Diseño de dietas alimentarias para soldadores y paileros a partir de su gasto energético / Design of food diets for welders and smiths based on their energy expenditure

RESUMEN Introducción: el desempeño laboral en algunos puestos de trabajo, determina un alto nivel de carga física por parte de los trabajadores, por lo que se impone la necesidad de disponer de una adecuada dieta alimentaria para mantener la salud física y mental. Objetivo: se desarrolló una investigación para diseñar una dieta alimentaria para soldadores y paileros a partir del gasto energético en actividades laborales. Materiales y métodos: se realizó un estudio de campo que partió de una muestra no probabilística de soldadores y paileros de la Empresa Industrial Ferroviaria José Valdés Reyes. Se ejecutó un procedimiento que permitió la determinación de la dieta alimentaria de los trabajadores a partir del gasto energético de las actividades que desarrollan. Se aplicaron ciertas técnicas de observación directa, entrevistas, tormenta de ideas, medición directa de variables fisiológicas y ecuaciones para el cálculo del gasto energético. Resultados: se diseñaron tres variantes de dietas ajustadas al gasto energético de tres puestos de trabajo de la mencionada empresa. Conclusiones: se espera que la aplicación de las dietas diseñadas contribuya a mantener una buena salud de los trabajadores de esos puestos de trabajo (AU).

ABSTRACT Introduction: the working performance of certain jobs determines a high level of physical load from the part of the workers, for what the necessity is imposed of having an appropriate food diet to preserve the physical and mental health. Objective: to design a food diet for welders and smiths starting from the energy expense in working activities. Materials and methods: a field study was carried out starting from a probabilistic sample of welders and smiths from the Industrial Railroad Enterprise Jose Valdes Reyes. A procedure was performed allowing to determine the energy expenditure of the activities they develop. Several techniques like direct observation, interviews, brain storm, direct measure of physiological variable and equations were used to calculate the energy expenditure. Results: three diet variants were designed adjusted to the energy expenditure of the three working places of the before mentioned enterprise. Conclusions: it is expected the application of the designed diets will contribute to keeping good health of the workers in those working places (AU).

Modelling the Cost-Effectiveness of Implementing a Dietary Intervention in Renal Transplant Recipients.

BACKGROUND: The Dietary Approach to Stop Hypertension (DASH) and potassium supplementation have been shown to reduce the risk of death with a functioning graft (DWFG) and renal graft failure in renal transplant recipients (RTR). Unfortunately, a key problem for patients is the adherence to these diets. The aim of this study is to evaluate the cost-effectiveness and budget impact of higher adherence to either the DASH or potassium supplementation. METHODS: A Markov model was used to simulate the life course of 1000 RTR in the Netherlands. A societal perspective with a lifetime time horizon was used. The potential effect of improvement of dietary adherence was modelled in different scenarios. The primary outcomes are the incremental cost-effectiveness ratio (ICER) and the budget impact. RESULTS: In the base case, improved adherence to the DASH diet saved 27,934,786 and gained 1880 quality-adjusted life years (QALYs). Improved adherence to potassium supplementation saved €1,217,803 and gained 2901 QALYs. Both resulted in dominant ICERs. The budget impact over a five-year period for the entire Dutch RTR population was €8,144,693. CONCLUSION: Improving dietary adherence in RTR is likely to be cost-saving and highly likely to be cost-effective compared to the current standard of care in the Netherlands.

A Systematic Review of Cost-Effectiveness Studies of Interventions With a Personalized Nutrition Component in Adults.

OBJECTIVES: Important links between dietary patterns and diseases have been widely applied to establish nutrition interventions. However, knowledge about between-person heterogeneity regarding the benefits of nutrition intervention can be used to personalize the intervention and thereby improve health outcomes and efficiency. We performed a systematic review of cost-effectiveness analyses (CEAs) of interventions with a personalized nutrition (PN) component to assess their methodology and findings. METHODS: A systematic search (March 2019) was performed in 5 databases: EMBASE, Medline Ovid, Web of Science, Cochrane CENTRAL, and Google Scholar. CEAs involving interventions in adults with a PN component were included; CEAs focusing on clinical nutrition or undernutrition were excluded. The CHEERS checklist was used to assess the quality of CEAs. RESULTS: We identified 49 eligible studies among 1792 unique records. Substantial variation in methodology was found. Most studies (91%) focused only on psychological concepts of PN such as behavior and preferences. Thirty-four CEAs were trial-based, 13 were modeling studies, and 4 studies were both trial- and model-based. Thirty-two studies used quality-adjusted life year as an outcome measure. Different time horizons, comparators, and modeling assumptions were applied, leading to differences in costs/quality-adjusted life years. Twenty-eight CEAs (49%) concluded that the intervention was cost-effective, and 75% of the incremental cost-utility ratios were cost-effective given a willingness-to-pay threshold of $50 000 per quality-adjusted life year. CONCLUSIONS: Interventions with PN components are often evaluated using various types of models. However, most PN interventions have been considered cost-effective. More studies should examine the cost-effectiveness of PN interventions that combine psychological and biological concepts of personalization.

Exercise-induced muscle damage: mechanism, assessment and nutritional factors to accelerate recovery.

There have been a multitude of reviews written on exercise-induced muscle damage (EIMD) and recovery. EIMD is a complex area of study as there are a host of factors such as sex, age, nutrition, fitness level, genetics and familiarity with exercise task, which influence the magnitude of performance decrement and the time course of recovery following EIMD. In addition, many reviews on recovery from exercise have ranged from the impact of nutritional strategies and recovery modalities, to complex mechanistic examination of various immune and endocrine signaling molecules. No one review can adequately address this broad array of study. Thus, in this present review, we aim to examine EIMD emanating from both endurance exercise and resistance exercise training in recreational and competitive athletes and shed light on nutritional strategies that can enhance and accelerate recovery following EIMD. In addition, the evaluation of EIMD and recovery from exercise is often complicated and conclusions often depend of the specific mode of assessment. As such, the focus of this review is also directed at the available techniques used to assess EIMD.

The Impact of Dietary Modifications and Medical Management on 24-Hour Urinary Metabolic Profiles and the Status of Renal Stone Disease in Recurrent Stone Formers.

BACKGROUND: Dietary modifications and patient-tailored medical management are significant in controlling renal stone disease. Nevertheless, the literature regarding effectiveness is sparse. OBJECTIVES: To explore the impact of dietary modifications and medical management on 24-hour urinary metabolic profiles (UMP) and renal stone status in recurrent kidney stone formers. METHODS: We reviewed our prospective registry database of patients treated for nephrolithiasis. Data included age, sex, 24-hour UMP, and stone burden before treatment. Under individual treatment, patients were followed at 6-8 month intervals with repeat 24-hour UMP and radiographic images. Nephrolithiasis-related events (e.g., surgery, renal colic) were also recorded. We included patients with established long-term follow-up prior to the initiation of designated treatment, comparing individual nephrolithiasis status before and after treatment initiation. RESULTS: Inclusion criteria were met by 44 patients. Median age at treatment start was 60.5 (50.2-70.2) years. Male:Female ratio was 3.9:1. Median follow-up was 10 (6-25) years and 5 (3-6) years before and after initiation of medical and dietary treatment, respectively. Metabolic abnormalities detected included: hypocitraturia (95.5%), low urine volume (56.8%), hypercalciuria (45.5%), hyperoxaluria (40.9%), and hyperuricosuria (13.6%). Repeat 24-hour UMP under appropriate diet and medical treatment revealed a progressive increase in citrate levels compared to baseline and significantly decreased calcium levels (P = 0.001 and 0.03, respectively). A significant decrease was observed in stone burden (P = 0.001) and overall nephrolithiasis-related events. CONCLUSIONS: Dietary modifications and medical management significantly aid in correcting urinary metabolic abnormalities. Consequently, reduced nehprolithiasis-related events and better stone burden control is expected.

Associations of Intensive Lifestyle Intervention in Type 2 Diabetes With Health Care Use, Spending, and Disability: An Ancillary Study of the Look AHEAD Study.

Importance: Intensive lifestyle interventions focused on diet and exercise can reduce weight and improve diabetes management. However, the long-term effects on health care use and spending are unclear, especially for public payers. Objective: To estimate the association of effective intensive lifestyle intervention for weight loss with long-term health care use and Medicare spending. Design, Setting, and Participants: This ancillary study used data from the Look AHEAD randomized clinical trial, which randomized participants with type 2 diabetes to an intensive lifestyle intervention or control group (ie, diabetes support and education), provided ongoing intervention from 2001 to 2012, and demonstrated improved diabetes management and reduced health care costs during the intervention. This study compared Medicare data between study arms from 2012 to 2015 to determine whether the intervention was associated with persistent reductions in health care spending. Exposure: Starting in 2001, Look AHEAD's intervention group participated in sessions with lifestyle counselors, dieticians, exercise specialists, and behavioral therapists with the goal of reducing weight 7% in the first year. Sessions occurred weekly in the first 6 months of the intervention and decreased over the intervention period. The controls participated in periodic group education sessions that occurred 3 times per year in the first year and decreased to 1 time per year later in the trial. Main Outcomes and Measures: Outcomes included total Medicare spending, Part D prescription drug costs, Part A and Part B Medicare spending, hospital admissions, emergency department visits, and disability-related Medicare eligibility. Results: This study matched Medicare administrative records for 2796 Look AHEAD study participants (54% of 5145 participants initially randomized and 86% of 3246 participants consenting to linkages). Linked intervention and control participants were of a similar age (mean [SD] age, 59.6 [5.4] years vs 59.6 [5.5] years at randomization) and sex (818 [58.1%] women vs 822 [59.3%] women). There was no statistically significant difference in total Medicare spending between groups (difference, -$133 [95% CI, -$1946 to $1681]; P = .89). In the intervention group, compared with the control group, there was statistically significantly higher Part B spending (difference, $513 [95% CI, $70 to $955]; P = .02) but lower prescription drug costs (difference, -$803 [95% CI, -$1522 to -$83]; P = .03). Conclusions and Relevance: This ancillary study of a randomized clinical trial found that reductions in health care use and spending associated with an intensive lifestyle intervention for type 2 diabetes diminished as participants aged. Intensive lifestyle interventions may need to be sustained to reduce long-term health care spending. Trial Registration: ClinicalTrials.gov Identifier: NCT03952728.

Brief Hospital Supervision of Exercise and Diet During Adjuvant Breast Cancer Therapy Is Not Enough to Relieve Fatigue: A Multicenter Randomized Controlled Trial.

Supervised exercise dietary programs are recommended to relieve cancer-related fatigue and weight increase induced by adjuvant treatment of early breast cancer (EBC). As this recommendation lacks a high level of evidence, we designed a multicenter randomized trial to evaluate the impact of an Adapted Physical Activity Diet (APAD) education program on fatigue. We randomized 360 women with EBC who were receiving adjuvant chemotherapy and radiotherapy to APAD or usual care at eight French cancer institutions. Data were collected at baseline, end of chemotherapy, end of radiotherapy, and 6 months post-treatment. The primary endpoint was the general cancer-related fatigue score using the MFI-20 questionnaire. Fatigue correlated with the level of precariousness, but we found no significant difference between the two groups in terms of general fatigue (p = 0.274). The APAD arm has a smaller proportion of patients with confirmed depression at the end of follow-up (p = 0.052). A transient modification in physical activity levels and dietary intake was reported in the experimental arm. However, a mixed hospital- and home-based APAD education program is not enough to improve fatigue caused by adjuvant treatment of EBC. Cancer care centers should consider integrating more proactive diet-exercise supportive care in this population, focusing on precarious patients.

Cost-effectiveness of 12 weeks of supervised treatment compared to written advice in patients with knee osteoarthritis: a secondary analysis of the 2-year outcome from a randomized trial.

OBJECTIVE: To assess the 24-month cost-effectiveness of supervised treatment compared to written advice in knee osteoarthritis (OA). DESIGN: 100 adults with moderate-severe OA not eligible for total knee replacement (TKR) randomized to a 12-week individualized, supervised treatment (exercise, education, diet, insoles and pain medication) or written advice. Effectiveness was measured as change in quality-adjusted life years (QALYs) from baseline to 24 months, including data from baseline, 3, 6, 12 and 24 months, while healthcare costs and transfer payments were derived from national registries after final follow-up. Incremental costs, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs) were calculated. A sensitivity analysis resampling existing data was conducted and the probability of cost-effectiveness was estimated using a 22,665 Euros/QALY threshold. In a sensitivity analysis, cost-effectiveness was calculated for different costs of the supervised treatment (actual cost in study; cost in private practice; and in-between cost). RESULTS: Average costs were similar between groups (6,758 Euros vs 6,880 Euros), while the supervised treatment were close to being more effective (incremental effect (95% CI) of 0.075 (-0.005 to 0.156). In the primary analysis excluding deaths, this led the supervised treatment to be cost-effective, compared to written advice. The sensitivity analysis demonstrated that the results were sensitive to changes in the cost of treatment, but in all scenarios the supervised treatment was cost-effective (ICERs of 6,229 to 20,688 Euros/QALY). CONCLUSIONS: From a 24-month perspective, a 12-week individualized, supervised treatment program is cost-effective compared to written advice in patients with moderate-severe knee OA not eligible for TKR. TRIAL REGISTRATION: ClinicalTrials.gov number: NCT01535001.

Validity and Reliability of the Reflux Sign Assessment.

OBJECTIVE: To develop and validate the Reflux Sign Assessment (RSA), a clinical instrument evaluating the physical findings of laryngopharyngeal reflux (LPR). METHODS: A total of 106 patients completed a 3-month treatment based on the association of diet, pantoprazole, alginate, or magaldrate with the LPR characteristics (acid, nonacid, mixed). Forty-two asymptomatic individuals completed the study (control group). The RSA results and reflux finding score (RFS) were documented for the LPR patients at baseline and after treatment. Intrarater reliability was assessed through a test-retest blinded evaluation of signs (7-day intervals). Interrater reliability was assessed by comparing the RSA evaluations of three blinded otolaryngologists through Kendall's W. Responsiveness to change was evaluated through a comparison of the baseline and 3-month posttreatment findings. The RSA cutoffs for determining the presence and absence of LPR were examined by receiver operating characteristic (ROC) analysis. RESULTS: A total of 102 LPR patients completed the study (68 females). The mean age was 53 years. The mean RSA at baseline was 25.95 ± 9.58; it significantly improved to 18.96 ± 7.58 after 3 months of therapy (P < .001). RSA exhibited good intra- (r = 0.813) and interrater (Kendall's W = 0.663) reliabilities (N = 56). There was no significant association between the RSA, gastrointestinal endoscopy findings, and the types of reflux (acid, nonacid, or mixed) according to impedance-pH monitoring. An RSA >14 may be suggestive of LPR. CONCLUSION: The RSA is a complete clinical instrument evaluating both laryngeal and extralaryngeal findings associated with LPR. The RSA demonstrated high intra- and interrater reliabilities and responsiveness to change.

Assessment of selected food intake frequency in patients with type 1 diabetes treated with personal insulin pumps

Background: It has been established that in Type 1 Diabetes Mellitus (T1DM), regardless of the insulin therapy model used, diet and proper eating habits are still important in the treatment of the disease. The dietary intervention in these patients is aimed at maintaining proper body weight, obtaining target fasting and post meal blood glucose levels, optimizing lipid profiles. Objective: The aim of the study was to assess dietary habits in a homogeneous group of adults with T1DM treated with personal insulin pumps. Material and methods: The study included 141 adult patients (57% women) with type 1 diabetes treated with personal insulin pumps. The surveyed population was characterized by an average age of 25.8 ± 6.2 years, an average duration of diabetes 13.9 ± 6.9 years, and treatment with a personal pump for 8.2 ± 4.1 years and mean BMI 23.0 ± 2.8 g/m2. All were dwellers of south-eastern Poland. The validated KomPAN questionnaire was used to assess the frequency of consumption of individual food products. Results: The mean percentage of HbA1c in the study group was 7.3% [56 mmol/mol]. The mean total cholesterol level was 4.4 mmol/l, HDL - 1.7 mmol/l, LDL - 2.3 mmol/l and triglycerides - 0.8 mmol/l. In the multivariate regression model, no correlation was found between dietary quality parameters and metabolic compensation measured with HbA1c or lipidogram and the place of residence (village, small town, big city). However, there were differences in the quality of the diet depending on the sex. Women were characterized by higher index of a healthy diet (pHDI-10) (26.3 vs 21.4, p=0.005) and lower index of unhealthy diet (nHDI-14) (13.3 vs 18.6, p <0.001) than men. Conclusions: The results of this study clearly suggest, that despite good metabolic control, patients require more education on the choice of healthy product groups.

Effectiveness of Low Glycemic Index Diet Consultations Through a Diet Glycemic Assessment App Tool on Maternal and Neonatal Insulin Resistance: A Randomized Controlled Trial.

BACKGROUND: Low glycemic index (LGI) diet has shown to be effective in reducing maternal and neonatal complications in high-risk pregnancies. OBJECTIVE: This trial aimed to examine the effectiveness of individualized LGI diet consultations based on the accurate diet glycemic load (GL) assessment tool on maternal and neonatal insulin resistance levels and diet behavior changes in overweight and obese pregnant women. METHODS: Overweight and obese pregnant women were recruited before 16 weeks of gestation and randomized to the LGI diet arm or the control arm. All participants received standard dietary education according to the Chinese Dietary Guide for Pregnant Women. In the intervention arm, additional individualized dietary GL assessments were performed using an app and instructions of lowering diet glycemic index (GI) to achieve LGI diet were provided by a clinical dietitian at early, middle, and late gestation. Primary outcomes were serum insulin at late gestation, incidence of gestational diabetes mellitus (GDM) for mothers, and cord blood C-peptide level of neonates. RESULTS: In total, 400 subjects were randomized and received different interventions. There were no significant differences in maternal serum insulin levels (13.2 [9.3-13.2] uU/mL vs 12.4 [10.5-12.4] uU/mL), incidence of GDM (45 [22.5%] vs 43 [21.5%]), or cord blood C-peptide levels (mean 0.9ng/mL [SD 0.7] vs mean 0.8ng/mL [SD 0.6]) in the intervention group compared with the controls. The diet GI at late gestation was similar (mean 63.2 [SD 10.4] vs mean 64.3 [SD 10.4]), whereas greater diet fiber intake was observed in the intervention group (mean 11.6 grams [SD 8.0] vs mean 9.0 grams [SD 5.6]; P=.006). Adherence measurements did not significantly differ between 2 groups. CONCLUSIONS: Individualized LGI diet consultations for overweight and obese pregnant women failed to make a significant difference in maternal or neonatal insulin resistance compared with the standard gestational diet consultation. TRIAL REGISTRATION: ClinicalTrials.gov NCT01628835; http://clinicaltrials.gov/ct2/show/NCT01628835 (Archived by WebCite at http://www.webcitation.org/77LHgWP0k).

Assessment of a Multidisciplinary Intervention in Patients With BMI ≥35 kg/m2 and Recently Diagnosed Type 2 Diabetes.

CONTEXT: Patients with a body mass index (BMI) ≥35 kg/m2 have lower benefits with intensive treatments and metabolic control goals are more difficult to reach. OBJECTIVE: Evaluate the effect of a comprehensive care program in patients with a BMI ≥35 kg/m2. DESIGN: Prospective cohort study. SETTING: Comprehensive Care Center in a National Institute of Health. PATIENTS: Patients with type 2 diabetes, ≤5 years of diagnosis, without disabling complications, nonsmokers, and a BMI <45 kg/m2. INTERVENTIONS: Exercise and nutritional interventions are modified for patients with a higher BMI to achieve metabolic control. MAIN OUTCOME MEASURES: Main outcome is achievement of treatment goals defined as HbA1c <7%, low-density lipoprotein cholesterol (LDL-c) <100 mg/dL, and blood pressure <130/80 mm Hg. Secondary measures were the percentage of patients achieving three metabolic goals. RESULTS: A total of 587 patients with annual evaluation were included. Mean age was 55.3 ± 9.5 years, 56.6% women, time since diagnosis of 1 year (0 to 5). BMI <35 kg/m2 group included 521 patients and BMI ≥35 kg/m2 group included 66 patients. In the BMI ≥35 kg/m2 group, we observed a greater decrease in weight and fat mass at 3 months compared with <35 kg/m2 group, but the HbA1c, LDL-c, or blood pressure goals were similar at 3 months and 1 year between groups. CONCLUSIONS: Comprehensive interventions are equally effective in patients with recently diagnosed type 2 diabetes with BMI ≥35 kg/m2 compared with patients with a lower BMI.

The Unregulated Probiotic Market.

BACKGROUND & AIMS: This narrative review provides an overview of the current regulation of probiotics, with a focus on those used for the dietary management of medical conditions (Medical Foods). FINDINGS: The probiotic market has grown rapidly, both for foods and supplements intended to enhance wellness in healthy individuals, and for preparations for the dietary management of disease. Regulation of probiotics varies between regions. Unless they make specific disease-related health claims, probiotics are regulated as food supplements and regulation is focused on the legitimacy of any claims, rather than efficacy, safety and quality. Many properties of probiotics are strain-specific, and safety and efficacy findings associated to specific formulations should not be generalized to other probiotic products. Manufacturing processes, conditions and ingredients are important determinants of product characteristics and changes to manufacturing are likely to give rise to a product not identical to the "original" in efficacy and safety if proper measures and controls are not taken. Current trademark law and the lack of stringent regulation of probiotic manufacturing mean that the trademark owner can commercialize any formulation under the same brand, even if significantly different from the original. These regulatory deficits may have serious consequences for patients where probiotics are used as part of clinical guideline-recommended management of serious conditions such as inflammatory bowel diseases, and may make doctors liable for prescribing a formulation not previously tested for safety and efficacy. CONCLUSIONS: Current regulation of probiotics is inadequate to protect consumers and doctors, especially when probiotics are aimed at the dietary management of serious conditions.

Investigating Information Needs of Saudi Diabetic Patients.

BACKGROUND: Studies have shown that newly diagnosed diabetic patients need a lot of information about medical examinations, checkups, tests and precautions for its control besides its disastrous effects on heart, kidneys, eyes, foot and nerves. Patients in Saudi Arabia are generally not aware of most of the information they may need which is one the major reasons for its increasing number of patients. Past studies conducted are based on clinical data of hospitals and healthcare centers only discussed its effects. METHODS: Present research was conducted through a survey questionnaire in the Arabic language from Type 1 and Type 2 patients to establish if they knew about this disease and its criticality in the day to day activities and were they being provided sufficient information about its requirements. Data for checkups, tests, management by food and nutrition and physical activity education were collected for this purpose. Approximately 25% female and 33% male patients reported that diabetes affected their day to day activities. RESULTS: Analysis of results showed that awareness of importance of tests including blood glucose level test HbA1c was only among 50% patients, 51% Type 1 did not have cholesterol test, 31% Type 1 and 16% Type 2 % never had eye test, 97% Type 1 and 60% Type 2 were unaware of barefoot examination, 34% Type 1 and 70% Type 2 never went to a dietician to ascertain their nutrition needs, 24% Type 2 did not know importance of exercise for diabetes control. CONCLUSION: It was concluded that Saudi patients suffering from diabetes seriously lacked information about its monitoring, control and treatment in form of tests to be conducted and requirements of diet control and physical activities. Therefore, a national level awareness campaign for providing this information could be considered as a key requirement.

Assessment of Quality and Readability of Internet Dietary Information on Irritable Bowel Syndrome.

Diet plays an important role for patients with irritable bowel syndrome (IBS). For medical conditions such as IBS, the Internet is a primary source of health information.1 However, recent evidence suggests that Internet health information may have several flaws including being extremely discrepant, of poor quality, and inaccurate.2 Therefore, our objectives were to evaluate both the quality and reading level of Internet dietary recommendations for both pediatric and adult IBS.

How do patients and carers make sense of renal dietary advice? A qualitative exploration.

BACKGROUND: Dietary modification is an integral part of chronic kidney disease (CKD) management. However, adherence to the renal diet is often suboptimal. METHODS: The aims of this study were to (i) describe the experiences of patients with CKD and their carers in their process of interpreting and implementing renal dietary advice; (ii) to explore strategies they used to make sense of and apply renal diet information and (iii) to develop recommendations for improved clinical practice. To achieve these aims, individual semi-structured interviews with 26 patients and 10 carers were conducted, using interview questions guided by Sensemaking theory. FINDINGS: Six themes emerged from the data which did not differ according to CKD stage, geographic location or renal replacement therapy (RRT) type. The renal diet was perceived by patients and carers to be overwhelming, frustrating and emotionally demanding; as well as being complex and challenging. To help make sense of and apply renal dietary advice, participants highly valued the input of the dietitian; and patients believed that their carer support was important. Individual problem-solving strategies were developed by participants to help them make sense of the renal diet, and many of them expressed a desire for additional resources and/or support. CONCLUSIONS: This study highlights that learning to make sense of renal diet information is an emotionally challenging journey for patients and carers. In addition to utilising the expertise of dietitians, carer support was perceived to be integral to learning and using renal dietary advice. The study describes a number of important problem-solving strategies utilised by patients and carers, as well as recommendations to help improve sensemaking and adherence to the renal diet.

Design and participant characteristics of a primary care adaptation of the Look AHEAD Lifestyle Intervention for weight loss in type 2 diabetes: The REAL HEALTH-diabetes study.

BACKGROUND/AIMS: The REAL HEALTH -Diabetes Study is a practice-based clinical trial that adapted the Look AHEAD lifestyle intervention for implementation in primary care settings. The trial will compare the effectiveness and cost-effectiveness of in-person group lifestyle intervention, telephone group lifestyle intervention, and individual medical nutrition therapy (MNT), the current recommended standard of care in type 2 diabetes. The primary outcome is percent weight loss at 6 months with outcomes also measured at 12, 18, 24 (intervention completion), and 36 months. Here, we describe the adaptation, trial design, implementation strategies, and baseline characteristics of enrolled participants. METHODS: The study is a three-arm, patient-level, randomized trial conducted in three community health centers (CHCs) and one diabetes practice affiliated with one academic medical center. RESULTS: The study used existing clinical infrastructure to recruit participants from study sites. Strategies for successful conduct of the trial included partnering with health-center based co-investigator clinicians, engaging primary care providers, and accommodating clinical workflows. Of 248 eligible patients who attended a screening visit, 211 enrolled, with 70 randomly assigned to in-person group lifestyle intervention, 72 to telephone group lifestyle intervention, and 69 to MNT. The cohort was 55% female, 29% non-white, with mean age 62 years and mean BMI 35 kg/m2. Enrollment rates were higher at CHC sites. CONCLUSIONS: A practice-based randomized trial of a complex behavioral lifestyle intervention for type 2 diabetes can be implemented in community health and usual clinical settings. Participant and provider engagement was higher at local CHC sites reflecting the study implementation focus. CLINICAL TRIAL REGISTRATION: NCT02320253.