'Everyone is trying to outcompete each other': a qualitative study of medical student attitudes to a novel peer-assessed undergraduate teamwork module.

The centrality of teamwork in ensuring the effective functioning of institutions across all sectors is undeniable. However, embedding teamwork into higher education has been hampered due to a range of deeply entrenched practices associated broadly with the foregrounding of knowledge, beliefs about the place of skill training and routines of assessment. As a result, despite an urgent need to address teamwork, little progress has been made with respect to progressing teamwork education. We have designed and evaluated a novel teamwork module delivered to fourth-year undergraduate medical students involving placements, a cocreated piece of work, reflection and summative peer assessment. This paper aimed to investigate whether the module increased students' insight into teamwork, including their own skill development, and whether their perceptions of teamwork changed. Throughout the evaluation, students played a key role, with four final-year medical students working alongside others in the multidisciplinary project team. Five distinct themes emerged from our in-depth, semi-structured interviews: (a) importance and meaning; (b) insight into skill development; (c) transferability; (d) peer assessment; and (e) resistance to teamwork education. Themes had positive and negative components, and student perceptions changed in multiple ways after experiencing a longitudinal educational opportunity to develop their teamwork skills. Before practice, students focused on superficial explanations and on where they might improve. In contrast, after practice, students conveyed deeper insights, contextualisation, focus on how they might improve, and shared structured reflection.

BestFIT Sequential Multiple Assignment Randomized Trial Results: A SMART Approach to Developing Individualized Weight Loss Treatment Sequences.

BACKGROUND: State-of-the-art behavioral weight loss treatment (SBT) can lead to clinically meaningful weight loss, but only 30-60% achieve this goal. Developing adaptive interventions that change based on individual progress could increase the number of people who benefit. PURPOSE: Conduct a Sequential Multiple Assignment Randomized Trial (SMART) to determine the optimal time to identify SBT suboptimal responders and whether it is better to switch to portion-controlled meals (PCM) or acceptance-based treatment (ABT). METHOD: The BestFIT trial enrolled 468 adults with obesity who started SBT and were randomized to treatment response assessment at Session 3 (Early TRA) or 7 (Late TRA). Suboptimal responders were re-randomized to PCM or ABT. Responders continued SBT. Primary outcomes were weight change at 6 and 18 months. RESULTS: PCM participants lost more weight at 6 months (-18.4 lbs, 95% CI -20.5, -16.2) than ABT participants (-15.7 lbs, 95% CI: -18.0, -13.4), but this difference was not statistically significant (-2.7 lbs, 95% CI: -5.8, 0.5, p = .09). PCM and ABT participant 18 month weight loss did not differ. Early and Late TRA participants had similar weight losses (p = .96), however, Early TRA PCM participants lost more weight than Late TRA PCM participants (p = .03). CONCLUSIONS: Results suggest adaptive intervention sequences that warrant further research (e.g., identify suboptimal responders at Session 3, use PCMs as second-stage treatment). Utilizing the SMART methodology to develop an adaptive weight loss intervention that would outperform gold standard SBT in a randomized controlled trial is an important next step, but may require additional optimization work. CLINICAL TRIAL INFORMATION: ClinicalTrials.gov identifier; NCT02368002.

Changes in mood and health-related quality of life in Look AHEAD 6 years after termination of the lifestyle intervention.

OBJECTIVE: The Action for Health in Diabetes (Look AHEAD) study previously reported that intensive lifestyle intervention (ILI) reduced incident depressive symptoms and improved health-related quality of life (HRQOL) over nearly 10 years of intervention compared with a control group (the diabetes support and education group [DSE]) in participants with type 2 diabetes and overweight or obesity. The present study compared incident depressive symptoms and changes in HRQOL in these groups for an additional 6 years following termination of the ILI in September 2012. METHODS: A total of 1,945 ILI participants and 1,900 DSE participants completed at least one of four planned postintervention assessments at which weight, mood (via the Patient Health Questionnaire-9), antidepressant medication use, and HRQOL (via the Medical Outcomes Scale, Short Form-36) were measured. RESULTS: ILI participants and DSE participants lost 3.1 (0.3) and 3.8 (0.3) kg [represented as mean (SE); p = 0.10], respectively, during the 6-year postintervention follow-up. No significant differences were observed between groups during this time in incident mild or greater symptoms of depression, antidepressant medication use, or in changes on the physical component summary or mental component summary scores of the Short Form-36. In both groups, mental component summary scores were higher than physical component summary scores. CONCLUSIONS: Prior participation in the ILI, compared with the DSE group, did not appear to improve subsequent mood or HRQOL during 6 years of postintervention follow-up.

Reduced Ambient PM2.5 Was Associated with a Decreased Risk of Chronic Kidney Disease: A Longitudinal Cohort Study.

Many countries have dedicated to the mitigation of air pollution in the past several decades. However, evidence of beneficial effects of air quality improvement on chronic kidney disease (CKD) remains limited. We thus investigated the effects of dynamic changes (including deterioration and improvement) in air quality on the incidence of CKD in a longitudinal study in Taiwan. During 2001-2016, this study recruited a total of 163,197 Taiwanese residents who received at least two standard physical examinations. The level of fine particle matter (PM2.5) was estimated using a high-resolution (1 km2) satellite-based spatio-temporal model. We defined changes of PM2.5 concentrations (ΔPM2.5) as the difference between the two-year average measurements during follow-up and during the immediately preceding visit. The time-dependent Cox regression model was adopted to evaluate the relationships between ΔPM2.5 and the incidence of CKD after adjusting for a series of covariates. The concentrations of PM2.5 in Taiwan peaked around 2004 and began to decrease since 2005. We observed an approximate linear concentration-response relationship of ΔPM2.5 with CKD incidence. Every 5 µg/m3 decrease in the ambient concentration of PM2.5 was associated with a 25% reduced risk of CKD development [hazard ratio (HR): 0.75; 95% CI: 0.73, 0.78]. In conclusion, this study demonstrated that the improvement of PM2.5 air quality might be associated with a lower risk of CKD development. Our findings indicate that reducing air pollution may effectively prevent the development of CKD.

Discrepancies Between Clinician and Participant Intervention Adherence Ratings Predict Percent Weight Change During a Six-Month Behavioral Weight Loss Intervention.

BACKGROUND: Individuals receiving behavioral weight loss treatment frequently fail to adhere to prescribed dietary and self-monitoring instructions, resulting in weight loss clinicians often needing to assess and intervene in these important weight control behaviors. A significant obstacle to improving adherence is that clinicians and clients sometimes disagree on the degree to which clients are actually adherent. However, prior research has not examined how clinicians and clients differ in their perceptions of client adherence to weight control behaviors, nor the implications for treatment outcomes. PURPOSE: In the context of a 6-month weight-loss treatment, we examined differences between participants and clinicians when rating adherence to weight control behaviors (dietary self-monitoring; limiting calorie intake) and evaluated the hypothesis that rating one's own adherence more highly than one's clinician would predict less weight loss during treatment. METHODS: Using clinician and participant-reported measures of self-monitoring and calorie intake adherence, each assessed using a single item with a 7- or 8-point scale, we characterized discrepancies between participant and clinician adherence and examined associations with percent weight change over 6 months using linear mixed-effects models. RESULTS: Results indicated that ratings of adherence were higher when reported by participants and supported the hypothesis that participants who provided higher adherence ratings relative to their clinicians lost less weight during treatment (p < 0.001). CONCLUSIONS: These findings suggest that participants in weight loss treatment frequently appraise their own adherence more highly than their clinicians and that participants who do so to a greater degree tend to lose less weight.

Within-Trial Cost-Effectiveness of a Structured Lifestyle Intervention in Adults With Overweight/Obesity and Type 2 Diabetes: Results From the Action for Health in Diabetes (Look AHEAD) Study.

OBJECTIVE: To assess the cost-effectiveness (CE) of an intensive lifestyle intervention (ILI) compared with standard diabetes support and education (DSE) in adults with overweight/obesity and type 2 diabetes, as implemented in the Action for Health in Diabetes study. RESEARCH DESIGN AND METHODS: Data were from 4,827 participants during their first 9 years of study participation from 2001 to 2012. Information on Health Utilities Index Mark 2 (HUI-2) and HUI-3, Short-Form 6D (SF-6D), and Feeling Thermometer (FT), cost of delivering the interventions, and health expenditures was collected during the study. CE was measured by incremental CE ratios (ICERs) in costs per quality-adjusted life year (QALY). Future costs and QALYs were discounted at 3% annually. Costs were in 2012 U.S. dollars. RESULTS: Over the 9 years studied, the mean cumulative intervention costs and mean cumulative health care expenditures were $11,275 and $64,453 per person for ILI and $887 and $68,174 for DSE. Thus, ILI cost $6,666 more per person than DSE. Additional QALYs gained by ILI were not statistically significant measured by the HUIs and were 0.07 and 0.15, respectively, measured by SF-6D and FT. The ICERs ranged from no health benefit with a higher cost based on HUIs to $96,458/QALY and $43,169/QALY, respectively, based on SF-6D and FT. CONCLUSIONS: Whether ILI was cost-effective over the 9-year period is unclear because different health utility measures led to different conclusions.

Intensive Weight Loss Intervention and Cancer Risk in Adults with Type 2 Diabetes: Analysis of the Look AHEAD Randomized Clinical Trial.

OBJECTIVE: This study was designed to determine whether intensive lifestyle intervention (ILI) aimed at weight loss lowers cancer incidence and mortality. METHODS: Data from the Look AHEAD trial were examined to investigate whether participants randomized to ILI designed for weight loss would have reduced overall cancer incidence, obesity-related cancer incidence, and cancer mortality, as compared with the diabetes support and education (DSE) comparison group. This analysis included 4,859 participants without a cancer diagnosis at baseline except for nonmelanoma skin cancer. RESULTS: After a median follow-up of 11 years, 684 participants (332 in ILI and 352 in DSE) were diagnosed with cancer. The incidence rates of obesity-related cancers were 6.1 and 7.3 per 1,000 person-years in ILI and DSE, respectively, with a hazard ratio (HR) of 0.84 (95% CI: 0.68-1.04). There was no significant difference between the two groups in total cancer incidence (HR, 0.93; 95% CI: 0.80-1.08), incidence of nonobesity-related cancers (HR, 1.02; 95% CI: 0.83-1.27), or total cancer mortality (HR, 0.92; 95% CI: 0.68-1.25). CONCLUSIONS: An ILI aimed at weight loss lowered incidence of obesity-related cancers by 16% in adults with overweight or obesity and type 2 diabetes. The study sample size likely lacked power to determine effect sizes of this magnitude and smaller.

Using targeting to recruit men and women of color into a behavioral weight loss trial.

BACKGROUND: The majority of participants in weight loss trials are non-Hispanic White women, while men and women of color are underrepresented. This study presents data obtained from non-targeted and targeted recruitment approaches in a trial of behavioral weight loss programs to (1) describe the yields from each approach and (2) compare the demographics, weight control histories, and study involvement of samples recruited by each approach. METHODS: Data for this observational study include source of recruitment, demographic information, weight loss experiences (e.g., lifetime weight loss, current weight loss behaviors), and completion of the 6-month assessment visit. RESULTS: Men comprised 14.2% of participants who responded to non-targeted recruitment efforts, while targeted efforts yielded 50.4% men. Similarly, people of color comprised 12.8% of those who responded to non-targeted approaches, whereas targeted recruitment methods yielded 47.2% people of color. Men recruited through targeted methods were younger (p = 0.01) than men recruited through non-targeted means but were otherwise similar. Women of color recruited through targeted methods reported use of fewer weight loss strategies relative to women of color recruited through non-targeted means (p = 0.006) but were otherwise similar. There were no differences by recruitment method on retention to the study. CONCLUSIONS: Using targeted recruitment methods increased the ethnic and gender diversity of the recruited sample without reducing study retention. This targeting also increased the enrollment of women with less weight loss experience who may not have otherwise sought out a weight loss program. Developing and implementing a targeted recruitment plan should be considered early in the clinical trial development process. TRIAL REGISTRATION: Clinicaltrials.gov, NCT02368002. Registered on 20 February 2015.

Weight Change 2 Years After Termination of the Intensive Lifestyle Intervention in the Look AHEAD Study.

OBJECTIVE: This study evaluated weight changes after cessation of the 10-year intensive lifestyle intervention (ILI) in the Look AHEAD (Action for Health in Diabetes) study. It was hypothesized that ILI participants would be more likely to gain weight during the 2-year observational period following termination of weight-loss-maintenance counseling than would participants in the diabetes support and education (DSE) control group. METHODS: Look AHEAD was a randomized controlled trial that compared the effects of ILI and DSE on cardiovascular morbidity and mortality in participants with overweight/obesity and type 2 diabetes. Look AHEAD was converted to an observational study in September 2012. RESULTS: Two years after the end of the intervention (EOI), ILI and DSE participants lost a mean (SE) of 1.2 (0.2) kg and 1.8 (0.2) kg, respectively (P = 0.003). In addition, 31% of ILI and 23.9% of DSE participants gained ≥ 2% (P < 0.001) of EOI weight, whereas 36.3% and 45.9% of the respective groups lost ≥ 2% of EOI weight (P = 0.001). Two years after the EOI, ILI participants reported greater use of weight-control behaviors than DSE participants. CONCLUSIONS: Both groups lost weight during the 2-year follow-up period, but more ILI than DSE participants gained ≥ 2% of EOI weight. Further understanding is needed of factors that affected long-term weight change in both groups.

History of Cardiovascular Disease, Intensive Lifestyle Intervention, and Cardiovascular Outcomes in the Look AHEAD Trial.

OBJECTIVE: To examine the effects of an intensive lifestyle intervention (ILI) on cardiovascular disease (CVD), the Action for Health in Diabetes (Look AHEAD) trial randomized 5,145 participants with type 2 diabetes and overweight/obesity to a ILI or diabetes support and education. Although the primary outcome did not differ between the groups, there was suggestive evidence of heterogeneity for prespecified baseline CVD history subgroups (interaction P = 0.063). Event rates were higher in the ILI group among those with a CVD history (hazard ratio 1.13 [95% CI: 0.90-1.41]) and lower among those without CVD (hazard ratio 0.86 [95% CI: 0.72-1.02]). METHODS: This study conducted post hoc analyses of the rates of the primary composite outcome and components, adjudicated cardiovascular death, nonfatal myocardial infarction (MI), stroke, and hospitalization for angina, as well as three secondary composite cardiovascular outcomes. RESULTS: Interaction P values for the primary and two secondary composites were similar (0.060-0.064). Of components, the interaction was significant for nonfatal MI (P = 0.035). This interaction was not due to confounding by baseline variables, different intervention responses for weight loss and physical fitness, or hypoglycemic events. In those with a CVD history, statin use was high and similar by group. In those without a CVD history, low-density lipoprotein cholesterol levels were higher (P = 0.003) and statin use was lower (P ≤ 0.001) in the ILI group. CONCLUSIONS: Intervention response heterogeneity was significant for nonfatal MI. Response heterogeneity may need consideration in a CVD-outcome trial design.

The Healthy Homes/Healthy Kids 5-10 Obesity Prevention Trial: 12 and 24-month outcomes.

BACKGROUND: Pediatric primary care is an important setting for addressing obesity prevention. OBJECTIVE: The Healthy Homes/Healthy Kids 5-10 randomized controlled trial evaluated the efficacy of an obesity prevention intervention integrating pediatric primary care provider counseling and parent-targeted phone coaching. METHODS: Children aged 5 to 10 years with a BMI between the 70th and 95th percentile and their parents were recruited from pediatric primary care clinics. Participants received well-child visit provider counseling about obesity and safety/injury prevention and were then randomized to a 14-session phone-based obesity prevention (OP; n = 212) or safety and injury prevention contact control (CC; n = 209) intervention. The primary outcome was 12 and 24-month child BMI percentile. RESULTS: There was no overall significant treatment effect on child BMI percentile. Caloric intake was significantly lower among OP compared with CC participants at 12 months (P < .005). In planned subgroup analyses, OP condition girls had significantly lower BMI percentile (P < .05) and BMI z-score (P < .02) at 12 and 24 months relative to CC girls and were less likely to be overweight (38.0% vs 53.0%, P < .01) or (obese 3.4% vs 8.8%, P < .10) at follow-up. CONCLUSIONS AND RELEVANCE: An obesity prevention intervention integrating brief provider counseling and parent-targeted phone counseling did not impact 12 and 24-month BMI status overall but did have a significant impact on BMI in girls.

Understanding Outcomes in Behavior Change Interventions to Prevent Pediatric Obesity: The Role of Dose and Behavior Change Techniques.

BACKGROUND: Behavioral interventions to prevent pediatric obesity have shown inconsistent results across the field. Studying what happens within the "black box" of these interventions and how differences in implementation lead to different outcomes will help researchers develop more effective interventions. AIM: To compare the implementation of three features of a phone-based intervention for parents (time spent discussing weight-related behaviors, behavior change techniques used in sessions, and intervention activities implemented by parents between sessions) with study outcomes. METHODS: A random selection of 100 parent-child dyads in the intervention arm of a phone-based obesity prevention trial was included in this analysis. Sessions were coded for overall session length, length of time spent discussing specific weight-related behaviors, number of behavior change techniques used during the sessions, and number of intervention-recommended activities implemented by the parents between sessions (e.g., parent-reported implementation of behavioral practice/rehearsal between sessions). The primary study outcome, prevention of unhealthy increase in child body mass index (BMI) percentile, was measured at baseline and 12 months. RESULTS: Overall session length was associated with decreases in child BMI percentile ( b = -0.02, p = .01). There was no association between the number of behavior change techniques used in the sessions and decreases in child BMI percentile ( b = -0.29, p = .27). The number of activities the parents reported implementing between sessions was associated with decreases in child BMI percentile ( b = -1.25, p = .02). DISCUSSION: To improve future interventions, greater attention should be paid to the intended and delivered session length, and efforts should be made to facilitate parents' implementation of intervention-recommended activities between sessions (ClinicalTrials.gov, No. NCT01084590).

Impact of a Multidomain Intensive Lifestyle Intervention on Complaints About Memory, Problem-Solving, and Decision-Making Abilities: The Action for Health in Diabetes Randomized Controlled Clinical Trial.

Background: Lifestyle interventions to reduce weight and increase activity may preserve higher-order cognitive abilities in overweight/obese adults with type 2 diabetes (T2D). Methods: Adults (N = 5,084) with T2D who enrolled in a randomized clinical trial of a 10-year intensive lifestyle intervention (ILI) compared with diabetes support and education were queried at baseline and repeatedly during follow-up for complaints about difficulties in memory, problem-solving, and decision-making abilities. Results: For those without baseline complaints, assignment to ILI was associated with lower odds that complaints would emerge during follow-up for decision-making ability (odds ratio [OR]=0.851, [95% CI, 0.748,0.967], p=0.014), and, among individuals who were not obese, lower odds that complaints would emerge about problem-solving ability (OR=0.694 [0.510,0.946]). No cognitive benefits from ILI were seen for individuals with baseline complaints about cognitive abilities. ILI may have exacerbated the severity of complaints about problem-solving ability during follow-up among individuals with baseline complaints and cardiovascular disease (OR=2.949 [1.378,6.311]). Conclusions: A long-term multidomain ILI may reduce the likelihood that complaints about difficulties in higher-order cognitive abilities will emerge in T2D adults without pre-existing complaints. Among those with pre-existing complaints, the ILI did not prevent increases in complaint severity.

Psychological status and weight variability over eight years: Results from Look AHEAD.

OBJECTIVE: Cross-sectional studies suggest an association between weight cycling and psychological status. Although this is often interpreted as suggesting that weight cycles "cause" psychological distress, the relationship could be bidirectional. This study provides a prospective analysis of the bidirectional association between weight variability and psychological status over an 8-year period in overweight/obese adults with Type 2 diabetes. METHOD: Data were from the first 8 years of Look AHEAD, a randomized controlled trial comparing health outcomes in individuals with Type 2 diabetes assigned to an intensive lifestyle intervention designed to produce weight loss or a diabetes education and support control group. Psychological status (mental health, depressive symptoms, binge eating) was assessed via surveys and were examined in relation to weight variability at both baseline and year 8. Weight variability was derived from 8 possible annual measurements from participants who had a minimum of 3 consecutive body weight measurements (N = 4,774) and operationalized as the number of year-to-year cycles and the coefficient of variation across all available weight measurements. RESULTS: Controlling for study group, higher baseline scores on mental health (Short Form-36 Mental Component Summary) and lower levels of depressive symptomatology (Beck Depression Inventory) and binge eating (Questionnaire on Eating and Weight Patterns) were associated with significantly less subsequent weight variability. The prospective association between weight variability and psychological status at year 8 was less robust. CONCLUSIONS: These results suggest that the cross-sectional relationship between weight variability and psychological status is due primarily to poorer psychological function preceding greater weight instability. (PsycINFO Database Record

Lifestyle Intervention and Medical Management With vs Without Roux-en-Y Gastric Bypass and Control of Hemoglobin A1c, LDL Cholesterol, and Systolic Blood Pressure at 5 Years in the Diabetes Surgery Study.

Importance: The Roux-en-Y gastric bypass is effective in achieving established diabetes treatment targets, but durability is unknown. Objective: To compare durability of Roux-en-Y gastric bypass added to intensive lifestyle and medical management in achieving diabetes control targets. Design, Setting, and Participants: Observational follow-up of a randomized clinical trial at 4 sites in the United States and Taiwan, involving 120 participants who had a hemoglobin A1c (HbA1c) level of 8.0% or higher and a body mass index between 30.0 and 39.9 (enrolled between April 2008 and December 2011) were followed up for 5 years, ending in November 2016. Interventions: Lifestyle-intensive medical management intervention based on the Diabetes Prevention Program and LookAHEAD trials for 2 years, with and without (60 participants each) Roux-en-Y gastric bypass surgery followed by observation to year 5. Main Outcomes and Measures: The American Diabetes Association composite triple end point of hemoglobin A1c less than 7.0%, low-density lipoprotein cholesterol less than 100 mg/dL, and systolic blood pressure less than 130 mm Hg at 5 years. Results: Of 120 participants who were initially randomized (mean age, 49 years [SD, 8 years], 72 women [60%]), 98 (82%) completed 5 years of follow-up. Baseline characteristics were similar between groups: mean (SD) body mass index 34.4 (3.2) for the lifestyle-medical management group and 34.9 (3.0) for the gastric bypass group and had hemoglobin A1c levels of 9.6% (1.2) and 9.6% (1.0), respectively. At 5 years, 13 participants (23%) in the gastric bypass group and 2 (4%) in the lifestyle-intensive medical management group had achieved the composite triple end point (difference, 19%; 95% CI, 4%-34%; P = .01). In the fifth year, 31 patients (55%) in the gastric bypass group vs 8 (14%) in the lifestyle-medical management group achieved an HbA1c level of less than 7.0% (difference, 41%; 95% CI, 19%-63%; P = .002). Gastric bypass had more serious adverse events than did the lifestyle-medical management intervention, 66 events vs 38 events, most frequently gastrointestinal events and surgical complications such as strictures, small bowel obstructions, and leaks. Gastric bypass had more parathyroid hormone elevation but no difference in B12 deficiency. Conclusions and Relevance: In extended follow-up of obese adults with type 2 diabetes randomized to adding gastric bypass compared with lifestyle and intensive medical management alone, there remained a significantly better composite triple end point in the surgical group at 5 years. However, because the effect size diminished over 5 years, further follow-up is needed to understand the durability of the improvement. Trial Registration: clinicaltrials.gov Identifier: NCT00641251.

Physical Function Following a Long-Term Lifestyle Intervention Among Middle Aged and Older Adults With Type 2 Diabetes: The Look AHEAD Study.

Background: Lifestyle interventions have been shown to improve physical function over the short term; however, whether these benefits are sustainable is unknown. The long-term effects of an intensive lifestyle intervention (ILI) on physical function were assessed using a randomized post-test design in the Look AHEAD trial. Methods: Overweight and obese (body mass index ≥ 25 kg/m2) middle-aged and older adults (aged 45-76 years at enrollment) with type 2 diabetes enrolled in Look AHEAD, a trial evaluating an ILI designed to achieve weight loss through caloric restriction and increased physical activity compared to diabetes support and education (DSE), underwent standardized assessments of performance-based physical function including a 4- and 400-m walk, lower extremity physical performance (expanded Short Physical Performance Battery, SPPBexp), and grip strength approximately 11 years postrandomization and 1.5 years after the intervention was stopped (n = 3,783). Results: Individuals randomized to ILI had lower odds of slow gait speed (<0.8 m/s) compared to those randomized to DSE (adjusted OR [95% CI]: 0.84 [0.71 to 0.99]). Individuals randomized to ILI also had faster gait speed over 4- and 400-m (adjusted mean difference [95% CI]: 0.019 [0.007 to 0.031] m/s, p = .002, and 0.023 [0.012 to 0.034] m/sec, p < .0001, respectively) and higher SPPBexp scores (0.037 [0.011 to 0.063], p = .005) compared to those randomized to DSE. The intervention effect was slightly larger for SPPBexp scores among older versus younger participants (0.081 [0.038 to 0.124] vs 0.013 [-0.021 to 0.047], p = .01). Conclusions: An intensive lifestyle intervention has modest but significant long-term benefits on physical function in overweight and obese middle-aged and older adults with type 2 diabetes. ClinicalTrials.gov Identifier: NCT00017953.

The Effect of Intentional Weight Loss on Fracture Risk in Persons With Diabetes: Results From the Look AHEAD Randomized Clinical Trial.

Intentional weight loss is an important treatment option for overweight persons with type 2 diabetes mellitus (DM), but the effects on long-term fracture risk are not known. The purpose of this Look AHEAD analysis was to evaluate whether long-term intentional weight loss would increase fracture risk in overweight or obese persons with DM. Look AHEAD is a multicenter, randomized clinical trial. Recruitment began in August 2001 and follow-up continued for a median of 11.3 years at 16 academic centers. A total of 5145 persons aged 45 to 76 years with DM were randomized to either an intensive lifestyle intervention (ILI) with reduced calorie consumption and increased physical activity designed to achieve and maintain ≥7% weight loss or to diabetes support and education intervention (DSE). Incident fractures were ascertained every 6 months by self-report and confirmed with central adjudication of medical records. The baseline mean age of participants was 59 years, 60% were women, 63% were white, and the mean BMI was 36 kg/m2 . Weight loss over the intervention period (median 9.6 years) was 6.0% in ILI and 3.5% in DSE. A total of 731 participants had a confirmed incident fracture (358 in DSE versus 373 in ILI). There were no statistically significant differences in incident total or hip fracture rates between the ILI and DSE groups. However, compared to the DSE group, the ILI group had a statistically significant 39% increased risk of a frailty fracture (HR 1.39; 95% CI, 1.02 to 1.89). An intensive lifestyle intervention resulting in long-term weight loss in overweight/obese adults with DM was not associated with an overall increased risk of incident fracture but may be associated with an increased risk of frailty fracture. When intentional weight loss is planned, consideration of bone preservation and fracture prevention is warranted. © 2017 American Society for Bone and Mineral Research.

Effect of a long-term intensive lifestyle intervention on prevalence of cognitive impairment.

OBJECTIVE: To assess whether an average of 10 years of lifestyle intervention designed to reduce weight and increase physical activity lowers the prevalence of cognitive impairment among adults at increased risk due to type 2 diabetes and obesity or overweight. METHODS: Central adjudication of mild cognitive impairment and probable dementia was based on standardized cognitive test battery scores administered to 3,802 individuals who had been randomly assigned, with equal probability, to either the lifestyle intervention or the diabetes support and education control. When scores fell below a prespecified threshold, functional information was obtained through proxy interview. RESULTS: Compared with control, the intensive lifestyle intervention induced and maintained marked differences in weight loss and self-reported physical activity throughout follow-up. At an average (range) of 11.4 (9.5-13.5) years after enrollment, when participants' mean age was 69.6 (54.9-87.2) years, the prevalence of mild cognitive impairment and probable dementia was 6.4% and 1.8%, respectively, in the intervention group, compared with 6.6% and 1.8%, respectively, in the control group (p = 0.93). The lack of an intervention effect on the prevalence of cognitive impairment was consistent among individuals grouped by cardiovascular disease history, diabetes duration, sex, and APOE ε4 allele status (all p ≥ 0.50). However, there was evidence (p = 0.03) that the intervention effect ranged from benefit to harm across participants ordered from lowest to highest baseline BMI. CONCLUSIONS: Ten years of behavioral weight loss intervention did not result in an overall difference in the prevalence of cognitive impairment among overweight or obese adults with type 2 diabetes. CLINICALTRIALSGOV IDENTIFIER: NCT00017953 (Action for Health in Diabetes). LEVEL OF EVIDENCE: This study provides Class II evidence that for overweight adults with type 2 diabetes, a lifestyle intervention designed to reduce weight and increase physical activity does not lower the risk of cognitive impairment.

Feasibility of standardized methods to specify behavioral pediatric obesity prevention interventions.

Standardized methods are needed to evaluate what occurs within the 'black box' of behavioral interventions to prevent pediatric obesity. The purpose of this research is to evaluate methods to specify the behavior change techniques used and the amount of time spent discussing target weight-related behaviors in an intervention for parents of children at risk for becoming overweight or obese. Independent coders were trained to identify behavior change techniques and time spent discussing weight-related behaviors in audio recordings and transcripts of intervention sessions from 100 randomly selected participants. The behavior change technique taxonomy (BCTTv1) was used to code techniques present in sessions. A newly-developed tool was used to code time spent discussing each target weight-related behavior (e.g., physical activity, screen time). Sessions from a subset of these participants (N = 20) were double coded to evaluate inter-rater reliability. After revisions to coding protocols, coders reliably coded behavior change techniques used and time spent discussing target weight-related behaviors in sessions from the subset of 20 participants. The most commonly discussed target weight-related behavior was physical activity followed by energy intake and fruit and vegetable intake. On average, 13.9 (SD = 2.8) unique behavior change techniques were present across sessions for a given participant. These results offer reliable methods for systematically identifying behavior change techniques used and time spent discussing weight-related behaviors in a pediatric obesity prevention intervention. This work paves the way for future research to identify which specific target behaviors and techniques are most associated with the prevention of unhealthy weight gain in children.

Effect of a Long-Term Intensive Lifestyle Intervention on Cognitive Function: Action for Health in Diabetes Study.

OBJECTIVES: To assess whether randomization to 10 years of lifestyle intervention to induce and maintain weight loss improves cognitive function. DESIGN: Randomized controlled clinical trial. SETTING: Data obtained as part of the Action for Health in Diabetes (Look AHEAD) trial (NCT00017953) and Look AHEAD Continuation study (U01 DK057136-15). PARTICIPANTS: Overweight and obese individuals with type 2 diabetes mellitus aged 45 to 76 (N = 3,751). INTERVENTION: Intensive lifestyle intervention (ILI) for weight loss through reduced caloric intake and increased physical activity compared with a control condition of diabetes support and education (DSE). MEASUREMENTS: Certified examiners who were masked to intervention assignment administered a standard battery of cognitive function tests (Modified Mini-Mental State Examination, Rey Auditory Verbal Learning Test, Digit Symbol Coding, Trail-Making Test, Modified Stroop Color-Word Test) to participants 10 to 13 years after enrollment. RESULTS: Assignment to lifestyle intervention was not associated with significantly different overall (P = .10) or domain-specific (all P > .10) cognitive function than assignment to diabetes support and education. Results were fairly consistent across prespecified groups, but there was some evidence of trends for differential intervention effects showing modest harm in ILI in participants with greater body mass index and in individuals with a history of cardiovascular disease. Cognitive function was not associated with changes in weight or fitness (all P > .05). CONCLUSION: A long-term behavioral weight loss intervention for overweight and obese adults with diabetes mellitus was not associated with cognitive benefit. Trial Registration clinicaltrials.gov Identifier: NCT00017953.