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Can Teenage Men Be Targeted to Prevent Teenage Pregnancy? A Feasibility Cluster Randomised Controlled Intervention Trial in Schools.

ABSTRACT: The World Health Organisation advocates a direct focus on adolescent men in reducing adolescent pregnancy; however, no trials have been conducted. This trial (ISRCTN11632300; NCT02092480) determines whether a novel Relationship and Sexuality Educational intervention, If I Were Jack, is acceptable and feasible to implement in mixed sex UK classrooms. The intervention is a teacher-delivered intervention that emphasises male alongside female responsibility in preventing unintended pregnancies and is designed to prevent unprotected sex. The trial was a parallel-group cluster randomised controlled feasibility trial with embedded process and cost evaluation in eight secondary schools (unit of randomisation) among 831 pupils (mean age 14) in Northern Ireland, alongside a qualitative evaluation of transferability in ten schools in Scotland, Wales and England. The sampling strategy was a maximum variation quota sample designed to capture a range of school management types. Four schools were randomised to each arm and the control arm continued with usual practice. Study duration was 12 months (from November 2014), with follow-up 9 months post-baseline. Results demonstrated that the intervention was acceptable to schools, pupils and teachers, and could be feasibly implemented, cost-effectively, with minor enhancements. The between-group difference in incidence of unprotected sex (primary outcome at pupil level) of 1.3% (95% CI 0.5-2.2) by 9 months demonstrated a potential effect size consistent with those reported to have had meaningful impact on teenage pregnancy. The study responds to global health policy for a paradigm shift towards inclusion of men in the achievement of sexual and reproductive health goals in a practical way by demonstrating that a gender-sensitive as well as a gender transformative intervention targeting males to prevent teenage pregnancy is acceptable to adolescent men and women and implementable in formal education structures. If I Were Jack now merits further effectiveness testing.

SUBMITTER: Lohan M

PROVIDER: S-EPMC6208578 | biostudies-literature | 2018 Nov

REPOSITORIES: biostudies-literature

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Can Teenage Men Be Targeted to Prevent Teenage Pregnancy? A Feasibility Cluster Randomised Controlled Intervention Trial in Schools.

Lohan Maria M Aventin Áine Á Clarke Mike M Curran Rhonda M RM McDowell Clíona C Agus Ashley A McDaid Lisa L Bonell Chris C Young Honor H

Prevention science : the official journal of the Society for Prevention Research 20181101 8

The World Health Organisation advocates a direct focus on adolescent men in reducing adolescent pregnancy; however, no trials have been conducted. This trial (ISRCTN11632300; NCT02092480) determines whether a novel Relationship and Sexuality Educational intervention, If I Were Jack, is acceptable and feasible to implement in mixed sex UK classrooms. The intervention is a teacher-delivered intervention that emphasises male alongside female responsibility in preventing unintended pregnancies and ...[more]

PMID: 30022356

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Project description:Since the introduction of the Teenage Pregnancy Strategy (TPS), England's under-18 conception rate has fallen by 55%, but a continued focus on prevention is needed to maintain and accelerate progress. The teenage birth rate remains higher in the UK than comparable Western European countries. Previous trials indicate that school-based social marketing interventions are a promising approach to addressing teenage pregnancy and improving sexual health. Such interventions are yet to be trialled in the UK. This study aims to optimise and establish the feasibility and acceptability of one such intervention: Positive Choices.Design: Optimisation, feasibility testing and pilot cluster randomised trial.Interventions: The Positive Choices intervention comprises a student needs survey, a student/staff led School Health Promotion Council (SHPC), a classroom curriculum for year nine students covering social and emotional skills and sex education, student-led social marketing activities, parent information and a review of school sexual health services.Systematic optimisation of Positive Choices will be carried out with the National Children's Bureau Sex Education Forum (NCB SEF), one state secondary school in England and other youth and policy stakeholders.Feasibility testing will involve the same state secondary school and will assess progression criteria to advance to the pilot cluster RCT.Pilot cluster RCT with integral process evaluation will involve six different state secondary schools (four interventions and two controls) and will assess the feasibility and utility of progressing to a full effectiveness trial.The following outcome measures will be trialled as part of the pilot:Self-reported pregnancy and unintended pregnancy (initiation of pregnancy for boys) and sexually transmitted infections,Age of sexual debut, number of sexual partners, use of contraception at first and last sex and non-volitional sexEducational attainmentThe feasibility of linking administrative data on births and termination to self-report survey data to measure our primary outcome (unintended teenage pregnancy) will also be tested.This will be the first UK-based pilot trial of a school-wide social marketing intervention to reduce unintended teenage pregnancy and improve sexual health. If this study indicates feasibility and acceptability of the optimised Positive Choices intervention in English secondary schools, plans will be initiated for a phase III trial and economic evaluation of the intervention.ISRCTN registry (ISCTN12524938. Registered 03/07/2017).

Project description:BACKGROUND:Excessive gestational weight gain (GWG) leads to obstetric complications, maternal postpartum weight retention and an increased risk of offspring obesity. The GeliS study examines the effect of a lifestyle intervention during pregnancy on the proportion of women with excessive GWG and pregnancy and obstetric complications, as well as the long-term risk of maternal and infant obesity. METHODS:The GeliS study is a cluster-randomised multicentre controlled trial including 2286 women with a pre-pregnancy BMI between 18.5 and 40.0 kg/m2 recruited from gynaecological and midwifery practices prior to the end of the 12th week of gestation in five Bavarian regions. In the intervention regions, four lifestyle counselling sessions covering a balanced healthy diet, regular physical activity and self-monitoring of weight gain were performed by trained healthcare providers alongside routine pre- and postnatal practice visits. In the control regions, leaflets with general recommendations for a healthy lifestyle during pregnancy were provided. RESULTS:The intervention did not result in a significant reduction of women showing excessive GWG (adjusted OR 0.95, 95% CI 0.66-1.38, p = 0.789), with 45.1% and 45.7% of women in the intervention and control groups, respectively, gaining weight above the Institute of Medicine recommendations. Gestational diabetes mellitus was diagnosed in 10.8% and 11.1% of women in the intervention and control groups, respectively (p = 0.622). Mean birth weight and length were slightly lower in the intervention group (3313 ± 536 g vs. 3363 ± 498 g, p = 0.020; 51.1 ± 2.7 cm vs. 51.6 ± 2.5 cm, p = 0.001). CONCLUSION:In the setting of routine prenatal care, lifestyle advice given by trained healthcare providers was not successful in limiting GWG and pregnancy complications. Nevertheless, the potential long-term effects of the intervention remain to be assessed. TRIAL REGISTRATION:NCT01958307 , ClinicalTrials.gov, retrospectively registered October 9, 2013.

Project description:ObjectivesAssess feasibility, acceptability and costs of delivering a physically active lessons (PAL) training programme to secondary school teachers and explore preliminary effectiveness for reducing pupils' sedentary time.Design and settingSecondary schools in East England; one school participated in a pre-post feasibility study, two in a pilot cluster-randomised controlled trial. In the pilot trial, blinding to group assignment was not possible.ParticipantsAcross studies, 321 randomly selected students (51% male; mean age: 12.9 years), 78 teachers (35% male) and 2 assistant head teachers enrolled; 296 (92%) students, 69 (88%) teachers and 2 assistant head teachers completed the studies.InterventionPAL training was delivered to teachers over two after-school sessions. Teachers were made aware of how to integrate movement into lessons; strategies included students collecting data from the environment for class activities and completing activities posted on classroom walls, instead of sitting at desks.Primary and secondary outcomesQuantitative and qualitative data were collected to assess feasibility and acceptability of PAL training and delivery. Outcomes were assessed at baseline and ~8 weeks post-training; measures included accelerometer-assessed activity, self-reported well-being and observations of time-on-task. Process evaluation was conducted at follow-up.ResultsIn the feasibility study, teachers reported good acceptability of PAL training and mixed experiences of delivering PAL. In the pilot study, teachers' acceptability of training was lower and teachers identified aspects of the training in need of review, including the outdoor PAL training and learning challenge of PAL strategies. In both studies, students and assistant head teachers reported good acceptability of the intervention. Preliminary effectiveness for reducing students' sedentary time was not demonstrated in either study.ConclusionsNo evidence of preliminary effectiveness on the primary outcome and mixed reports of teachers' acceptability of PAL training suggest the need to review the training. The results do not support continuation of research with the current intervention.Trial registration numberISRCTN38409550.

Project description:BackgroundHigh 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.MethodsSix 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.ResultsThe 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.ConclusionsBefore 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 registrationISRCTN12831555.

Project description:BackgroundBangladesh is one of the most vulnerable countries to climate change. People are getting educated at different levels on how to deal with potential impacts. One such educational mode was the preparation of a school manual, for high school students on climate change and health protection endorsed by the National Curriculum and Textbook Board, which is based on a 2008 World Health Organization manual. The objective of this study was to test the effectiveness of the manual in increasing the knowledge level of the school children about climate change and health adaptation.MethodsThis cluster randomized intervention trial involved 60 schools throughout Bangladesh, with 3293 secondary school students participating. School upazilas (sub-districts) were randomised into intervention and control groups, and two schools from each upazila were randomly selected. All year seven students from both groups of schools sat for a pre-test of 30 short questions of binary response. A total of 1515 students from 30 intervention schools received the intervention through classroom training based on the school manual and 1778 students of the 30 control schools did not get the manual but a leaflet on climate change and health issues. Six months later, a post-intervention test of the same questionnaire used in the pre-test was performed at both intervention and control schools. The pre and post test scores were analysed along with the demographic data by using random effects model.ResultsNone of the various school level and student level variables were significantly different between the control and intervention group. However, the intervention group had a 17.42% (95% CI: 14.45 to 20.38, P = <0.001) higher score in the post-test after adjusting for pre-test score and other covariates in a multi-level linear regression model.ConclusionsThese results suggest that school-based intervention for climate change and health adaptation is effective for increasing the knowledge level of school children on this topic.

Project description:BackgroundInternational debate around the best models of speech and language therapy provision for children with language disorders has highlighted the need for research into classroom-based approaches and intervention dosage. Working memory (WM) is a cognitive skill linked to attention and language. 'Recall to Enhance Children's Attention, Language and Learning' (RECALL) is a novel, 6-week, classroom-based intervention delivered by health professionals (HPs) and teachers. It is designed to target WM and enhance attention and language skills in 4-5 year olds.MethodsA cluster randomised feasibility trial was conducted to investigate aspects of the feasibility of a definitive trial to evaluate RECALL: (i) recruitment and sampling procedures; (ii) compliance and fidelity; (iii) the acceptability of RECALL to HPs and teachers; (iv) the appropriateness of the outcome measures. Six classes of 4-5 year olds participated: two received RECALL, two received an existing intervention targeting attention skills (not underpinned by WM theory), and two received education as usual (no intervention). Ten children in each class (n = 60) were sampled to assess the appropriateness of the outcome measures. Classroom observations were conducted to measure fidelity and semi-structured interviews with HPs, and teachers explored the acceptability of RECALL.ResultsThe recruitment targets were met, and all six schools completed the trial, but the sampling procedures require modification. Compliance was good (95% of RECALL sessions were delivered), but fidelity to the intervention protocol varied between 76% and 45% across the two schools. This was influenced by large class sizes, child factors, and facilitator factors, e.g., their understanding of the theory underpinning the intervention. The lack of fidelity reduced the dose (number of practice items) accessed by individual children, particularly those most at risk. There were mixed findings regarding the acceptability of RECALL and the appropriateness of the outcome measures.ConclusionsThe trial protocol could be easily scaled-up in a future definitive trial, with an amended sampling procedure. RECALL should be repackaged as a small group intervention to enhance the fidelity of its delivery and its acceptability to HPs and teachers. This study highlights the need for thorough training for professionals who deliver classroom-based interventions for children with language disorders.Trial registrationISRCTN13633886 . Registered on 7 September 2018.

Project description:Introduction: India is in the process of a major epidemiological transition towards non-communicable diseases. Cardiovascular disease (CVD) is the leading cause of death in women in India. Predisposing independent risk factors include pregnancy-related conditions, e.g., hypertensive disorders of pregnancy (HDP) and gestational diabetes (GDM) - also associated with significant perinatal mortality and morbidity. Early identification, referral and management of pregnant women at increased risk of future CVD may offer opportunities for prevention. In rural India, Community Health Workers (CHWs) provide most antenatal and postnatal care. Innovative solutions are required to address integrated care for rural women during transitions between antenatal, postnatal and general health services. The George Institute's SMARThealth Programme has shown that CHWs in rural India screening non-pregnant adults for cardiovascular risk, using a decision support system, is feasible. Building on this, we developed a targeted training programme for CHWs and a complex system-level intervention that uses mobile clinical decision support for CHWs and primary care doctors to screen high-risk pregnant women. In addition to addressing HDP and GDM, the intervention also screens for anaemia in pregnancy. Methods/Design: A pilot study will be undertaken in two diverse rural districts of India: Jhajjar (Haryana) and Guntur (Andhra Pradesh). Two Primary Health Centre clusters will be randomised to intervention or control groups at each study site. The primary objective of this pilot study is to explore the feasibility and acceptability of the SMARThealth Pregnancy intervention. Secondary objectives are to estimate: (a) prevalence rates of moderate to severe anaemia, HDPs and GDM at the study sites; (b) referral and follow-up rates, and (c) mean haemoglobin and blood pressure values at the routine 6 week postnatal visit. A process evaluation will be conducted to explore the acceptability of the SMARThealth Pregnancy intervention for pregnant women and healthcare workers using qualitative methods. Discussion: It is anticipated that the findings of this pilot study will help determine the feasibility and acceptability of the SMARThealth Pregnancy intervention, and highlight how the intervention might be further developed for evaluation in a larger, cluster randomised controlled trial. Clinical Trial Registration:www.ClinicalTrials.gov, identifier: NCT03968952.

Dataset Information

Can Teenage Men Be Targeted to Prevent Teenage Pregnancy? A Feasibility Cluster Randomised Controlled Intervention Trial in Schools.

Publications

Can Teenage Men Be Targeted to Prevent Teenage Pregnancy? A Feasibility Cluster Randomised Controlled Intervention Trial in Schools.

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