Background: Research suggests dyadic interventions can increase physical activity; such interventions are untested within postpartum parent couples.Methods: A three-armed pilot randomized trial addressed this gap and tested which type of dyadic intervention is most effective. Inactive postpartum mothers and a significant other were recruited in Australia (n = 143 assessed for eligibility) and randomised in a single-blinded fashion (i.e. participants were blinded) to 1 of 3 dyadic conditions involving a single face-to-face session with access to web-based group support: a minimal treatment control (n = 34), collaborative planning group (n = 38), or collaborative planning + need supportive communication group (n = 30). Participants were asked to wear their accelerometers for 8 days and completed self-report measures at baseline, end of intervention (week 4), and follow-up (week 12). We expected dyads in the collaborative planning + need supportive communication group would have the greatest increases in Physical Activity (PA), autonomous motivation, and partners' need supportive behaviours; and decreases in controlled motivation and controlling partner behaviours.Results: Results from 51 dyads using Bayesian actor-partner interdependence models provided some evidence for a small positive effect on total PA at follow-up for postpartum mothers in the collaborative planning group and for partners in the collaborative planning + need supportive communication group. Furthermore, partners in the collaborative planning + need supportive communication group were more likely to engage in some vigorous PA. At follow-up, postpartum mothers in the collaborative planning + need supportive communication group scored lower on personal autonomous reasons.Conclusions: The impact of prior specification mean intervention effects need to be interpreted with caution. Progression to a full trial is warranted.
Dyadic interventions may promote physical activity (PA) amongst postpartum mothers. However, such interventions may not always be effective, and research is needed to explore the factors influencing engagement. Amongst this population, this study explores the perceived benefits, barriers to, and facilitators of a) PA participation, and b) engagement with two dyadic PA interventions. We conducted interviews with 17 postpartum mothers and 10 significant others (aged 26–61 years old). Data were analysed with reflexive thematic analysis. Barriers to PA engagement were that it was easy to set plans, but hard to carry them out due to childcare, work, studying/chores. Setting PA plans and receiving practical support from their partner were important ways to overcome barriers to being active, e.g., some participants looked after the children, so their partner could engage in PA, as a part of their plan. Feeling motivated to exercise as a family was also a facilitator of PA. Barriers to programme participation were a lack of motivation and a preference for exercise prescription. Perceived benefits of programme participation included increased PA commitment and accountability to the plans. Amongst other techniques, participants used prompts (e.g. spouse getting their children breakfast/coming home from work/their partner 'checking in'), as a cue to start their PA plans. Findings show that tailored interventions to address the challenges of being a postpartum mother are needed; "one-size" fits all approach does not work.
Several interventions have targeted dyads to promote physical activity (PA) or reduce sedentary behaviour (SB), but the evidence has not been synthesised. Sixty-nine studies were identified from MEDLINE, PsycINFO, and Web of Science, and 59 were included in the main meta-analyses (providing 72 independent tests). Intervention details, type of dyadic goal, participant characteristics, and methodological quality were extracted and their impact on the overall effect size was examined. Sensitivity analyses tested effect robustness to (a) the effects of other statistically significant moderators; (b) outliers; (c) data included for participants who were not the main target of the intervention. Dyadic interventions had a small positive, highly heterogeneous, effect on PA g = .203, 95% CI [0.123–0.282], compared to comparison conditions including equivalent interventions targeting individuals. Shared target-oriented goals (where both dyad members hold the same PA goal for the main target of the intervention) and peer/friend dyads were associated with larger effect sizes across most analyses. Dyadic interventions produced a small homogeneous reduction in SB. Given dyadic interventions promote PA over-and-above equivalent interventions targeting individuals, these interventions should be more widespread. However, moderating factors such as the types of PA goal and dyad need to be considered to maximise effects.
Background A proportionate universal (PU) approach to early years’ service provision has been advocated to improve children’s health and development and to reduce health inequality, by ensuring that services provide timely and high-quality parenting support commensurate with need. Process-oriented research is critical to examine the factors that contribute to, or hinder, the effective delivery/implementation of such a model in community-based family services. This study aimed to assess the delivery, acceptability and feasibility of a new PU parenting intervention model (called E-SEE Steps), using the Incredible Years® (IY) parent program, when delivered by trained health/family service staff in three “steps”—one universal step (the IY Babies Book), and two targeted steps (group-based IY Infant and Toddler programs). Methods An embedded mixed-methods process evaluation within a pragmatic parallel two-arm, assessor blinded, randomized controlled trial was conducted in community services in four local authorities in England. The process evaluation used qualitative data gathered via interviews and focus groups with intervention arm parents who were offered the targeted steps (n = 29), practitioners (n = 50), service managers (n = 7) and IY program mentors (n = 3). This was supplemented by quantitative data collected using group leader pre-training (n = 50) and post-delivery (n = 39) questionnaires, and research notes of service design decisions. Results The E-SEE Steps model was acceptable to most parents, particularly when it was accompanied by engagement strategies that supported attendance, such as providing childcare. Practitioners also highlighted the positive development opportunities provided by the IY training and supervision. However, participant views did not support the provision of the IY Babies book as a standalone universal component, and there were barriers to eligible parents—particularly those with low mood—taking up the targeted programs. Service providers struggled to align the PU model with their commissioned service contracts and with their staff capacity to engage appropriate parents, including tackling common barriers to attendance. Conclusions Despite general enthusiasm and support for delivering high-quality parenting programs in community services in the England, several barriers exist to successfully delivering IY in a proportionate universal model within current services/systems.
Ideally all participants in a randomised controlled trial (RCT) should fully receive their allocated intervention; however, this rarely occurs in practice. Intervention adherence affects Type II error so influences the interpretation of trial results and subsequent implementation. We aimed to describe current practice in the definition, measurement, and reporting of intervention adherence in non-pharmacological RCTs, and how this data is incorporated into a trial's interpretation and conclusions.We conducted a systematic review of phase III RCTs published between January 2018 and June 2020 in the National Institute for Health Research Journals Library for the Health Technology Assessment, Programme Grants for Applied Research, and Public Health Research funding streams.Of 237 reports published, 76 met the eligibility criteria and were included. Most RCTs (n = 68, 89.5%) reported adherence, though use of terminology varied widely; nearly three quarters of these (n = 49, 72.1%) conducted a sensitivity analysis. Adherence measures varied between intervention types: behavioural change (n = 10, 43.5%), psychological therapy (n = 5, 83.3%) and physiotherapy/rehabilitation (n = 8, 66.7%) interventions predominately measured adherence based on session attendance. Whereas medical device and surgical interventions (n = 17, 73.9%) primarily record the number of participants receiving the allocated intervention, a third (n = 33, 67.3%) of studies reported a difference in findings between primary and sensitivity analyses.Although most trials report elements of adherence, terminology was inconsistent, and there was no systematic approach to its measurement, analyses, interpretation, or reporting. Given the importance of adherence within clinical trials, there is a pressing need for a standardised approach or framework.
Background The Covid-19 pandemic had a profound effect on the delivery of healthcare research. Covid-19 research was prioritised and many non-essential trials were paused. This study explores the engagement experiences of trial participants’, PPIE contributors’ and trial staff during the Covid-19 pandemic and towards recovery and restoring a diverse and balanced UK clinical trials portfolio. Methods Interviews and focus groups were undertaken with PPIE contributors, trial participants and trial staff members from NIHR research trials across the UK (November 2020-June 2021) across portfolio specialities: Cancer, Oral and Dental Health, Musculoskeletal Disorders, Cardiovascular Disease, Neurological Disorders, Primary Care, and Conditions associated with susceptibility to Covid-19 (Diabetes, Stroke, Respiratory Disorders). Topic guides were developed for each participant group and interviews were conducted over Zoom. The transcripts were analysed using codebook thematic analysis in NVivo (V.12). Results 106 participants comprising, 45 PPIE contributors, 27 trial participants and 34 trial staff members were recruited. Three themes to engagement with trials during Covid-19 were developed. 1) Ensuring continued contact . Continued and tailored communication, having a trial point of contact and regular updates all enhanced trial engagement and retention. Patients’ unfamiliarity with materials being sent electronically reduced engagement and trust. 2) A balanced move to remote consultations . Remote follow-up and monitoring were convenient and allowed for wider recruitment across the UK. Participants were more likely to discuss personal subjects in their own homes. Remote visits lacked a personal touch, some concerns over missed diagnoses or being unable to appreciate the situation, technical abilities or equipment failures were seen as barriers, especially for disadvantaged or older people. 3) The importance of feeling fully informed . Factors that supported attendance were knowledge about trial conduct adherence to Covid-19 regulations, social distancing, clear signage at the site and opportunities to ask questions. Barriers included not knowing what to expect and not feeling safe with rules and regulations. Conclusions Our findings highlight a number of ways to future proof trial delivery against future pandemics or disruptions such as offering online options to participate in research, ensuring consistent communication between participants and the research team, making sure participants feel fully informed and the continued reassurance of safety in the clinical setting.
The purpose of this study was to determine the nature and incidence of injury in a group of young competitive female gymnasts (n=47) and to determine if injured and noninjured gymnasts could be distinguished on the basis of their anthropometric characteristics. The gymnasts ranged in age from 6 to 18(mean age=10.29) years and represented USGF Levels 4 through 10. The study followed a prospective epidemiologic design. Baseline information was collected prior to injury surveillance and included musculoskeletal screening and a battery of anthropometric measures (basic four, breadths, girths, segment lengths, and skinfolds) administered according to the protocol of Ross and Marfell-Jones (1990). On-site injury surveillance followed for one year. Injuries were determined using the direct interview technique. Injury was defined as any gymnastics-related incident which resulted in the gymnast missing all or part of a workout or competitive event. During the injury surveillance period 18 of the gymnasts incurred 47 injuries. Overall injury rates were 1.45 injuries per 1000 hours (training) and 5.31 injuries per 1000 athletic exposures (an athletic exposure is one gymnast participating in one practice or competition). The most often injured body parts were the wrist(14.9%) and lower back (14.9%). Overuse injuries accounted for 55.3% of injuries and 44.7% were acute. Most injuries (93.6%) occurred during practice with 6.4% occurring in competition. The most common injury types were strains(42.6%) and sprains (19.1%). Reinjuries accounted for 19.1% of all injuries. There was one case of spondylolysis and 1 case of premature closure involving the distal radial physis. There were no catastrophic injuries; however, 3 injuries required surgery. Discriminant analyses run on the anthropometric variables successfully classified injured and non-injured groups with 100% accuracy (p=.05) suggesting that these variables, likely reflecting a body size factor, appear to be an important factor in injury prediction. These findings may assist in the eventual identification of risk factors and thus in the prevention of injuries among female gymnasts.