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1.
Peter A. Coventry Peter Bower Amy Blakemore Liz Baker Mark Hann Angela Paisley Charlotte Renwick Jinshuo Li Atushi Ugajin Martin Gibson 《Trials》2016,17(1)
BackgroundDiabetes is highly prevalent and contributes to significant morbidity and mortality worldwide. Behaviour change interventions that target health and lifestyle factors associated with the onset of diabetes can delay progression to diabetes, but many approaches rely on intensive one-to-one contact by specialists. Health coaching is an approach based on motivational interviewing that can potentially deliver behaviour change interventions by non-specialists at a larger scale. This trial protocol describes a randomized controlled trial (CATFISH) that tests whether a web-enhanced telephone health coaching intervention (IGR3) is more acceptable and efficient than a telephone-only health coaching intervention (IGR2) for people with prediabetes (impaired glucose regulation).MethodsCATFISH is a two-parallel group, single-centre individually randomized controlled trial. Eligible participants are patients aged ≥18 years with impaired glucose regulation (HbA1c concentration between 42 and 47 mmol/mol), have access to a telephone and home internet and have been referred to an existing telephone health coaching service at Salford Royal NHS Foundation Trust, Salford, UK. Participants who give written informed consent will be randomized remotely (via a clinical trials unit) to either the existing pathway (IGR2) or the new web-enhanced pathway (IGR3) for 9 months. The primary outcome measure is patient acceptability at 9 months, determined using the Client Satisfaction Questionnaire. Secondary outcome measures at 9 months are: cost of delivery of IGR2 and IGR3, mental health, quality of life, patient activation, self-management, weight (kg), HbA1c concentration, and body mass index. All outcome measures will be analyzed on an intention-to-treat basis. A qualitative process evaluation will explore the experiences of participants and providers with a focus on understanding usability of interventions, mechanisms of behaviour change, and impact of context on delivery and user acceptability. Qualitative data will be analyzed using Framework.DiscussionThe CATFISH trial will provide a pragmatic assessment of whether a web-based information technology platform can enhance acceptability of a telephone health coaching intervention for people with prediabetes. The data will prove critical in understanding the role of web applications to improve engagement with evidence-based approaches to preventing diabetes.
Trial registration
ISRCTN16534814. Registered on 7 February 2016.Electronic supplementary material
The online version of this article (doi:10.1186/s13063-016-1519-6) contains supplementary material, which is available to authorized users. 相似文献2.
Background
Excess gestational weight gain (GWG) is an important risk factor for long term obesity in women. However, current interventions aimed at preventing excess GWG appear to have a limited effect. Several studies have highlighted the importance of linking theory with empirical evidence for producing effective interventions for behaviour change. Theorists have demonstrated that goals can be an important source of human motivation and goal setting has shown promise in promoting diet and physical activity behaviour change within non-pregnant individuals. The use of goal setting as a behaviour change strategy has been systematically evaluated within overweight and obese individuals, yet its use within pregnancy has not yet been systematically explored.Aim of review
To explore the use of goal setting within healthy lifestyle interventions for the prevention of excess GWG.Data collection and analysis
Searches were conducted in seven databases alongside hand searching of relevant journals and citation tracking. Studies were included if interventions used goal setting alongside modification of diet and/or physical activity with an aim to prevent excess GWG. The PRISMA guidelines were followed and a two-stage methodological approach was used. Stage one focused on systematically evaluating the methodological quality of included interventions. The second stage assessed intervention integrity and the implementation of key goal setting components.Findings
From a total of 839 citations, 54 full-text articles were assessed for eligibility and 5 studies met the inclusion criteria. Among interventions reporting positive results a combination of individualised diet and physical activity goals, self-monitoring and performance feedback indicators were described as active components.Conclusion
Interventions based on goal setting appear to be useful for helping women achieve optimal weight gain during pregnancy. However, overweight and obese women may require more theoretically-designed interventions. Further high quality, theoretically-designed interventions are required to determine the most effective and replicable components for optimal GWG. 相似文献3.
Gray LJ Khunti K Williams S Goldby S Troughton J Yates T Gray A Davies MJ;for the Let’s Prevent Collaborators 《Cardiovascular diabetology》2012,11(1):56
ABSTRACT: BACKGROUND: The prevention of type 2 diabetes is a globally recognised health care priority, but there is a lack of rigorous research investigating optimal methods of translating diabetes prevention programmes, based on the promotion of a healthy lifestyle, into routine primary care. The aim of the study is to establish whether a pragmatic structured education programme targeting lifestyle and behaviour change in conjunction with motivational maintenance via the telephone can reduce the incidence of type 2 diabetes in people with impaired glucose regulation (a composite of impaired glucose tolerance and/or impaired fasting glucose) identified through a validated risk score screening programme in primary care. DESIGN: Cluster randomised controlled trial undertaken at the level of primary care practices. Follow-up will be conducted at 12, 24 and 36 months. The primary outcome is the incidence of type 2 diabetes. Secondary outcomes include changes in HbA1c, blood glucose levels, cardiovascular risk, the presence of the Metabolic Syndrome and the cost-effectiveness of the intervention. METHODS: The study consists of screening and intervention phases within 44 general practices coordinated from a single academic research centre. Those at high risk of impaired glucose regulation or type 2 diabetes are identified using a risk score and invited for screening using a 75 g-oral glucose tolerance test. Those with screen detected impaired glucose regulation will be invited to take part in the trial. Practices will be randomised to standard care or the intensive arm. Participants from intensive arm practices will receive a structured education programme with motivational maintenance via the telephone and annual refresher sessions. The study will run from 2009-2014. DISCUSSION: This study will provide new evidence surrounding the long-term effectiveness of a diabetes prevention programme conducted within routine primary care in the United Kingdom. TRIAL REGISTRATION: Clinicaltrials.gov NCT00677937. 相似文献
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ABSTRACT: BACKGROUND: Cardiac rehabilitation is very important for the recovery and the secondary prevention of cardiovascular disease, and one of its main strategies is to increase the level of physical activity. Internet and mobile phone based interventions have been successfully used to help people to achieve this. One of the components that are related to the efficacy of these interventions is tailoring of content to the individual. This trial is studying the effect of a longitudinally tailored Internet- and mobile phone based intervention that is based on models of health behaviour, on the level of physical activity and the adherence to the intervention, as an extension of a face-to-face cardiac rehabilitation stay. METHODS: A parallel group, cluster randomized controlled trial. The study population is adult participants of a cardiac rehabilitation programme in Norway with home Internet access and mobile phone, who in monthly clusters are randomized to the control or the intervention condition. Participants have access to a website with information regarding cardiac rehabilitation, an online discussion forum and an online activity calendar. Those randomized to the intervention condition, receive in addition tailored content based on models of health behaviour, through the website and mobile text messages. The objective is to assess the effect of the intervention on maintenance of self-management behaviours after the rehabilitation stay. Main outcome is the level of physical activity one month, three months and one year after the end of the cardiac rehabilitation programme. The randomization of clusters is based on a true random number online service, and participants, investigators and outcome assessor are blinded to the condition of the clusters. DISCUSSION: The study suggests a theory-based intervention that combines models of health behaviour in an innovative way, in order to tailor the delivered content. The users have been actively involved in its design, and because of the use of Open-Source software, the intervention can easily and at low-cost be reproduced and expanded by others. Challenges are the recruitment in the elderly population and the possible underrepresentation of women in the study sample. Funding by Northern Norway Regional Health Authority. Trial registration Trial registry www.clinicaltrials.gov: NCT01223170. 相似文献
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Since women living in socioeconomically disadvantaged neighborhoods are more likely to be physically inactive and engage in higher levels of sedentary behavior than women living in more advantaged neighborhoods, it is important to develop and test the feasibility of strategies aimed to promote physical activity and reduce sedentary behavior amongst this high-risk target group. Thirty-seven women (aged 19–85) living in a disadvantaged neighborhood, and five key stakeholders, received a suite of potential intervention materials and completed a qualitative questionnaire assessing the perceived feasibility of strategies aimed to increase physical activity and reduce sedentary behavior. Thematic analyses were performed. Women perceived the use of a locally-relevant information booklet as a feasible strategy to increase physical activity and reduce sedentary behavior. Including weight-loss information was suggested to motivate women to be active. Half the women felt the best delivery method was mailed leaflets. Other suggestions included reference books and websites. Many women mentioned that an online activity calendar was motivational but too time-consuming to commit to. Most women preferred the information booklet as a strategy to increase physical activity/reduce sedentary behavior, yet several suggested that using the booklet together with the online calendar may be more effective. These findings make an important contribution to research informing the development of intervention strategies to increase physical activity and reduce sedentary behavior amongst women living in disadvantaged neighborhoods. 相似文献
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BackgroundThe main behaviour change intervention available for coronary heart disease (CHD) patients is cardiac rehabilitation. There is little recognition of what the active ingredients of behavioural interventions for CHD might be. Using a behaviour change technique (BCT) framework to code existing interventions may help to identify this. The objectives of this systematic review are to determine the effectiveness of CHD behaviour change interventions and how this may be explained by BCT content and structure.ConclusionsBehaviour change interventions for CHD patients appear to have a positive impact on a number of outcomes. Using an existing BCT taxonomy to code the interventions helped us to understand which were the most commonly used techniques, providing information and goal setting, but not the active components of these complex interventions. 相似文献
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Christian Puta Birgit Schulz Saskia Schoeler Walter Magerl Brunhild Gabriel Holger H W Gabriel Wolfgang H R Miltner Thomas Weiss 《BMC neurology》2012,12(1):1-8
Background
Chronic fatigue and inactivity are prevalent problems among individuals with multiple sclerosis (MS) and may independently or interactively have detrimental effects on quality of life and ability to participate in life roles. However, no studies to date have systematically evaluated the benefits of an intervention for both managing fatigue and promoting physical activity in individuals with MS. This study involves a randomized controlled trial to examine the effectiveness of a telehealth intervention that supports individuals with MS in managing fatigue and increasing physical activity levels.Methods/Design
A randomly-allocated, three-parallel group, time-series design with a social support program serving as the control group will be used to accomplish the purpose of the study. Our goal is to recruit 189 ambulatory individuals with MS who will be randomized into one of three telehealth interventions: (1) a contact-control social support intervention, (2) a physical activity-only intervention, and (3) a physical activity plus fatigue management intervention. All interventions will last 12?weeks and will be delivered entirely over the phone. Our hypothesis is that, in comparison to the contact-control condition, both the physical activity-only intervention and the physical activity plus fatigue management intervention will yield significant increases in physical activity levels as well as improve fatigue and health and function, with the physical activity plus fatigue management intervention yielding significantly larger improvements. To test this hypothesis, outcome measures will be administered at Weeks 1, 12, and 24. Primary outcomes will be the Fatigue Impact Scale, the Godin Leisure-Time Exercise Questionnaire (GLTEQ), and Actigraph accelerometers. Secondary outcomes will include the SF-12 Survey, Mental Health Inventory, Multiple Sclerosis Impact Scale, the Community Participation Indicator, and psychosocial constructs (e.g., self-efficacy).Discussion
The proposed study is novel, in that it represents a multi-disciplinary effort to merge two promising lines of research on MS: fatigue management and physical activity promotion. Collectively, the proposed study will be the largest randomized controlled trial to examine the effects of a lifestyle physical activity intervention in people with MS.Trial registration
NCT01572714 相似文献10.
Background
The possible effects of research assessments on participant behaviour have attracted research interest, especially in studies with behavioural interventions and/or outcomes. Assessments may introduce bias in randomised controlled trials by altering receptivity to intervention in experimental groups and differentially impacting on the behaviour of control groups. In a Solomon 4-group design, participants are randomly allocated to one of four arms: (1) assessed experimental group; (2) unassessed experimental group (3) assessed control group; or (4) unassessed control group. This design provides a test of the internal validity of effect sizes obtained in conventional two-group trials by controlling for the effects of baseline assessment, and assessing interactions between the intervention and baseline assessment. The aim of this systematic review is to evaluate evidence from Solomon 4-group studies with behavioural outcomes that baseline research assessments themselves can introduce bias into trials.Methodology/Principal Findings
Electronic databases were searched, supplemented by citation searching. Studies were eligible if they reported appropriately analysed results in peer-reviewed journals and used Solomon 4-group designs in non-laboratory settings with behavioural outcome measures and sample sizes of 20 per group or greater. Ten studies from a range of applied areas were included. There was inconsistent evidence of main effects of assessment, sparse evidence of interactions with behavioural interventions, and a lack of convincing data in relation to the research question for this review.Conclusions/Significance
There were too few high quality completed studies to infer conclusively that biases stemming from baseline research assessments do or do not exist. There is, therefore a need for new rigorous Solomon 4-group studies that are purposively designed to evaluate the potential for research assessments to cause bias in behaviour change trials. 相似文献11.
Stuart J. H. Biddle Charlotte L. Edwardson Emma G. Wilmot Thomas Yates Trish Gorely Danielle H. Bodicoat Nuzhat Ashra Kamlesh Khunti Myra A. Nimmo Melanie J. Davies 《PloS one》2015,10(12)
Aims
Type 2 diabetes mellitus (T2DM), a serious and prevalent chronic disease, is traditionally associated with older age. However, due to the rising rates of obesity and sedentary lifestyles, it is increasingly being diagnosed in the younger population. Sedentary (sitting) behaviour has been shown to be associated with greater risk of cardio-metabolic health outcomes, including T2DM. Little is known about effective interventions to reduce sedentary behaviour in younger adults at risk of T2DM. We aimed to investigate, through a randomised controlled trial (RCT) design, whether a group-based structured education workshop focused on sitting reduction, with self-monitoring, reduced sitting time.Methods
Adults aged 18–40 years who were either overweight (with an additional risk factor for T2DM) or obese were recruited for the Sedentary Time ANd Diabetes (STAND) RCT. The intervention programme comprised of a 3-hour group-based structured education workshop, use of a self-monitoring tool, and follow-up motivational phone call. Data were collected at three time points: baseline, 3 and 12 months after baseline. The primary outcome measure was accelerometer-assessed sedentary behaviour after 12 months. Secondary outcomes included other objective (activPAL) and self-reported measures of sedentary behaviour and physical activity, and biochemical, anthropometric, and psycho-social variables.Results
187 individuals (69% female; mean age 33 years; mean BMI 35 kg/m2) were randomised to intervention and control groups. 12 month data, when analysed using intention-to-treat analysis (ITT) and per-protocol analyses, showed no significant difference in the primary outcome variable, nor in the majority of the secondary outcome measures.Conclusions
A structured education intervention designed to reduce sitting in young adults at risk of T2DM was not successful in changing behaviour at 12 months. Lack of change may be due to the brief nature of such an intervention and lack of focus on environmental change. Moreover, some participants reported a focus on physical activity rather than reductions in sitting per se. The habitual nature of sedentary behaviour means that behaviour change is challenging.Trial Registration
Controlled-Trials.com ISRCTN08434554 相似文献12.
Chandrashekhar D Kamat Jessica E Thorpe Satyendra S Shenoy Antonio Ceriello Dixy E Green Linda A Warnke Michael A Ihnat 《BMC cardiovascular disorders》2007,7(1):1-13
Background
Cardiovascular diseases (CVD) are the leading cause of death and the third cause of disability in Europe. Prevention programmes should include interventions aimed at a reduction of medical risk factors (hypertension, hypercholesterol, hyperglycemia, overweight and obesity) as well as behavioural risk factors (sedentary lifestyle, high fat intake and low fruit and vegetable intake, smoking). The aim of this study is to investigate the effects of a multifaceted, multidisciplinary electronic prevention programme on cardiovascular risk factors.Methods/Design
In a randomized controlled trial, one group will receive a maximal intervention (= intervention group). The intervention group will be compared to the control group receiving a minimal intervention. An inclusion of 350 patients in total, with a follow-up of 3 years is foreseen. The inclusion criteria are age between 25–65 and insured by the Onderlinge Ziekenkas, insuring for guaranteed income in case of illness for self-employed. The maximal intervention group receives several prevention consultations by their general practitioner (GP) using a new type of cardiovascular risk calculator with personalised feedback on behavioural risk factors. These patients receive a follow-up with intensive support of health behaviour change via different methods, i.e. a tailored website and personal advice of a multidisciplinary team (psychologist, physiotherapist and dietician). The aim of this strategy is to reduce cardiovascular risk factors according to the guidelines. The primary outcome measures will be cardiovascular risk factors. The secondary outcome measures are cardiovascular events, quality of life, costs and incremental cost effectiveness ratios. The control group receives prevention consultations using a new type of cardiovascular risk calculator and general feedback.Discussion
This trial incorporates interventions by GPs and other health professionals aiming at a reduction of medical and behavioural cardiovascular risk factors. An assessment of clinical, psychological and economical outcome measures will be performed.Trial registration
ISRCTN23940498 相似文献13.
Displacement activities are behavioural patterns defined by their apparent irrelevance to an animal's ongoing actions. Despite being identified in diverse taxa, their function remains poorly understood. One hypothesis posits that displacement activities facilitate transitions between different behaviours by mediating changes in animals' motivational state. Under this hypothesis, it is predicted that displacement activities will occur more frequently around changes in behaviour than at other times, and also that rates of displacement activities will be higher before than after such behavioural transitions. We tested these two predictions in wild ring-tailed lemurs (Lemur catta). During focal observations, animals' behavioural state was continuously recorded, as were all occurrences of self-scratching, a common displacement activity in this species. Self-scratching rates were found to be significantly elevated both before and after behavioural transitions. Furthermore, self-scratching rates were significantly higher before behavioural transitions occurred than after. These results, therefore, provide support for the hypothesis that displacement activities facilitate behavioural transitions in L. catta. 相似文献
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Beverly A. Garcia Larry F. Johnston Ziya Gizlice Andy Ni Jianwen Cai Jennifer L. Kraschnewski Alison A. Gustafson Arnita F. Norwood Russell E. Glasgow Alison D. Gold John W. Graham Kelly R. Evenson Stewart Trost Thomas C. Keyserling 《Obesity (Silver Spring, Md.)》2013,21(9):1764-1773
Objective: To translate a behavioral weight loss intervention for mid‐life, low‐income women in real world settings. Design and Methods: In this pragmatic clinical trial, we randomly selected six North Carolina county health departments and trained their current staff to deliver a 16‐session evidence‐based behavioral weight loss intervention (special intervention, SI). SI weight loss outcomes were compared to a delayed intervention (DI) control group. Results: Of 432 women expressing interest, 189 completed baseline measures and were randomized within health departments to SI (N = 126) or DI (N = 63). At baseline, average age was 51 years, 53% were African American, mean weight was 100 kg, and BMI averaged 37 kg/m2. A total of 96 (76%) SI and 55 (87%) DI participants returned for 5‐month follow‐up measures. The crude weight change was ?3.1 kg in the SI and ?0.4 kg in the DI group, for a difference of 2.8 kg (95% CI 1.4 to 4.1, p = 0.0001). Diet quality and physical activity improved significantly more in the SI group, and estimated intervention costs were $327 per participant. Conclusion: This pragmatic short‐term weight loss intervention targeted to low‐income mid‐life women yielded meaningful weight loss when translated to the county health department setting. 相似文献
16.
Stolley MR Fitzgibbon ML Schiffer L Sharp LK Singh V Van Horn L Dyer A 《Obesity (Silver Spring, Md.)》2009,17(1):100-106
The Obesity Reduction Black Intervention Trial (ORBIT) is a randomized controlled trial designed to assess the efficacy of a culturally proficient 6-month weight loss intervention followed by a 1-year maintenance intervention. This article describes the results of the 6-month weight loss intervention. Two hundred thirteen obese black women aged 30-65 years were randomized to the intervention group or a general health control group. The intervention consisted of a 6-month culturally adapted weight loss program that targeted changes in diet and physical activity patterns. Weight, dietary intake, and physical activity were measured at baseline and 6 months. A total of 198 women (93%) completed both the baseline and postintervention assessments. Women in the intervention group lost significantly more weight than women in the control group (P < 0.001). However, weight change was variable within the intervention group, with a maximum weight loss of 19.4% of initial body weight and a maximum weight gain of 6.4% of initial body weight. Women in the intervention group also showed significant improvements in fruit intake (P < 0.01), Healthy Eating Index score (P < 0.001), and moderate (P = 0.05), and vigorous (P < 0.001) physical activity compared to women in the control group. This study demonstrates that a culturally adapted program can successfully promote weight loss in obese black women. However, average weight loss was relatively modest, and weight change varied widely within the intervention group. Further research is needed in order to develop programs that will allow more black women to achieve their weight loss goals.. 相似文献
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Bianca L. Share Geraldine A. Naughton Philippe Obert Jennifer K. Peat Elizabeth A. Aumand Justin G. Kemp 《PloS one》2015,10(6)
Background
Young women are under-represented in cardiovascular disease research, with obesity and cardiometabolic risk factor interventions generally targeting older adults. Furthermore, appropriate study designs for young women remain uncertain. This study aimed to assess the impact of a 12 week multi-disciplinary lifestyle intervention on cardiometabolic risk factors in premenopausal women with abdominal obesity.Methods
Women aged 18–30 y with abdominal obesity [waist circumference (WC) ≥ 80 cm] were randomised to a 12 week lifestyle intervention (n = 26) of physical activity, nutrition education and cognitive behavioural therapy, or a wait-list control group (n = 17). Both groups completed anthropometric, biochemical, nutrition and fitness testing, at pre (0 weeks) and post (12 weeks), with intervention participants completed follow-up testing at 24 weeks.Results
Results from a linear mixed model showed no between-group differences, other than increased physical activity in the intervention group, at post. In the intervention group alone, positive within-group changes were observed in WC, waist-hip-ratio (WHR), waist-height-ratio (WHtR), resting heart rate, blood pressure, predicted VO2max, and total energy intake. Most changes were maintained at 24 weeks post-intervention. Similar within-group improvements were observed in control participants in WC, WHR, WHtR, and systolic blood pressure but no changes were detected in physical activity and nutrition.Conclusions
Cardiometabolic risk factors were decreased as a result of a lifestyle intervention in young women with abdominal obesity. It is difficult to describe observations in the control group without greater understanding of the behaviour of wait-list participants.Trial Registration
Australian New Zealand Clinical Trials Registry ACTRN12612001017819 相似文献19.
Colleen G Canning Cathie Sherrington Stephen R Lord Victor SC Fung Jacqueline CT Close Mark D Latt Kirsten Howard Natalie E Allen Sandra D O'Rourke Susan M Murray 《BMC neurology》2009,9(1):4-7
Background
People with Parkinson's disease are twice as likely to be recurrent fallers compared to other older people. As these falls have devastating consequences, there is an urgent need to identify and test innovative interventions with the potential to reduce falls in people with Parkinson's disease. The main objective of this randomised controlled trial is to determine whether fall rates can be reduced in people with Parkinson's disease using exercise targeting three potentially remediable risk factors for falls (reduced balance, reduced leg muscle strength and freezing of gait). In addition we will establish the cost effectiveness of the exercise program from the health provider's perspective.Methods/Design
230 community-dwelling participants with idiopathic Parkinson's disease will be recruited. Eligible participants will also have a history of falls or be identified as being at risk of falls on assessment. Participants will be randomly allocated to a usual-care control group or an intervention group which will undertake weight-bearing balance and strengthening exercises and use cueing strategies to address freezing of gait. The intervention group will choose between the home-based or support group-based mode of the program. Participants in both groups will receive standardized falls prevention advice. The primary outcome measure will be fall rates. Participants will record falls and medical interventions in a diary for the duration of the 6-month intervention period. Secondary measures include the Parkinson's Disease Falls Risk Score, maximal leg muscle strength, standing balance, the Short Physical Performance Battery, freezing of gait, health and well being, habitual physical activity and positive and negative affect schedule.Discussion
No adequately powered studies have investigated exercise interventions aimed at reducing falls in people with Parkinson's disease. This trial will determine the effectiveness of the exercise intervention in reducing falls and its cost effectiveness. This pragmatic program, if found to be effective, has the potential to be implemented within existing community services.Trial registration
The protocol for this study is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12608000303347). 相似文献20.