Dataset Information

Protocol for a cluster randomised controlled trial of a Peer-Led physical Activity iNtervention for Adolescent girls (PLAN-A).

ABSTRACT:

Background

Adolescent girls are less physically active than recommended for health, and levels decline further as they approach adulthood. Peers can influence adolescent girls' physical activity. Interventions capitalising on peer support could positively impact physical activity behaviour in this group. Building on promising feasibility work, the purpose of this cluster randomised controlled trial is to assess whether the Peer-Led physical Activity iNtervention for Adolescent girls (PLAN-A) increases adolescent girls' physical activity and is cost effective.

Methods

PLAN-A is a two-arm secondary school-based cluster randomised controlled trial, conducted with girls aged 13-14?years from twenty schools in the south west of England. The intervention requires participants to nominate influential girls within their year group to become peer supporters. The top 15% of girls nominated in each school receive three days of training designed to prepare them to support their peers to be more physically active during a ten-week intervention period. Data will be collected at two time points, at baseline (T0) and 5-6?months post-intervention (T1). Schools will be randomly allocated to the intervention (n?=?10) or control (n?=?10) arm after T0. At each time point, all consenting participants will wear an accelerometer for seven days to assess the primary outcome of mean weekday minutes of moderate-to-vigorous physical activity. Multivariable mixed effects linear regression will be used to estimate differences in the primary outcome between the two arms and will be examined on an Intention-to-Treat (ITT) basis. A self-report psychosocial questionnaire will be completed by participants to assess self-esteem and physical activity motivation. Resource use and quality of life will be measured for the purposes of an economic evaluation. A mixed-methods process evaluation will be conducted to explore intervention fidelity, acceptability and sustainability. Analysis of quantitative process evaluation data will be descriptive, and the framework method will be used to analyse qualitative data.

Discussion

This paper describes the protocol for the PLAN-A cluster randomised controlled trial, a novel approach to increasing adolescent girls' physical activity levels through peer support.

Trial registration

ISRCTN14539759-31 May, 2018.

SUBMITTER: Willis K

PROVIDER: S-EPMC6537278 | biostudies-literature | 2019 May

REPOSITORIES: biostudies-literature

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Protocol for a cluster randomised controlled trial of a Peer-Led physical Activity iNtervention for Adolescent girls (PLAN-A).

Willis Kathryn K Tibbitts Byron B Sebire Simon J SJ Reid Tom T MacNeill Stephanie J SJ Sanderson Emily E Hollingworth William W Kandiyali Rebecca R Campbell Rona R Kipping Ruth R RR Jago Russell R

BMC public health 20190528 1

<h4>Background</h4>Adolescent girls are less physically active than recommended for health, and levels decline further as they approach adulthood. Peers can influence adolescent girls' physical activity. Interventions capitalising on peer support could positively impact physical activity behaviour in this group. Building on promising feasibility work, the purpose of this cluster randomised controlled trial is to assess whether the Peer-Led physical Activity iNtervention for Adolescent girls (PLA ...[more]

PMID: 31138171

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Project description:BackgroundPhysical 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.MethodsWe 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.ResultsA 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.ConclusionsThis 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 registrationISRCTN14539759 -31 May, 2018.

Project description:BackgroundMost adolescent girls in the UK do not meet government physical activity recommendations and effective interventions are needed. This study reports the results of a feasibility trial of PLAN-A, a novel school-based peer-led physical activity intervention for adolescent girls.MethodsA two-arm cluster randomised controlled feasibility study was conducted in six English secondary schools (4 intervention & 2 control). Year 8 (age 12-13) girls were eligible and randomisation was at school-level. The intervention involved training Year 8 girls (out of school for two consecutive days, plus one top-up day 5 weeks later), who were identified by their peers as influential, to provide informal support to their friends to increase their physical activity. Feasibility of the intervention and the research was examined, including: recruitment, training attendance and data provision rates, evidence of promise of the intervention to affect weekday moderate-to-vigorous physical activity (MVPA), intervention cost and estimation of the sample size for a definitive trial. Accelerometer and questionnaire data were collected at the beginning of Year 8 (Time 0), the end of Year 8 (10-weeks after peer-supporter training) and the beginning of Year 9 (Time 2).ResultsFour hundred twenty-seven girls were recruited (95% recruitment rate). 55 girls consented to be a peer-supporter and 53 peer-supporters were trained (97% of those invited). Accelerometer return rates exceeded 85% at each time point and wear time criteria was met by 83%, 71% and 62% participants at Time 0, 1 and 2 respectively. Questionnaire data were provided by >91% of participants at each time point. Complete-case adjusted linear regression analysis showed evidence of a 6.09 minute (95% CI = 1.43, 10.76) between-arms difference in weekday MVPA at Time 2 in favour of the intervention arm. On average PLAN-A cost £2685 per school to deliver (£37 per Year 8 girl). There were no adverse events. A trial involving 20 schools would be adequately powered to detect a between-arms difference in weekday MVPA of at least six minutes.ConclusionsThe PLAN-A intervention adopts a novel peer-led approach, is feasible, and shows evidence of promise to positively affect girls' physical activity levels. A definitive trial is warranted.Trial registrationISCTRN, ISRCTN12543546, Registered on 28/7/2015, URL of registry record: http://www.isrctn.com/ISRCTN12543546.

Project description:BACKGROUND:School-based interventions may be effective at increasing levels of physical activity (PA) among adolescents; however, there is a paucity of evidence on whether walking can be successfully promoted to increase PA in this age group. This pilot study aimed to assess the effects of a 12-week school-based peer-led brisk walking programme on levels of school-time PA post intervention. METHODS:Female participants, aged 11-13 years, were recruited from six post-primary schools in Northern Ireland. Participants were randomized by school (cluster) to participate in regular 10-15-min peer-led brisk walks throughout the school week (the WISH study) (n?=?101, two schools) or to continue with their usual PA (n?=?98, four schools). The primary outcome measure was school-time PA post intervention (week 12), assessed objectively using an Actigraph accelerometer. Secondary outcome measures included anthropometry, cardiorespiratory fitness and psychosocial measures. Changes in PA data between baseline (T0) and end of intervention (week 12) (T1) were analysed using a mixed between-within subjects analysis of variance with one between (group) and one within (time) subjects factor, with two levels. RESULTS:Of 199 participants recruited (mean age?=?12.4?±?0.6 years, 27% overweight/obese), 187 had valid accelerometer data for inclusion in subsequent analysis. A significant interaction effect was observed for changes in light intensity PA across the school day (p?=?0.003), with those in the intervention increasing their light intensity PA by 8.27 mins/day compared with a decrease of 2.14 mins/day in the control group. No significant interactions were observed for the other PA measures across the intervention. Intervention effects on school-time PA were not sustained four months post intervention. CONCLUSIONS:The intervention increased daily light intensity PA behaviour in these adolescent girls but did not change moderate to vigorous physical activity (MVPA). These findings suggest that a school-based brisk walking intervention may be feasible and can change PA behaviour in the short term, but it is possible that the self-selected walking speeds determined by a peer-leader may not be sufficient to reach MVPA in this age group. Further research is needed to evaluate the potential of school-based brisk walking to contribute to MVPA in adolescent girls. TRIAL REGISTRATION:ClinicalTrials.gov, NCT02871830 . Registered on 16 August 2016).

Project description:BACKGROUND:Adolescent girls in the UK and Ireland are failing to meet current physical activity guidelines. Physical activity behaviours track from childhood to adulthood and it is important that adolescent girls are provided with opportunities to be physically active. Walking has been a central focus for physical activity promotion in adults and may effectively increase physical activity levels among younger people. Following on from a pilot feasibility trial, the purpose of this cluster randomised controlled trial (c-RCT) is to evaluate the effectiveness of a novel, low-cost, peer-led school-based walking intervention delivered across the school year at increasing physical activity levels of adolescent girls. METHODS:The Walking In ScHools (WISH) Study is a school-based c-RCT conducted with girls aged 12-14?years from eighteen schools across the Border Region of Ireland / Northern Ireland. Following baseline data collection, schools will be randomly allocated to intervention or control group. In intervention schools, female pupils aged 15-18?years will be invited to train as walk leaders and will lead younger pupils in 10-15?min walks before school, at break and lunch recess. All walks will take place in school grounds and pupils will be encouraged to participate in as many walks as possible each week. The intervention will be delivered for the whole school year (minimum 20-22?weeks). The primary outcome measure is accelerometer-measured total physical activity (counts per minute) (end of intervention). Secondary outcomes will include time spent in sedentary behaviour, light, moderate and vigorous intensity physical activity, anthropometry measures, social media usage and sleep. A mixed-methods process evaluation will also be undertaken. DISCUSSION:The WISH Study will examine the effectiveness of a low-cost, school-based, peer-led walking intervention in increasing physical activity in adolescent girls when delivered across the school year. If the intervention increases physical activity, it would benefit adolescent girls in the defined target area with potential for wider adoption by schools across the UK and Ireland. TRIAL REGISTRATION:ISRCTN; ISRCTN12847782; Registered 2nd July 2019.

Project description:IntroductionThere is a critical need for interventions that can be feasibly implemented and are effective in successfully engaging adolescent females in physical activity (PA). A theory-based, peer-led, after-school PA intervention, the Girls Active Project (GAP), was codesigned with adolescent females. This study aimed to assess the feasibility of implementing and evaluating the GAP programme.SettingOne single-sex, female-only, designated disadvantaged postprimary school (students aged 12-18) in Dublin, Ireland.MethodsMixed methods were applied with multiple stakeholders over a 12-week trial (March to May 2021). A single-arm study design was used to examine intervention: reach, dose, fidelity, acceptability, compatibility and context. Feasibility of using proposed self-reported outcome measures (moderate-to-vigorous PA levels, self-rated health, life satisfaction, PA self-efficacy and PA enjoyment) was also explored. Due to school closure resulting from the COVID-19 pandemic, the intervention was delivered both online and in person in the school setting.ResultsEight exercise classes were peer delivered by project leaders (n = 6, students aged 15-17) to intervention recipients (students aged 13-14). Recruitment was low (n = 8, 10% of eligible students, mean age: 13.3 SD: 0.46), yet retention was high (n = 7/8, 88%). Attendance rates were satisfactory (68%), and the intervention was implemented with high fidelity (87%). Data completion rates suggested proposed self-reported outcome measures were deemed appropriate (≥ 95%), except for weight (50%) and height data (80%). Despite COVID-19 hindering intervention implementation, both quantitative and qualitative data suggested that stakeholders were satisfied and perceived the in-person delivered intervention to be compatible with the school setting. Recommended refinements included extending class duration, introducing different rewards, and boosting programme awareness.ConclusionsFurther thought must be given on how to increase recruitment. Overall, the in-person delivered after-school PA programme was well-received by stakeholders and shows promise as an intervention that can be feasibly implemented and evaluated. Suggested improvements to the GAP intervention programme are recommended, before continuing to a more robust evaluation.Trial registration10.17605/OSF.IO/75HWJ (prospectively registered, date of registration: 9th December 2020).

Project description:BackgroundThe purpose was to explore whether baseline sociodemographic and physical characteristics moderated effects of an intervention on moderate-to-vigorous physical activity (MVPA), percent body fat, body mass index z-score, and cardiorespiratory fitness (CRF) at post intervention, relative to the control condition.MethodsA secondary analysis of data from a group randomized trial including 24 schools (12 intervention and 12 control; N = 1519 girls) was conducted. Age, ethnicity, race, socioeconomic status, and pubertal stage were assessed via survey. Height, weight, MVPA (min/h), percent body fat, and CRF were measured. Mixed-effects linear models were performed.ResultsCompared to the control, the intervention increased overweight and obese girls' CRF (b = 0.28, p = 0.049; b = 0.31, p < 0.01, respectively), but not healthy weight girls' CRF (b = 0.04, p = 0.706). Pre- to mid-puberty girls in the intervention group had slightly lower post-intervention MVPA than those in the control (3.04 vs. 3.31, p = 0.055), while late to post-puberty intervention and control girls' post-intervention MVPA was similar (3.12 vs. 3.04, p = 0.542).ConclusionsA PA intervention can improve overweight and obese girls' CRF, possibly attenuating their cardiovascular risk. Effective strategies are needed to assist adolescent girls, especially those in pre- to mid-puberty, in maintaining their MVPA after an intervention ends.ImpactModerators of physical activity intervention effects among adolescent girls are important to identify because the effectiveness of these interventions to date in this population has been limited. This article contributes to the notable gap in knowledge regarding moderators in physical activity interventions involving adolescent girls, particularly baseline characteristics that may moderate their responses to physical activity interventions. Awareness of the moderators can be useful for determining the type of intervention that may be successful in subgroups of adolescent girls and for tailoring a physical activity intervention to optimally meet each girl's needs to achieve maximal effects. Findings show that weight status moderated the intervention effects on cardiorespiratory fitness. Compared to the control condition, the intervention increased overweight and obese, but not healthy weight, girls' cardiorespiratory fitness. A physical activity intervention can improve overweight and obese girls' cardiorespiratory fitness, possibly attenuating their cardiovascular risk. Therefore, it is essential to include overweight and obese girls in PA interventions to help them reap this important benefit.

Project description:IntroductionMany stroke survivors have unmet psychosocial needs during the recovery phase following a stroke. There is emerging evidence that peer support interventions may play a valuable role in managing stroke. However, evidence regarding the effectiveness of peer support interventions on the psychosocial outcomes of stroke survivors is uncertain. This study aims to develop a nurse-led peer support intervention for stroke survivors based on the Person-Environment-Occupation-Performance Model and evaluate its effects on the psychosocial outcomes of stroke survivors.Methods and analysisThis is an assessor-blinded two-arm randomised controlled trial. A convenience sample of 120 stroke survivors will be recruited from two community centres and one rehabilitation unit in Yangzhou, a medium-sized city in eastern China, with 60 participants each in the intervention and control groups. The participants allocated to the intervention group will receive the nurse-led peer support intervention, which includes 6 weekly peer support sessions facilitated by a nurse and at least one peer facilitator. Participants randomised to the control group will receive the same dose of interpersonal interaction as intervention participants, including weekly individual face-to-face session for 6 weeks. The primary outcomes are social participation and participation self-efficacy. The secondary outcomes are psychosocial distress, social support, stigma towards disease, self-efficacy in managing chronic conditions and quality of life. Data will be collected at baseline, immediately after the intervention and 3 months after the intervention. A process evaluation will be conducted qualitatively and quantitively to examine the mechanism by which the intervention impacts the psychosocial outcomes of stroke survivors. All outcomes will be analysed following the intention to treat principle. Generalised Estimation Equation models will be used to assess the intervention effect.Ethics and disseminationThis protocol was approved by the Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee (CREC Ref. No.: 2021.196-T). All participants will be required to provide written informed consent. Results of the study will be disseminated through publication in peer-reviewed journals and presentation at local or international conferences.Trial registration numberChiCTR2100050853.

Dataset Information

Protocol for a cluster randomised controlled trial of a Peer-Led physical Activity iNtervention for Adolescent girls (PLAN-A).

Background

Methods

Discussion

Trial registration

Publications

Protocol for a cluster randomised controlled trial of a Peer-Led physical Activity iNtervention for Adolescent girls (PLAN-A).

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