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Promoting sport participation during early parenthood: a randomized controlled trial protocol.

ABSTRACT: BACKGROUND:Adult participation in sport is associated with important positive psychosocial outcomes. Despite the multitude of benefits that have been linked to sport participation, adult participation rates in Canada remain low. Parents with young children represent a demographic that may benefit considerably from sport participation, given the prevalence of inactivity coupled with increased levels of psychosocial distress among this group. This study aims to evaluate the efficacy of two types of sport participation (individual sport and team sport) on key psychosocial outcomes compared with a "personal time" control condition among parents with young children. METHODS/DESIGN:The three-arm, parallel design, single-blind, randomized controlled trial will compare a team sport condition, an individual sport condition, and a "personal time" control condition over 3 months. Parents are eligible if they have a child under 13 years of age, are not participating in a sport at baseline, and are not meeting Canadian Physical Activity Guidelines. Psychosocial variables (quality of life, relationship satisfaction, social functioning, parental stress, and enjoyment) will be assessed at baseline, 6 weeks, and 3 months. A total of 161 parents have been recruited thus far from the Greater Victoria region in British Columbia, Canada. The study is ongoing with a target goal of 240 participants and an anticipated completion date of December 2021. DISCUSSION:This protocol describes the implementation of a randomized controlled trial that evaluates the effectiveness of sport participation for increasing positive psychosocial outcomes. This information could prove useful for future adult sport participation and potentially inform public health initiatives involving parents and families. TRIAL REGISTRATION:ClinicalTrials.gov, NCT02898285. Registered 13 September 2016.

SUBMITTER: Grant SJ

PROVIDER: S-EPMC7045446 | biostudies-literature | 2020 Feb

REPOSITORIES: biostudies-literature

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Promoting sport participation during early parenthood: a randomized controlled trial protocol.

Grant Stina J SJ Beauchamp Mark R MR Blanchard Chris M CM Carson Valerie V Rhodes Ryan E RE

Trials 20200227 1

<h4>Background</h4>Adult participation in sport is associated with important positive psychosocial outcomes. Despite the multitude of benefits that have been linked to sport participation, adult participation rates in Canada remain low. Parents with young children represent a demographic that may benefit considerably from sport participation, given the prevalence of inactivity coupled with increased levels of psychosocial distress among this group. This study aims to evaluate the efficacy of two ...[more]

PMID: 32103772

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Project description:BackgroundSince the beginning of the COVID-19 pandemic, sanitary context and e-learning have greatly modified student lifestyles and led to deteriorations in their mental health. An increase in anxiety and depressive symptoms and sedentary behaviors, reduction in physical activity, and a stronger tendency to move toward unhealthy diet have been demonstrated. This finding highlights the need for innovative interventions to promote healthy lifestyle among students.ObjectiveThis research protocol aims to evaluate the effects of an intervention program on the lifestyle and psychological state of students.MethodsStudents from University of Nîmes were recruited and randomly assigned to 1 of 2 following conditions: an intervention group and a control group. Participants in the intervention group were engaged in an 8-week physical activity program. Prior to the start of the program, design-based innovative workshops were conducted with participants to ensure that the program was co-constructed by the users and met their specific needs. Students in the control group did not receive any intervention. For each group, measures of physical activity, sedentary time, anthropometric data, sleep, physical condition, and psychological variables (eg, anxiety, depression, motivation, body appreciation, perceived control, well-being) were conducted at baseline and 9 weeks later.ResultsA total of 110 participants were initially included. Reporting of the results is projected for the spring of 2022.ConclusionsIt is anticipated that this innovative intervention co-constructed by pairs will promote a healthier lifestyle and psychological health in students. There is every reason to believe that a mobilized co-construction approach is a promising strategy to limit unhealthy habits and promote physical activity while increasing motivation. The development and evaluation of interventions to address the specific needs of university students is essential and could be transferred to other vulnerable populations such as people with chronic diseases or older people.Trial registrationClinicalTrials.gov NCT05019482; https://clinicaltrials.gov/ct2/show/NCT05019482.International registered report identifier (irrid)DERR1-10.2196/36429.

Project description:Anterior cruciate ligament (ACL) injuries in female athletes lead to a variety of short- and long-term physical, financial, and psychosocial ramifications. While dedicated injury prevention training programs have shown promise, ACL injury rates remain high as implementation has not become widespread. Conventional prevention programs use a combination of resistance, plyometric, balance and agility training to improve high-risk biomechanics and reduce the risk of injury. While many of these programs focus on reducing knee abduction load and posture during dynamic activity, targeting hip extensor strength and utilization may be more efficacious, as it is theorized to be an underlying mechanism of injury in adolescent female athletes. Biofeedback training may complement traditional preventive training, but has not been widely studied in connection with ACL injuries. We hypothesize that biofeedback may be needed to maximize the effectiveness of neuromuscular prophylactic interventions, and that hip-focused biofeedback will improve lower extremity biomechanics to a larger extent than knee-focused biofeedback during dynamic sport-specific tasks and long-term movement strategies.This is an assessor-blind, randomized control trial of 150 adolescent competitive female (9-19 years) soccer players. Each participant receives 3x/week neuromuscular preventive training and 1x/week biofeedback, the mode depending on their randomization to one of 3 biofeedback groups (hip-focused, knee-focused, sham). The primary aim is to assess the impact of biofeedback training on knee abduction moments (the primary biomechanical predictor of future ACL injury) during double-leg landings, single-leg landings, and unplanned cutting. Testing will occur immediately before the training intervention, immediately after the training intervention, and 6 months after the training intervention to assess the long-term retention of modified biomechanics. Secondary aims will assess performance changes, including hip and core strength, power, and agility, and the extent to which maturation effects biofeedback efficacy.The results of the Real-time Optimized Biofeedback Utilizing Sport Techniques (ROBUST) trial will help complement current preventive training and may lead to clinician-friendly methods of biofeedback to incorporate into widespread training practices.Date of publication in ClinicalTrials.gov: 20/04/2016. ClinicalTrials.gov Identifier: NCT02754700 .

Project description:BACKGROUND:Vaccination has a huge public health impact. Maintaining vaccine coverage is key to avoid the devastating consequences of resurgence. In the Province of Québec, vaccine coverage in young children are sub-optimal, mostly due to ambivalence toward vaccine safety and efficacy. We previously conducted a regional study in the Québec's Eastern Townships region, the PromoVac Study, to test a new educational intervention, based on motivational interviewing techniques, aimed at promoting infant vaccination. This first study evidenced that the intervention led to a marked increase in mothers' intention to vaccinate, and vaccine coverage in their infants. The current study protocol aims at scaling up these results at a provincial level using a randomized controlled trial design. METHODS:This pragmatic, randomized, controlled, parallel-group clinical trial will compare the effectiveness of the motivational interviewing to an educational intervention, including the distribution of an information flyer as standard of care on vaccination coverage in four maternity wards across the Province of Québec (PromovaQ). Adult mothers of children born in participating maternity wards were recruited between March 2014 and February 2015. Vaccination coverage will be assessed at 3-years of age, thus the trial is expected to be completed in March 2019. Statistical analyses will be conducted under the intention-to-treat principle. Vaccine coverage will be analyzed using Chi-squared distribution testing and logistic regression to identify determinant factors. Secondary outcomes will include vaccine hesitation and intention scores, mother's knowledge, attitudes and beliefs about immunization, and psychosocial determinants of intention to vaccinate. DISCUSSION:In the case results of this Provincial RCT be confirmed, serious consideration should then be given by Ministry of Health authorities to the possible implementation of MI-based strategies across provincial maternity wards. To ensure adequate input and secure implementation, study design and results will be reviewed with relevant stakeholders, including the children's families, and provincial and regional decision-makers. Results will be adapted and shared with all stakeholders. TRIAL REGISTRATION:ClinicalTrials.gov NCT02666872 (Retrospectively registered as January 28, 2016).

Project description:Stroke is a major public health threat globally. Psychosocial well-being may be affected following stroke. Depressive symptoms, anxiety, general psychological distress and social isolation are prevalent. Approximately one third report depressive symptoms and 20% report anxiety during the first months or years after the stroke. Psychosocial difficulties may impact significantly on long-term functioning and quality of life, reduce the effects of rehabilitation services and lead to higher mortality rates. The aim of the study is to evaluate the effect of a previously developed and feasibility tested dialogue-based psychosocial intervention aimed at promoting psychosocial well-being and coping following stroke among stroke survivors with and without aphasia.The study will be conducted as a multicenter, randomized, single blind controlled trial with one intervention and one control arm. It will include a total of 330 stroke survivors randomly allocated into either an intervention group (dialogue-based intervention to promote psychosocial well-being) or a control group (usual care). Participants in the intervention group will receive eight individual sessions of supported dialogues in their homes during the first six months following an acute stroke. The primary outcome measure will be psychosocial well-being measured by the General Health Questionnaire (GHQ). Secondary outcome measures will be quality of life (SAQoL), sense of coherence (SOC), and depression (Yale). Process evaluation will be conducted in a longitudinal mixed methods study by individual qualitative interviews with 15-20 participants in the intervention and control groups, focus group interviews with the intervention personnel and data collectors, and a comprehensive analysis of implementation fidelity.The intervention described in this study protocol is based on thorough development and feasibility work, guided by the UK medical research council framework for developing and testing complex interventions. It combines classical effectiveness evaluation with a thorough process evaluation. The results from this study may inform the development of further trials aimed at promoting psychosocial well-being following stroke as well as inform the psychosocial follow up of stroke patients living at home.NCT02338869 ; registered 10/04/2014 (On-going trial).

Project description:BackgroundSlowing the decline in participation in physical activity among adolescent girls is a public health priority. This study reports the outcomes from a multi-component school-based intervention (Girls in Sport), focused on promoting physical activity among adolescent girls.MethodsGroup randomized controlled trial in 24 secondary schools (12 intervention and 12 control). Assessments were conducted at baseline (2009) and at 18 months post-baseline (2010). The setting was secondary schools in urban, regional and rural areas of New South Wales, Australia. All girls in Grade 8 in 2009 who attended these schools were invited to participate in the study (N?=?1769). Using a Health Promoting Schools and Action Learning Frameworks, each school formed a committee and developed an action plan for promoting physical activity among Grade 8 girls. The action plan incorporated strategies in three main areas - i) the formal curriculum, ii) school environment, and iii) home/school/community links - based on the results of formative data from target girls and staff and on individual needs of the school. A member of the research team supported each school throughout the intervention. The main outcome measure was accelerometer-derived total physical activity (TPA) spent in physical activity. Data were analyzed from December 2011 to March 2012.Results1518 girls (mean age 13.6y ±0.02) were assessed at baseline. There was a significant decline in TPA from baseline to 18-month follow-up with no differences between girls in the intervention and control schools. Only one-third of schools (4/12) implemented the intervention as per their action plan. Per-protocol analyses on these schools revealed a smaller decline in percentage of time spent in MVPA among girls in the intervention group (adjusted difference 0.5%, 95% CI?=?-0.01, 0.99, P?=?0.05).ConclusionsThe Girls in Sport intervention was not effective in reducing the decline in physical activity among adolescent girls. Lack of implementation by most intervention schools was the main reason for a null effect. Identifying strategies to enhance implementation levels is critical to determining the true potential of this intervention approach.Trial registrationThis study was retrospectively registered with the Australian New Zealand Clinical Trials Registry ACTRN12610001077055 . Date of registration: 7 December 2010.

Project description:BackgroundStroke survivors are more physically inactive than even the most sedentary older adults, and low activity is associated with increased risk of recurrent stroke, medical complications, and mortality. We hypothesize that the combination of a fast walking intervention that improves walking capacity, with a step activity monitoring program that facilitates translation of gains from the clinic to the "real-world", would generate greater improvements in real world walking activity than with either intervention alone.MethodsUsing a single-blind randomized controlled experimental design, 225 chronic (> 6 months) stroke survivors complete 12 weeks of fast walking training, a step activity monitoring program or a fast walking training + step activity monitoring program. Main eligibility criteria include: chronic ischemic or hemorrhagic stroke (> 6 months post), no evidence of cerebellar stroke, baseline walking speed between 0.3 m/s and 1.0 m/s, and baseline average steps / day < 8000. The primary (steps per day), secondary (self-selected and fastest walking speed, walking endurance, oxygen consumption) and exploratory (vascular events, blood lipids, glucose, blood pressure) outcomes are assessed prior to initiating treatment, after the last treatment and at a 6 and 12-month follow-up. Moderation of the changes in outcomes by baseline characteristics are evaluated to determine for whom the interventions are effective.DiscussionFollowing completion of this study, we will not only understand the efficacy of the interventions and the individuals for which they are effective, we will have the necessary information to design a study investigating the secondary prevention benefits of improved physical activity post-stroke. This study is, therefore, an important step in the development of both rehabilitative and secondary prevention guidelines for persons with stroke.Trial registrationClinicalTrials.gov Identifier: NCT02835313 . First Posted: July 18, 2016.

Project description:BACKGROUND: The number of people with diabetes is increasing worldwide, especially in developing South Asian countries. Therefore, preventing diabetes at the early stages has become an important issue. Recent clinical trials, systematic reviews, and meta-analysis have shown that zinc has beneficial effects on glycemic and metabolic control in those with diabetes. The present study is designed to evaluate the effects of zinc supplementation on glycemic control and other metabolic parameters in those with pre-diabetes. METHODS/DESIGN: The study will be conducted as a randomized, double-blind, placebo-controlled clinical trial for a period of 12 months at the Faculty of Medicine, University of Colombo, Sri Lanka. The study has been approved by the Ethics Review Committee of Faculty of Medicine, University of Colombo (EC/11/189). A total of 200 adults (age 18-60 years) with pre-diabetes will be recruited for the study. They will be stratified according to age, gender, and body mass index and randomly assigned into the test and placebo groups on a 1:1 ratio. The zinc capsules, each weighing 456 mg, will contain the following ingredients:zinc sulfate monohydrate 55.096 mg (elemental zinc 20 mg), lactose monohydrate 399.504 mg, and stearic acid 1.400 mg. The placebo capsule with the same weight will be comprised of lactose monohydrate 454.600 mg and stearic acid 1.400 mg. The subjects will receive either zinc 20 mg capsules or placebo daily for a period of 12 months. The study drugs will be double blinded to both investigators and subjects. The visits and the evaluations will be done as follows: screening (visit 0), 1 month (visit 1), 3 month (visit 2), 6 month (visit 3), and 12 month (visit 4). The following primary outcome measures will be evaluated:fasting plasma glucose (FPG), post oral glucose tolerance test (OGTT), serum insulin, HbA1c, total/low-density lipoprotein (LDL)/high-density lipoprotein (HDL) cholesterol, triglycerides, serum zinc, and appetite using a visual analog scale. Secondary outcome measures include: blood pressure, anthropometry, and dietary assessment using a validated food frequency questionnaire. Data will be analyzed using SPSS v16. DISCUSSION: The present protocol will aim to establish the beneficial effects of zinc supplementation on disease progression in those with pre-diabetes and also establish its effectiveness in the prevention of diabetes mellitus. TRIAL REGISTRATION: Sri Lanka Clinical Trial Registry: SLCTR/2012/010.

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Promoting sport participation during early parenthood: a randomized controlled trial protocol.

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Promoting sport participation during early parenthood: a randomized controlled trial protocol.

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