Amanda L Lewis

Screening and brief intervention for obesity in primary care: a parallel, two-arm, randomised trial.

• Users may freely distribute the URL that is used to identify this publication. • Users may download and/or print one copy of the publication from the University of Birmingham research portal for the purpose of private study or non-commercial research. • User may use extracts from the document in line with the concept of ‘fair dealing’ under the Copyright, Designs and Patents Act 1988 (?) • Users may not further distribute the material nor use it for the purposes of commercial gain.BACKGROUNDnObesity is a common cause of non-communicable disease. Guidelines recommend that physicians screen and offer brief advice to motivate weight loss through referral to behavioural weight loss programmes. However, physicians rarely intervene and no trials have been done on the subject. We did this trial to establish whether physician brief intervention is acceptable and effective for reducing bodyweight in patients with obesity.nnnMETHODSnIn this parallel, two-arm, randomised trial, patients who consulted 137 primary care physicians in England were screened for obesity. Individuals could be enrolled if they were aged at least 18 years, had a body-mass index of at least 30 kg/m2 (or at least 25 kg/m2 if of Asian ethnicity), and had a raised body fat percentage. At the end of the consultation, the physician randomly assigned participants (1:1) to one of two 30 s interventions. Randomisation was done via preprepared randomisation cards labelled with a code representing the allocation, which were placed in opaque sealed envelopes and given to physicians to open at the time of treatment assignment. In the active intervention, the physician offered referral to a weight management group (12 sessions of 1 h each, once per week) and, if the referral was accepted, the physician ensured the patient made an appointment and offered follow-up. In the control intervention, the physician advised the patient that their health would benefit from weight loss. The primary outcome was weight change at 12 months in the intention-to-treat population, which was assessed blinded to treatment allocation. We also assessed asked patients about their feelings on discussing their weight when they have visited their general practitioner for other reasons. Given the nature of the intervention, we did not anticipate any adverse events in the usual sense, so safety outcomes were not assessed. This trial is registered with the ISRCTN Registry, number ISRCTN26563137.nnnFINDINGSnBetween June 4, 2013, and Dec 23, 2014, we screened 8403 patients, of whom 2728 (32%) were obese. Of these obese patients, 2256 (83%) agreed to participate and 1882 were eligible, enrolled, and included in the intention-to-treat analysis, with 940 individuals in the support group and 942 individuals in the advice group. 722 (77%) individuals assigned to the support intervention agreed to attend the weight management group and 379 (40%) of these individuals attended, compared with 82 (9%) participants who were allocated the advice intervention. In the entire study population, mean weight change at 12 months was 2·43 kg with the support intervention and 1·04 kg with the advice intervention, giving an adjusted difference of 1·43 kg (95% CI 0·89-1·97). The reactions of the patients to the general practitioners brief interventions did not differ significantly between the study groups in terms of appropriateness (adjusted odds ratio 0·89, 95% CI 0·75-1·07, p=0·21) or helpfulness (1·05, 0·89-1·26, p=0·54); overall, four (<1%) patients thought their intervention was inappropriate and unhelpful and 1530 (81%) patients thought it was appropriate and helpful.nnnINTERPRETATIONnA behaviourally-informed, very brief, physician-delivered opportunistic intervention is acceptable to patients and an effective way to reduce population mean weight.nnnFUNDINGnThe UK National Prevention Research Initiative.Summary Background Obesity is a common cause of non-communicable disease. Guidelines recommend that physicians screen and offer brief advice to motivate weight loss through referral to behavioural weight loss programmes. However, physicians rarely intervene and no trials have been done on the subject. We did this trial to establish whether physician brief intervention is acceptable and effective for reducing bodyweight in patients with obesity. Methods In this parallel, two-arm, randomised trial, patients who consulted 137 primary care physicians in England were screened for obesity. Individuals could be enrolled if they were aged at least 18 years, had a body-mass index of at least 30 kg/m2 (or at least 25 kg/m2 if of Asian ethnicity), and had a raised body fat percentage. At the end of the consultation, the physician randomly assigned participants (1:1) to one of two 30 s interventions. Randomisation was done via preprepared randomisation cards labelled with a code representing the allocation, which were placed in opaque sealed envelopes and given to physicians to open at the time of treatment assignment. In the active intervention, the physician offered referral to a weight management group (12 sessions of 1 h each, once per week) and, if the referral was accepted, the physician ensured the patient made an appointment and offered follow-up. In the control intervention, the physician advised the patient that their health would benefit from weight loss. The primary outcome was weight change at 12 months in the intention-to-treat population, which was assessed blinded to treatment allocation. We also assessed asked patients about their feelings on discussing their weight when they have visited their general practitioner for other reasons. Given the nature of the intervention, we did not anticipate any adverse events in the usual sense, so safety outcomes were not assessed. This trial is registered with the ISRCTN Registry, number ISRCTN26563137. Findings Between June 4, 2013, and Dec 23, 2014, we screened 8403 patients, of whom 2728 (32%) were obese. Of these obese patients, 2256 (83%) agreed to participate and 1882 were eligible, enrolled, and included in the intention-to-treat analysis, with 940 individuals in the support group and 942 individuals in the advice group. 722 (77%) individuals assigned to the support intervention agreed to attend the weight management group and 379 (40%) of these individuals attended, compared with 82 (9%) participants who were allocated the advice intervention. In the entire study population, mean weight change at 12 months was 2·43 kg with the support intervention and 1·04 kg with the advice intervention, giving an adjusted difference of 1·43 kg (95% CI 0·89–1·97). The reactions of the patients to the general practitioners brief interventions did not differ significantly between the study groups in terms of appropriateness (adjusted odds ratio 0·89, 95% CI 0·75–1·07, p=0·21) or helpfulness (1·05, 0·89–1·26, p=0·54); overall, four (<1%) patients thought their intervention was inappropriate and unhelpful and 1530 (81%) patients thought it was appropriate and helpful. Interpretation A behaviourally-informed, very brief, physician-delivered opportunistic intervention is acceptable to patients and an effective way to reduce population mean weight. Funding The UK National Prevention Research Initiative.

Which weight-loss programmes are as effective as Weight Watchers®?: Non-inferiority analysis

BACKGROUNDnThree randomised controlled trials have provided strong evidence that Weight Watchers(®) is an effective weight-loss programme but there is insufficient evidence to determine whether three other weight-loss programmes are also effective.nnnAIMnTo examine whether other group-based weight-loss programmes were not inferior to Weight Watchers.nnnDESIGN AND SETTINGnA prospective cohort study using a non-inferiority analysis of 3290 adults referred through primary care. METHOD Participants who met the eligibility criteria for primary care obesity management treatment chose a free programme (Weight Watchers, Rosemary Conley Diet and Fitness Clubs, Slimming World or a NHS group programme) lasting 3 months; they were weighed at 3 months (programme end) and self-reported their weight at 12 months.nnnRESULTSnAt 3 months, weight loss achieved through Rosemary Conley and Slimming World was not inferior to Weight Watchers. The NHS group programme was inferior. At 12 months Slimming World and Rosemary Conley were not inferior to Weight Watchers, although participants using Slimming World lost significantly more weight than those using Weight Watchers. Data on the NHS group programme were inconclusive.nnnCONCLUSIONnIn the short term all commercial weight-loss programmes appear to result in similar weight loss but the NHS alternative appears to produce less weight loss. At 12 months Slimming World led to greater weight loss but the differences between commercial programmes was small and of minor clinical importance.

Is self-weighing an effective tool for weight loss: a systematic literature review and meta-analysis

BackgroundThere is a need to identify effective behavioural strategies for weight loss. Self-weighing may be one such strategy.PurposeTo examine the effectiveness of self-weighing for weight loss.MethodsA systematic review and meta-analysis of randomised controlled trials that included self-weighing as an isolated intervention or as a component within an intervention. We used sub groups to analyse differences in frequency of weighing instruction (daily and weekly) and also whether including accountability affected weight loss.ResultsOnly one study examined self-weighing as a single strategy and there was no evidence it was effective (-0.5xa0kg 95xa0% CI -1.3 to 0.3). Four trials added self-weighing/self-regulation techniques to multi-component programmes and resulted in a significant difference of -1.7xa0kg (95xa0% CI -2.6 to -0.8). Fifteen trials comparing multi-component interventions including self-weighing compared with no intervention or minimal control resulted in a significant mean difference of -3.4xa0kg (95xa0% CI -4.2 to -2.6). There was no significant difference in the interventions with weekly or daily weighing. In trials which included accountability there was significantly greater weight loss (pu2009=u20090.03).ConclusionsThere is a lack of evidence of whether advising self-weighing without other intervention components is effective. Adding self-weighing to a behavioural weight loss programme may improve weight loss. Behavioural weight loss programmes that include self-weighing are more effective than minimal interventions. Accountability may improve the effectiveness of interventions that include self-weighing.

A randomised controlled trial of the effectiveness of self-weighing as a weight loss intervention.

BackgroundThere is a need to find simple cost effective weight loss interventions that can be used in primary care. There is evidence that self-monitoring is an effective intervention for problem drinking and self-weighing might be an effective intervention for weight loss.PurposeTo examine the efficacy of daily self-weighing as an intervention for weight loss.MethodsA randomised controlled trial of 183 obese adults, follow-up three months. The intervention group were given a set of weighing scales and instructed to weigh themselves daily and record their weight. Both groups received two weight loss consultations which were known to be ineffective.Results92 participants were randomised to the intervention group and 91 to the control group. The intervention group lost 0.5 kg (95% CI 0.3 to 1.3 kg) more than the control group, but this was not significant. There was no evidence that self-weighing frequency was associated with more weight loss.ConclusionsAs an intervention for weight loss, instruction to weigh daily is ineffective. Unlike other studies, there was no evidence that greater frequency of self-weighing is associated with greater weight loss.Trial registrationISRCTN05815264

Urodynamics for Prostate Surgery Trial; Randomised Evaluation of Assessment Methods (UPSTREAM) for diagnosis and management of bladder outlet obstruction in men: study protocol for a randomised controlled trial

BackgroundLower urinary tract symptoms (LUTS) comprise storage symptoms, voiding symptoms and post-voiding symptoms. Prevalence and severity of LUTS increase with age and the progressive increase in the aged population group has emphasised the importance to our society of appropriate and effective management of male LUTS. Identification of causal mechanisms is needed to optimise treatment and uroflowmetry is the simplest non-invasive test of voiding function. Invasive urodynamics can evaluate storage function and voiding function; however, there is currently insufficient evidence to support urodynamics becoming part of routine practice in the clinical evaluation of male LUTS.DesignA 2-arm trial, set in urology departments of at least 26 National Health Service (NHS) hospitals in the United Kingdom (UK), randomising men with bothersome LUTS for whom surgeons would consider offering surgery, between a care pathway based on urodynamic tests with invasive multichannel cystometry and a care pathway based on non-invasive routine tests. The aim of the trial is to determine whether a care pathway not including invasive urodynamics is no worse for men in terms of symptom outcome than one in which it is included, at 18 months after randomisation. This primary clinical outcome will be measured with the International Prostate Symptom Score (IPSS). We will also establish whether inclusion of invasive urodynamics reduces rates of bladder outlet surgery as a main secondary outcome.DiscussionThe general population has an increased life-expectancy and, as men get older, their prostates enlarge and potentially cause benign prostatic obstruction (BPO) which often requires surgery. Furthermore, voiding symptoms become increasingly prevalent, some of which may not be due to BPO. Therefore, as the population ages, more operations will be considered to relieve BPO, some of which may not actually be appropriate. Hence, there is sustained interest in the diagnostic pathway and this trial could improve the chances of an accurate diagnosis and reduce overall numbers of surgical interventions for BPO in the NHS. The morbidity, and therapy costs, of testing must be weighed against the cost saving of surgery reduction.Trial registrationControlled-trials.com - ISRCTN56164274 (confirmed registration: 8 April 2014).

Clinical effectiveness of very-low-energy diets in the management of weight loss: a systematic review and meta-analysis of randomized controlled trials.

Guidelines suggest that very‐low‐energy diets (VLEDs) should be used to treat obesity only when rapid weight loss is clinically indicated because of concerns about rapid weight regain.

Feasibility and acceptability of regular weighing, setting weight gain limits and providing feedback by community midwives to prevent excess weight gain during pregnancy: randomised controlled trial and qualitative study

BackgroundRegular weighing in pregnant women is not currently recommended in many countries but has been suggested to prevent excessive gestational weight gain. This study aimed to establish the feasibility and acceptability of incorporating regular weighing, setting maximum weight gain targets and feedback by community midwives.MethodsLow risk pregnant women cared for by eight community midwives were randomised to usual care or usual care plus the intervention at 10–14 weeks of pregnancy. The intervention involved community midwives weighing and plotting weight on a weight gain chart, setting weight gain limit targets, giving brief feedback at each antenatal appointment and encouraging women to weigh themselves weekly between antenatal appointments. Women and midwives were interviewed about their views of the intervention. The focus of the study was on process evaluation.ResultsCommunity midwives referred 123 women and 115 were scheduled for their dating scan within the study period. Of these, 84/115 were approached at their dating scan and 76/84 (90.5xa0%) randomised. Data showed a modest difference favouring the intervention group in the percentage of women gaining excessive gestational weight (23.5xa0% versus 29.4xa0%). The intervention group consistently reported smaller increases in depression and anxiety scores throughout pregnancy compared with usual care. Most women commented the intervention was useful in encouraging them to think about their weight and believed it should be part of routine antenatal care. Community midwives felt the intervention could be implemented within routine care without adding substantially to consultation length, thus not perceived as adding substantially to their workload.ConclusionsThe intervention was feasible and acceptable to pregnant women and community midwives and was readily implemented in routine care.Trial registrationISRCTN81605162

Study protocol: The effectiveness and cost effectiveness of a brief behavioural intervention to promote regular self-weighing to prevent weight regain after weight loss: Randomised controlled trial (The LIMIT Study)

BackgroundAlthough obesity causes many adverse health consequences, modest weight loss reduces the incidence. There are effective interventions that help people to lose weight but weight regain is common and long term maintenance remains a critical challenge. As a high proportion of the population of most high and middle income countries are overweight, there are many people who would benefit from weight loss and its maintenance. Therefore, we need to find effective low cost scalable interventions to help people achieve this. One such intervention that has shown promise is regular self-weighing, to check progress against a target, however there is no trial that has tested this using a randomised controlled design (RCT). The aim of this RCT is to evaluate the effectiveness and cost effectiveness of a brief behavioural intervention delivered by non-specialist staff to promote regular self-weighing to prevent weight regain after intentional weight loss.MethodsA randomised trial of 560 adults who have lost ≥5xa0% of their initial body weight through a 12xa0week weight loss programme. The comparator group receive a weight maintenance leaflet, a diagram representing healthy diet composition, and a list of websites for weight control. The intervention group receive the same plus minimally trained telephonists will ask participants to set a weight target and encourage them to weigh themselves daily, and provide support materials such as a weight record card. The primary outcome is the difference between groups in weight change from baseline to 12xa0months.DiscussionIf effective, this study will provide public health agencies with a simple, low cost maintenance intervention that could be implemented immediately.Trial registrationISRCTN52341938 Date Registered: 31/03/2014

Urodynamic Testing for Men with Voiding Symptoms Considering Interventional Therapy: The Merits of a Properly Constructed Randomised Trial

Insufficient evidence exists regarding the role of invasive urodynamics in routine practice in the clinical assessment of male lower urinary tract symptoms. UPSTREAM, a multicentre randomised trial, will inform patients, clinicians, and policy-makers about whether urodynamics should be more widely used for such patients.

Effectiveness of regular weighing, weight target setting and feedback by community midwives within routine antenatal care in preventing excessive gestational weight gain: randomised controlled trial

BackgroundMany pregnant women gain excess weight during pregnancy which increases the health risks to the mother and her baby. Interventions to prevent excess weight gain need to be given to the whole population to prevent excess weight gain. The aim of this study was to assess the effectiveness of a simple and brief intervention embedded withinroutine antenatal care to prevent excessive gestation weight gain.MethodsSix hundred and ten pregnant women (between 10-14 weeks gestation), aged ≥18 years with a body mass index (BMI) ≥18.5 kg/m2, planned to receive community midwife led care or shared care at the time of recruitment are eligible to take part in the study. Women will be recruited from four maternity centres in England. Community midwives complete a short training module before delivering the intervention. In the intervention, midwives weigh women, set maximum weight limits for weight gain at each antenatal appointment and ask women to monitor their weight at home. Themaximum weight limit is adjusted by the midwife at each antenatal appointment if women have exceeded their maximum weight gain limit set at their previous appointment. The intervention will be compared with usual antenatal care. The primary outcome is the proportion of women per group who exceed the Institute of Medicine guidelines for gestational weight gain at 38 weeks of pregnancy according to their early pregnancy BMI category.DiscussionThe proposed trial will test a brief intervention comprising regular weighing, target setting and monitoring ofweight during pregnancy that can be delivered at scale as part of routine antenatal care. Using the professional expertise of community midwives, but without specialist training in weight management, the intervention will incur minimal additionalhealthcare costs, and if effective at reducing excess weight gain, is likely to be very cost effective. Trial registrationCurrent controlled trials ISRCTN67427351. Date assigned 29/10/2014.