Practice-based Opportunities For Weight Reduction Research Articles

Searching for the Scale-Able Weight Loss Intervention: Can One Size Fit All? Lessons to Be Learned from the EQUAL Trial.

Overweight and obesity affect 71.2% of adults in the United States, with cancer survivors not far behind at 70.3%. Subgroups such as those diagnosed with acute lymphoblastic leukemia (ALL) face even greater challenges. The Exercise and Quality Diet after Leukemia (EQUAL) trial sought to address weight management issues among ALL survivors by implementing a remotely delivered weight loss intervention, leveraging the previously proven Practice-based Opportunities for Weight Reduction (POWER) program. Despite a strong foundation and design, the EQUAL trial yielded null results. Key differences in study populations and intervention contexts between the EQUAL and POWER trials, such as the lack of primary care physician involvement in EQUAL, contributed to these outcomes. EQUAL's failure to meet its accrual target and poor adherence among participants highlighted challenges in engaging this unique population. Contrary to EQUAL's conclusions, evidence from other studies supports the efficacy of remote interventions for weight loss among cancer survivors. The lack of qualitative assessment among ALL survivors and key integration to inform intervention adaptations undermined EQUAL's impact. However, EQUAL's impressive retention rate offers valuable insights. Lessons from EQUAL underscore the need for well-fitted, remotely delivered interventions and the importance of thoughtfully adapted and tailored approaches to specific survivor populations. See related article by Fiedmann et al., p. 1158.

Cost of behavioral weight loss programs implemented in clinical practice: The POWER trial at Johns Hopkins.

Obesity presents an important public health problem that affects more than a third of the U.S. adult population and that is associated with increased morbidity, mortality, and costs. Previously, we documented that two primary care-based weight loss interventions were clinically effective. To encourage the implementation of and reimbursement for these interventions, we evaluated their relative cost-effectiveness. We performed a cost analysis of the Practice-based Opportunities for Weight Reduction (POWER) trial, a three-arm trial that enrolled 415 patients with obesity from six primary care practices. Trial participants were randomized to a control arm, an in-person support intervention, or a remote support intervention; in the two intervention arms, behavioral interventions were delivered over 24 months, in two phases. Weight loss was measured at 6, 12, and 24 months. Using timesheets and empirical data, we evaluated the cost of the in-person and remote support interventions from the perspective of a health care system delivering the interventions. A univariate sensitivity analysis was conducted to evaluate uncertainty around model assumptions. All comparisons were tested using independent t-tests. Cost of the in-person intervention was higher at 6 months ($113 per participant per month and $117 per kg lost) than the remote support intervention ($101 per participant per month and $99 per kg lost; p < .001). Costs were also higher for the in-person support intervention at 24 months ($73 per participant per month and $342 per kg lost) than for the remote support intervention ($53 per participant per month and $275 per kg lost; p < .001). In the sensitivity analyses, cost ranged from $274/kg lost to $456/kg lost for the in-person support intervention and from $218/kg to $367/kg lost for the remote support intervention. A primary care weight loss intervention administered remotely was relatively more cost-effective than an in-person intervention. Expanding the scope of reimbursable programs to include other cost-effective interventions could help ensure that a broader range of patients receive the type of support needed.

Abstract P4-14-01: POWER-remote: A randomized study evaluating the effect of a remote-based weight loss program in women with early stage breast cancer

Abstract Background: The majority of women diagnosed with breast cancer are overweight or obese, and gain weight after diagnosis. The Practice-based Opportunities for Weight Reduction (POWER) study reported that, in an obese population with cardiovascular risk factors, a scalable remote weight loss intervention with web support was equally effective to an in-person intervention (Appel NEJM 2011). We adapted the remote intervention for breast cancer survivors. Methods: We conducted a phase II single-blind trial in which women with stage 0-III breast cancer and a BMI ≥25 were randomized to a remotely-delivered weight loss intervention with a study specific website (POWER-remote) or to self-directed weight loss. Participants were stratified by menopausal status and concomitant hormone therapy use. Weight was assessed at baseline, 6 and 12 months. The primary objective was to compare the proportion of women who lost ≥5% of their baseline body weight after 6 months in the POWER-remote and the self-directed arms. A sample size of 80 patients yielded approximately 93.6% power to detect a difference in weight loss response of 19.0% in the self-directed arm and 38.2% in the POWER-remote arm with a one-sided type I error of 10%. We obtained blood samples for correlative studies including inflammatory biomarkers and assessment of telomere length at baseline and 6 months. Results: From 2013-2015 we enrolled 96 women; 84 were evaluable for the primary analysis. Both cohorts had similar baseline characteristics including menopausal status, race (77% Caucasian and 20% African American in entire cohort), and BMI (average mean 32 kg/m2). The majority (93%) of patients received endocrine therapy, and 55% had completed chemotherapy. At 6 months 43.1% (95% CI 29.3–57.8) of women randomized to POWER-remote had lost ≥5% of their baseline body weight, compared to 11.1% (95% CI 3.7–24.1) in the self-directed arm, p&amp;lt;0.001. A significant difference continued at 12 months, and was observed in all subgroups (Table 1). Biomarker analysis will be presented at the meeting. Table 1. Proportion of patients achieving ≥5% weight loss after 6 and 12 months POWER-remotePOWER-remoteSelf-DirectedSelf-Directed n% [95% CI]n% [95% CI]p-valueInteraction p-value for heterogeneity of treatment effectLost &amp;gt;=5% of baseline weight at 6 months All patients4343.1 [29.3, 57.8]4111.1 [3.7, 24.1]&amp;lt;0.001 Endocrine therapy3545 [29.3, 61.5]3211.1 [3.1, 26.1]&amp;lt; 0.0010.96No endocrine therapy836.4 [10.9, 69.2]911.1 [0.3, 48.2]0.11 Chemotherapy2126.9 [11.6, 47.8]253.7 [0.1, 19]0.010.64No chemotherapy2260 [38.7, 78.9]1622.2 [6.4, 47.6]0.01 Lost &amp;gt;=5% of baseline weight at 12 months All patients3031.4 [19.1, 45.9]3113.3 [5.1, 26.8]0.006 Endocrine therapy2632.5 [18.6, 49.1]2616.7 [6.4, 32.8]0.040.99No endocrine therapy427.3 [6, 61]50 [0, 33.6]0.05 Chemotherapy1119.2 [6.6, 39.4]167.4 [0.9, 24.3]0.070.72No chemotherapy1944 [24.4, 65.1]1522.2 [6.4, 47.6]0.07 Conclusions: Sustained weight loss over 1 year is feasible in breast cancer survivors who undergo a remotely delivered weight loss intervention. Weight loss was observed irrespective of endocrine therapy or chemotherapy. These data will be used to design a new trial with a physical activity component. Citation Format: Santa-Maria CA, Coughlin J, Blackford A, Carpenter A, Dalcin A, Huang C-Y, Luber B, Schreyer C, Armanios M, Sharma D, Chaudhry M, Jerome GJ, Snyder C, Appel L, Stearns V. POWER-remote: A randomized study evaluating the effect of a remote-based weight loss program in women with early stage breast cancer [abstract]. In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2017;77(4 Suppl):Abstract nr P4-14-01.

Perceived helpfulness of the individual components of a behavioural weight loss program: results from the Hopkins POWER Trial.

SummaryBackgroundBehavioural weight loss programs are effective first‐line treatments for obesity and are recommended by the US Preventive Services Task Force. Gaining an understanding of intervention components that are found helpful by different demographic groups can improve tailoring of weight loss programs. This paper examined the perceived helpfulness of different weight loss program components.MethodsParticipants (n = 236) from the active intervention conditions of the Practice‐based Opportunities for Weight Reduction (POWER) Hopkins Trial rated the helpfulness of 15 different components of a multicomponent behavioural weight loss program at 24‐month follow‐up. These ratings were examined in relation to demographic variables, treatment arm and weight loss success.ResultsThe components most frequently identified as helpful were individual telephone sessions (88%), tracking weight online (81%) and coach review of tracking (81%). The component least frequently rated as helpful was the primary care providers' general involvement (50%). Groups such as older adults, Blacks and those with lower education levels more frequently reported intervention components as helpful compared with their counterparts.DiscussionWeight loss coaching delivered telephonically with web support was well received. Findings support the use of remote behavioural interventions for a wide variety of individuals.

Initial Evaluation of a Scalable Lifestyle Program for Sustained Weight Loss

The growing prevalence of obesity and associated morbidity indicates the need for effective programs for sustainable lifestyle changes to achieve and maintain meaningful weight loss. The Practice-based Opportunities for Weight Reduction (POWER) trial found that a scalable, remotely-delivered intervention achieved significant and meaningful weight loss over 24 months compared to a usual care control group, with results that were statistically comparable to an in-person-based intervention also tested in the study and designed with the same principles. Given that results from clinical trials in research settings do not necessarily translate to larger scaled delivery of interventions, the objective of this study is to evaluate a pilot-implementation of Innergy, a weight loss program designed to replicate the remote-arm of the POWER trial that provided online support and regular telephonic coaching. An intention-totreat retrospective design evaluates weight loss within 6-months among 265 participants offered the program through their employer. The mean change in weight from baseline for the study group was -6.8 lbs. (P<0.0001) and 23% of participants lost 5.0% or more of their initial starting weight. Greater weight loss was associated with greater levels of participation. Specifically, members who utilized a broader range of program support components, took more coaching calls, regularly used the website, and tracked their weight, food and exercise lost significantly more weight. Similarly, longer duration of active participation was associated with greater weight loss. Participants who interacted with the program into the final month of study lost an average of 11.5 lbs, 5.0% of their starting weight. Study results show that Innergy is an effective weight loss program that can be delivered at scale, and thus can have a broad-spanning impact on obesity.

Managing obesity in primary care practice: an overview with perspective from the POWER-UP study

Primary care practitioners (PCPs) have been encouraged to screen all adults for obesity and to offer behavioral weight loss counseling to the affected individuals. However, there is limited research and guidance on how to provide such intervention in primary care settings. This led the National Heart, Lung and Blood Institute in 2005 to issue a request for applications to investigate the management of obesity in routine clinical care. Three institutions were funded under a cooperative agreement to undertake the practice-based opportunities for weight reduction (POWER) trials. The present article reviews selected randomized controlled trials, published before the initiation of POWER, and then provides a detailed overview of the rationale, methods and results of the POWER trial conducted at the University of Pennsylvania (POWER-UP). POWER-UP's findings are briefly compared with those from the two other POWER trials, conducted at Johns Hopkins University and Harvard University/Washington University. The methods of delivering behavioral weight loss counseling differed markedly across the three trials, as captured by an algorithm presented in the article. Delivery methods ranged from having medical assistants and PCPs from the practices provide counseling to using a commercially available call center, coordinated with an interactive website. Evaluation of the efficacy of primary care-based weight loss interventions must be considered in light of costs, as discussed in relation to the recent treatment model proposed by the Centers for Medicare and Medicaid Services.

Patient-reported outcomes in the practice-based opportunities for weight reduction (POWER) trial.

To evaluate effects of two behavioral weight-loss interventions (in-person, remote) on health-related quality of life (HRQOL) compared to a control intervention. Four hundred and fifty-one obese US adults with at least one cardiovascular risk factor completed five measures of HRQOL and depression: MOS SF-12 physical component summary (PCS) and mental component summary; EuroQoL-5 dimensions single index and visual analog scale; PHQ-8 depression symptoms; and PSQI sleep quality scores at baseline and 6 and 24months after randomization. Change in each outcome was analyzed using outcome-specific mixed-effects models controlling for participant demographic characteristics. PCS-12 scores over 24months improved more among participants in the in-person active intervention arm than among control arm participants (P<0.05, ES=0.21); there were no other statistically significant treatment arm differences in HRQOL change. Greater weight loss was associated with improvements in most outcomes (P<0.05 to<0.0001). Participants in the in-person active intervention improved more in physical function HRQOL than participants in the control arm did. Greater weight loss during the study was associated with greater improvement in all PRO except for sleep quality, suggesting that weight loss is a key factor in improving HRQOL.

AHA 2011 Scientific Sessions highlight key studies

AHA 2011 Scientific Sessions highlight key studies

Applying the PRECIS criteria to describe three effectiveness trials of weight loss in obese patients with comorbid conditions.

To characterize Practice-Based Opportunities for Weight Reduction (POWER) trials along the pragmatic-explanatory continuum. The POWER trials consist of three individual studies that target obesity treatment in primary care settings. Using the PRagmatic Explanatory Continuum Indicator Summary (PRECIS) criteria, nine reviewers independently scored each trial. Average and median ratings, inter-rater reliability, and relationships to additional ratings of the extent to which study designs were explanatory (i.e., efficacy) versus pragmatic (i.e., practical) and related to external validity were determined. One trial was consistently rated as being significantly more pragmatic than the others (R(2) =0.43, p< .001), although all three were in the moderate range on the PRECIS scales. Ratings varied across PRECIS dimensions, being most pragmatic on comparison condition and primary outcome. Raters, although undergoing training and using identical definitions, scored their own study as more pragmatic than the other studies/interventions. These results highlight the need for more comprehensive reporting on PRECIS and related criteria for research translation. The PRECIS criteria provide a richer understanding of the POWER studies. It is not clear whether the original criteria are sufficient to provide a comprehensive profile.

Independent but coordinated trials: insights from the Practice-based Opportunities for Weight Reduction Trials Collaborative Research Group

The National Heart, Lung, and Blood Institute (NHLBI) funded three institutions to conduct effectiveness trials of weight loss interventions in primary care settings. Unlike traditional multi-center clinical trials, each study was established as an independent trial with a distinct protocol. Still, efforts were made to coordinate and standardize several aspects of the trials. The three trials formed a collaborative group, the 'Practice-based Opportunities for Weight Reduction (POWER) Trials Collaborative Research Group.' We describe the common and distinct features of the three trials, the key characteristics of the collaborative group, and the lessons learned from this novel organizational approach. The Collaborative Research Group consists of three individual studies: 'Be Fit, Be Well' (Washington University in St. Louis/Harvard University), 'POWER Hopkins' (Johns Hopkins), and 'POWER-UP' (University of Pennsylvania). There are a total of 15 participating clinics with ~1100 participants. The common primary outcome is change in weight at 24 months of follow-up, but each protocol has trial-specific elements including different interventions and different secondary outcomes. A Resource Coordinating Unit at Johns Hopkins provides administrative support. The Collaborative Research Group established common components to facilitate potential cross-site comparisons. The main advantage of this approach is to develop and evaluate several interventions, when there is insufficient evidence to test one or two approaches, as would be done in a traditional multi-center trial. The challenges of the organizational design include the complex decision-making process, the extent of potential data pooling, time intensive efforts to standardize reports, and the additional responsibilities of the DSMB to monitor three distinct protocols.

Treatment of Obesity in Primary Care Practice: The Practice Based Opportunities for Weight Reduction (POWER) Trial at Johns Hopkins.

Treatment of Obesity in Primary Care Practice: The Practice Based Opportunities for Weight Reduction (POWER) Trial at Johns Hopkins.