Browsing by Subject "Weight Loss"
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Item Open Access A clinician's guide to the ABCs of cardiovascular disease prevention: the Johns Hopkins Ciccarone Center for the Prevention of Heart Disease and American College of Cardiology Cardiosource Approach to the Million Hearts Initiative.(Clinical cardiology, 2013-07) Hsu, Steven; Ton, Van-Khue; Dominique Ashen, M; Martin, Seth S; Gluckman, Ty J; Kohli, Payal; Sisson, Stephen D; Blumenthal, Roger S; Blaha, Michael JAtherosclerotic cardiovascular disease (CVD) is the leading cause of death in the United States and worldwide. Fortunately, it is often preventable with early adoption of lifestyle modification, prevention of risk factor onset, and aggressive treatment of existing risk factors. The Million Hearts Initiative is an effort by the Centers for Disease Control that aims to prevent 1 million myocardial infarctions and strokes over the next 5 years. As part of this initiative, we present a simply organized "ABCDE" approach for guiding a consistent comprehensive approach to managing cardiovascular risk in daily clinical practice. ABCDE stands for assessment of risk, antiplatelet therapy, blood pressure management, cholesterol management, cigarette/tobacco cessation, diet and weight management, diabetes prevention and treatment, and exercise, interventions regularly used to reduce cardiovascular (CV) risk. Throughout this article we summarize recommendations related to each topic and reference landmark trials and data that support our approach. We believe that the ABCDE approach will be the core framework for addressing CV risk in our effort to prevent CVD.Item Open Access A community-based intervention increases physical activity and reduces obesity in school-age children in North Carolina.(Child Obes, 2015-06) Benjamin Neelon, Sara E; Namenek Brouwer, Rebecca J; Østbye, Truls; Evenson, Kelly R; Neelon, Brian; Martinie, Annie; Bennett, GaryBACKGROUND: Community-based interventions are promising approaches to obesity prevention, but few studies have prospectively evaluated them. The aim of this study was to evaluate a natural experiment—a community intervention designed to promote active living and decrease obesity within a small southern town. METHODS: In 2011, community leaders implemented the Mebane on the Move intervention—a community-wide effort to promote physical activity (PA) and decrease obesity among residents of Mebane, North Carolina. We measured child PA and BMI before and after the intervention, using a nearby town not implementing an intervention as the comparison. In total, we assessed 64 children from Mebane and 40 from the comparison community 6 months before, as well as 34 and 18 children 6 months after the intervention. We assessed PA with accelerometers worn for 7 days and calculated BMI z-scores using children's height and weight. We conducted multivariable linear regressions examining pre- to postintervention change in minutes of PA and BMI z-score, adjusting for confounders. RESULTS: At follow-up, children in Mebane modestly increased their moderate-to-vigorous PA (1.3 minutes per hour; 95% confidence interval (CI): 0.2, 2.3; p=0.03) and vigorous activity (0.8 minutes per hour; 95% CI: 0.1, 1.5; p=0.04) more than comparison children. In intervention children, BMI z-scores decreased 0.5 units (kg/m(2); 95% CI: -0.9, -0.02; p=0.045), compared to children in the comparison community. CONCLUSIONS: We observed positive effects on PA level and weight status of children in Mebane, despite high rates of attrition, suggesting that the community-based intervention may have been successful.Item Open Access A lifestyle intervention of weight loss via a low-carbohydrate diet plus walking to reduce metabolic disturbances caused by androgen deprivation therapy among prostate cancer patients: carbohydrate and prostate study 1 (CAPS1) randomized controlled trial.(Prostate cancer and prostatic diseases, 2019-09) Freedland, Stephen J; Howard, Lauren; Allen, Jenifer; Smith, Jordan; Stout, Jennifer; Aronson, William; Inman, Brant A; Armstrong, Andrew J; George, Daniel; Westman, Eric; Lin, Pao-HwaPurpose
The objective of this study was to test a low-carbohydrate diet (LCD) plus walking to reduce androgen deprivation therapy (ADT)-induced metabolic disturbances.Materials and methods
This randomized multi-center trial of prostate cancer (PCa) patients initiating ADT was designed to compare an LCD (≤20g carbohydrate/day) plus walking (≥30 min for ≥5 days/week) intervention vs. control advised to maintain usual diet and exercise patterns. Primary outcome was change in insulin resistance by homeostatic model assessment at 6 months. To detect 20% reduction in insulin resistance, 100 men were required. The study was stopped early after randomizing 42 men due to slow accrual. Secondary outcomes included weight, body composition, lipids, and prostate-specific antigen (PSA). Changes from baseline were compared between arms using rank-sum tests.Results
At 6 months, LCD/walking reduced insulin resistance by 4% vs. 36% increase in control (p = 0.13). At 3 months, vs. control, LCD/walking arm significantly lost weight (7.8kg; p<0.001), improved insulin resistance (↑36%; p = 0.015), hemoglobin A1c (↓3.3%; p = 0.01), high-density lipoprotein (HDL) (↑13%; p = 0.004), and triglyceride (↓37%; p = 0.036). At 6 months, weight loss (10.6kg; p<0.001) and HDL (↑27%; p = 0.003) remained significant. LCD/walking preserved total body bone mineral count (p = 0.025), reduced fat mass (p = 0.002), lean mass (p = 0.036), and percent body fat (p = 0.004). There were no differences in PSA. Limitations include the effect of LCD, weight loss vs. walking instruction are indistinguishable, and small sample size.Conclusions
In an underpowered study, LCD/walking did not improve insulin sensitivity at 6 months. Given most secondary outcomes were improved at 3 months with some remaining improved at 6 months and a secondary analysis showed that LCD/walking reduced insulin resistance over the study, supporting future larger studies of LCD/walking intervention to reduce ADT-induced disturbances.Item Open Access A systematic review of reviews: exploring the relationship between obesity, weight loss and health-related quality of life.(Clinical obesity, 2017-10) Kolotkin, RL; Andersen, JRThis is the first systematic review of reviews to assess the effect of obesity and weight loss on health-related quality of life (HRQoL). We identified 12 meta-analyses/systematic reviews published between January 2001 and July 2016. They addressed the following themes: (i) the relationship between weight/body mass index and HRQoL (baseline/pre-intervention; n = 2). (ii) HRQoL after weight loss (varied interventions and/or study design; n = 2). (iii) HRQoL after weight loss (randomized controlled trials only; n = 2). (iv) HRQoL after bariatric surgery (n = 6). We found that in all populations, obesity was associated with significantly lower generic and obesity-specific HRQoL. The relationship between weight loss and improved HRQoL was consistently demonstrated after bariatric surgery, perhaps due to a greater than average weight loss compared with other treatments. Improved HRQoL was evident after non-surgical weight loss, but was not consistently demonstrated, even in randomized controlled trials. This inconsistency may be attributed to variation in quality of reporting, assessment measures, study populations and weight-loss interventions. We recommend longer-term studies, using both generic and obesity-specific measures, which go beyond HRQoL in isolation to exploring mediators of HRQoL changes and interactions with other variables, such as comorbidities, fitness level and body image.Item Open Access Associations between body mass index, weight loss and overall survival in patients with advanced lung cancer.(Journal of cachexia, sarcopenia and muscle, 2022-12) Oswalt, Cameron; Liu, Yingzhou; Pang, Herbert; Le-Rademacher, Jennifer; Wang, Xiaofei; Crawford, JeffreyBackground
Weight loss (WL) has been associated with shorter survival in patients with advanced cancer, while obesity has been associated with longer survival. Integrating body mass index (BMI) and WL provides a powerful prognostic tool but has not been well-studied in lung cancer patients, particularly in the setting of clinical trials.Methods
We analysed patient data (n = 10 128) from 63 National Cancer Institute sponsored advanced non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC) trials. Risk matrices were created using BMI and WL percentage, which were divided into 'grades' based on median survival. Relationships between survival, BMI and WL percentage were examined using Kaplan-Meier estimators and Cox proportional hazards (PH) models with restricted cubic splines.Results
For NSCLC, a twofold difference was noted in median survival between the BMI > 28 and WL ≤ 5% group (13.5 months) compared with the BMI < 20 and WL > 5% group (6.6 months). These associations were less pronounced in SCLC. Kaplan-Meier curves showed significant survival differences between grades for both NSCLC and SCLC (log-rank, P < 0.0001). In Stage IV NSCLC, Cox PH analyses with restricted cubic splines demonstrated significant associations between BMI and survival in both WL ≤ 5% (P = 0.0004) and >5% (P = 0.0129) groups, as well as in WL > 5% in Stage III (P = 0.0306). In SCLC, these relationships were more complex.Conclusions
BMI and WL have strong associations with overall survival in patients with advanced lung cancer, with a greater impact seen in NSCLC compared with SCLC. The integration of a BMI/WL grading scale may provide additional prognostic information and should be included in the evaluation of therapeutic interventions in future clinical trials in advanced lung cancer.Item Open Access Asthma medication usage is significantly reduced following bariatric surgery.(Surgical endoscopy, 2019-06) Guerron, Alfredo D; Ortega, Camila B; Lee, Hui-Jie; Davalos, Gerardo; Ingram, Jennifer; Portenier, DanaIntroduction
Asthma is an important healthcare problem affecting millions in the United States. Additionally, a large proportion of patients with asthma suffer from obesity. These patients exhibit poor asthma control and reduced therapy response, increasing utilization of healthcare resources. Pulmonary symptoms improve after bariatric surgery (BS), and we hypothesized that asthma medication usage would decrease following BS.Methods
A retrospective data analysis was performed in adult patients from a single institution's database. Patients with obesity using at least one asthma medication pre-operatively who underwent BS were studied for up to 3-years post-operation. Poisson generalized linear mixed models for repeated measures were used to evaluate the effects of time and procedure type on the number of asthma medication.Results
Bariatric patients with at least one prescribed asthma medication (mean 1.4 ± 0.6) were included (n = 751). The mean age at time of operation was 46.8 ± 11.6 years, mean weight was 295.9 ± 57 lbs, and mean body mass index (BMI) was 49 ± 8.2 kg/m2; 87.7% were female, 33.4% had diabetes, 44.2% used gastroesophageal reflux disease (GERD) medication, and 64.4% used hypertension medication. The most common procedure was Roux-en-Y gastric bypass (79%), followed by sleeve gastrectomy (10.7%), adjustable gastric banding (8.1%), and duodenal switch (2.3%). The mean number of prescribed asthma medications among all procedures decreased by 27% at 30 days post-operation (p < 0.0001), 37% at 6 months (p < 0.0001), 44% at 1 year (p < 0.0001), and 46% at 3 years (p < 0.0001) after adjusting for risk factors. No significant differences in medication use over time between procedure types were observed. In the adjusted analysis, the mean number of asthma medications was 12% higher in patients using at least one GERD medication (p = 0.015) and 8% higher with 10-unit increase in pre-operative BMI (p = 0.006).Conclusion
BS significantly decreases asthma medication use starting 30 days post-operation with a sustained reduction for up to 3 years.Item Open Access Cell phone intervention for you (CITY): A randomized, controlled trial of behavioral weight loss intervention for young adults using mobile technology.(Obesity (Silver Spring, Md.), 2015-11) Svetkey, Laura P; Batch, Bryan C; Lin, Pao-Hwa; Intille, Stephen S; Corsino, Leonor; Tyson, Crystal C; Bosworth, Hayden B; Grambow, Steven C; Voils, Corrine; Loria, Catherine; Gallis, John A; Schwager, Jenifer; Bennett, Gary GObjective
To determine the effect on weight of two mobile technology-based (mHealth) behavioral weight loss interventions in young adults.Methods
Randomized, controlled comparative effectiveness trial in 18- to 35-year-olds with BMI ≥ 25 kg/m(2) (overweight/obese), with participants randomized to 24 months of mHealth intervention delivered by interactive smartphone application on a cell phone (CP); personal coaching enhanced by smartphone self-monitoring (PC); or Control.Results
The 365 randomized participants had mean baseline BMI of 35 kg/m(2) . Final weight was measured in 86% of participants. CP was not superior to Control at any measurement point. PC participants lost significantly more weight than Controls at 6 months (net effect -1.92 kg [CI -3.17, -0.67], P = 0.003), but not at 12 and 24 months.Conclusions
Despite high intervention engagement and study retention, the inclusion of behavioral principles and tools in both interventions, and weight loss in all treatment groups, CP did not lead to weight loss, and PC did not lead to sustained weight loss relative to Control. Although mHealth solutions offer broad dissemination and scalability, the CITY results sound a cautionary note concerning intervention delivery by mobile applications. Effective intervention may require the efficiency of mobile technology, the social support and human interaction of personal coaching, and an adaptive approach to intervention design.Item Open Access Comparison of a reduced carbohydrate and reduced fat diet for LDL, HDL, and VLDL subclasses during 9-months of weight maintenance subsequent to weight loss.(Lipids Health Dis, 2010-06-01) LeCheminant, James D; Smith, Bryan K; Westman, Eric C; Vernon, Mary C; Donnelly, Joseph EOBJECTIVES: This study compared LDL, HDL, and VLDL subclasses in overweight or obese adults consuming either a reduced carbohydrate (RC) or reduced fat (RF) weight maintenance diet for 9 months following significant weight loss. METHODS: Thirty-five (21 RC; 14 RF) overweight or obese middle-aged adults completed a 1-year weight management clinic. Participants met weekly for the first six months and bi-weekly thereafter. Meetings included instruction for diet, physical activity, and behavior change related to weight management. Additionally, participants followed a liquid very low-energy diet of approximately 2092 kJ per day for the first three months of the study. Subsequently, participants followed a dietary plan for nine months that targeted a reduced percentage of carbohydrate (approximately 20%) or fat (approximately 30%) intake and an energy intake level calculated to maintain weight loss. Lipid subclasses using NMR spectroscopy were analyzed prior to weight loss and at multiple intervals during weight maintenance. RESULTS: Body weight change was not significantly different within or between groups during weight maintenance (p>0.05). The RC group showed significant increases in mean LDL size, large LDL, total HDL, large and small HDL, mean VLDL size, and large VLDL during weight maintenance while the RF group showed increases in total HDL, large and small HDL, total VLDL, and large, medium, and small VLDL (p<0.05). Group*time interactions were significant for large and medium VLDL (p>0.05). CONCLUSION: Some individual lipid subclasses improved in both dietary groups. Large and medium VLDL subclasses increased to a greater extent across weight maintenance in the RF group.Item Open Access Effect of behavioral weight-loss program on biomarkers of cardiometabolic disease risk: Heart Health Study randomized trial.(Obesity (Silver Spring, Md.), 2023-02) Collins, Katherine A; Kraus, William E; Rogers, Renee J; Hauser, Elizabeth R; Lang, Wei; Jiang, Rong; Schelbert, Erik B; Huffman, Kim M; Jakicic, John MObjective
This study aimed to determine whether novel biomarkers of cardiometabolic health improve in response to a 12-month behavioral weight-loss intervention and to compare benefits of diet alone with diet plus physical activity for these biomarkers.Methods
Participants (N = 374) were randomized to either diet alone (DIET), diet plus 150 min/wk of prescribed moderate-intensity physical activity (DIET + PA150), or diet plus 250 min/wk of prescribed moderate-intensity physical activity (DIET + PA250). Biomarker concentrations were determined using nuclear magnetic resonance spectroscopy. Mixed models assessed for a time effect, group effect, or group by time interaction.Results
All groups significantly improved body weight (time: p < 0.0001), Lipoprotein Insulin Resistance Index score (time: p < 0.0001), Diabetes Risk Index score (time: p < 0.0001), branched-chain amino acid concentration (time: p < 0.0001), and GlycA concentration (time: p < 0.0001), with no group effect or group by time interactions.Conclusions
All intervention groups prompted a notable beneficial change among biomarkers of insulin resistance and cardiometabolic health. However, the addition of at least moderate-intensity physical activity to a diet-only intervention did not provide any additional benefit. These findings highlight that an average weight loss of approximately 10% profoundly impacts biomarkers of insulin resistance and cardiometabolic disease in adults with overweight or obesity.Item Open Access Efficacy of Commercial Weight-Loss Programs.(Ann Intern Med, 2015-09-01) .Item Open Access Family PArtners in Lifestyle Support (PALS): Family-based weight loss for African American adults with type 2 diabetes.(Obesity (Silver Spring), 2017-01) Samuel-Hodge, Carmen D; Holder-Cooper, Judith C; Gizlice, Ziya; Davis, Gwendolyn; Steele, Sonia P; Keyserling, Thomas C; Kumanyika, Shiriki K; Brantley, Phillip J; Svetkey, Laura POBJECTIVE: To develop and test a family-centered behavioral weight loss intervention for African American adults with type 2 diabetes. METHODS: In this randomized trial, dyads consisting of an African American adult with overweight or obesity and type 2 diabetes (index participant) paired with a family partner with overweight or obesity but not diagnosed with diabetes were assigned in a 2:1 ratio to a 20-week special intervention (SI) or delayed intervention (DI) control group. The primary outcome was weight loss among index participants at the 20-week follow-up. RESULTS: One hundred eight participants (54 dyads-36 (SI) and 18 (DI) dyads) were enrolled: 81% females; mean age, 51 years; mean weight,103 kg; and mean BMI, 37 kg/m(2) . At post-intervention, 96 participants (89%) returned for follow-up measures. Among index participants, mean difference in weight loss between groups was -5.0 kg, P <0.0001 (-3.6 kg loss among SI; 1.4 kg gain in DI). SI index participants showed significantly greater improvements in hemoglobin A1c, depressive symptoms, family interactions, and dietary, physical activity, and diabetes self-care behaviors. SI family partners also had significant weight loss (-3.9 kg (SI) vs. -1.0 kg (DI), P = 0.02). CONCLUSIONS: A family-centered, behavioral weight loss intervention led to clinically significant short-term weight loss among family dyads.Item Open Access High prevalence of geriatric syndromes in older adults.(PloS one, 2020-01) Sanford, Angela M; Morley, John E; Berg-Weger, Marla; Lundy, Janice; Little, Milta O; Leonard, Kathleen; Malmstrom, Theodore KINTRODUCTION:The geriatric syndromes of frailty, sarcopenia, weight loss, and dementia are highly prevalent in elderly individuals across all care continuums. Despite their deleterious impact on quality of life, disability, and mortality in older adults, they are frequently under-recognized. At Saint Louis University, the Rapid Geriatric Assessment (RGA) was developed as a brief screening tool to identify these four geriatric syndromes. MATERIALS AND METHODS:From 2015-2019, the RGA, comprised of the FRAIL, SARC-F, Simplified Nutritional Appetite Questionnaire (SNAQ), and Rapid Cognitive Screen (RCS) tools and a question on Advance Directives, was administered to 11,344 individuals ≥ 65 years of age across Missouri in community, office-based, hospital, Programs of All-Inclusive Care for the Elderly (PACE), and nursing home care settings. Standard statistical methods were used to calculate the prevalence of frailty, sarcopenia, weight loss, and dementia across the sample. RESULTS:Among the 11,344 individuals screened by the RGA, 41.0% and 30.4% met the screening criteria for pre-frailty and frailty respectively, 42.9% met the screening criteria for sarcopenia, 29.3% were anorectic and at risk for weight loss, and 28.1% screened positive for dementia. The prevalence of frailty, risk for weight loss, sarcopenia, and dementia increased with age and decreased when hospitalized patients and those in the PACE program or nursing home were excluded. CONCLUSIONS:Using the RGA as a valid screening tool, the prevalence of one or more of the geriatric syndromes of frailty, sarcopenia, weight loss, and dementia in older adults across all care continuums is quite high. Management approaches exist for each of these syndromes that can improve outcomes. It is suggested that the brief RGA screening tool be administered to persons 65 and older yearly as part of the Medicare Annual Wellness Visit.Item Open Access Improved Function With Enhanced Protein Intake per Meal: A Pilot Study of Weight Reduction in Frail, Obese Older Adults.(J Gerontol A Biol Sci Med Sci, 2016-10) Porter Starr, Kathryn N; Pieper, Carl F; Orenduff, Melissa C; McDonald, Shelley R; McClure, Luisa B; Zhou, Run; Payne, Martha E; Bales, Connie WBACKGROUND: Obesity is a significant cause of functional limitations in older adults; yet, concerns that weight reduction could diminish muscle along with fat mass have impeded progress toward an intervention. Meal-based enhancement of protein intake could protect function and/or lean mass but has not been studied during geriatric obesity reduction. METHODS: In this 6-month randomized controlled trial, 67 obese (body mass index ≥30kg/m(2)) older (≥60 years) adults with a Short Physical Performance Battery score of 4-10 were randomly assigned to a traditional (Control) weight loss regimen or one with higher protein intake (>30g) at each meal (Protein). All participants were prescribed a hypo-caloric diet, and weighed and provided dietary guidance weekly. Physical function (Short Physical Performance Battery) and lean mass (BOD POD), along with secondary measures, were assessed at 0, 3, and 6 months. RESULTS: At the 6-month endpoint, there was significant (p < .001) weight loss in both the Control (-7.5±6.2kg) and Protein (-8.7±7.4kg) groups. Both groups also improved function but the increase in the Protein (+2.4±1.7 units; p < .001) was greater than in the Control (+0.9±1.7 units; p < .01) group (p = .02). CONCLUSION: Obese, functionally limited older adults undergoing a 6-month weight loss intervention with a meal-based enhancement of protein quantity and quality lost similar amounts of weight but had greater functional improvements relative to the Control group. If confirmed, this dietary approach could have important implications for improving the functional status of this vulnerable population (ClinicalTrials.gov identifier: NCT01715753).Item Open Access Innovative interventions to promote behavioral change in overweight or obese individuals: A review of the literature.(Annals of medicine, 2015-05) Okorodudu, Daniel E; Bosworth, Hayden B; Corsino, LeonorThe overweight and obesity trends have risen over the past few decades, placing significant burdens on health care in terms of increased morbidity and cost. Behavioral change therapy is an effective treatment strategy and includes goal setting, self-monitoring, problem solving, and reinforcement tactics. Traditionally, behavior change therapy has been delivered using face-to-face counseling along with paper and pen recording of dietary intake and physical activity. The current advances in technology provide opportunities to deliver interventions using cellphones, internet, and active video games. These new methods to deliver behavior change for the management and prevention of obesity are being developed in order to increase access, improve convenience, decrease cost, and increase participant engagement. In this review, we present new approaches to promote behavior changes in the management of obesity. Currently available data show promising results. However, future research is needed to address study limitations and implementation challenges of these innovative interventions.Item Open Access Knowledge and perceptions among overweight and obese employees about lifestyle-related health benefit changes.(N C Med J, 2011-05) Li, Jiang; Linnan, Laura; Finkelstein, Eric A; Tate, Deborah F; Naseer, Carolyn; Evenson, Kelly RBACKGROUND: We investigated perceptions among overweight and obese state employees about changes to health insurance that were designed to reduce the scope of health benefits for employees who are obese or who smoke. METHODS: Before implementation of health benefit plan changes, 658 state employees who were overweight (ie, those with a body mass index [BMI] of 25-29.9) or obese (ie, those with a BMI of > or = 30) enrolled in a weight-loss intervention study were asked about their attitudes and beliefs concerning the new benefit plan changes. RESULTS: Thirty-one percent of employees with a measured BMI of 40 or greater self-reported a BMI of less than 40, suggesting they were unaware that their current BMI would place them in a higher-risk benefit plan. More than half of all respondents reported that the new benefit changes would motivate them to make behavioral changes, but fewer than half felt confident in their ability to make changes. Respondents with a BMI of 40 or greater were more likely than respondents in lower BMI categories to oppose the new changes focused on obesity (P < .001). Current smokers were more likely than former smokers and nonsmokers to oppose the new benefit changes focused on tobacco use (P < .01). LIMITATIONS: Participants represented a sample of employees enrolled in a weight-loss study, limiting generalizability to the larger population of state employees. CONCLUSIONS: Benefit plan changes that require employees who are obese and smoke to pay more for health care may motivate some, but not all, individuals to change their behaviors. Since confidence to lose weight was lowest among individuals in the highest BMI categories, more-intense intervention options may be needed to achieve desired health behavior changes.Item Open Access mHealth interventions for weight loss: a guide for achieving treatment fidelity.(Journal of the American Medical Informatics Association : JAMIA, 2014-11) Shaw, Ryan J; Steinberg, Dori M; Zullig, Leah L; Bosworth, Hayden B; Johnson, Constance M; Davis, Linda LUnlabelled
mHealth interventions have shown promise for helping people sustain healthy behaviors such as weight loss. However, few have assessed treatment fidelity, that is, the accurate delivery, receipt, and enactment of the intervention. Treatment fidelity is critical because the valid interpretation and translation of intervention studies depend on treatment fidelity assessments. We describe strategies used to assess treatment fidelity in mobile health (mHealth) interventions aimed at sustaining healthy behaviors in weight loss. We reviewed treatment fidelity recommendations for mHealth-based behavioral interventions and described how these recommendations were applied in three recent weight loss studies. We illustrate how treatment fidelity can be supported during study design, training of providers, treatment delivery, receipt of treatment, and enactment of treatment skills. Pre-planned strategies to ensure the treatment fidelity of mHealth interventions will help counter doubts concerning valid conclusions about their effectiveness and allow investigators and clinicians to implement robustly efficacious mobile health programs.Trial registration number
1F31 NR012599.Item Restricted Missing data in randomized clinical trials for weight loss: scope of the problem, state of the field, and performance of statistical methods.(PLoS One, 2009-08-13) Elobeid, Mai A; Padilla, Miguel A; McVie, Theresa; Thomas, Olivia; Brock, David W; Musser, Bret; Lu, Kaifeng; Coffey, Christopher S; Desmond, Renee A; St-Onge, Marie-Pierre; Gadde, Kishore M; Heymsfield, Steven B; Allison, David BBACKGROUND: Dropouts and missing data are nearly-ubiquitous in obesity randomized controlled trails, threatening validity and generalizability of conclusions. Herein, we meta-analytically evaluate the extent of missing data, the frequency with which various analytic methods are employed to accommodate dropouts, and the performance of multiple statistical methods. METHODOLOGY/PRINCIPAL FINDINGS: We searched PubMed and Cochrane databases (2000-2006) for articles published in English and manually searched bibliographic references. Articles of pharmaceutical randomized controlled trials with weight loss or weight gain prevention as major endpoints were included. Two authors independently reviewed each publication for inclusion. 121 articles met the inclusion criteria. Two authors independently extracted treatment, sample size, drop-out rates, study duration, and statistical method used to handle missing data from all articles and resolved disagreements by consensus. In the meta-analysis, drop-out rates were substantial with the survival (non-dropout) rates being approximated by an exponential decay curve (e(-lambdat)) where lambda was estimated to be .0088 (95% bootstrap confidence interval: .0076 to .0100) and t represents time in weeks. The estimated drop-out rate at 1 year was 37%. Most studies used last observation carried forward as the primary analytic method to handle missing data. We also obtained 12 raw obesity randomized controlled trial datasets for empirical analyses. Analyses of raw randomized controlled trial data suggested that both mixed models and multiple imputation performed well, but that multiple imputation may be more robust when missing data are extensive. CONCLUSION/SIGNIFICANCE: Our analysis offers an equation for predictions of dropout rates useful for future study planning. Our raw data analyses suggests that multiple imputation is better than other methods for handling missing data in obesity randomized controlled trials, followed closely by mixed models. We suggest these methods supplant last observation carried forward as the primary method of analysis.Item Open Access Outcome by Gender in the Veterans Health Administration Motivating Overweight/Obese Veterans Everywhere Weight Management Program.(Journal of women's health (2002), 2018-01) Batch, Bryan C; Goldstein, Karen; Yancy, William S; Sanders, Linda L; Danus, Susanne; Grambow, Steven C; Bosworth, Hayden BBackground
Few evaluations of the Veterans Health Administration Motivating Overweight/Obese Veterans Everywhere (MOVE!) weight management program have assessed 6-month weight change or factors associated with weight change by gender.Materials and methods
Analysis of administrative data from a national sample of veterans in the VA MOVE!Program
Results
A total of 62,882 participants were included, 14.6% were women. Compared with men, women were younger (49.6 years [standard deviation, SD, 10.8] vs. 59.3 years [SD, 9.8], p < 0.0001), less likely to be married (34.1% vs. 56.0%, p < 0.0001), and had higher rates of post-traumatic stress disorder (26.0% vs. 22.4%, p < 0.0001) and depression (49.3% vs. 32.9%, p < 0.001). The mean number of MOVE! visits attended by women was lower than men (5.6 [SD, 5.3] vs. 6.0 [SD, 5.9], p < 0.0001). Women, compared with men, reported lower rates of being able to rely on family or friends (35.7% vs. 40.8%, p < 0.0001). Observed mean percent change in weight for women was -1.5% (SD, 5.2) and for men was -1.9% (SD, 4.8, p < 0.0001). The odds of ≥5% weight loss were no different for women (body-mass index [BMI] >25 kg/m2) compared with men (BMI >25 kg/m2; odds ratio, 1.05 [95% confidence interval, 0.99-1.11; p = 0.13]).Conclusions
Women veterans lost less weight overall compared with men. There was no difference in the odds of achieving clinically significant weight loss by gender. The majority of women and men enrolled lost <5% weight despite being enrolled in a lifestyle intervention. Future studies should focus on identifying program- and participant-level barriers to weight loss.Item Open Access Patient, Provider, and Combined Interventions for Managing Osteoarthritis in Primary Care: A Cluster Randomized Trial.(Annals of internal medicine, 2017-03) Allen, Kelli D; Oddone, Eugene Z; Coffman, Cynthia J; Jeffreys, Amy S; Bosworth, Hayden B; Chatterjee, Ranee; McDuffie, Jennifer; Strauss, Jennifer L; Yancy, William S; Datta, Santanu K; Corsino, Leonor; Dolor, Rowena JBackground
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.Item Open Access Relief and Recurrence of Congestion During and After Hospitalization for Acute Heart Failure: Insights From Diuretic Optimization Strategy Evaluation in Acute Decompensated Heart Failure (DOSE-AHF) and Cardiorenal Rescue Study in Acute Decompensated Heart Failure (CARESS-HF).(Circ Heart Fail, 2015-07) Lala, Anuradha; McNulty, Steven E; Mentz, Robert J; Dunlay, Shannon M; Vader, Justin M; AbouEzzeddine, Omar F; DeVore, Adam D; Khazanie, Prateeti; Redfield, Margaret M; Goldsmith, Steven R; Bart, Bradley A; Anstrom, Kevin J; Felker, G Michael; Hernandez, Adrian F; Stevenson, Lynne WBACKGROUND: Congestion is the most frequent cause for hospitalization in acute decompensated heart failure. Although decongestion is a major goal of acute therapy, it is unclear how the clinical components of congestion (eg, peripheral edema, orthopnea) contribute to outcomes after discharge or how well decongestion is maintained. METHODS AND RESULTS: A post hoc analysis was performed of 496 patients enrolled in the Diuretic Optimization Strategy Evaluation in Acute Decompensated Heart Failure (DOSE-AHF) and Cardiorenal Rescue Study in Acute Decompensated Heart Failure (CARRESS-HF) trials during hospitalization with acute decompensated heart failure and clinical congestion. A simple orthodema congestion score was generated based on symptoms of orthopnea (≥2 pillows=2 points, <2 pillows=0 points) and peripheral edema (trace=0 points, moderate=1 point, severe=2 points) at baseline, discharge, and 60-day follow-up. Orthodema scores were classified as absent (score of 0), low-grade (score of 1-2), and high-grade (score of 3-4), and the association with death, rehospitalization, or unscheduled medical visits through 60 days was assessed. At baseline, 65% of patients had high-grade orthodema and 35% had low-grade orthodema. At discharge, 52% patients were free from orthodema at discharge (score=0) and these patients had lower 60-day rates of death, rehospitalization, or unscheduled visits (50%) compared with those with low-grade or high-grade orthodema (52% and 68%, respectively; P=0.038). Of the patients without orthodema at discharge, 27% relapsed to low-grade orthodema and 38% to high-grade orthodema at 60-day follow-up. CONCLUSIONS: Increased severity of congestion by a simple orthodema assessment is associated with increased morbidity and mortality. Despite intent to relieve congestion, current therapy often fails to relieve orthodema during hospitalization or to prevent recurrence after discharge. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifiers: NCT00608491, NCT00577135.