scholarly journals Adapting the ToyBox obesity prevention intervention for use in Scottish preschools: protocol for a feasibility cluster randomised controlled trial

BMJ Open ◽  
2018 ◽  
Vol 8 (10) ◽  
pp. e023707 ◽  
Author(s):  
Stephen Malden ◽  
Adrienne R Hughes ◽  
Ann-Marie Gibson ◽  
Farid Bardid ◽  
Odysseas Androutsos ◽  
...  
Keyword(s):  
Physical Activity ◽  
Randomised Controlled Trial ◽  
Sedentary Behaviour ◽  
Obesity Prevention ◽  
Water Consumption ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Control Group ◽  
Cluster Randomised ◽  
Randomised Controlled

IntroductionThere is an increasing need for the adoption of effective preschool obesity prevention interventions to combat the high levels of early-childhood obesity in the UK. This study will examine the feasibility and acceptability of the adapted version of the ToyBox intervention—a preschool obesity prevention programme—for use in Scotland (ToyBox-Scotland). This will inform the design of a full-scale cluster randomised controlled trial (RCT).Methods and analysisThe ToyBox-Scotland intervention will be evaluated using a feasibility cluster RCT, which involves children aged 3–5 years at six preschools in Glasgow, three randomly assigned to the intervention group and three to the usual-care control group. The original ToyBox intervention was adapted for the Scottish context using a coproduction approach. Within the 18-week intervention, physical activity and sedentary behaviour will be targeted in the preschool through environmental changes to the classroom, physical activity sessions and movement breaks. Parents will receive home activity packs every 3 weeks containing sticker incentives and interactive parent–child games that target sedentary behaviour, physical activity, eating/snacking and water consumption. As this is a feasibility study, parameters such as recruitment rates, attrition rates and SDs of outcome measures will be obtained which will inform a power calculation for a future RCT. Additional variables to be assessed include accelerometer-measured physical activity, sedentary behaviour and sleep, body mass index, home screen time, eating/snacking and water consumption. Outcomes will be assessed at baseline and 14–17 weeks later. Intervention fidelity will be assessed using questionnaires and interviews with parents and practitioners, observation and session delivery records.Ethics and disseminationThis study was granted ethical approval by the University of Strathclyde’s School of Psychological Sciences and Health Ethics Committee. Results will be disseminated through publication in peer-reviewed journals, presentation at conferences and in lay summaries provided to participants.Trial registration numberISRCTN12831555.

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 The effectiveness of multi-component interventions targeting physical activity or sedentary behaviour amongst office workers: a 3-arm cluster randomised controlled trial

2020 ◽  
Author(s):  
Carla F. J. Nooijen ◽  
Victoria Blom ◽  
Örjan Ekblom ◽  
Emerald G. Heiland ◽  
Lisa-Marie Larisch ◽  
...  
Keyword(s):  
Physical Activity ◽  
Randomised Controlled Trial ◽  
Sedentary Behaviour ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Activity Level ◽  
Office Workers ◽  
Group Differences ◽  
Cluster Randomised ◽  
Randomised Controlled

Abstract Background: Interventions to increase physical activity or reduce sedentary behaviour within the workplace setting have shown mixed effects. This cluster randomised controlled trial assessed whether multi-component interventions, focusing on changes at the individual, environmental, and organisational levels, either increased physical activity or reduced sedentary behaviour, compared to a passive control group.Methods: Teams of office-workers from two companies participated in two interventions (iPA: targeting physical activity; iSED: targeting sedentary behaviour), or a waiting list control group. Exclusion criteria was a very high physical activity level. Randomisation was done on a cluster level, and groups were randomly allocated (1:1) with stratification for company and cluster size Personnel involved in data collection and processing were blinded for group allocation. Both interventions included five sessions of cognitive behavioural therapy counselling for 6-months. iPA included counselling focused on physical activity, access to a gym, and encouragement to exercise and go for lunch walks. iSED included counselling on sedentary behaviour and encouragement to reduce sitting and increase engagement in standing- and walking-meetings. At baseline and the 6-month mark accelerometers were worn on the hip and thigh for 7 days. The primary outcomes were group differences in time spent in moderate-to-vigorous physical activity (%MVPA) and in sedentary behaviour (%), analysed for those with complete data using Bayesian multilevel modelling.Results: 263 office-workers (73% women, mean age 42±9 years, education 15±2 years) in 23 cluster teams were randomised (iPA n=84, 8 clusters; iSED n=87, 7 clusters; C n=92, 7 clusters). No significant group differences (posterior mean ratios: 95% credible interval) were found after the intervention for %MVPA or for %Sedentary. %MVPA: iPA vs C (0·04: -0·80 – 0·82); iSED vs C (0·47: -0·41 – 1·32); iPA vs iSED (0·43: -0·42 – 1·27). %Sedentary: iPA vs C (1·16: -1·66 – 4·02); iSED vs C (-0·44: -3·50 – 2·64); iPA vs iSED (-1·60: -4·72 – 1·47).Conclusions: The multi-component interventions focusing on either physical activity or sedentary behaviour were unsuccessful at increasing device-measured physical activity or reducing sedentary behaviour compared to control.Trial registration: ISRCTN92968402

scholarly journals A feasibility cluster randomised controlled trial of a preschool obesity prevention intervention: ToyBox-Scotland

2019 ◽  
Vol 5 (1) ◽  
Author(s):  
Stephen Malden ◽  
John. J. Reilly ◽  
Ann-Marie Gibson ◽  
Farid Bardid ◽  
Carolyn Summerbell ◽  
...  
Keyword(s):  
Physical Activity ◽  
Randomised Controlled Trial ◽  
Obesity Prevention ◽  
Sedentary Time ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Recruitment Rate ◽  
Cluster Randomised ◽  
Randomised Controlled

Abstract Background High levels of childhood obesity have been observed globally over the last three decades. Preschools are promising settings to implement obesity prevention interventions in the early years. The aim of this study was to test the feasibility of a cluster randomised controlled trial of the ToyBox-Scotland preschool obesity prevention intervention. Methods Six preschools in predominantly deprived areas of Glasgow, UK, were randomised to either the ToyBox intervention (n = 3) or usual curriculum control group (n = 3). The intervention ran for 18 weeks from March–June 2018, and consisted of practitioner-led physical activity and sedentary behaviour sessions in preschools, with an additional interactive home component. Primary outcome measures were intervention fidelity, recruitment rates, attrition rates, and compliance with trial procedures. Secondary outcomes were body mass index (BMI) z-score, bioelectrical impedance analysis (BIA), objectively measured physical activity and sedentary time via activPAL accelerometer, and parent-reported home eating, snacking, and water consumption. Results The preschool component of the intervention was implemented with high fidelity (64%), while the home component was implemented with low fidelity (41%). A cluster-level recruitment rate of 10% was achieved, and the individual-level recruitment rate was 18% (42/233 children, mean age 4.4 years; 17 girls). The attrition rate was 14%, and compliance rates varied considerably by the outcome. Compliance was highest for BMI (86%), while 19% of the sample returned valid accelerometer data for both baseline and follow-up and the parental questionnaire response rate was 23%. Both intervention and control groups showed small increases in BMI z-scores at follow-up of 0.02 and 0.06, respectively. Both groups had small decreases in physical activity and increases in sedentary time at follow-up. Conclusions Before progression to an effectiveness trial, additional procedures should be considered to improve recruitment rates, compliance with outcome measures, and implementation of the home-based component of the ToyBox-Scotland intervention. Trial registration ISRCTN12831555

scholarly journals Efficacy of a smartphone-based coaching program for addiction prevention among apprentices: study protocol of a cluster-randomised controlled trial

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Severin Haug ◽  
Raquel Paz Castro ◽  
Andreas Wenger ◽  
Michael P. Schaub
Keyword(s):  
Randomised Controlled Trial ◽  
Cigarette Smoking ◽  
Internet Use ◽  
Controlled Trial ◽  
Intervention Group ◽  
Cluster Randomised Controlled Trial ◽  
Control Group ◽  
Addiction Prevention ◽  
Cluster Randomised ◽  
Randomised Controlled

Abstract Background A large proportion of apprentices shows addictive behaviours like cigarette smoking, alcohol, cannabis, or compulsive Internet use, others do not show such behaviours at all. ready4life is a smartphone application-based coaching program for apprentices, which takes into account the heterogeneity of adolescent addictive behaviour by promoting life skills and reducing risk behaviours. The main objective of the planned study is to test the efficacy of ready4life for addiction prevention among apprentices in Switzerland within a controlled trial. Methods/design The efficacy of the ready4life coaching program will be tested in comparison to an assessment only control group, within a cluster-randomised controlled trial with one follow-up assessment after 6 months. At the beginning of the program, participants of the intervention group will receive an individual profile, showing areas in which they have sufficient resources and in which there is a need for coaching. Based on this feedback, they can select two out of the following six program modules: stress, social skills, Internet use, tobacco/e-cigarettes, cannabis, and alcohol. Participants of the intervention group will receive individualised coaching by a conversational agent (chatbot) for a period of four months. The coaching relies on motivational and social-cognitive principles of behaviour change. Within weekly dialogues, the coach provides individually tailored information in different formats, such as videoclips, texts, or pictures. Study participants will be 1318 apprentices with a minimum age of 15, recruited in approximately 100 vocational school classes in Switzerland. Primary outcome will be a composite measure for addictive behaviours including (1) at risk-drinking, (2) tobacco/e-cigarette smoking, (3) cannabis use, and (4) problematic Internet use. Discussion The study will reveal whether this universally implementable but individually tailored intervention approach is effective in preventing the onset and escalation of addictive behaviors among apprentices. Trial registration ISRCTN59908406 (registration date: 21/10/2020).

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