messages about positive health behaviours, such as diet and PA, for the adolescents now, in adulthood and their future offspring, with the aim of promoting personal plans for change. The EACH-B research trial aims to recruit approximately 2300 secondary school students aged 12–13 years from 50 schools (the clusters) from Hampshire and neighbouring counties. Participating schools will be randomised to either the control or intervention arm. The intervention will be run during two academic years, with continual recruitment of schools throughout the school year until the sample size is reached. The schools allocated to the control arm will receive normal schooling but will be offered the intervention after data collection for the trial is complete. An economic model will be developed to assess the cost-effectiveness of the EACH-B intervention compared with usual schooling. Discussion Adolescents’ health needs are often ignored and they can be difficult to engage in behaviour change. Building a cheap, sustainable way of engaging them in making healthier choices will benefit their long-term health and that of their future children. Trial registration ISRCTN 74109264. Registered on 30 August 2019. EACH-B is a cluster randomised controlled trial, funded by the National Institute for Health Research (RP-PG-0216-20004).

scholarly journals Engaging adolescents in changing behaviour (EACH-B): A study protocol for a cluster randomised controlled trial

2020 ◽  
Author(s):  
Sofia Strömmer ◽  
Millie Barrett ◽  
Kathryn Woods-Townsend ◽  
Janis Baird ◽  
David Farrell ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Secondary School ◽  
Secondary School Students ◽  
Controlled Trial ◽  
Health Behaviours ◽  
Cluster Randomised Controlled Trial ◽  
School Students ◽  
Cluster Randomised ◽  
Important Time ◽  
Randomised Controlled

Abstract BackgroundPoor diet and lack of physical activity are strongly linked to non-communicable disease risk, but modifying them is challenging. There is increasing recognition that adolescence is an important time to intervene; habits formed during this period tend to last, and physical and psychological changes during adolescence make it an important time to help individuals form healthier habits. Improving adolescents’ health behaviours is important not only for their own health now and in adulthood, but also for the health of any future children. Building on LifeLab - an existing, purpose-built educational facility at the University of Southampton - we have developed a multi-component intervention for secondary school students called Engaging Adolescents in Changing Behaviour (EACH-B) that aims to motivate and support adolescents to eat better and be more physically active.MethodsA cluster randomised controlled trial is being conducted to evaluate the effectiveness of the EACH-B intervention. The primary outcomes of the intervention are self-reported dietary quality and objectively measured physical activity (PA) levels, both assessed at baseline and at 12-month follow-up. The EACH-B intervention consists of three linked elements: professional development for teachers including training in communication skills to support health behaviour change; the LifeLab educational module comprising in-school teaching of nine science lessons linked to the English National Curriculum and a practical day visit to the LifeLab facility; and a personalised digital intervention that involves social support and game features that promote eating better and being more active. Both the taught module and the LifeLab day are designed with a focus on the science behind the messages about positive health behaviours, such as diet and PA, for the adolescents now, in adulthood and their future offspring, with the aim of promoting personal plans for change. The EACH-B research trial aims to recruit approximately 2,300 secondary school students aged 12-13 years from 50 schools (the clusters) from Hampshire and neighbouring counties. Participating schools will be randomised to either the control or intervention arm. The intervention will be run during two academic years, with continual recruitment of schools throughout the school year until the sample size is reached. The schools allocated to the control arm will receive normal schooling but will be offered the intervention after data collection for the trial is complete. An economic model will be developed to assess the cost-effectiveness of the EACH-B intervention compared with usual schooling.DiscussionAdolescents’ health needs are often ignored and they can be difficult to engage in behaviour change. Building a cheap, sustainable way of engaging them in making healthier choices will benefit their long-term health and that of their future children.Trial registrationEACH-B is a cluster randomised controlled trial (ISRCTN 74109264, registered 30th August 2019), funded by the National Institute for Health Research (RP-PG-0216-20004).

scholarly journals School-based physical activity intervention for older adolescents: rationale and study protocol for the Burn 2 Learn cluster randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (5) ◽  
pp. e026029 ◽  
Author(s):  
Angus A Leahy ◽  
Narelle Eather ◽  
Jordan J Smith ◽  
Charles Hillman ◽  
Philip J Morgan ◽  
...  
Keyword(s):  
Physical Activity ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Phase Iii ◽  
School Students ◽  
School Based ◽  
Cluster Randomised ◽  
Randomised Controlled ◽  
The Impact

IntroductionThis trial aims to investigate the impact of a school-based physical activity programme, involving high-intensity interval training (HIIT), on the physical, mental and cognitive health of senior school students.Methods and analysisThe Burn 2 Learn (B2L) intervention will be evaluated using a two-arm parallel group cluster randomised controlled trial with allocation occurring at the school level (to treatment or wait-list control). Schools will be recruited in two cohorts from New South Wales, Australia. The trial will aim to recruit ~720 senior school students (aged 16–18 years) from 20 secondary schools (ie, 10 schools per cohort). A range of implementation strategies will be provided to teachers (eg, training, equipment and support) to facilitate the delivery of HIIT sessions during scheduled classes. In phase I and II (3 months each), teachers will facilitate the delivery of at least two HIIT sessions/week during lesson-time. In phase III (6 months), students will be encouraged to complete sessions outside of lesson-time (teachers may continue to facilitate the delivery of B2L sessions during lesson-time). Study outcomes will be assessed at baseline, 6 months (primary end point) and 12 months. Cardiorespiratory fitness (shuttle run test) is the primary outcome. Secondary outcomes include: vigorous physical activity, muscular fitness, cognition and mental health. A subsample of students will (i) provide hair samples to determine their accumulated exposure to stressful events and (ii) undergo multimodal MRI to examine brain structure and function. A process evaluation will be conducted (ie, recruitment, retention, attendance and programme satisfaction).Ethics and disseminationThis study has received approval from the University of Newcastle (H-2016–0424) and the NSW Department of Education (SERAP: 2017116) human research ethics committees.Trial registration numberACTRN12618000293268; Pre-results.

scholarly journals Effectiveness and cost-effectiveness of the PLAN-A intervention, a peer led physical activity program for adolescent girls: results of a cluster randomised controlled trial

2021 ◽  
Vol 18 (1) ◽  
Author(s):  
Russell Jago ◽  
Byron Tibbitts ◽  
Kathryn Willis ◽  
Emily Sanderson ◽  
Rebecca Kandiyali ◽  
...  
Keyword(s):  
Physical Activity ◽  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Control Group ◽  
Cluster Randomised ◽  
Secondary Outcomes ◽  
Randomised Controlled

Abstract Background Physical activity is associated with improved health. Girls are less active than boys. Pilot work showed that a peer-led physical activity intervention called PLAN-A was a promising method of increasing physical activity in secondary school age girls. This study examined the effectiveness and cost-effectiveness of the PLAN-A intervention. Methods We conducted a cluster randomised controlled trial with Year 9 (13–14 year old) girls recruited from 20 secondary schools. Schools were randomly assigned to the PLAN-A intervention or a non-intervention control group after baseline data collection. Girls nominated students to be peer leaders. The top 18 % of girls nominated by their peers in intervention schools received three days of training designed to prepare them to support physical activity. Data were collected at two time points, baseline (T0) and 5–6 months post-intervention (T1). Participants wore an accelerometer for seven days to assess the primary outcome of mean weekday minutes of moderate-to-vigorous physical activity (MVPA). Multivariable mixed effects linear regression was used to estimate differences in the primary outcome between the two arms on an Intention-to-Treat (ITT) basis. Resource use and quality of life were measured and a within trial economic evaluation from a public sector perspective was conducted. Results A total of 1558 girls were recruited to the study. At T0, girls in both arms engaged in an average of 51 min of MVPA per weekday. The adjusted mean difference in weekday MVPA at T1 was − 2.84 min per day (95 % CI = -5.94 to 0.25) indicating a slightly larger decline in weekday MVPA in the intervention group. Results were broadly consistent when repeated using a multiple imputation approach and for pre-specified secondary outcomes and sub-groups. The mean cost of the PLAN-A intervention was £2817 per school, equivalent to £31 per girl. Economic analyses indicated that PLAN-A did not lead to demonstrable cost-effectiveness in terms of cost per unit change in QALY. Conclusions This study has shown that the PLAN-A intervention did not result in higher levels of weekday MVPA or associated secondary outcomes among Year 9 girls. The PLAN-A intervention should not be disseminated as a public health strategy. Trial registration ISRCTN14539759–31 May, 2018.

scholarly journals Community- and mHealth-based integrated management of diabetes in primary healthcare in Rwanda (D²Rwanda): the protocol of a mixed-methods study including a cluster randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (7) ◽  
pp. e028427 ◽  
Author(s):  
Charilaos Lygidakis ◽  
Jean Paul Uwizihiwe ◽  
Per Kallestrup ◽  
Michela Bia ◽  
Jeanine Condo ◽  
...  
Keyword(s):  
Mixed Methods ◽  
Randomised Controlled Trial ◽  
Integrated Management ◽  
Controlled Trial ◽  
Health Behaviours ◽  
Cluster Randomised Controlled Trial ◽  
Control Group ◽  
Chronic Patients ◽  
Cluster Randomised ◽  
Randomised Controlled

IntroductionIn Rwanda, diabetes mellitus prevalence is estimated between 3.1% and 4.3%. To address non-communicable diseases and the shortage of health workforce, the Rwandan Ministry of Health has introduced the home-based care practitioners (HBCPs) programme: laypeople provide longitudinal care to chronic patients after receiving a six-month training. Leveraging technological mobile solutions may also help improve health and healthcare. The D²Rwanda study aims at: (a) determining the efficacy of an integrated programme for the management of diabetes in Rwanda, which will provide monthly patient assessments by HBCPs, and an educational and self-management mHealth patient tool, and; (b) exploring qualitatively the ways the interventions will have been enacted, their challenges and effects, and changes in the patients’ health behaviours and HBCPs’ work satisfaction.Methods and analysisThis is a mixed-methods sequential explanatory study. First, there will be a one-year cluster randomised controlled trial including two interventions ((1) HBCPs’ programme; (2) HBCPs’ programme + mobile health application) and usual care (control). Currently, nine hospitals run the HBCPs’ programme. Under each hospital, administrative areas implementing the HBCPs’ programme will be randomised to receive intervention 1 or 2. Eligible patients from each area will receive the same intervention. Areas without the HBCPs’ programme will be assigned to the control group. The primary outcome will be changes in glycated haemoglobin. Secondary outcomes include medication adherence, mortality, complications, health-related quality of life, diabetes-related distress and health literacy. Second, at the end of the trial, focus group discussions will be conducted with patients and HBCPs. Financial support was received from the Karen Elise Jensens Fond, and the Universities of Aarhus and Luxembourg.Ethics and disseminationEthics approval was obtained from the Rwanda National Ethics Committee and the Ethics Review Panel of the University of Luxembourg. Findings will be disseminated via peer-reviewed publications and conference presentations.Trial registration numberNCT03376607; Pre-results.

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