Effects of Sedentary Behavior Reduction on Blood Pressure in Desk Workers: Results From the RESET-BP Randomized Clinical Trial.

BACKGROUND: Sedentary behavior (SB) is observationally associated with cardiovascular disease risk. However, randomized clinical trials testing causation are limited. We hypothesized that reducing SB would decrease blood pressure (BP) and pulse wave velocity (PWV) in sedentary adults. METHODS: This parallel-arm, 3-month randomized clinical trial recruited desk workers, age 18 to 65 years, with systolic BP 120 to 159 or diastolic BP (DBP) 80 to 99 mm Hg, off antihypertensive medications, and reporting <150 min/wk of moderate to vigorous intensity physical activity. Participants were randomized to a SB reduction intervention or a no-contact control group. The intervention sought to replace 2 to 4 h/d of SB with standing and stepping through coaching, a wrist-worn activity prompter, and a sit-stand desk. SB and physical activity were measured with a thigh-worn accelerometer and quantified during all waking hours and separately during work and nonwork times. Clinic-based resting systolic BP (primary outcome) and DBP, 24-hour ambulatory BP, and PWV were assessed by blinded technicians at baseline and 3 months. RESULTS: Participants (n=271) had a mean age of 45 years and systolic BP/DBP 129/83 mm Hg. Compared with controls, intervention participants reduced SB (-1.15±0.17 h/d), increased standing (0.94±0.14 h/d), and increased stepping (5.4±2.4 min/d; all P<0.05). SB and activity changes mainly occurred during work time and were below the goal. The intervention did not reduce BP or PWV in the intervention group compared with controls. Between-group differences in resting systolic BP and DBP changes were -0.22±0.90 (P=0.808) and 0.13±0.61 mm Hg (P=0.827), respectively. The findings were similarly null for ambulatory BP and PWV. Decreases in work-time SB were associated with favorable reductions in resting DBP (r=0.15, P=0.017). Contrary to our hypotheses, reductions in work-time SB (r=-0.19, P=0.006) and increases in work-time standing (r=0.17, P=0.011) were associated with unfavorable increases in carotid-femoral PWV. As expected, increases in nonwork-time standing were favorably associated with carotid-femoral PWV (r=-0.14, P=0.038). CONCLUSIONS: A 3-month intervention that decreased SB and increased standing by ≈1 hour during the work day was not effective for reducing BP. Future directions include examining effects of interventions reducing SB through activity other than work-time standing and clarifying association between standing and PWV in opposite directions for work and nonwork time. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03307343.

Algorithm Validation for Quantifying ActiGraph™ Physical Activity Metrics in Individuals with Chronic Low Back Pain and Healthy Controls.

Assessing physical activity is important in the treatment of chronic conditions, including chronic low back pain (cLBP). ActiGraph™, a widely used physical activity monitor, collects raw acceleration data, and processes these data through proprietary algorithms to produce physical activity measures. The purpose of this study was to replicate ActiGraph™ algorithms in MATLAB and test the validity of this method with both healthy controls and participants with cLBP. MATLAB code was developed to replicate ActiGraph™'s activity counts and step counts algorithms, to sum the activity counts into counts per minute (CPM), and categorize each minute into activity intensity cut points. A free-living validation was performed where 24 individuals, 12 cLBP and 12 healthy, wore an ActiGraph™ GT9X on their non-dominant hip for up to seven days. The raw acceleration data were processed in both ActiLife™ (v6), ActiGraph™'s data analysis software platform, and through MATLAB (2022a). Percent errors between methods for all 24 participants, as well as separated by cLBP and healthy, were all less than 2%. ActiGraph™ algorithms were replicated and validated for both populations, based on minimal error differences between ActiLife™ and MATLAB, allowing researchers to analyze data from any accelerometer in a manner comparable to ActiLife™.

Long-Term Outcomes of Medical Management vs Bariatric Surgery in Type 2 Diabetes.

Importance: Randomized clinical trials of bariatric surgery have been limited in size, type of surgical procedure, and follow-up duration. Objective: To determine long-term glycemic control and safety of bariatric surgery compared with medical/lifestyle management of type 2 diabetes. Design, Setting, and Participants: ARMMS-T2D (Alliance of Randomized Trials of Medicine vs Metabolic Surgery in Type 2 Diabetes) is a pooled analysis from 4 US single-center randomized trials conducted between May 2007 and August 2013, with observational follow-up through July 2022. Intervention: Participants were originally randomized to undergo either medical/lifestyle management or 1 of the following 3 bariatric surgical procedures: Roux-en-Y gastric bypass, sleeve gastrectomy, or adjustable gastric banding. Main Outcome and Measures: The primary outcome was change in hemoglobin A1c (HbA1c) from baseline to 7 years for all participants. Data are reported for up to 12 years. Results: A total of 262 of 305 eligible participants (86%) enrolled in long-term follow-up for this pooled analysis. The mean (SD) age of participants was 49.9 (8.3) years, mean (SD) body mass index was 36.4 (3.5), 68.3% were women, 31% were Black, and 67.2% were White. During follow-up, 25% of participants randomized to undergo medical/lifestyle management underwent bariatric surgery. The median follow-up was 11 years. At 7 years, HbA1c decreased by 0.2% (95% CI, -0.5% to 0.2%), from a baseline of 8.2%, in the medical/lifestyle group and by 1.6% (95% CI, -1.8% to -1.3%), from a baseline of 8.7%, in the bariatric surgery group. The between-group difference was -1.4% (95% CI, -1.8% to -1.0%; P < .001) at 7 years and -1.1% (95% CI, -1.7% to -0.5%; P = .002) at 12 years. Fewer antidiabetes medications were used in the bariatric surgery group. Diabetes remission was greater after bariatric surgery (6.2% in the medical/lifestyle group vs 18.2% in the bariatric surgery group; P = .02) at 7 years and at 12 years (0.0% in the medical/lifestyle group vs 12.7% in the bariatric surgery group; P < .001). There were 4 deaths (2.2%), 2 in each group, and no differences in major cardiovascular adverse events. Anemia, fractures, and gastrointestinal adverse events were more common after bariatric surgery. Conclusion and Relevance: After 7 to 12 years of follow-up, individuals originally randomized to undergo bariatric surgery compared with medical/lifestyle intervention had superior glycemic control with less diabetes medication use and higher rates of diabetes remission. Trial Registration: ClinicalTrials.gov Identifier: NCT02328599.

Challenges and Solutions for Monitoring Alcohol Use in Patients With Alcohol-Related Liver Disease: Pilot Study of a Wearable Alcohol Biosensor.

OBJECTIVES: Early alcohol use identification can prevent morbidity/mortality for alcohol-associated liver disease (ALD). Innovative wearable alcohol biosensors (biosensors) that identify alcohol use through perspiration are an emerging technology with potential application for patients with ALD. Our primary aim was to determine biosensor acceptability and feasibility for patients with ALD. We describe participant acceptance and challenges using biosensor technology in a pilot study of biosensors with patients with ALD. DESIGN: Participants had a recent diagnosis or hospitalization for decompensated ALD, had to be drinking within the past 3 months, and had to be followed at our center. Participants wore the biosensor daily for 3 months. Quantitative data using the Technology Acceptance Model 2 (TAM2) measure were collected at intake and study conclusion. The TAM2's 13 items cover four scales: perceived usefulness, ease of use, attitude toward technology, and intention to use on a 7-point Likert scale. Lower scores indicate higher acceptance. Participants were asked open-ended questions about issues wearing the biosensor. RESULTS: Among 27 participants, 60% were women with an average age of 45 (10) years, and 89% were White. TAM2 subscales indicated initially high acceptance (mean scores = 1.2-2.2) and remained high (mean scores = 1.3-2.3) without a statistically significant decline at study conclusion. From open-ended questions, several themes regarding problems with device wear emerged a) uncomfortable or cumbersome to wear, b) problems with biosensor appearance, and c) issues with usability. Challenges to biosensor usage included data being lost when devices were damaged and devices being lost during the study. CONCLUSIONS: Alcohol biosensors seem to be acceptable to ALD participants. However, improving the appearance, comfort, durability, and functionality of biosensor devices is critical to clinical deployment.Trial Registration:Clinicaltrials.gov identifier NCT03533660: Alcohol biosensor monitoring for alcohol liver disease.

Program Factors Affecting Weight Loss and Mobility in Older Adults: Evidence From the Mobility and Vitality Lifestyle Program (MOVE UP).

Background. The Mobility and Vitality Lifestyle Program (MOVE UP) is a behavioral weight-management intervention for improving mobility among community-dwelling older adults. We examined program factors that affect implementation outcomes and participant-level health outcomes. Methods. The MOVE UP program was implemented in the greater Pittsburgh area from January 2015 to June 2019 to improve lower extremity performance in community-dwelling older adults who were overweight or obese. Thirty-two sessions were delivered over 13 months. All sessions were designed to be 1-hour in length, on-site, group-based, and led by trained and supported community health workers (CHWs). Participants completed weekly Lifestyle Logs for self-monitoring of body weight, diet, and physical activity. We evaluated the MOVE UP program using the RE-AIM framework, and collected quantitative data at baseline, 5-, 9-, and 13-months. Multilevel linear regression models assessed the impacts of program factors (site, CHW, and participant characteristics) on implementation outcomes and participant-level health outcomes. Results. Twenty-two CHWs delivered MOVE UP program to 303 participants in 26 cohorts. Participants were similar to the target source population in weight but differed in some demographic characteristics. The program was effective for weight loss and lower extremity function in both intervention and maintenance periods (Ps < .01), with an independent effect for Lifestyle Logs submission but not session attendance. Discussion. CHWs were able to deliver a multi-component weight loss intervention effectively in community settings. CHW and site characteristics had independent impacts on participants' adherence. Lifestyle Log submission may be a more potent measure of adherence in weight loss interventions than attendance.

The Relationship Between Objectively Measured Step Count, Clinical Characteristics, and Quality of Life Among Depressed Patients Recently Hospitalized With Systolic Heart Failure.

OBJECTIVE: Physical activity (PA) can improve symptoms of both depression and heart failure (HF), but objective activity data among recently hospitalized HF patients with comorbid depression are lacking. We examined PA and the relationship between daily step counts and mood, health-related quality of life (HRQoL), and heart health among patients enrolled in a clinical trial treating HF and comorbid depression. METHODS: We screened hospitalized patients with systolic HF (left ventricular ejection fraction [LVEF] ≤45%) and New York Heart Association class II-IV symptoms for depression using the two-item Patient Health Questionnaire (PHQ-2) and telephoned screen-positive patients to administer the PHQ-9 2 weeks after discharge. If the patient scored PHQ-9 ≥10 and agreed to continue in our study, we administered our baseline assessment and mailed them an armband accelerometer. We instructed patients to wear the armbands for 7 days before returning them and classified their data as "usable" if they wore it ≥10 hours per day on ≥4 separate days. RESULTS: We mailed accelerometers to 531 depressed HF patients, and 222 (42%) returned them with usable data. Their median age was 64 years, 54% were women, 23% were non-White, and they walked a median of 1170 steps daily. Higher median daily step counts were associated with lower New York Heart Association class and better physical- and HF-specific HRQoL, but not mood symptoms, mental HRQoL, or LVEF. CONCLUSIONS: Patients with HF and comorbid depression are generally sedentary after hospital discharge. Although mood symptoms and LVEF were unrelated to objective PA, patients with higher step counts self-reported better HRQoL.Trial Registration:ClinicalTrials.gov identifier NCT02044211.

Alliance of Randomized Trials of Medicine vs Metabolic Surgery in Type 2 Diabetes (ARMMS-T2D): Study rationale, design, and methods.

AIMS: Long-term data from randomized clinical trials comparing metabolic (bariatric) surgery versus a medical/lifestyle intervention for treatment of patients with obesity/overweight and type 2 diabetes (T2D) are lacking. The Alliance of Randomized Trials of Medicine vs Metabolic Surgery in Type 2 Diabetes (ARMMS-T2D) is a consortium of four randomized trials designed to compare long-term efficacy and safety of surgery versus medical/lifestyle therapy on diabetes control and clinical outcomes. MATERIALS AND METHODS: Patients with T2D and body mass index (BMI) of 27-45 kg/m2 who were previously randomized to metabolic surgery (Roux-en-Y gastric bypass, adjustable gastric band, or sleeve gastrectomy) versus medical/lifestyle intervention in the STAMPEDE, SLIMM-T2D, TRIABETES, or CROSSROADS trials have been enrolled in ARMMS-T2D for observational follow-up. The primary outcome is change in glycated haemoglobin after a minimum 7 years of follow-up, with additional analyses to determine rates of diabetes remission and relapse, as well as cardiovascular and renal endpoints. RESULTS: In total, 302 patients (192 surgical, 110 medical/lifestyle) previously randomized in the four parent studies were eligible for participation in the ARMMS-T2D observational study. Participant demographics were 71% white, 27% African-American and 68% female. At baseline: age, 50 ± 8 years; BMI, 36.5 ± 3.5 kg/m2 ; duration of diabetes, 8.8 ± 5.6 years; glycated haemoglobin, 8.6% ± 1.6%; and fasting glucose, 168 ± 64 mg/dl. More than 35% of patients had a BMI <35 kg/m2 . CONCLUSIONS: ARMMS-T2D will provide the largest body of long-term, level 1 evidence to inform clinical decision-making regarding the comparative durability, efficacy and safety of metabolic surgery relative to a medical/lifestyle intervention among patients with T2D, including those with milder class I obesity or mere overweight.

Wearables, Physical Activity, and Exercise Testing in Liver Disease.

Physical inactivity is a major cause of deterioration in all forms of advanced liver disease. It is especially important as a driver of the components of the metabolic syndrome, with nonalcoholic fatty liver disease rapidly becoming the dominant cause of liver-related death worldwide. Growing realization of the health benefits of moderate-to-vigorous physical activity has captured the interest of persons who desire to improve their health, including those at risk for chronic liver injury. They are increasingly adopting wearable activity trackers to measure the activity that they seek to improve. Improved physical activity is the key lifestyle behavior that can improve cardiorespiratory fitness, which is most accurately measured with cardiopulmonary exercise testing (CPET). CPET is showing promise to identify risk and predict outcomes in transplant hepatology. Team effort among engaged patients, social support networks, and clinicians supported by web-based connectivity is needed to fully exploit the benefits of physical activity tracking.

Prehabilitation-Driven Changes in Frailty Metrics Predict Mortality in Patients With Advanced Liver Disease.

INTRODUCTION: Frailty is a predictor of morbidity and mortality in cirrhosis. Although evidence for prehabilitation is promising, the data for liver transplant (LT) candidates are limited. The primary aim of this study was to evaluate the effect of a novel prehabilitation strategy on changes in frailty metrics and survival in LT candidates. The secondary aim was to determine liver-related and extrahepatic conditions associated with frailty. METHODS: In this ambispective cohort study, all patients underwent frailty assessment using the liver frailty index (LFI), 6-minute walk test, and gait speed test performed by a dedicated physical therapist. Home-based exercise prescription was individualized to each patient's baseline physical fitness. RESULTS: We included 517 patients (59% men, median age 61 years, and a model for end-stage liver disease score of 12) evaluated during 936 PT visits. Frailty metrics were affected by age, sex, and liver-related parameters, but not by model for end-stage liver disease. Patients with nonalcoholic fatty liver disease and alcohol-related cirrhosis had worse frailty metrics by all tools. We demonstrated the feasibility of prehabilitation in improving both LFI and 6-minute walk test, particularly in adherent patients. A median LFI improvement of 0.3 in frail patients was associated with improved survival in univariate analysis. Compliance with physical therapist visits (hazards ratio = 0.35 [0.18-0.67] for 2 visits and hazards ratio = 0.54 [0.31-0.94] for ≥3 visits) was independently associated with increased survival. DISCUSSION: Prehabilitation improves frailty metrics in LT candidates and is associated with a survival advantage. Our findings provide a framework for the standardized prehabilitation program in LT candidates while prioritizing compliance, adherence, and on-training LFI goal accomplishment.

Introducing EL-FIT (Exercise and Liver FITness): A Smartphone App to Prehabilitate and Monitor Liver Transplant Candidates.

Preserved physical function is key for successful liver transplantation (LT); however, prehabilitation strategies are underdeveloped. We created a smartphone application (app), EL-FIT (Exercise and Liver FITness), to facilitate exercise training in end-stage liver disease (ESLD). In this feasibility study, we tested EL-FIT app usage and the accuracy of physical activity data transfer and obtained feedback from initial users. A total of 28 participants used the EL-FIT app and wore a physical activity tracker for 38 ± 12 days (age, 60 ± 8 years; 57% males; Model for End-Stage Liver Disease-sodium, 19 ± 5). There was fidelity in data transfer from the tracker to the EL-FIT app. Participants were sedentary (1957 [interquartile range, 873-4643] steps/day) at baseline. Level of training assigned by the EL-FIT app agreed with that from a physical therapist in 89% of cases. Participants interacted with all app features (videos, perceived exertion, and gamification/motivational features). We rearranged training data to generate heart rate-validated steps as a marker of performance and showed that 35% of the participants had significant increases in their physical performance. Participants emphasized their interest in having choices to better engage in exercise, and they appreciated the sense of community the EL-FIT app generated. We showed that patients with ESLD are able to use and interact with the EL-FIT app. This novel smartphone app has the potential of becoming an invaluable tool for home-based prehabilitation in LT candidates.

Weight Management Strategies for the Patient with Diabetes.

PURPOSE OF REVIEW: Obesity is associated with an increased risk for type 2 diabetes, and weight loss in adults with obesity and type 2 diabetes may be indicated to reduce health risk and improve diabetes control. It is important to understand the effectiveness of weight loss interventions for the prevention and treatment of type 2 diabetes. RECENT FINDINGS: Lifestyle interventions for weight loss show effectiveness for prevention of type 2 diabetes. Weight loss in patients with type 2 diabetes can decrease cardiometabolic risk and improve diabetes control. However, diabetes remission with lifestyle approaches is limited and to achieve this medical approaches such as bariatric surgery that result in greater magnitudes of weight loss may be necessary. Dissemination of lifestyle interventions for weight loss, along with other medical approaches such as bariatric surgery when indicated, are needed to reduce the health burden of type 2 diabetes in patients with obesity.

Comparison of Food Cue-Evoked and Resting-State Functional Connectivity in Obesity.

OBJECTIVE: Obesity is associated with differences in task-evoked and resting-state functional brain connectivity (FC). However, no studies have compared obesity-related differences in FC evoked by high-calorie food cues from that observed at rest. Such a comparison could improve our understanding of the neural mechanisms of reward valuation and decision making in the context of obesity. METHODS: The sample included 122 adults (78% female; mean age = 44.43 [8.67] years) with body mass index (BMI) in the overweight or obese range (mean = 31.28 [3.92] kg/m). Participants completed a functional magnetic resonance imaging scan that included a resting period followed by a visual food cue task. Whole-brain FC analyses examined seed-to-voxel signal covariation during the presentation of high-calorie food and at rest using seeds located in the left and right orbitofrontal cortex, left hippocampus, and left dorsomedial prefrontal cortex. RESULTS: For all seeds examined, BMI was associated with stronger FC during the presentation of high-calorie food, but weaker FC at rest. Regions exhibiting BMI-related modulation of signal coherence in the presence of palatable food cues were largely located within the default mode network (z range = 2.34-4.91), whereas regions exhibiting BMI-related modulation of signal coherence at rest were located within the frontostriatal and default mode networks (z range = 3.05-4.11). All FC results exceeded a voxelwise threshold of p < .01 and cluster-defining familywise error threshold of p < .05. CONCLUSIONS: These dissociable patterns of FC may suggest separate neural mechanisms contributing to variation in distinct cognitive, psychological, or behavioral domains that may be related to individual differences in risk for obesity.

Role of Physical Activity and Exercise in Treating Patients with Overweight and Obesity.

BACKGROUND: Overweight and obesity are significant public health concerns that are linked to numerous negative health consequences. Physical activity is an important lifestyle behavior that contributes to body weight regulation. CONTENT: Physical activity is inversely associated with weight gain and the incidence of obesity. Physical activity also contributes to additional weight loss when coupled with dietary modification, and it can result in modest weight loss when not coupled with dietary modification. Moreover, physical activity is associated with improved long-term weight loss and prevention of weight gain following initial weight loss. Current evidence supports that physical activity should be moderate to vigorous in intensity to influence body weight regulation. There is also a growing body of evidence that physical activity can be accumulated throughout the day in shorter periods of time rather than being performed during a structured and longer period, and that physical activity performed in this manner can be important for body weight regulation. SUMMARY: The literature supports the inclusion of physical activity as an important lifestyle behavior for regulating body weight. There are multiple intervention approaches that may be effective for enhancing physical activity engagement within the context of weight control.

Association of Hippocampal Substructure Resting-State Functional Connectivity with Memory Performance in Older Adults.

OBJECTIVES: Hippocampal hyperactivation marks preclinical dementia pathophysiology, potentially due to differences in the connectivity of specific medial temporal lobe structures. Our aims were to characterize the resting-state functional connectivity of medial temporal lobe sub-structures in older adults, and evaluate whether specific substructural (rather than global) functional connectivity relates to memory function. METHODS: In 15 adults (mean age: 69 years), we evaluated the resting state functional connectivity of medial temporal lobe substructures: dentate/Cornu Ammonis (CA) 4, CA1, CA2/3, subiculum, the molecular layer, entorhinal cortex, and parahippocampus. We used 7-Tesla susceptibility weighted imaging and magnetization-prepared rapid gradient echo sequences to segment substructures of the hippocampus, which were used as structural seeds for examining functional connectivity in a resting BOLD sequence. We then assessed correlations between functional connectivity with memory performance (short and long delay free recall on the California Verbal Learning Test [CVLT]). RESULTS: All the seed regions had significant connectivity within the temporal lobe (including the fusiform, temporal, and lingual gyri). The left CA1 was the only seed with significant functional connectivity to the amygdala. The left entorhinal cortex was the only seed to have significant functional connectivity with frontal cortex (anterior cingulate and superior frontal gyrus). Only higher left dentate-left lingual connectivity was associated with poorer CVLT performance (Spearman r = -0.81, p = 0.0003, Benjamini-Hochberg false discovery rate: 0.01) after multiple comparison correction. CONCLUSIONS: Rather than global hyper-connectivity of the medial temporal lobe, left dentate-lingual connectivity may provide a specific assay of medial temporal lobe hyper-connectivity relevant to memory in aging.

Reducing sedentary behaviour to decrease chronic low back pain: the stand back randomised trial.

OBJECTIVE: The Stand Back study evaluated the feasibility and effects of a multicomponent intervention targeting reduced prolonged sitting and pain self-management in desk workers with chronic low back pain (LBP). METHODS: This randomised controlled trial recruited 27 individuals with chronic LBP, Oswestry Disability Index (ODI) >10% and desk jobs (sitting ≥20 hours/week). Participants were randomised within strata of ODI (>10%-<20%, ≥20%) to receive bimonthly behavioural counselling (in-person and telephone), a sit-stand desk attachment, a wrist-worn activity-prompting device and cognitive behavioural therapy for LBP self-management or control. Self-reported work sitting time, visual analogue scales (VAS) for LBP and the ODI were assessed by monthly, online questionnaires and compared across intervention groups using linear mixed models. RESULTS: Baseline mean (SD) age was 52 (11) years, 78% were women, and ODI was 24.1 (10.5)%. Across the 6-month follow-up in models adjusted for baseline value, work sitting time was 1.5 hour/day (P<0.001) lower comparing intervention to controls. Also across follow-up, ODI was on average 8 points lower in intervention versus control (P=0.001). At 6 months, the relative decrease in ODI from baseline was 50% in intervention and 14% in control (P=0.042). LBP from VAS was not significantly reduced in intervention versus control, though small-to-moderate effect sizes favouring the intervention were observed (Cohen's d ranged from 0.22 to 0.42). CONCLUSION: An intervention coupling behavioural counselling targeting reduced sedentary behaviour and pain self-management is a translatable treatment strategy that shows promise for treating chronic LBP in desk-bound employees. TRIAL REGISTRATION NUMBER: NCT0224687; Pre-results.

Physical Activity for Health-Every Minute Counts.

This Viewpoint discusses the amount of physical activity recommended by the Physical Activity Guidelines for Americans, 2nd Edition, and how clinicians should use these recommendations to personalize and set achievable physical activity goals for their patients.

Effects of a lifestyle intervention on REM sleep-related OSA severity in obese individuals with type 2 diabetes.

The aim of this study was to determine if an intensive lifestyle intervention (ILI) reduces the severity of obstructive sleep apnea (OSA) in rapid-eye movement (REM) sleep, and to determine if longitudinal changes in glycaemic control are related to changes in OSA severity during REM sleep over a 4-year follow-up. This was a randomized controlled trial including 264 overweight/obese adults with type 2 diabetes (T2D) and OSA. Participants were randomized to an ILI targeted to weight loss or a diabetes support and education (DSE) control group. Measures included anthropometry, apnea-hypopnea index (AHI) during REM sleep (REM-AHI) and non-REM sleep (NREM-AHI) and glycated haemoglobin (HbA1c) at baseline and year 1, year 2 and year 4 follow-ups. Mean baseline values of REM-AHI were significantly higher than NREM-AHI in both groups. Both REM-AHI and NREM-AHI were reduced significantly more in ILI versus DSE, but these differences were attenuated slightly after adjustment for weight changes. Repeated-measure mixed-model analyses including data to year 4 demonstrated that changes in HbA1c were related significantly to changes in weight, but not to changes in REM-AHI and NREM-AHI. Compared to control, the ILI reduced REM-AHI and NREM-AHI during the 4-year follow-up. Weight, as opposed to REM-AHI and NREM-AHI, was related to changes in HbA1c. The findings imply that weight loss from a lifestyle intervention is more important than reductions in AHI for improving glycaemic control in T2D patients with OSA.

Cardiovascular effects of intensive lifestyle intervention in type 2 diabetes.

BACKGROUND: Weight loss is recommended for overweight or obese patients with type 2 diabetes on the basis of short-term studies, but long-term effects on cardiovascular disease remain unknown. We examined whether an intensive lifestyle intervention for weight loss would decrease cardiovascular morbidity and mortality among such patients. METHODS: In 16 study centers in the United States, we randomly assigned 5145 overweight or obese patients with type 2 diabetes to participate in an intensive lifestyle intervention that promoted weight loss through decreased caloric intake and increased physical activity (intervention group) or to receive diabetes support and education (control group). The primary outcome was a composite of death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for angina during a maximum follow-up of 13.5 years. RESULTS: The trial was stopped early on the basis of a futility analysis when the median follow-up was 9.6 years. Weight loss was greater in the intervention group than in the control group throughout the study (8.6% vs. 0.7% at 1 year; 6.0% vs. 3.5% at study end). The intensive lifestyle intervention also produced greater reductions in glycated hemoglobin and greater initial improvements in fitness and all cardiovascular risk factors, except for low-density-lipoprotein cholesterol levels. The primary outcome occurred in 403 patients in the intervention group and in 418 in the control group (1.83 and 1.92 events per 100 person-years, respectively; hazard ratio in the intervention group, 0.95; 95% confidence interval, 0.83 to 1.09; P=0.51). CONCLUSIONS: An intensive lifestyle intervention focusing on weight loss did not reduce the rate of cardiovascular events in overweight or obese adults with type 2 diabetes. (Funded by the National Institutes of Health and others; Look AHEAD ClinicalTrials.gov number, NCT00017953.).

Six-month changes in ideal cardiovascular health vs. Framingham 10-year coronary heart disease risk among young adults enrolled in a weight loss intervention.

The Framingham Risk equation uses sex, age, smoking, total cholesterol, high-density lipoprotein (HDL) cholesterol and systolic blood pressure to predict 10-year risk of coronary heart disease (FR-10). The American Heart Association's Ideal Cardiovascular Health (IDEAL) score uses smoking, total cholesterol, fasting glucose, blood pressure, body mass index (BMI), diet, and physical activity to encourage a healthy cardiovascular phenotype. This study aimed to compare 6-month changes in the FR-10 vs. IDEAL score among young adults with BMI ≥25 to <40kg/m(2) enrolled in a behavioral weight loss intervention at the University of Pittsburgh (2010-12). Medians [25th, 75th percentiles] are reported. Weight decreased by 8kg [-12, -4] among 335 participants. Of 7 possible points, IDEAL score was 4 [3, 4] at baseline, improved (i.e., increased) by 1 [0, 2] over 6months, and improved in 64.2% and worsened in 6.6% of participants (p<0.001). IDEAL classification of BMI, physical activity, total cholesterol, blood pressure and glucose improved (all p<0.001), but not of smoking or diet (both p≥0.05). FR-10 was <1% at baseline for 88.1% of participants and changed in few participants (improved, i.e. decreased, in 7.5%, worsened in 1.8%, p<0.001). Among young adults with overweight or obesity enrolled in a weight loss intervention, IDEAL detected positive changes in a majority of participants while the FR-10 did not. These findings suggest that IDEAL score may be more sensitive to positive cardiovascular health changes resulting from a behavioral intervention in this population.

A Randomized Clinical Trial of a Tailored Lifestyle Intervention for Obese, Sedentary, Primary Care Patients.

PURPOSE: The aim of the study was to test a tailored lifestyle intervention for helping obese primary care patients achieve weight loss and increase physical activity. METHODS: We conducted a 24-month randomized clinical trial in Rhode Island. Primary care physicians identified obese, sedentary patients motivated to lose weight and increase their moderate to vigorous physical activity. These patients were randomized to 1 of 2 experimental groups: enhanced intervention (EI) or standard intervention (SI). Both groups received 3 face-to-face weight loss meetings. The enhanced intervention group also received telephone counseling calls, individually tailored print materials, and DVDs focused on diet and physical activity. Active intervention occurred in year 1 with a tapered maintenance phase in year 2. RESULTS: Two hundred eleven obese, sedentary patients were recruited from 24 primary care practices. Participants were 79% women and 16% minorities. They averaged 48.6 years of age, with a mean body mass index (BMI) of 37.8 kg/m(2), and 21.2 minutes/week of moderate to vigorous physical activity. Significantly more EI participants lost 5% of their baseline weight than SI participants (group by visit, P <.001). The difference was significant during active treatment at 6 months (37.2% EI vs 12.9% SI) and 12 months (47.8% vs 11.6%), but was no longer significant during the maintenance phase at 18 months (31.4% vs 26.7%,) or 24 months (33.3% vs 24.6%). The EI group reported significantly more minutes of moderate to vigorous physical activity over time than the SI group (group by visit, P = 0.04). The differences in minutes per week at 6 months was 95.7 for the EI group vs 68.3 minutes for the SI group; at 12 months, it was 126.1 vs 73.7; at 18 months, 103.7 vs 63.7, and at 24 months, 101.3 vs 75.4. Similar trends were found for absolute weight loss and the percentage reaching national guidelines for physical activity. CONCLUSION: A home-based tailored lifestyle intervention in obese, sedentary primary care patients was effective in promoting weight loss and increasing moderate to vigorous physical activity, with the effects peaking at 12 months but waning at 24 months.