Diversity of plant DNA in stool is linked to dietary quality, age, and household income.

Eating a varied diet is a central tenet of good nutrition. Here, we develop a molecular tool to quantify human dietary plant diversity by applying DNA metabarcoding with the chloroplast trnL-P6 marker to 1,029 fecal samples from 324 participants across two interventional feeding studies and three observational cohorts. The number of plant taxa per sample (plant metabarcoding richness or pMR) correlated with recorded intakes in interventional diets and with indices calculated from a food frequency questionnaire in typical diets (ρ = 0.40 to 0.63). In adolescents unable to collect validated dietary survey data, trnL metabarcoding detected 111 plant taxa, with 86 consumed by more than one individual and four (wheat, chocolate, corn, and potato family) consumed by >70% of individuals. Adolescent pMR was associated with age and household income, replicating prior epidemiologic findings. Overall, trnL metabarcoding promises an objective and accurate measure of the number and types of plants consumed that is applicable to diverse human populations.

Does Medically Supervised Weight Loss Prior to Total Knee Arthroplasty Improve Patient-Reported Pain and Physical Function?

BACKGROUND: Weight loss is commonly recommended before total knee arthroplasty (TKA) despite inconsistent evidence for better outcomes. This study sought to examine the impacts of preoperative weight loss on patient-reported and adverse outcomes among TKA patients supervised by a medical weight management clinic. METHODS: This study retrospectively analyzed patients who underwent medical weight management supervision within 18 months before TKA comparing patients who did and did not have clinically relevant weight loss. Preoperative body mass indices, demographics, Patient-Reported Outcomes Measurement Information System physical function and pain interference scores, pain intensity scores, and adverse outcomes were extracted. Multivariable linear regressions were performed to determine if preoperative weight loss correlated with patient-reported outcomes after controlling for confounders. RESULTS: There were 90 patients, 75.6% women, who had a mean age of 65 years (range, 42-82) and were analyzed. There were 51 (56.7%) patients who underwent clinically relevant weight loss with a mean weight loss of 10.4% and experienced no difference in adverse outcomes. Preoperative weight loss predicted significantly improved 3-month postoperative physical function (ß = 15.2 [13.0-17.3], P < .001), but not pain interference (ß = -18.9 [-57.1-19.4], P = .215) or pain intensity (ß = -1.8 [-4.9-1.2], P = .222) scores. CONCLUSION: We found that medically supervised preoperative weight loss predicted improvement in physical function 3 months after TKA. This weight loss caused no major adverse effects. Further research is needed to understand the causal relationships between preoperative weight loss, medical supervision, and outcome after TKA and to elucidate potential longer-term benefits in a larger sample.

Does Preoperative Weight Loss Within 6 Months or 1 Year Change the Risk of Adverse Outcomes in Total Knee Arthroplasty by Initial Body Mass Index Classification?

BACKGROUND: High body mass index (BMI) is associated with adverse outcomes after total knee arthroplasty (TKA). Thus, many patients are advised to lose weight before TKA. This study examined how weight loss before TKA is associated with adverse outcomes depending on patients' initial BMI. METHODS: This was a retrospective study of 2,110 primary TKAs at a single academic center. Data on preoperative BMIs, demographics, comorbidities, and incidences of revision or prosthetic joint infection (PJI) were obtained. Multivariable logistic regressions segmented by patients' initial (1-year preoperative) BMI classifications were performed to determine if a > 5% BMI decrease from 1 year or 6 months preoperatively predicted PJI and revision controlling for patient age, race, sex, and Elixhauser comorbidity index. RESULTS: Preoperative weight loss did not predict adverse outcomes for patients who had Obesity Class II or III. 6-month weight loss had greater odds of adverse outcomes than 1-year weight loss and most significantly predicted the occurrence of 1-year PJI (adjusted odds ratio: 6.55, P < .001) for patients who had Obesity Class 1 or lower. CONCLUSION: This study does not show a statistically significant effect to patients who had Obesity Class II and III losing weight preoperatively with respect to PJI or revision. For patients who have Obesity Class I or lower pursuing TKA, future research should consider potential risks associated with weight loss. Further study is needed to determine if weight loss can be implemented as a safe and effective risk reduction strategy for specific BMI classes of TKA patients.

Heterogeneity of Treatment Effects Among Patients With Type 2 Diabetes and Elevated Body Mass Index in a Study Comparing Group Medical Visits Focused on Weight Management and Medication Intensification.

BACKGROUND: Illuminating heterogeneity of treatment effect (HTE) within trials is important for identifying target populations for implementation. OBJECTIVE: The aim of this study was to examine HTE in a trial of group medical visits (GMVs) for patients with type 2 diabetes and elevated body mass index. RESEARCH DESIGN AND MEASURES: Participants (n=263) were randomized to GMV-based medication management plus low carbohydrate diet-focused weight management (WM/GMV; n=127) or GMV-based medication management alone (GMV; n=136) for diabetes control. We used QUalitative INteraction Trees, a tree-based clustering method, to identify subgroups with greater improvement in hemoglobin A1c (HbA1c) and weight from either WM/GMV or GMV. Subgroup predictors included 32 baseline demographic, clinical, and psychosocial factors. Internal validation was conducted to estimate bias in the range of mean outcome differences between arms. RESULTS: QUalitative INteraction Trees analyses indicated that for patients who had not previously attempted weight loss, WM/GMV resulted in better glycemic control than GMV (mean difference in HbA1c improvement=1.48%). For patients who had previously attempted weight loss and had lower cholesterol and blood urea nitrogen, GMV was better than WM/GMV (mean difference in HbA1c improvement=1.51%). No treatment-subgroup effects were identified for weight. Internal validation resulted in moderate corrections in mean HbA1c differences between arms; however, differences remained in the clinically significant range. CONCLUSION: This work represents a novel step toward targeting care approaches for patients to maximize benefit based on individual patient characteristics.

Quantity of Resistance Exercise for Breast Cancer Patients: Does the Dose Match the Objective?

ABSTRACT: Rosenberg, J, Hyde, PN, Yancy, WS, Ford, KM, and Champ, CE. Quantity of resistance exercise for breast cancer patients: does the dose match the objective? J Strength Cond Res 35(5): 1467-1476, 2021-There is currently a lack of consensus as to what defines exercise and resistance training in the cancer setting and whether current studies comply with exercise guidelines. This study aimed to quantify the available research studies using resistance training exercise interventions in the breast cancer setting for future clinical trial utilization. We systemically reviewed all available resistance exercise studies during and after breast cancer treatment in an attempt to quantify to the prescribed dose and whether regimens aligned with general exercise guidelines to improve functional mobility, body composition, and metabolic function. They were then compared with recommendations set forth by the national committees that create evidence-based exercise guidelines. Fifty studies met the initial criteria, with 35 meeting analysis criteria for evaluation. Fifteen studies evaluated an exercise regimen during cancer treatment, and 20 evaluated a regimen after treatment. The average adherence rates were 84% for all studies. Only 23 studies listed specific exercises used within the protocol. Most exercise regimens relied on open chain movements and machine exercises. Around half of studies met criteria to achieve hypertrophy, and 66% met American College of Sports Medicine exercise guidelines for cancer patients. A minority of breast cancer studies implementing a resistance training exercise regimen prescribed a regimen or specific dose that follows general exercise guidelines. This study highlights a potential deficiency in exercise programs designed for patients with breast cancer, and these findings should be considered in future study design.

Type 2 Diabetes and Atherosclerotic Cardiovascular Disease in South Asians: a Unique Population with a Growing Challenge.

PURPOSE OF REVIEW: The purpose of this review is to summarize our current knowledge of factors that influence clinical decision making and management of type 2 diabetes mellitus (T2DM) and atherosclerotic cardiovascular disease (ASCVD) among South Asians (SA). RECENT FINDINGS: ASCVD and T2DM in SAs have been examined in recent times. Pathophysiologic and genetic factors including the role of adiponectin, visceral adiposity, lower beta cell function, and psycho-social factors like sedentary lifestyle, poor adherence to medications, and carbohydrate dense meals play a role in early development and the high-risk presentation of both ASCVD and T2DM in SA. Recently, large population-based cohort studies have attempted to compare outcomes and interventions that can be translated to timely detection and targeted interventions in this high-risk group. SAs in the USA are more likely to be diagnosed with T2DM and ASCVD when compared to non-Hispanic whites, non-Hispanic Blacks, and Hispanic populations. The development of personalized ethnic risk assessment tools and better representation of SAs in prospective studies are essential to increasing our understanding and management of cardio-metabolic disease in SA living in the USA.

Application of nutrient essentiality criteria to dietary carbohydrates.

The purpose of the present review is to describe how human physiology at very low carbohydrate intakes relates to the criteria for nutritional essentiality. Although we did not limit ourselves to one particular type or function of carbohydrates, we did primarily focus on glucose utilisation as that function was used to determine the recommended daily allowance. In the general population, the human body is able to endogenously synthesise carbohydrates, and does not show signs of deficiency in the absence of dietary carbohydrates. However, in certain genetic defects, such as glycogen storage disease type I, absence of dietary carbohydrates causes abnormalities that are resolved with dietary supplementation of carbohydrates. Therefore, dietary carbohydrates may be defined as conditionally essential nutrients because they are nutrients that are not required in the diet for the general population but are required for specific subpopulations. Ketosis may be considered a physiological normal state due to its occurrence in infants in addition to at very low carbohydrate intakes. Although sources of dietary carbohydrates can provide beneficial micronutrients, no signs of micronutrient deficiencies have been reported in clinical trials of low-carbohydrate ketogenic diets. Nonetheless, more research is needed on how micronutrient requirements can change depending on the dietary and metabolic context. More research is also needed on the role of dietary fibre during a low-carbohydrate ketogenic diet as the beneficial effects of dietary fibre were determined on a standard diet and several studies have shown beneficial effects of decreasing non-digestible carbohydrates.

Low-Carbohydrate and Very-Low-Carbohydrate Diets in Patients With Diabetes.

Low-carbohydrate diets have been advocated as an effective method for promoting weight loss in overweight and obese individuals and preventing and treating type 2 diabetes. This article reviews the differences between various low-carbohydrate eating plans and discusses the benefits and drawbacks of such a diet based on available evidence. It also offers practical pointers for clinicians.

The role of group cohesion in a group-based behavioral weight loss intervention.

Behavioral weight loss interventions are often delivered in groups. Group cohesion may enhance program attendance and, thereby, weight loss. In this secondary analysis, our goals were to: (1a) assess whether group cohesion measured early in a behavioral weight loss intervention predicts program attendance and weight loss outcomes and, if so, (1b) explore whether attendance mediates the link between group cohesion and weight loss; (2) characterize the association between change in group cohesion and weight loss throughout the intervention. Veterans (n = 324) initiated a 16-week, group-based behavioral weight loss program involving biweekly in-person group visits. In linear regression models, early group cohesion was unrelated to group attendance or weight loss. Although group cohesion significantly increased during the intervention, this change was not associated with weight loss. These findings are consistent with the limited literature; however, they are inconsistent with theoretical assertions and clinical observations of the influence of group factors on outcomes.

Effects of an energy-restricted low-carbohydrate, high unsaturated fat/low saturated fat diet versus a high-carbohydrate, low-fat diet in type 2 diabetes: A 2-year randomized clinical trial.

AIM: To examine whether a low-carbohydrate, high-unsaturated/low-saturated fat diet (LC) improves glycaemic control and cardiovascular disease (CVD) risk factors in overweight and obese patients with type 2 diabetes (T2D). METHODS: A total of 115 adults with T2D (mean [SD]; BMI, 34.6 [4.3] kg/m2 ; age, 58 [7] years; HbA1c, 7.3 [1.1]%) were randomized to 1 of 2 planned energy-matched, hypocaloric diets combined with aerobic/resistance exercise (1 hour, 3 days/week) for 2 years: LC: 14% energy as carbohydrate, 28% as protein, 58% as fat (<10% saturated fat); or low-fat, high-carbohydrate, low-glycaemic index diet (HC): 53% as CHO, 17% as protein, 30% as fat (<10% saturated fat). HbA1c, glycaemic variability (GV), anti-glycaemic medication effect score (MES, calculated based on the potency and dosage of diabetes medication), weight, body composition, CVD and renal risk markers were assessed before and after intervention. RESULTS: A total of 61 (LC = 33, HC = 28) participants completed the study (trial registration: http://www.anzctr.org.au/, ANZCTR No. ACTRN12612000369820). Reductions in weight (estimated marginal mean [95% CI]; LC, -6.8 [-8.8,-4.7], HC, -6.6 [-8.8, -4.5] kg), body fat (LC, -4.3 [-6.2, -2.4], HC, -4.6 [-6.6, -2.7] kg), blood pressure (LC, -2.0 [-5.9, 1.8]/ -1.2 [-3.6, 1.2], HC, -3.2 [-7.3, 0.9]/ -2.0 [-4.5, 0.5] mmHg), HbA1c (LC, -0.6 [-0.9, -0.3], HC, -0.9 [-1.2, -0.5] %) and fasting glucose (LC, 0.3 [-0.4, 1.0], HC, -0.4 [-1.1, 0.4] mmol/L) were similar between groups (P ≥ 0.09). Compared to HC, the LC achieved greater reductions in diabetes medication use (MES; LC, -0.5 [-0.6, -0.3], HC, -0.2 [-0.4, -0.02] units; P = 0.03), GV (Continuous Overall Net Glycemic Action calculated every 1 hour (LC, -0.4 [-0.6, -0.3], HC, -0.1 [-0.1, 0.2] mmol/L; P = 0.001), and 4 hours (LC, -0.9 [-1.3, -0.6], HC, -0.2 [-0.6, 0.1] mmol/L; P = 0.02)); triglycerides (LC, -0.1 [-0.3, 0.2], HC, 0.1 [-0.2, 0.3] mmol/L; P = 0.001), and maintained HDL-C levels (LC, 0.02 [-0.05, 0.1], HC, -0.1 [-0.1, 0.01] mmol/L; P = 0.004), but had similar changes in LDL-C (LC, 0.2 [-0.1, 0.5], HC, 0.1 [-0.2, 0.4] mmol/L; P = 0.85), brachial artery flow mediated dilatation (LC, -0.5 [-1.5, 0.5], HC, -0.4 [-1.4, 0.7] %; P = 0.73), eGFR and albuminuria. CONCLUSIONS: Both diets achieved comparable weight loss and HbA1c reductions. The LC sustained greater reductions in diabetes medication requirements, and in improvements in diurnal blood glucose stability and blood lipid profile, with no adverse renal effects, suggesting greater optimization of T2D management.

Perceived barriers and facilitators of initiation of behavioral weight loss interventions among adults with obesity: a qualitative study.

BACKGROUND: Evidence-based behavioral weight loss interventions are under-utilized. To inform efforts to increase uptake of these interventions, it is important to understand the perspectives of adults with obesity regarding barriers and facilitators of weight loss intervention initiation. METHODS: We conducted a qualitative study in adults with obesity who had recently attempted weight loss either with assistance from an evidence-based behavioral intervention (intervention initiators) or without use of a formal intervention (intervention non-initiators). We recruited primary care patients, members of a commercial weight loss program, and members of a Veterans Affairs weight loss program. Intervention initiators and non-initiators were interviewed separately using a semi-structured interview guide that asked participants about barriers and facilitators of weight loss intervention initiation. Conversations were audio-recorded and transcribed. Data were analyzed with qualitative content analysis. Two researchers used open coding to generate the code book on a subset of transcripts and a single researcher coded remaining transcripts. Codes were combined into subthemes, which were combined in to higher order themes. Intervention initiators and non-initiators were compared. RESULTS: We conducted three focus groups with participants who had initiated interventions (n = 26) and three focus groups (n = 24) and 8 individual interviews with participants who had not initiated interventions. Intervention initiators and non-initiators were, respectively, 65% and 37.5% white, 62% and 63% female, mean age of 55 and 54 years old, and mean BMI of 34 kg/m2. Three themes were identified. One theme was practical factors, with subthemes of reasonable cost and scheduling compatibility. A second theme was anticipated effectiveness of intervention, with subthemes of intervention content addressing individual needs; social aspects influencing effectiveness; and evaluating evidence of effectiveness. A third theme was anticipated pleasantness of intervention, with subthemes of social aspects influencing enjoyment; anticipated dietary and tracking prescriptions; and identity and self-reliance factors. Different perspectives were identified from intervention initiators and non-initiators. CONCLUSIONS: Strategies to engage individuals in evidence-based weight loss interventions can be developed using these results. Strategies could target individuals' perceived barriers and benefits to initiating interventions, or could focus on refining interventions to appeal to more individuals.

Maintenance of Weight Loss After Initiation of Nutrition Training: A Randomized Trial.

BACKGROUND: Weight regain after successful weight loss interventions is common. OBJECTIVE: To establish the efficacy of a weight loss maintenance program compared with usual care in obese adults. DESIGN: 2-group, parallel, randomized trial stratified by initial weight loss (<10 kg vs. ≥10 kg), conducted from 20 August 2012 to 18 December 2015. Outcome assessors were blinded to treatment assignment. (ClinicalTrials.gov: NCT01357551). SETTING: 3 primary care clinics at the Veterans Affairs Medical Center in Durham and Raleigh, North Carolina. PATIENTS: Obese outpatients (body mass index ≥30 kg/m2) who lost 4 kg or more of body weight during a 16-week, group-based weight loss program. INTERVENTION: The maintenance intervention, delivered primarily by telephone, addressed satisfaction with outcomes, relapse-prevention planning, self-monitoring, and social support. Usual care involved no contact except for study measurements. MEASUREMENTS: Primary outcome was mean weight regain at week 56. Secondary outcomes included self-reported caloric intake, walking, and moderate physical activity. RESULTS: Of 504 patients in the initial program, 222 lost at least 4 kg of body weight and were randomly assigned to maintenance (n = 110) or usual care (n = 112). Retention was 85%. Most patients were middle-aged white men. Mean weight loss during initiation was 7.2 kg (SD, 3.1); mean weight at randomization was 103.6 kg (SD, 20.4). Estimated mean weight regain was statistically significantly lower in the intervention (0.75 kg) than the usual care (2.36 kg) group (estimated mean difference, 1.60 kg [95% CI, 0.07 to 3.13 kg]; P = 0.040). No statistically significant differences in secondary outcomes were seen at 56 weeks. No adverse events directly attributable to the intervention were observed. LIMITATIONS: Results may not generalize to other settings or populations. Dietary intake and physical activity were self-reported. Duration was limited to 56 weeks. CONCLUSION: An intervention focused on maintenance-specific strategies and delivered in a resource-conserving way modestly slowed the rate of weight regain in obese adults. PRIMARY FUNDING SOURCE: Veterans Affairs Health Services Research and Development Service.

Prevalence of and characteristics associated with insomnia and obstructive sleep apnea among veterans with knee and hip osteoarthritis.

BACKGROUND: Few studies have examined patterns of specific sleep problems among individuals with osteoarthritis (OA). The primary objective of this study was to examine prevalence of symptoms of insomnia and obstructive sleep apnea (OSA) among Veterans with OA. Secondary objectives were to assess proportions of individuals with insomnia and OSA symptoms who may have been undiagnosed and to examine Veterans' characteristics associated with insomnia and OSA symptoms. METHODS: Veterans (n = 300) enrolled in a clinical trial completed the Insomnia Severity Index (ISI) and the Berlin Questionnaire (BQ) at baseline; proportions of participants with symptoms consistent with insomnia and OSA were calculated, using standard cut-offs for ISI and BQ. For Veterans with insomnia and OSA symptoms, electronic medical records were searched to identify whether there was a diagnosis code for these conditions. Multivariable linear (ISI) and logistic (BQ) regression models examined associations of the following characteristics with symptoms of insomnia and OSA: age, gender, race, self-reported general health, body mass index (BMI), diagnosis of post-traumatic stress disorder (PTSD), pain severity, depressive symptoms, number of joints with arthritis symptoms and opioid use. RESULTS: Symptoms consistent with insomnia and OSA were found in 53 and 66% of this sample, respectively. Among participants screening positive for insomnia and OSA, diagnosis codes for these disorders were present in the electronic medical record for 22 and 51%, respectively. Characteristics associated with insomnia were lower age (ß (SE) = - 0.09 (0.04), 95% confidence interval [CI] = - 0.16, - 0.02), having a PTSD diagnosis (ß (SE) = 1.68 (0.73), CI = 0.25, 3.11), greater pain severity (ß (SE) = 0.36 (0.09), CI = 0.17, 0.55), and greater depressive symptoms (ß (SE) = 0.84 (0.07), CI = 0.70, 0.98). Characteristics associated with OSA were higher BMI (odds ratio [OR] = 1.13, CI = 1.06, 1.21), greater depressive symptoms (OR = 1.12, CI = 1.05, 1.20), and opioid use (OR = 0.51, CI = 0.26, 0.99). CONCLUSIONS: Insomnia and OSA symptoms were very common in Veterans with OA, and a substantial proportion of individuals with symptoms may have been undiagnosed. Characteristics associated with insomnia and OSA symptoms were consistent with prior studies. TRIAL REGISTRATION: NCT01130740 .

Patient, Provider, and Combined Interventions for Managing Osteoarthritis in Primary Care: A Cluster Randomized Trial.

BACKGROUND: A single-site study showed that a combined patient and provider intervention improved outcomes for patients with knee osteoarthritis, but it did not assess separate effects of the interventions. OBJECTIVE: To examine whether patient-based, provider-based, and patient-provider interventions improve osteoarthritis outcomes. DESIGN: Cluster randomized trial with assignment to patient, provider, and patient-provider interventions or usual care. (ClinicalTrials.gov: NCT01435109). SETTING: 10 Duke University Health System community-based primary care clinics. PARTICIPANTS: 537 outpatients with symptomatic hip or knee osteoarthritis. INTERVENTION: The telephone-based patient intervention focused on weight management, physical activity, and cognitive behavioral pain management. The provider intervention involved electronic delivery of patient-specific osteoarthritis treatment recommendations to providers. MEASUREMENTS: The primary outcome was the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score at 12 months. Secondary outcomes were objective physical function (Short Physical Performance Battery) and depressive symptoms (Patient Health Questionnaire). Linear mixed models assessed the difference in improvement among groups. RESULTS: No difference was observed in WOMAC score changes from baseline to 12 months in the patient (-1.5 [95% CI, -5.1 to 2.0]; P = 0.40), provider (2.5 [CI, -0.9 to 5.9]; P = 0.152), or patient-provider (-0.7 [CI, -4.2 to 2.8]; P = 0.69) intervention groups compared with usual care. All groups had improvements in WOMAC scores at 12 months (range, -3.7 to -7.7). In addition, no differences were seen in objective physical function or depressive symptoms at 12 months in any of the intervention groups compared with usual care. LIMITATIONS: The study involved 1 health care network. Data on provider referrals were not collected. CONCLUSION: Contrary to a previous study of a combined patient and provider intervention for osteoarthritis in a Department of Veterans Affairs medical center, this study found no statistically significant improvements in the osteoarthritis intervention groups compared with usual care. PRIMARY FUNDING SOURCE: National Institute of Arthritis and Musculoskeletal and Skin Diseases.

Patient predictors of weight loss following a behavioral weight management intervention among US Veterans with severe obesity.

PURPOSE: Identification of patient characteristics that are associated with behavioral weight loss success among bariatric surgery candidates could inform selection of optimal bariatric surgery candidates. We examined the associations between psychosocial characteristics and weight loss in a group of Veterans with severe obesity who participated in a behavioral weight loss intervention. METHODS: The MAINTAIN trial involved a 16-week weight loss program followed by randomization among participants losing at least 4 kg to a maintenance intervention or usual care. This secondary analysis was performed on Veterans who participated in the 16-week weight loss program and met NIH criteria for bariatric surgery (body mass index [BMI] 35.0-39.9 with at least 1 obesity-related comorbidity or BMI ≥ 40). Unadjusted and adjusted associations between baseline patient characteristics and weight loss during the 16-week induction phase were evaluated with linear regression. Missing weight measurements were multiply imputed, and results combined across ten imputations. RESULTS: Among the 206 patients who met inclusion criteria, mean initial BMI was 40.8 kg/m2 (SD 6.0), and mean age was 59.2 years (SD 9.4). Approximately 20% of participants were female, 51.5% were Black, and 44.7% were White. Estimated mean 16-week weight loss was 5.16 kg (SD 4.31). In adjusted analyses, greater social support and older age were associated with greater weight loss (p < 0.05). None of the nine psychosocial characteristics we examined were associated with greater weight loss. CONCLUSIONS: Understanding and strengthening the level of social support for bariatric surgery candidates may be important given that it appears to be strongly correlated with behavioral weight loss success. LEVEL OF EVIDENCE: Level II, Evidence obtained from well-designed controlled trials without randomization. TRIAL REGISTRATION: ClinicalTrials.gov NCT01357551 http://clinicaltrials.gov/show/NCT01357551 .

The design and conduct of Keep It Off: An online randomized trial of financial incentives for weight-loss maintenance.

Background Obesity continues to be a serious public health challenge. Rates are increasing worldwide, with nearly 70% of the US adults overweight or obese, leading to increased clinical and economic burden. While successful approaches for achieving weight loss have been identified, techniques for long-term maintenance of initial weight loss have largely been unsuccessful. Financial incentive interventions have been shown in several settings to be successful in motivating participants to adopt healthy behaviors. Purpose Keep It Off is a three-arm randomized controlled trial that compares the efficacy of a lottery-based incentive, traditional direct payment incentive, and control of daily feedback without any incentive for weight-loss maintenance. This design allows comparison of a traditional direct payment incentive with one based on behavioral economic principles that consider the underlying psychology of decision-making. Methods Participants were randomized in a 2:1 ratio for each active arm relative to control, with a targeted 188 participants in total. Eligible participants were those aged 30-80 who lost at least 11 lb (5 kg) during the first 4 months of participation in Weight Watchers, a national weight-loss program, with whom we partnered. The interventions lasted 6 months (Phase I); participants were followed for an additional 6 months without intervention (Phase II). The primary outcome is weight change from baseline to the end of Phase I, with the change at the end of Phase II a key secondary endpoint. Keep It Off is a pragmatic trial that recruited, consented, enrolled, and followed patients electronically. Participants were provided a wireless weight scale that electronically transmitted daily self-monitored weights. Weights were verified every 3 months at a Weight Watchers center local to the participant and electronically transmitted. Results Using the study web-based platform, we integrated recruitment, enrollment, and follow-up procedures into a digital platform that required little staff effort to implement and manage. We randomized 191 participants in less than 1 year. We describe the design of Keep It Off and implementation of enrollment. Lessons Learned We demonstrated that our pragmatic design was successful in rapid accrual of participants in a trial of interventions to maintain weight loss. Limitations Despite the nationwide reach of Weight Watchers, the generalizability of study findings may be limited by the characteristics of its members. The interventions under study are appropriate for settings where an entity, such as an employer or health insurance company, could offer them as a benefit. Conclusions Keep It Off was implemented and conducted with minimal staff effort. This study has the potential to identify a practical and effective weight-loss maintenance strategy.

A Combined Patient and Provider Intervention for Management of Osteoarthritis in Veterans: A Randomized Clinical Trial.

BACKGROUND: Management of osteoarthritis requires both medical and behavioral strategies, but some recommended therapies are underused. OBJECTIVE: To examine the effectiveness of a combined patient and provider intervention for improving osteoarthritis outcomes. DESIGN: Cluster randomized clinical trial with assignment to osteoarthritis intervention and usual care groups. (ClinicalTrials.gov: NCT01130740). SETTING: Department of Veterans Affairs Medical Center in Durham, North Carolina. PARTICIPANTS: 30 providers (clusters) and 300 outpatients with symptomatic hip or knee osteoarthritis. INTERVENTION: The telephone-based patient intervention focused on weight management, physical activity, and cognitive behavioral pain management. The provider intervention involved delivery of patient-specific osteoarthritis treatment recommendations to primary care providers through the electronic medical record. MEASUREMENTS: The primary outcome was total score on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at 12 months. Secondary outcomes were WOMAC function and pain subscale scores, physical performance (Short Physical Performance Battery), and depressive symptoms (Patient Health Questionnaire-8). Linear mixed models that were adjusted for clustering of providers assessed between-group differences in improvement in outcomes. RESULTS: At 12 months, WOMAC scores were 4.1 points lower (indicating improvement) in the osteoarthritis intervention group versus usual care (95% CI, -7.2 to -1.1 points; P = 0.009). WOMAC function subscale scores were 3.3 points lower in the intervention group (CI, -5.7 to -1.0 points; P = 0.005). WOMAC pain subscale scores (P = 0.126), physical performance, and depressive symptoms did not differ between groups. Although more patients in the osteoarthritis intervention group received provider referral for recommended osteoarthritis treatments, the numbers who received them did not differ. LIMITATION: The study was conducted in a single Veterans Affairs medical center. CONCLUSION: The combined patient and provider intervention resulted in modest improvement in self-reported physical function in patients with hip and knee osteoarthritis. PRIMARY FUNDING SOURCE: Department of Veterans Affairs, Health Services Research and Development Service.

Food preferences and weight change during low-fat and low-carbohydrate diets.

UNLABELLED: Understanding associations between food preferences and weight loss during various effective diets could inform efforts to personalize dietary recommendations and provide insight into weight loss mechanisms. We conducted a secondary analysis of data from a clinical trial in which participants were randomized to either a 'choice' arm, in which they were allowed to select between a low-fat diet (n = 44) or low-carbohydrate diet (n = 61), or to a 'no choice' arm, in which they were randomly assigned to a low-fat diet (n = 49) or low-carbohydrate diet (n = 53). All participants were provided 48 weeks of lifestyle counseling. Food preferences were measured at baseline and every 12 weeks thereafter with the Geiselman Food Preference Questionnaire. Participants were 73% male and 51% African American, with a mean age of 55. Baseline food preferences, including congruency of food preferences with diet, were not associated with weight outcomes. In the low-fat diet group, no associations were found between changes in food preferences and weight over time. In the low-carbohydrate diet group, increased preference for low-carbohydrate diet congruent foods from baseline to 12 weeks was associated with weight loss from 12 to 24 weeks. Additionally, weight loss from baseline to 12 weeks was associated with increased preference for low-carbohydrate diet congruent foods from 12 to 24 weeks. Results suggest that basing selection of low-carbohydrate diet or low-fat diet on food preferences is unlikely to influence weight loss. Congruency of food preferences and weight loss may influence each other early during a low-carbohydrate diet but not low-fat diet, possibly due to different features of these diets. CLINICAL TRIAL REGISTRY: NCT01152359.

Effect of Allowing Choice of Diet on Weight Loss: A Randomized Trial.

BACKGROUND: Choosing a diet rather than being prescribed one could improve weight loss. OBJECTIVE: To examine whether offering choice of diet improves weight loss. DESIGN: Double-randomized preference trial of choice between 2 diets (choice) versus random assignment to a diet (comparator) over 48 weeks. (ClinicalTrials.gov: NCT01152359). SETTING: Outpatient clinic at a Veterans Affairs medical center. PATIENTS: Outpatients with a body mass index of at least 30 kg/m2. INTERVENTION: Choice participants received information about their food preferences and 2 diet options (low-carbohydrate diet [LCD] or low-fat diet [LFD]) before choosing and were allowed to switch diets at 12 weeks. Comparator participants were randomly assigned to 1 diet for 48 weeks. Both groups received group and telephone counseling for 48 weeks. MEASUREMENTS: The primary outcome was weight at 48 weeks. RESULTS: Of 105 choice participants, 61 (58%) chose the LCD and 44 (42%) chose the LFD; 5 (3 on the LCD and 2 on the LFD) switched diets at 12 weeks, and 87 (83%) completed measurements at 48 weeks. Of 102 comparator participants, 53 (52%) were randomly assigned to the LCD and 49 (48%) were assigned to the LFD; 88 (86%) completed measurements. At 48 weeks, estimated mean weight loss was 5.7 kg (95% CI, 4.3 to 7.0 kg) in the choice group and 6.7 kg (CI, 5.4 to 8.0 kg) in the comparator group (mean difference, -1.1 kg [CI, -2.9 to 0.8 kg]; P = 0.26). Secondary outcomes of dietary adherence, physical activity, and weight-related quality of life were similar between groups at 48 weeks. LIMITATIONS: Only 2 diet options were provided. Results from this sample of older veterans might not be generalizable to other populations. CONCLUSION: Contrary to expectations, the opportunity to choose a diet did not improve weight loss.

Post-traumatic stress disorder, physical activity, and eating behaviors.

Post-traumatic stress disorder (PTSD), a prevalent and costly psychiatric disorder, is associated with high rates of obesity and cardiometabolic diseases. Many studies have examined PTSD and risky behaviors (e.g., smoking, alcohol/substance abuse); far fewer have examined the relationship between PTSD and health-promoting behaviors. Physical activity and eating behaviors are 2 lifestyle factors that impact cardiometabolic risk and long-term health. This comprehensive review of the literature (1980-2014) examined studies that reported physical activity and eating behaviors in adults with PTSD or PTSD symptoms. A systematic search of electronic databases identified 15 articles on PTSD-physical activity and 10 articles on PTSD-eating behaviors in adults. These studies suggest that there may be a negative association among PTSD, physical activity, and eating behaviors. Preliminary evidence from 3 pilot intervention studies suggests that changes in physical activity or diet may have beneficial effects on PTSD symptoms. There was considerable heterogeneity in the study designs and sample populations, and many of the studies had methodological and reporting limitations. More evidence in representative samples, using multivariable analytical techniques, is needed to identify a definitive relationship between PTSD and these health behaviors. Intervention studies for PTSD that examine secondary effects on physical activity/eating behaviors, as well as interventions to change physical activity/eating behaviors that examine change in PTSD, are also of interest.