Applying the practice-based competencies to evaluate and characterize the contracting process within genetic counseling sessions.

Contracting is a skill used by genetic counselors (GCs) to establish a shared vision for the session. Ensuring that patients and GCs are aligned on expectations for the encounter allows GCs to meet patient needs and support patient autonomy. Although contracting is described in the practice-based competencies (PBCs), the process has not been systematically observed in practice. We sought to further elucidate the skills used for contracting within genetic counseling sessions through directed content analysis of transcripts from 148 simulated prenatal and cancer genetic counseling sessions. An a priori codebook and rating scale were developed based on four contracting sample skills described in the PBCs: (a) describing the genetic counseling process, (b) eliciting client concerns, (c) applying client concerns to a session agenda, (d) modifying the agenda in response to emerging concerns. The rating scale described the quality of each skill on a 4-point scale of "absent," "minimal," "adequate," and "excellent." The codebook and rating scale were pilot tested with 40% of transcripts (n = 60). Three authors independently coded and rated the final 60% of transcripts (n = 88), resolving discrepancies via a consensus process. We found that the four PBC skills were present in most sessions (88%-98%), and on average, GCs received "adequate" scores on all four skills. We also identified three additional components of contracting not described in the PBCs: assessing whether client concerns were met, inviting to interrupt, and providing opportunity for partner concerns. This study represents the first attempt to evaluate GC performance of a PBC during a genetic counseling session. Our findings demonstrate that the PBC sample contracting skills reflect practice and suggest that they can be used in assessment of the genetic counseling contracting process. This type of analysis could be adapted in the future to provide support for other standards of practice in the genetic counseling field.

Application of motivational interviewing strategies with the extended parallel process model to improve risk communication for parents of children with familial hypercholesterolemia.

Current genetic counseling practice has not been found to significantly increase risk communication between family members. A more diverse set of genetic counseling approaches may be needed. A genetic counseling intervention based on motivational interviewing principles and the extended parallel process model was utilized to increase cascade outcomes within families with familial hypercholesterolemia, a common, underdiagnosed, and treatable condition. Parents of children with familial hypercholesterolemia were invited to participate in an online pre-survey, single-session genetic counseling intervention, and post-intervention surveys as a part of the CHEERS (Cholesterol Evaluation to Explore Risk Screening) intervention. This study investigated the efficacy of a genetic counselor delivered motivational interviewing intervention and how parents of children with familial hypercholesterolemia react by assessing family member cholesterol screening and risk communication to at-risk relatives. Transcripts were audio-recorded, transcribed, and analyzed for change talk using the Motivational Interviewing Skill Code version 2.1. Participant surveys were analyzed for self-reported extended parallel process constructs and motivations. Coincidence analysis was conducted to explore differences between those with and without positive cascade outcomes within 12 months after the intervention. On average, change talk increased during the session in order of the extended parallel process constructs (perceived severity, susceptibility, response efficacy, self-efficacy). Coincidence analysis revealed that 6 of the 7 cases with positive cascade outcomes were explained by either the presence of high change talk during the intervention or presence of positive motivations shortly after, while 5 of the 5 cases without a positive outcome lacked both of these key factors that were associated with cascade outcomes. Results of this study suggest that incorporating motivational interviewing and the extended parallel process model increases change talk and that the presence of either high levels of change talk or positive motivations is associated with positive cascade outcomes.

Outcomes from a pilot genetic counseling intervention using motivational interviewing and the extended parallel process model to increase cascade cholesterol screening.

Familial hypercholesterolemia (FH) is an inherited condition resulting in increased risk of premature cardiovascular disease. This risk can be reduced with early diagnosis and treatment, but it can be challenging to identify individuals with FH. Cascade screening, the most efficient and cost-effective identification method, requires FH patients to communicate with their at-risk family and encourage them to pursue screening. Beyond FH, patients with conditions increasing disease risk to family members report barriers to the communication process such as insufficient knowledge of the condition and discomfort informing relatives. We conducted a pilot study of a genetic counseling intervention incorporating behavior-change principles from motivational interviewing (MI) and the extended parallel process model (EPPM) to help parents of children with FH overcome these barriers and improve cascade screening rates for FH. Of the 13 participants who completed the intervention and post-intervention surveys, 6 reported contacting and/or screening additional relatives. A large effect size in increasing communication and screening was observed (η2  = 0.20), with the mean percent of at-risk relatives contacted rising from 33% to 45%, and the mean percent screened rising from 32% to 42%. On average, 2.23 new relatives were contacted and 2.46 were screened, per participant, by the end of the study. Direct content analysis revealed that despite the open-ended nature of the goal-setting process, participant goals fell into two categories including those who set goals focused on communicating with and screening family members (n = 9) and those who set goals only focused on managing FH (n = 4). Overall, the communication and screening rates reported after the intervention were higher than previous observations in adult FH populations. These results suggest this EPPM/MI genetic counseling intervention could be a useful tool for increasing communication and cascade screening for FH. With further research on goal-setting techniques, the intervention could be refined and replicated to identify more individuals affected by FH or modified for use with other actionable genetic conditions.

Physical behaviors and chronotype in people with type 2 diabetes.

INTRODUCTION: Previous investigations have suggested that evening chronotypes may be more susceptible to obesity-related metabolic alterations. However, whether device-measured physical behaviors differ by chronotype in those with type 2 diabetes (T2DM) remains unknown. RESEARCH DESIGN AND METHODS: This analysis reports data from the ongoing Chronotype of Patients with Type 2 Diabetes and Effect on Glycaemic Control (CODEC) observational study. Eligible participants were recruited from both primary and secondary care settings in the Midlands area, UK. Participants were asked to wear an accelerometer (GENEActiv, ActivInsights, Kimbolton, UK) on their non-dominant wrist for 7 days to quantify different physical behaviors (sleep, sedentary, light, moderate-to-vigorous physical activity (MVPA), intensity gradient, average acceleration and the acceleration above which the most active continuous 2, 10, 30 and 60 min are accumulated). Chronotype preference (morning, intermediate or evening) was assessed using the Morningness-Eveningness Questionnaire. Multiple linear regression analyses assessed whether chronotype preference was associated with physical behaviors and their timing. Evening chronotypes were considered as the reference group. RESULTS: 635 participants were included (age=63.8±8.4 years, 34.6% female, body mass index=30.9±5.1 kg/m2). 25% (n=159) of the cohort were morning chronotypes, 52% (n=330) intermediate and 23% (n=146) evening chronotypes. Evening chronotypes had higher sedentary time (28.7 min/day, 95% CI 8.6 to 48.3) and lower MVPA levels (-9.7 min/day, -14.9 to -4.6) compared to morning chronotypes. The intensity of the most active continuous 2-60 min of the day, average acceleration and intensity gradient were lower in evening chronotypes. The timing of physical behaviors also differed across chronotypes, with evening chronotypes displaying a later sleep onset and consistently later physical activity time. CONCLUSIONS: People with T2DM lead a lifestyle characterized by sedentary behaviors and insufficient MVPA. This may be exacerbated in those with a preference for 'eveningness' (ie, go to bed late and get up late).

Effects of Low-Energy Diet or Exercise on Cardiovascular Function in Working-Age Adults With Type 2 Diabetes: A Prospective, Randomized, Open-Label, Blinded End Point Trial.

OBJECTIVE: To confirm the presence of subclinical cardiovascular dysfunction in working-age adults with type 2 diabetes (T2D) and determine whether this is improved by a low-energy meal replacement diet (MRP) or exercise training. RESEARCH DESIGN AND METHODS: This article reports on a prospective, randomized, open-label, blinded end point trial with nested case-control study. Asymptomatic younger adults with T2D were randomized 1:1:1 to a 12-week intervention of 1) routine care, 2) supervised aerobic exercise training, or 3) a low-energy (∼810 kcal/day) MRP. Participants underwent echocardiography, cardiopulmonary exercise testing, and cardiac magnetic resonance (CMR) at baseline and 12 weeks. The primary outcome was change in left ventricular (LV) peak early diastolic strain rate (PEDSR) as measured by CMR. Healthy volunteers were enrolled for baseline case-control comparison. RESULTS: Eighty-seven participants with T2D (age 51 ± 7 years, HbA1c 7.3 ± 1.1%) and 36 matched control participants were included. At baseline, those with T2D had evidence of diastolic dysfunction (PEDSR 1.01 ± 0.19 vs. 1.10 ± 0.16 s-1, P = 0.02) compared with control participants. Seventy-six participants with T2D completed the trial (30 routine care, 22 exercise, and 24 MRP). The MRP arm lost 13 kg in weight and had improved blood pressure, glycemia, LV mass/volume, and aortic stiffness. The exercise arm had negligible weight loss but increased exercise capacity. PEDSR increased in the exercise arm versus routine care (ß = 0.132, P = 0.002) but did not improve with the MRP (ß = 0.016, P = 0.731). CONCLUSIONS: In asymptomatic working-age adults with T2D, exercise training improved diastolic function. Despite beneficial effects of weight loss on glycemic control, concentric LV remodeling, and aortic stiffness, a low-energy MRP did not improve diastolic function.

Rationale and design of a cross-sectional study to investigate and describe the chronotype of patients with type 2 diabetes and the effect on glycaemic control: the CODEC study.

INTRODUCTION: A person's chronotype is their entrained preference for sleep time within the 24 hours clock. It is described by the well-known concept of the 'lark' (early riser) and 'owl' (late sleeper). Evidence suggests that the 'owl' is metabolically disadvantaged due to the standard organisation of our society which favours the 'lark' and places physiological stresses on this chronotype. The aim of this study is to explore cardiometabolic health between the lark and owl in a population with an established metabolic condition - type 2 diabetes. METHODS: This cross-sectional, multisite study aims to recruit 2247 participants from both secondary and primary care settings. The primary objective is to compare glycaemic control between late and early chronotypes. Secondary objectives include determining if late-chronotype is associated with poorer cardiometabolic health and other lifestyle factors, including well-being, compared with early-chronotype; describing the prevalence of the five different chronotypes in this cohort and examining the trends in glycaemic control, cardiometabolic health, well-being and lifestyle factors across chronotype. ANALYSIS: The primary outcome (glycated haemoglobin (HbA1c)), linear regression analysis will compare HbA1c between early and late chronotypes, with and without adjustment for confounding variables. Chronotype will be modelled as a categorical variable with all five levels (from extreme-morning to extreme-late type), and as a continuous variable to calculate p for trend across the five categories. A number of models will be created; unadjusted through to adjusted with age, sex, ethnicity, body mass index, duration of diabetes, family history of diabetes, current medication and dietary habits. All secondary outcomes will be analysed using the same method. ETHICS: Ethical approval from the West Midlands - Black Country Research Ethics Committee (16/WM/0457). DISSEMINATION: The results will be disseminated through publication in peer-reviewed medical journal, relevant medical/health conferences and a summary report sent to patients. TRIAL REGISTRATION NUMBER: NCT02973412 (Pre-Results).

Rationale, design and study protocol of the randomised controlled trial: Diabetes Interventional Assessment of Slimming or Training tO Lessen Inconspicuous Cardiovascular Dysfunction (the DIASTOLIC study).

INTRODUCTION: Despite their young age and relatively short duration of disease, younger adults with type 2 diabetes (T2D) already have diastolic dysfunction and may be at risk of incipient heart failure. Whether weight loss or exercise training improve cardiac dysfunction in people with T2D remains to be established. METHODS AND ANALYSIS: Prospective, randomised, open-label, blind endpoint trial. The primary aim of the study is to determine if diastolic function can be improved by either a meal replacement plan or a supervised exercise programme, compared with guideline-directed care. A total of 90 obese participants with T2D (aged 18-65 years), diabetes duration <12 years and not on insulin treatment will be randomised to either guideline-directed clinical care with lifestyle coaching, a low-energy meal replacement diet (average ≈810 kcal/day) or a supervised exercise programme for 12 weeks. Participants undergo glycometabolic profiling, cardiopulmonary exercise testing, echocardiography and MRI scanning to assesses cardiac structure and function and dual-energy X-ray absorptiometry scanning for body composition. Key secondary aims are to assess the effects of the interventions on glycaemic control and insulin resistance, exercise capacity, blood pressure, changes in body composition and association of favourable cardiac remodelling with improvements in weight loss, exercise capacity and glycometabolic control. ETHICS AND DISSEMINATION: The study has full ethical approval, and data collection was completed in August 2018. The study results will be submitted for publication within 6 months of completion. TRIAL REGISTRATION NUMBER: NCT02590822; Pre-results.

Efficacy of low- and very-low-energy diets in people with type 2 diabetes mellitus: A systematic review and meta-analysis of interventional studies.

AIMS: To review systematically and quantify the weight loss achieved through low- (LEDs) and very-low-energy diets (VLEDs) in people with type 2 diabetes mellitus (T2DM). MATERIALS AND METHODS: Studies reporting the effects of diet-only interventions of up to 1600 kcal/d in people with T2DM were searched in MEDLINE, EMBASE and CINAHL up to July 2018. Changes in the primary (body weight and body mass index [BMI]) and secondary outcomes (glycated haemoglobin, blood lipids) according to energy restriction and duration of diet were modelled using restricted cubic splines. RESULTS: Forty-four studies (3817 participants) were included. The overall quality of the evidence was moderate and limited to short-term interventions up to 4 months. Baseline mean weight and BMI were 92.1 kg and 36.6 kg/m2 . VLEDs of 400 kcal/d led to 5.4% weight loss at 2 weeks, increasing to 17.9% at 3 months. More modest reductions of 7.3% were observed on LEDs of 1200 kcal/d and 2.0% on 1600 kcal/d after 3 months. No clear patterns emerged for secondary outcomes. Publication bias was significant for primary outcomes. CONCLUSIONS: Through modelling, we were able to describe effective dietary deficit strategies to achieve weight reduction up to 4 months in people with T2DM. High-quality studies are required to further support clinical practice with evidence-based dietary interventions.

Movement through Active Personalised engagement (MAP) - a self-management programme designed to promote physical activity in people with multimorbidity: study protocol for a randomised controlled trial.

BACKGROUND: Multimorbidity, defined as two or more concurrent chronic diseases within the same individual, is becoming the clinical norm within primary care. Given the burden of multimorbidity on individuals, carers and health care systems, there is a need for effective self-management programmes. Promoting active participation within their clinical care and following a healthy lifestyle will help empower patients and target lifestyle factors that are exacerbating their conditions. The aim of this study is to establish whether a tailored, structured self-management programme can improve levels of physical activity at 12 months, in people with multimorbidity. METHODS/DESIGN: This study is a single-centre randomised controlled trial, with follow-up at 6 and 12 months. The primary outcome is change in objectively assessed average daily physical activity at 12 months. Secondary outcomes include medication adherence, lifestyle behaviours, quality of life, chronic disease self-efficacy and self-efficacy for exercise. Anthropometric and clinical measurements include blood pressure, muscle strength, lipid profile, kidney function and glycated haemoglobin (HbA1c). Participants are recruited from primary care. Those between 40 and 85 years of age with multimorbidity, with a good understanding of written and verbal English, who are able to give informed consent, have access to a mobile phone for use in study activities and are able to walk independently will be invited to participate. Multimorbidity is defined as two or more of the chronic conditions listed in the Quality and Outcomes Framework. A total of 338 participants will be randomly assigned, with stratification for gender and ethnicity, to either the control group, receiving usual care, or the intervention group, who are invited to the Movement through Active Personalised engagement programme. This involves attending four group-based self-management sessions aimed at increasing physical activity, mastering emotions, managing treatments and using effective communication. The sessions are delivered by trained facilitators, and regular text messages during the study period provide ongoing support. Changes in primary and secondary outcomes will be assessed, and an economic evaluation of the intervention undertaken. DISCUSSION: This study will provide new evidence on whether physical activity can be promoted alongside other self-management strategies in a multimorbid population and whether this leads to improvements in clinical, biomedical, psychological and quality of life outcomes. TRIAL REGISTRATION: ISRCTN, ISRCTN 42791781 . Registered on 14 March 2017.

Effects of short-term energy restriction on liver lipid content and inflammatory status in severely obese adults: Results of a randomized controlled trial using 2 dietary approaches.

Short-term very-low-energy diets (VLEDs) are used in clinical practice prior to bariatric surgery, but regimens vary and outcomes of a short intervention are unclear. We examined the effect of 2 VLEDs, a food-based diet (FD) and a meal-replacement plan (MRP; LighterLife UK Limited, Harlow, UK), over the course of 2 weeks in a randomized controlled trial. We collected clinical and anthropometric data, fasting blood samples, and dietary evaluation questionnaires. Surgeons took liver biopsies and made a visual assessment of the liver. We enrolled 60 participants of whom 54 completed the study (FD, n = 26; MRP, n = 28). Baseline demographic features, reported energy intake, dietary evaluation and liver histology were similar in the 2 groups. Both diets induced significant weight loss. Perceived difficulty of surgery correlated significantly with the degree of steatosis on histology. There were reductions in the circulating inflammatory mediators C-reactive protein, fetuin-A and interleukin-6 between baseline (pre-diet) and post-diet. The diets achieved similar weight loss and reduction in inflammatory biomarkers. There were no significant differences in perceived operative difficulty or between patients' evaluation of diet satisfaction, ease of use or hunger frequency. Non-alcoholic fatty liver disease histology assessments post-diet were also not significantly different between diets. The results of this study show the effectiveness of short-term VLEDs and energy restriction, irrespective of macronutrient composition, although the small sample size precluded detection of subtle differences between interventions.

Pre-operative dietary restriction for patients undergoing bariatric surgery in the UK: observational study of current practice and dietary effects.

BACKGROUND: Bariatric surgery is effective at achieving weight loss in the severely obese, with the majority of procedures performed laparoscopically. A short-term pre-operative energy restrictive diet is widely adopted to enable surgery by reducing liver size and improving liver flexibility. However, the dietary approach is not standardised. This observational study reports on pre-operative restrictive diets in use across bariatric services in the UK. METHODS: Between September and November 2012, information was collected from bariatric services on current or past pre-operative diets, and any research providing evidence for the use or modification of their diets. RESULTS: Around one third of bariatric services (28) in the UK responded, with a total of 49 diets in current use. Types of diet include low energy, low carbohydrate and liquid, with 59 % offering low energy/low carbohydrate food-based, 21 % milk/yoghurt, 18 % meal replacement (liquid) and 2 % clear liquid. Diet duration varies between 7 and 42 days. Limited anecdotal evidence was provided by services evaluating the pre-operative diet, and its alternative approaches, with dietary choice primarily clinician-led. CONCLUSIONS: This study has highlighted variability and lack of consensus in the form of pre-bariatric surgery diet used across different centres. Further research comparing outcomes for alternative diets would support best practice in the future.