The prevention of type 2 diabetes is recognised as a health care priority. Lifestyle change has proven effective at reducing the risk of type 2 diabetes, but limitations in the current evidence have been identified in: the promotion of physical activity; availability of interventions that are suitable for commissioning and implementation; availability of evidence-based interventions using new technologies; and physical activity promotion among ethnic minorities. We aim to investigate whether a structured education programme with differing levels of ongoing support, including text-messaging, can increase physical activity over a 4 year period in a multi-ethnic population at high risk of diabetes.
A multi-centre randomised controlled trial, with follow-up at 12 and 48 months. The primary outcome is change in ambulatory activity at 48 months. Secondary outcomes include changes to markers of metabolic, cardiovascular, anthropometric and psychological health along with cost-effectiveness. Participants aged 40–74 years for White European, or 25–74 years for South Asians, with an HbA1c value of between 6.0 and < 6.4 % (42 and 47 mmol/mol) or with a previously recorded plasma glucose level or HbA1c value within the high risk (prediabetes) range within the last five years, are invited to take part in the trial. Participants are identified through primary care, using an automated diabetes risk score within their practice database, or from a database of previous research participants.
Participants are randomly assigned to either: 1) the control group who receive a detailed advice leaflet; 2) the Walking Away group, who receive the same leaflet and attend a 3 hour structured education programme with annual maintenance sessions delivered in groups; or 3) the Walking Away Plus group, who receive the leaflet, attend the structured education programme with annual maintenance sessions, plus receive follow-on support through highly-tailored text-messaging and telephone calls to help to aid pedometer use and behaviour change.
This study will provide new evidence for the long-term effectiveness of a structured education programme focused on physical activity, conducted within routine care in a multi-ethnic population in the UK. It will also investigate the impact of different levels of ongoing support and the cost-effectiveness of each intervention.
ISRCTN83465245 Trial registration date: 14/06/2012
Prevention; Impaired glucose regulation; Type 2 diabetes; Prediabetes; Walking; Physical activity; Pedometer; Structured education; Primary care; Randomised controlled trial; mHealth
Trials show that oral anticoagulation therapy (OAT) substantially reduces thromboembolic events without an increase in major haemorrhagic events, but it is not known whether these results translate into routine practice.
To estimate the current levels of control and adverse events in patients self-monitoring OAT, explore the factors that predict success, and determine whether the level of side effects reported from randomised controlled trials are translated to a non-selected population.
Design and setting
Prospective cohort study in the UK.
Participants were aged ≥18 years and registered with a GP. Main outcomes were the proportion of participants, over 12 months, who were still self-monitoring, had not experienced adverse events, and had achieved >80% of time in therapeutic range (TTR).
In total, 296 participants were recruited; their median age was 61 years and 55.1% were male. Participants were predominately professional or held a university qualification (82.7%). At 12 months, 267 (90.2%) were still self-monitoring. Mean TTR was 75.3% (standard deviation 16.9).Six serious and two minor adverse events were reported by GPs. Only 45.9% of participants received any in-person training at the outset. Increased age (P = 0.027), general wellbeing (EQ-5D visual score, P = 0.020), and lower target international normalised range (INR, P = 0.032) were all associated with high (>80% TTR) levels of control.
The findings show that, even with little training, people on OAT can successfully self-monitor, and even self-manage, their INR. TTR was shown to improve with age. However, widespread use of self-monitoring of INR may be limited by the initial costs, as well as a lack of training and support at the outset.
anticoagulants; primary care; monitoring; self-management; self-monitoring
Clinical trials suggest that oral anticoagulation therapy (OAT) self-monitoring is safe and effective, however little is known about the patient experience of this process. There is a lack of understanding about how best to train and support patients embarking on OAT self-monitoring.
To collect in-depth information about patients’ experiences of OAT self-monitoring outside of clinical trial conditions and to produce a set of recommendations on how best to support such patients.
Design and setting
Semi-structured qualitative interviews with patients who self-monitor and live in England.
In total, 26 of the 267 (9.7%) who participated in the Cohort study of Anticoagulation Self-Monitoring (CASM) and were still self-monitoring after 12 months’ follow-up were interviewed. Topics discussed included experiences of OAT self-monitoring, healthcare support, training, and decision making. Framework analysis was used.
Following initial problems using the monitoring device, interviewees described a mostly positive experience. Although less effort was expended attending monitoring appointments with health professionals, effort was required to conduct self-monitoring tests and to interpret and act on the results. Desire to self-manage was variable, especially when dosing advice systems worked promptly and reliably. Interviewees overcame patchy healthcare system knowledge and support of self-monitoring by educating themselves. Family and friends provided support with learning to use the monitor and managing OAT dosage adjustments.
Better, more-consistent training and health-service support would have alleviated a number of problems encountered by these patients who were self-monitoring. This training and support will become even more important if self-monitoring becomes more accessible to the general population of people on OAT.
anticoagulants; primary care; qualitative research; self-monitoring; self-management
There is increasing interest in brief and very brief behaviour change interventions for physical activity as they are potentially scalable to the population level. However, few very brief interventions (VBIs) have been published, and evidence is lacking about their feasibility, acceptability and which ‘active ingredients’ (behaviour change techniques) would maximise their effectiveness. The aim of this research was to identify and develop promising VBIs for physical activity and test their feasibility and acceptability in the context of preventive health checks in primary care.
The process included two stages, guided by four criteria: effectiveness, feasibility, acceptability, and cost. In Stage 1, we used an iterative approach informed by systematic reviews, a scoping review of BCTs, team discussion, stakeholder consultation, a qualitative study, and cost estimation to guide the development of promising VBIs. In Stage 2, a feasibility study assessed the feasibility and acceptability of the short-listed VBIs, using tape-recordings and interviews with practitioners (n = 4) and patients (n = 68), to decide which VBIs merited further evaluation in a pilot trial.
Four VBIs were short-listed: Motivational intervention; Action Planning intervention; Pedometer intervention; and Physical Activity Diary intervention. All were deliverable in around five minutes and were feasible and acceptable to participants and practitioners. Based on the results of interviews with practitioners and patients, techniques from the VBIs were combined into three new VBIs for further evaluation in a pilot trial.
Using a two-stage approach, in which we considered the practicability of VBIs (acceptability, feasibility and cost) alongside potential efficacy from the outset, we developed a short-list of four promising VBIs for physical activity and demonstrated that they were acceptable and feasible as part of a preventive health check in primary care.
Current Controlled Trials ISRCTN02863077. Registered 5 October 2012.
Electronic supplementary material
The online version of this article (doi:10.1186/s12889-015-1703-8) contains supplementary material, which is available to authorized users.
Very brief interventions; Brief interventions; Physical activity; Behaviour change; Behaviour change techniques; Health Checks; Health promotion; Public health; Intervention development; Feasibility study
Web-based interventions for physical activity offer several advantages over face-to-face, print-and telephone-based interventions and are scalable and potentially cost-effective. Recent reviews of web-based interventions in adults show that they have positive but small effects on physical activity but identify a number of limitations including a reliance on self-report measures of outcome. This trial used an objective measure of physical activity to assess the effectiveness of three minimal contact interventions: 1) A multi-component web-based intervention incorporating objective monitoring and graphical feedback of physical activity; 2) A version of the first intervention that consisted only of objective monitoring plus web-based graphical feedback; and 3) Self-monitoring of physical activity using a paper diary.
Get Moving is an individually randomised controlled trial with allocation of 488 participants to one of three interventions or to a no-intervention control group. Participants are physically inactive working adults aged 18–65 years. They attended a baseline assessment session at which anthropometric, biological and questionnaire measures were taken and they completed a treadmill exercise test. They then wore a combined movement and heart rate monitor for six days and nights before being randomised to one of the four trial arms. The baseline measures were repeated at the follow-up assessment which took place approximately 12 weeks post-randomisation, conducted by staff blind to group allocation. Participants wore the movement and heart rate monitor for six days and nights before this. The co-primary outcomes are: physical activity energy expenditure measured using individually calibrated combined heart-rate and movement data; and cardiorespiratory fitness measured using a sub-maximal treadmill exercise test.
Strengths of the trial include the use of an objective measure of physical activity, a measure of cardiorespiratory fitness, relatively large sample size and the use of robust methods of randomisation, allocation concealment and blinding to outcome assessment. Get Moving will contribute to the evidence base on minimal contact interventions for increasing physical activity. The interventions could be implemented in other settings such as primary care.
ISRCTN31844443. Registered 18 June 2010.
Physical activity; Intervention; Internet; Monitoring and feedback; Self-monitoring
To determine the perceived risk of type 2 diabetes in a sample of healthy middle-aged adults and examine the association between perceived risk and modelled risk, clinical risk factors, and psychological factors theorised to be antecedents of behaviour change.
An exploratory, cross-sectional analysis of perceived risk of type 2 diabetes (framed according to time and in comparison with peers) was conducted using baseline data collected from 569 participants of the Diabetes Risk Communication Trial (Cambridgeshire, UK). Type 2 diabetes risk factors were measured during a health assessment and the Framingham Offspring Diabetes Risk Score was used to model risk. Questionnaires assessed psychological factors including anxiety, diabetes-related worry, behavioural intentions, and other theory-based antecedents of behaviour change. Multivariable regression analyses were used to examine associations between perceived risk and potential correlates.
Participants with a high perceived risk were at higher risk according to the Framingham Offspring Diabetes Risk Score (p < 0.001). Higher perceived risk was observed in those with a higher body fat percentage, lower self-rated health, higher diabetes-related worry, and lower self-efficacy for adhering to governmental recommendations for physical activity (all p < 0.001). The framing of perceived risk according to time and in comparison with peers did not influence these results.
High perceived risk of type 2 diabetes is associated with higher risk of developing the disease, and a decreased likelihood of engagement in risk-reducing health behaviours. Risk communication interventions should target high-risk individuals with messages about the effectiveness of prevention strategies.
Type 2 diabetes; Perceived risk; Modelled risk; Psychology; Risk communication; Prevention
Smoking in pregnancy is a public health problem. Self-help smoking cessation support can help pregnant women to stop smoking, but the effects of delivering this kind of support via SMS text message are not known. A previous randomised controlled trial (RCT) demonstrated the feasibility and acceptability of providing such support to pregnant smokers using an automated, tailored text message intervention called MiQuit. This larger RCT will estimate key parameters for and will test the feasibility of delivering a major trial run within the United Kingdom National Health Service settings aimed at providing definitive evidence on the utility of MiQuit for helping pregnant smokers to stop.
This will be a multi-centre, parallel group RCT. Participants are being identified in 16 English antenatal care settings and must be >16 years old, pregnant, <25 weeks gestation, smoke >1 daily cigarette, have smoked >5 daily cigarettes before pregnancy, and able to understand texts in English. After consenting and the collection of baseline data, participants are randomised to control or intervention groups in a 1:1 ratio; randomisation is stratified by trial site and gestation and employs computer-generated pseudo-random code using random permuted blocks of randomly varying size, and held on a secure server. All participants receive a National Health Service (NHS) leaflet aimed at helping them to stop smoking. Intervention group women also receive the 12-week MiQuit programme of tailored, supportive, interactive text message, self-help cessation support. Women are followed up by telephone 4 weeks after randomisation and at 36 weeks gestation. The study aims to recruit 400 women, and with this sample we will be able to estimate trial centres’ recruitment rates to within +/−1% (margin of error = half width of 95% confidence interval); individual trial groups’ ascertainment of rates for smoking outcomes between 4 weeks after randomisation until approximately 36 weeks gestation to within +/−4%, and across both groups, the combined cessation rate at 36 weeks +/−3%.
Pilot trial completion will provide data to facilitate planning for a definitive trial investigating whether MiQuit works for smoking cessation in pregnancy.
ClinicalTrials.gov NCT02043509 Registered 14 January 2014.
Smoking cessation; Pregnancy; Self-help; Randomised controlled trial; Protocol
The analysis of randomized controlled trials with incomplete binary outcome data is challenging. We develop a general method for exploring the impact of missing data in such trials, with a focus on abstinence outcomes.
We propose a sensitivity analysis where standard analyses, which could include ‘missing = smoking’ and ‘last observation carried forward’, are embedded in a wider class of models.
We apply our general method to data from two smoking cessation trials.
A total of 489 and 1758 participants from two smoking cessation trials.
The abstinence outcomes were obtained using telephone interviews.
The estimated intervention effects from both trials depend on the sensitivity parameters used. The findings differ considerably in magnitude and statistical significance under quite extreme assumptions about the missing data, but are reasonably consistent under more moderate assumptions.
A new method for undertaking sensitivity analyses when handling missing data in trials with binary outcomes allows a wide range of assumptions about the missing data to be assessed. In two smoking cessation trials the results were insensitive to all but extreme assumptions.
Last observation carried forward; missing data; missing not at random; Russell Standard; sensitivity analysis; smoking cessation trials
Nicotine replacement therapy (NRT) medications have been shown to be effective in increasing smoking cessation rates. There is, however, a lack of good evidence describing how individuals in primary care use these medications and which factors are likely to affect this. The study objectives are to describe adherence and consumption, examine key factors that may determine use, and examine the relationship between consumption of NRT and abstinence from smoking.
Secondary analysis of data from a randomized controlled trial conducted in smoking cessation services in primary care. Adult smokers (n = 633) starting a quit attempt within smoking cessation clinics were followed for 6 months, with NRT use closely monitored for an initial treatment period of 4 weeks. The main outcomes were 4-week adherence to prescribed NRT, mean daily consumption of NRT over the 4-week period, and abstinence from smoking at 4 weeks.
Levels of adherence to prescribed NRT were high: more than 94% in participants who completed the treatment period. After controlling for possible confounders, prescribing higher doses of patch and oral NRT was associated with higher mean daily consumption of NRT. Using an inhalator to deliver oral NRT was associated with both higher adherence and higher consumption. The amount of NRT consumed predicted future abstinence when reverse causation was accounted for.
Most individuals within a clinical trial in primary care who persisted with a quit attempt adhered closely to their prescription. Prescribing higher doses of NRT led to higher consumption and higher consumption to higher abstinence.
Implementation of trial interventions is rarely assessed, despite its effects on findings. We assessed the implementation of a nurse-led intervention to facilitate medication adherence in type 2 diabetes (SAMS) in a trial against standard care in general practice. The intervention increased adherence, but not through the hypothesised psychological mechanism. This study aimed to develop a reliable coding frame for tape-recorded consultations, assessing both a priori hypothesised and potential active ingredients observed during implementation, and to describe the delivery and receipt of intervention and standard care components to understand how the intervention might have worked.
211 patients were randomised to intervention or comparison groups and 194/211 consultations were tape-recorded. Practice nurses delivered standard care to all patients and motivational and action planning (implementation intention) techniques to intervention patients only. The coding frame was developed and piloted iteratively on selected tape recordings until a priori reliability thresholds were achieved. All tape-recorded consultations were coded and a random subsample double-coded.
Nurse communication, nurse-patient relationship and patient responses were identified as potential active ingredients over and above the a priori hypothesised techniques. The coding frame proved reliable. Intervention and standard care were clearly differentiated. Nurse protocol adherence was good (M (SD) = 3.95 (0.91)) and competence of intervention delivery moderate (M (SD) = 3.15 (1.01)). Nurses frequently reinforced positive beliefs about taking medication (e.g., 65% for advantages) but rarely prompted problem solving of negative beliefs (e.g., 21% for barriers). Patients’ action plans were virtually identical to current routines. Nurses showed significantly less patient-centred communication with the intervention than comparison group.
It is feasible to reliably assess the implementation of behaviour change interventions in clinical practice. The main study results could not be explained by poor delivery of motivational and action planning components, definition of new action plans, improved problem solving or patient-centred communication. Possible mechanisms of increased medication adherence include spending more time discussing it and mental rehearsal of successful performance of current routines, combined with action planning. Delivery of a new behaviour change intervention may lead to less patient-centred communication and possible reduction in overall trial effects.
Fidelity; Implementation; Medication adherence; Behaviour change techniques; Process evaluation
Family history is an important risk factor for many common chronic diseases, but it remains underutilised for diagnostic assessment and disease prevention in routine primary care.
To develop and validate a brief self-completed family history questionnaire (FHQ) for systematic primary care assessment for family history of diabetes, ischaemic heart disease, breast cancer, and colorectal cancer.
Design and setting
Two-stage diagnostic validation study in 10 general practices in eastern England.
Participants aged 18–50 years were identified via random sampling from electronic searches of general practice records. Participants completed a FHQ then had a three-generational ‘gold standard’ pedigree taken, to determine disease risk category. In stage 1, the FHQ comprised 12 items; in stage 2 the shorter 6-item FHQ was validated against the same ‘gold standard’.
There were 1147 participants (stage 1: 618; stage 2: 529). Overall, 32% were at increased risk of one or more marker conditions (diabetes 18.9%, ischaemic heart disease 13.3%, breast cancer 6.2%, colorectal cancer 2.2%). The shorter 6-item FHQ performed very well for all four conditions: pooled data from both stages show diabetes, sensitivity = 98%, specificity = 94%; ischaemic heart disease, sensitivity = 93%, specificity = 81%; breast cancer, sensitivity = 81%, specificity = 83%; colorectal cancer, sensitivity = 96%, specificity = 88%, with an area under the receiver operating characteristic curve of 0.90 for males and 0.89 for females.
This brief self-completed FHQ shows good diagnostic accuracy for identifying people at higher risk of four common chronic diseases. It could be used in routine primary care to identify patients who would be most likely to benefit from a more detailed pedigree and risk assessment, and consequent management strategies.
breast cancer; colorectal cancer; ischaemic heart disease; diabetes mellitus, type 2; family history; primary health care; risk assessment
To report the methods used to assemble a contemporary pregnancy cohort for investigating influences on smoking behaviour before, during and after pregnancy and to report characteristics of women recruited.
Longitudinal cohort survey.
Two maternity hospitals, Nottingham, England.
3265 women who attended antenatal ultrasound scan clinics were offered cohort enrolment; those who were 8–26 weeks pregnant and were currently smoking or had recently stopped smoking were eligible. Cohort enrollment took place between August 2011 and August 2012.
Primary and secondary outcome measures
Prevalence of smoking at cohort entry and at two follow-up time points (34–36 weeks gestation and 3 months postnatally); response rate, participants’ sociodemographic characteristics.
1101 (33.7%, 95% CI 32.1% to 35.4%) women were eligible for inclusion in the cohort, and of these 850 (77.2%, 95% CI 74.6% to 79.6%) were recruited. Within the cohort, 57.4% (N=488, 95% CI 54.1% to 60.7%) reported to be current smokers. Current smokers were significantly younger than ex-smokers (p<0.05), more likely to have no formal qualifications and to not be in current paid employment compared to recent ex-smokers (p<0.001).
This contemporary cohort, which seeks very detailed information on smoking in pregnancy and its determinants, includes women with comparable sociodemographic characteristics to those in other UK cross-sectional studies and cohorts. This suggests that future analyses using this cohort and aimed at understanding smoking behaviour in pregnancy may produce findings that are broadly generalisable.
Public Health; Primary Care; Epidemiology
Meta-analyses have identified promising behavior change techniques (BCTs) in changing obesity-related behaviors from intervention descriptions. However, it is unclear whether these BCTs are used by intervention participants and are related to outcomes.
The purpose of this study is to investigate BCT use by participants of an intervention targeting physical activity and diet and whether BCT use was related to behavior change and weight loss.
Intervention participants (N = 239; 40–69 years) with recently diagnosed type 2 diabetes in the ADDITION-Plus trial received a theory-based intervention which taught them a range of BCTs. BCT usage was reported at 1 year.
Thirty-six percent of the participants reported using all 16 intervention BCTs. Use of a higher number of BCTs and specific BCTs (e.g., goal setting) were associated with a reduction in body mass index (BMI).
BCT use was associated with weight loss. Future research should identify strategies to promote BCT use in daily life. (Trial Registration: ISRCTN99175498.)
Electronic supplementary material
The online version of this article (doi:10.1007/s12160-014-9624-9) contains supplementary material, which is available to authorized users.
Behavior change techniques; Diet; Physical activity; Weight loss; Theory-based intervention; Intervention fidelity; Diabetes
Interventions to promote physical activity have had limited success. One reason may be that inactive adults are unaware that their level of physical activity is inadequate and do not perceive a need to change their behaviour. We aimed to assess awareness of physical activity, defined as the agreement between self-rated and objective physical activity, and to investigate associations with sociodemographic, biological, behavioural, and psychological factors.
We conducted an exploratory, cross-sectional analysis of awareness of physical activity using baseline data collected from 453 participants of the Feedback, Awareness and Behaviour study (Cambridgeshire, UK). Self-rated physical activity was measured dichotomously by asking participants if they believed they were achieving the recommended level of physical activity. Responses were compared to objective physical activity, measured using a combined accelerometer and heart rate monitor (Actiheart®). Four awareness groups were created: overestimators, realistic inactives, underestimators, and realistic actives. Logistic regression was used to assess associations between awareness group and potential correlates.
The mean (standard deviation) age of participants was 47.0 (6.9) years, 44.4% were male, and 65.1% were overweight (body mass index ≥ 25). Of the 258 (57.0%) who were objectively classified as inactive, 130 (50.4%) misperceived their physical activity by incorrectly stating that they were meeting the guidelines (overestimators). In a multivariable logistic regression model adjusted for age and sex, those with a lower body mass index (Odds Ratio (OR) = 0.95, 95% Confidence Interval (CI) = 0.90 to 1.00), higher physical activity energy expenditure (OR = 1.03, 95% CI = 1.00 to 1.06) and self-reported physical activity (OR = 1.13, 95% CI = 1.07 to 1.19), and lower intention to increase physical activity (OR = 0.69, 95% CI = 0.48 to 0.99) and response efficacy (OR = 0.53, 95% CI = 0.31 to 0.91) were more likely to overestimate their physical activity.
Overestimators have more favourable health characteristics than those who are realistic about their inactivity, and their psychological characteristics suggest that they are less likely to change their behaviour. Personalised feedback about physical activity may be an important first step to behaviour change.
Physical activity; Objective measurement; Awareness; Misperception; Barriers; Correlates; Behaviour change; Personalised feedback
The aim of this study was to assess whether or not a theory-based behaviour change intervention delivered by trained and quality-assured lifestyle facilitators can achieve and maintain improvements in physical activity, dietary change, medication adherence and smoking cessation in people with recently diagnosed type 2 diabetes.
An explanatory randomised controlled trial was conducted in 34 general practices in Eastern England (Anglo–Danish–Dutch Study of Intensive Treatment in People with Screen Detected Diabetes in Primary Care-Plus [ADDITION-Plus]). In all, 478 patients meeting eligibility criteria (age 40 to 69 years with recently diagnosed screen or clinically detected diabetes) were individually randomised to receive either intensive treatment (n = 239) or intensive treatment plus a theory-based behaviour change intervention led by a facilitator external to the general practice team (n = 239). Randomisation was central and independent using a partial minimisation procedure to balance stratifiers between treatment arms. Facilitators taught patients skills to facilitate change in and maintenance of key health behaviours, including goal setting, self-monitoring and building habits. Primary outcomes included physical activity energy expenditure (individually calibrated heart rate monitoring and movement sensing), change in objectively measured fruit and vegetable intake (plasma vitamin C), medication adherence (plasma drug levels) and smoking status (plasma cotinine levels) at 1 year. Measurements, data entry and laboratory analysis were conducted with staff unaware of participants’ study group allocation.
Of 475 participants still alive, 444 (93%; intervention group 95%, comparison group 92%) attended 1-year follow-up. There were no significant differences between groups in physical activity (difference: +1.50 kJ kg−1 day−1; 95% CI −1.74, 4.74), plasma vitamin C (difference: −3.84 μmol/l; 95% CI −8.07, 0.38), smoking (OR 1.37; 95% CI 0.77, 2.43) and plasma drug levels (difference in metformin levels: −119.5 μmol/l; 95% CI −335.0, 95.9). Cardiovascular risk factors and self-reported behaviour improved in both groups with no significant differences between groups.
For patients with recently diagnosed type 2 diabetes receiving intensive treatment in UK primary care, a facilitator-led individually tailored behaviour change intervention did not improve objectively measured health behaviours or cardiovascular risk factors over 1 year.
The trial is supported by the Medical Research Council, the Wellcome Trust, National Health Service R&D support funding (including the Primary Care Research and Diabetes Research Networks) and National Institute of Health Research under its Programme Grants for Applied Research scheme. The Primary Care Unit is supported by NIHR Research funds. Bio-Rad provided equipment for HbA1c testing during the screening phase.
Electronic supplementary material
The online version of this article (doi:10.1007/s00125-014-3236-6) contains peer-reviewed but unedited supplementary material, which is available to authorised users.
ADDITION-Plus; Diabetes; General practice; Health behaviour; Randomised trial
Electronic monitoring is recommended for accurate measurement of medication adherence but a possible limitation is that it may influence adherence.
To test the reactive effect of electronic monitoring in a randomized controlled trial.
A total of 226 adults with type 2 diabetes and HbA1c ≥58 mmol/mol were randomized to receiving their main oral glucose lowering medication in electronic containers or standard packaging. The primary outcomes were self-reported adherence measured with the MARS (Medication Adherence Report Scale; range 5–25) and HbA1c at 8 weeks.
Non-significantly higher adherence and lower HbA1c were observed in the electronic container group (differences in means, adjusting for baseline value: MARS, 0.4 [95 % CI −0.1 to 0.8, p = 0.11]; HbA1c (mmol/mol), −1.02 [−2.73 to 0.71, p = 0.25]).
Electronic containers may lead to a small increase in adherence but this potential limitation is outweighed by their advantages. Our findings support electronic monitoring as the method of choice in research on medication adherence. (Trial registration Current Controlled Trials ISRCT N30522359)
Measurement reactivity; Medication adherence; Electronic monitoring; Diabetes
Smokers attend preferentially to cigarettes and other smoking-related cues in the environment, in what is known as an attentional bias. There is evidence that attentional bias may contribute to craving and failure to stop smoking. Attentional retraining procedures have been used in laboratory studies to train smokers to reduce attentional bias, although these procedures have not been applied in smoking cessation programmes. This trial will examine the efficacy of multiple sessions of attentional retraining on attentional bias, craving, and abstinence in smokers attempting cessation.
This is a double-blind randomised controlled trial. Adult smokers attending a 7-session weekly stop smoking clinic will be randomised to either a modified visual probe task with attentional retraining or placebo training. Training will start 1 week prior to quit day and be given weekly for 5 sessions. Both groups will receive 21 mg transdermal nicotine patches for 8–12 weeks and withdrawal-orientated behavioural support for 7 sessions. Primary outcome measures are the change in attentional bias reaction time and urge to smoke on the Mood and Physical Symptoms Scale at 4 weeks post-quit. Secondary outcome measures include differences in withdrawal, time to first lapse and prolonged abstinence at 4 weeks post-quit, which will be biochemically validated at each clinic visit. Follow-up will take place at 8 weeks, 3 months and 6 months post-quit.
This is the first randomised controlled trial of attentional retraining in smokers attempting cessation. This trial could provide proof of principle for a treatment aimed at a fundamental cause of addiction.
Current Controlled Trials: ISRCTN54375405.
There is limited evidence about predictors of health behaviour change in people with type 2 diabetes. The aim of this study was to assess change in health behaviours over one year and to identify predictors of behaviour change among adults with screen-detected and recently clinically diagnosed diabetes.
ADDITION-Plus was a randomised controlled trial of a behaviour change intervention among 478 patients (40–69 years). Physical activity and diet were measured objectively (physical activity at 1 year) and by self-report at baseline and one year. Associations between baseline predictors and behaviour change were quantified using multivariable linear regression.
Participants increased their plasma vitamin C and fruit intake, reduced energy and fat intake from baseline to follow-up. Younger age, male sex, a smaller waist circumference, and a lower systolic blood pressure at baseline were associated with higher levels of objectively measured physical activity at one year. Greater increases in plasma vitamin C were observed in women (beta-coefficient [95% CI]: beta = −5.52 [−9.81, -1.22]) and in those with screen-detected diabetes (beta = 6.09 [1.74, 10.43]). Younger age predicted a greater reduction in fat (beta = −0.43 [−0.72, -0.13]) and energy intake (beta = −6.62 [−13.2, -0.05]). Patients with screen-detected diabetes (beta = 74.2 [27.92, 120.41]) reported a greater increase in fruit intake. There were no significant predictors of change in self-reported physical activity. Beliefs about behaviour change and diabetes did not predict behaviour change.
Older patients, men and those with a longer duration of diabetes may need more intensive support for dietary change. We recommend that future studies use objective measurement of health behaviours and that researchers add predictors beyond the individual level. Our results support a focus on establishing healthy lifestyle changes early in the diabetes disease trajectory.
Health behaviour; Behaviour change; Predictors; Type 2 diabetes; Newly diagnosed
Low levels of physical activity are a major public health concern, and interventions to promote physical activity have had limited success. Whether or not personalised feedback about physical activity following objective measurement motivates behaviour change has yet to be rigorously examined.
And Findings: In a parallel group, open randomised controlled trial, 466 healthy adults aged 32 to 54 years were recruited from the ongoing population-based Fenland Study (Cambridgeshire, UK). Participants were randomised to receive either no feedback until the end of the trial (control group, n=120) or one of three different types of feedback: simple, visual, or contextualised (intervention groups, n=346). The primary outcome was physical activity (physical activity energy expenditure (PAEE) in kJ/kg/day and average body acceleration (ACC) in m/s2) measured objectively using a combined heart rate monitor and accelerometer (Actiheart®). The main secondary outcomes included self-reported physical activity, intention to increase physical activity, and awareness of physical activity (the agreement between self-rated and objectively measured physical activity). At 8 weeks, 391 (83.9%) participants had complete physical activity data. The intervention had no effect on objectively measured physical activity (PAEE: β=-0.92, 95% CI=-3.50 to 1.66, p=0.48 and ACC: β=0.01, 95% CI=-0.00 to 0.02, p=0.21), self-reported physical activity (β=-0.39, 95% CI=-1.59 to 0.81), or intention to increase physical activity (β=-0.05, 95% CI=-0.22 to 0.11). However, it was associated with an increase in awareness of physical activity (OR=1.74, 95% CI=1.05 to 2.89). Results did not differ according to the type of feedback.
Personalised feedback about physical activity following objective measurement increased awareness but did not result in changes in physical activity in the short term. Measurement and feedback may have a role in promoting behaviour change but are ineffective on their own.
Current Controlled Trials ISRCTN92551397 http://www.controlled-trials.com/ISRCTN92551397
Physical activity (PA) levels in type 2 diabetes mellitus (T2DM) patients are generally low. Poor PA perception may impede healthy behaviour change in this high risk group. We describe (i) objective PA levels, (ii) the difference between objective and self-reported PA (‘PA disparity’) and the correlates of (iii) PA disparity and (iv) overestimation in recently diagnosed T2DM patients.
Cross-sectional analysis of 425 recently diagnosed T2DM patients aged 42 to 71, participating in the ADDITION-Plus study in Eastern England, UK. We define ‘PA disparity’ as the non-negative value of the difference (in mathematical terms the absolute difference) between objective and self-reported physical activity energy expenditure (PAEE in kJ · kg-1 · day-1). ‘Overestimators’ comprised those whose self-reported- exceeded objective-PAEE by 4.91 kJ · kg-1 · day-1(the equivalent of 30 minutes moderate activity per day). Multivariable linear regression examined the association between PA disparity (continuous) and socio-demographic, clinical, health behaviour, quality of life and psychological characteristics. Logistic regression examined the association between PA overestimation and individual characteristics.
Mean objective and self-reported PAEE levels ± SD were 34.4 ± 17.0 and 22.6 ± 19.4 kJ · kg-1 · day-1, respectively (difference in means =11.8; 95% CI = 9.7 to 13.9 kJ · kg-1 · day-1). Higher PA disparity was associated with male sex, younger age, lower socio-economic status and lower BMI. PA overestimators comprised 19% (n = 80), with those in routine/manual occupations more likely to be overestimators than those in managerial/professional occupations.
T2DM patients with poor physical activity perception are more likely to be male, younger, from a lower socio-economic class and to have a lower BMI. PA overestimators were more likely to be in lower socio-economic categories. Self-monitoring and targeted feedback, particularly to those in lower socio-economic categories, may improve PA perceptions and optimise interventions in T2DM patients. Our findings suggest that strategies for enabling realistic assessment of physical activity levels, through self-monitoring or feedback, warrant further investigation and may help refine and improve physical activity interventions.
Type 2 diabetes mellitus; Physical activity; Overestimation; Awareness; Perception; Health behaviour; Lifestyle behaviour; Social correlates of health; Health promotion intervention
Primary care is an important setting for smoking cessation interventions. There is evidence for the effectiveness of tailored interventions for smoking cessation, and text messaging interventions for smoking cessation show promise. The intervention to be evaluated in this trial consists of two components: (1) a web-based program designed to be used by a practice nurse or other smoking cessation advisor (SCA); the program generates a cessation advice report that is highly tailored to relevant characteristics of the smoker; and (2) a three-month programme of automated tailored text messages sent to the smoker’s mobile phone. The objectives of the trial are to assess the acceptability and feasibility of the intervention and to estimate the short-term effectiveness of the intervention in increasing the quit rate compared with usual care alone.
The design is a two parallel group randomised controlled trial (RCT). 600 smokers who want to quit will be recruited in up to 30 general practices in the East of England. During a consultation with an SCA, they will be individually randomised by computer program to usual care (Control) or to usual care plus the iQuit system (Intervention). At the four-week follow-up appointment, the SCA will record smoking status and measure carbon monoxide level. There will be two further follow-ups, at eight weeks and six months from randomisation date, by postal questionnaire sent from and returned to the study centre or by telephone interview conducted by a research interviewer. The primary outcome will be self-reported abstinence for at least two weeks at eight weeks. A sample size of 300 per group would give 80% power to detect an increase in quit rate from 20% to 30% (alpha = 0.05, 2-sided test). The main analyses of quit rates will be conducted on an intention-to-treat basis, making the usual assumption that participants lost to follow up are smoking.
This trial will focus on acceptability, feasibility and short-term effectiveness. The findings will be used to refine the intervention and to inform the decision to proceed to a pragmatic trial to estimate longer-term effectiveness and cost-effectiveness.
Although government-funded specialist smoking cessation services in England offer advice and support to smokers motivated to quit, only a small proportion of smokers make use of this service. Evidence suggests that if smokers are proactively and personally invited to use services, use will be higher than with a standard referral made by health professionals. Computer-based systems generating personalised tailored communications also have the potential to engage with a larger proportion of the smoking population. In this study smokers are proactively invited to use the NHS Stop Smoking Service (SSS), with a personal computer-tailored letter and the offer of a no-commitment introductory session designed to give more information about the service. The primary objective is to assess the relative effectiveness on attendance at the NHS SSS, of proactive recruitment by a brief personal letter, tailored to individual characteristics, and invitation to a taster session, over a standard generic letter advertising the service.
This randomised controlled trial will recruit smokers from general practice who are motivated to quit and have not recently attended the NHS SSS. Smokers aged 16 years and over, identified from medical records in participating practices, are sent a brief screening questionnaire and cover letter from their GP. Smokers giving consent are randomised to the Control group to receive a standard generic letter advertising the local service, or to the Intervention group to receive a brief personal, tailored letter with risk information and an invitation to attend a ‘Come and Try it’ taster session. The primary outcome, assessed 6 months after the date of randomisation, is the proportion of people attending the NHS SSS for at least one session. Planned recruitment is to secure 4,500 participants, from 18 regions in England served by an NHS SSS.
Personal risk information generated by computer, with the addition of taster sessions, could be widely replicated and delivered cost effectively to a large proportion of the smoking population. The results of this trial will inform the potential of this method to increase referrals to specialised smoking cessation services and prompt more quit attempts.
Current Controlled Trials ISRCTN76561916
Smoking cessation; Stop smoking clinics; Computer-tailoring; Personalisation; Risk information
Missing outcome data are very common in smoking cessation trials. It is often assumed that all such missing data are from participants who have been unsuccessful in giving up smoking (“missing=smoking”). Here we use data from a recent Internet based smoking cessation trial in order to investigate which of a set of a priori chosen baseline variables are predictive of missingness, and the evidence for and against the “missing=smoking” assumption.
We use a selection model, which models the probability that the outcome is observed given the outcome and other variables. The selection model includes a parameter for which zero indicates that the data are Missing at Random (MAR) and large values indicate “missing=smoking”. We examine the evidence for the predictive power of baseline variables in the context of a sensitivity analysis. We use data on the number and type of attempts made to obtain outcome data in order to estimate the association between smoking status and the missing data indicator.
We apply our methods to the iQuit smoking cessation trial data. From the sensitivity analysis, we obtain strong evidence that older participants are more likely to provide outcome data. The model for the number and type of attempts to obtain outcome data confirms that age is a good predictor of missing data. There is weak evidence from this model that participants who have successfully given up smoking are more likely to provide outcome data but this evidence does not support the “missing=smoking” assumption. The probability that participants with missing outcome data are not smoking at the end of the trial is estimated to be between 0.14 and 0.19.
Those conducting smoking cessation trials, and wishing to perform an analysis that assumes the data are MAR, should collect and incorporate baseline variables into their models that are thought to be good predictors of missing data in order to make this assumption more plausible. However they should also consider the possibility of Missing Not at Random (MNAR) models that make or allow for less extreme assumptions than “missing=smoking”.
Type 2 diabetes (T2D) is associated with increased risk of morbidity and premature mortality. Among those at high risk, incidence can be halved through healthy changes in behaviour. Information about genetic and phenotypic risk of T2D is now widely available. Whether such information motivates behaviour change is unknown. We aim to assess the effects of communicating genetic and phenotypic risk of T2D on risk-reducing health behaviours, anxiety, and other cognitive and emotional theory-based antecedents of behaviour change.
In a parallel group, open randomised controlled trial, approximately 580 adults born between 1950 and 1975 will be recruited from the on-going population-based, observational Fenland Study (Cambridgeshire, UK). Eligible participants will have undergone clinical, anthropometric, and psychosocial measurements, been genotyped for 23 single-nucleotide polymorphisms associated with T2D, and worn a combined heart rate monitor and accelerometer (Actiheart®) continuously for six days and nights to assess physical activity. Participants are randomised to receive either standard lifestyle advice alone (control group), or in combination with a genetic or a phenotypic risk estimate for T2D (intervention groups). The primary outcome is objectively measured physical activity. Secondary outcomes include self-reported diet, self-reported weight, intention to be physically active and to engage in a healthy diet, anxiety, diabetes-related worry, self-rated health, and other cognitive and emotional outcomes. Follow-up occurs eight weeks post-intervention. Values at follow-up, adjusted for baseline, will be compared between randomised groups.
This study will provide much needed evidence on the effects of providing information about the genetic and phenotypic risk of T2D. Importantly, it will be among the first to examine the impact of genetic risk information using a randomised controlled trial design, a population-based sample, and an objectively measured behavioural outcome. Results of this trial, along with recent evidence syntheses of similar studies, should inform policy concerning the availability and use of genetic risk information.
Current Controlled Trials ISRCTN09650496
Genetic; Phenotypic; Risk; Communication; Type 2 diabetes; Physical activity; Behaviour; Randomised controlled trial; Protocol
Supereruptions violently transfer huge amounts (100 s–1000 s km3) of magma to the surface in a matter of days and testify to the existence of giant pools of magma at depth. The longevity of these giant magma bodies is of significant scientific and societal interest. Radiometric data on whole rocks, glasses, feldspar and zircon crystals have been used to suggest that the Bishop Tuff giant magma body, which erupted ∼760,000 years ago and created the Long Valley caldera (California), was long-lived (>100,000 years) and evolved rather slowly. In this work, we present four lines of evidence to constrain the timescales of crystallization of the Bishop magma body: (1) quartz residence times based on diffusional relaxation of Ti profiles, (2) quartz residence times based on the kinetics of faceting of melt inclusions, (3) quartz and feldspar crystallization times derived using quartz+feldspar crystal size distributions, and (4) timescales of cooling and crystallization based on thermodynamic and heat flow modeling. All of our estimates suggest quartz crystallization on timescales of <10,000 years, more typically within 500–3,000 years before eruption. We conclude that large-volume, crystal-poor magma bodies are ephemeral features that, once established, evolve on millennial timescales. We also suggest that zircon crystals, rather than recording the timescales of crystallization of a large pool of crystal-poor magma, record the extended periods of time necessary for maturation of the crust and establishment of these giant magma bodies.