Alan Bauck

Comparison of Strategies for Sustaining Weight Loss: The Weight Loss Maintenance Randomized Controlled Trial

CONTEXT Behavioral weight loss interventions achieve short-term success, but re-gain is common. OBJECTIVE To compare 2 weight loss maintenance interventions with a self-directed control group. DESIGN, SETTING, AND PARTICIPANTS Two-phase trial in which 1032 overweight or obese adults (38% African American, 63% women) with hypertension, dyslipidemia, or both who had lost at least 4 kg during a 6-month weight loss program (phase 1) were randomized to a weight-loss maintenance intervention (phase 2). Enrollment at 4 academic centers occurred August 2003-July 2004 and randomization, February-December 2004. Data collection was completed in June 2007. INTERVENTIONS After the phase 1 weight-loss program, participants were randomized to one of the following groups for 30 months: monthly personal contact, unlimited access to an interactive technology-based intervention, or self-directed control. Main Outcome Changes in weight from randomization. RESULTS Mean entry weight was 96.7 kg. During the initial 6-month program, mean weight loss was 8.5 kg. After randomization, weight regain occurred. Participants in the personal-contact group regained less weight (4.0 kg) than those in the self-directed group (5.5 kg; mean difference at 30 months, -1.5 kg; 95% confidence interval [CI], -2.4 to -0.6 kg; P = .001). At 30 months, weight regain did not differ between the interactive technology-based (5.2 kg) and self-directed groups (5.5 kg; mean difference -0.3 kg; 95% CI, -1.2 to 0.6 kg; P = .51); however, weight regain was lower in the interactive technology-based than in the self-directed group at 18 months (mean difference, -1.1 kg; 95% CI, -1.9 to -0.4 kg; P = .003) and at 24 months (mean difference, -0.9 kg; 95% CI, -1.7 to -0.02 kg; P = .04). At 30 months, the difference between the personal-contact and interactive technology-based group was -1.2 kg (95% CI -2.1 to -0.3; P = .008). Effects did not differ significantly by sex, race, age, and body mass index subgroups. Overall, 71% of study participants remained below entry weight. CONCLUSIONS The majority of individuals who successfully completed an initial behavioral weight loss program maintained a weight below their initial level. Monthly brief personal contact provided modest benefit in sustaining weight loss, whereas an interactive technology-based intervention provided early but transient benefit. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00054925.

Design and Implementation of an Interactive Website to Support Long-Term Maintenance of Weight Loss

Background For most individuals, long-term maintenance of weight loss requires long-term, supportive intervention. Internet-based weight loss maintenance programs offer considerable potential for meeting this need. Careful design processes are required to maximize adherence and minimize attrition. Objective This paper describes the development, implementation and use of a Web-based intervention program designed to help those who have recently lost weight sustain their weight loss over 1 year. Methods The weight loss maintenance website was developed over a 1-year period by an interdisciplinary team of public health researchers, behavior change intervention experts, applications developers, and interface designers. Key interactive features of the final site include social support, self-monitoring, written guidelines for diet and physical activity, links to appropriate websites, supportive tools for behavior change, check-in accountability, tailored reinforcement messages, and problem solving and relapse prevention training. The weight loss maintenance program included a reminder system (automated email and telephone messages) that prompted participants to return to the website if they missed their check-in date. If there was no log-in response to the email and telephone automated prompts, a staff member called the participant. We tracked the proportion of participants with at least one log-in per month, and analyzed log-ins as a result of automated prompts. Results The mean age of the 348 participants enrolled in an ongoing randomized trial and assigned to use the website was 56 years; 63% were female, and 38% were African American. While weight loss data will not be available until mid-2008, website use remained high during the first year with over 80% of the participants still using the website during month 12. During the first 52 weeks, participants averaged 35 weeks with at least one log-in. Email and telephone prompts appear to be very effective at helping participants sustain ongoing website use. Conclusions Developing interactive websites is expensive, complex, and time consuming. We found that extensive paper prototyping well in advance of programming and a versatile product manager who could work with project staff at all levels of detail were essential to keeping the development process efficient. Trial Registration clinicaltrials.gov NCT00054925

Associations of Internet Website Use With Weight Change in a Long-term Weight Loss Maintenance Program

Background The Weight Loss Maintenance Trial (WLM) compared two long-term weight-maintenance interventions, a personal contact arm and an Internet arm, with a no-treatment control after an initial six-month Phase I weight loss program. The Internet arm focused on use of an interactive website for support of long-term weight maintenance. There is limited information about patterns of website use and specific components of an interactive website that might help promote maintenance of weight loss. Objective This paper presents a secondary analysis of the subset of participants in the Internet arm and focuses on website use patterns and features associated with long-term weight maintenance. Methods Adults at risk for cardiovascular disease (CVD) who lost at least 4 kilograms in an initial 20-week group-based, behavioral weight-loss program were trained to use an interactive website for weight loss maintenance. Of the 348 participants, 37% were male and 38% were African American. Mean weight loss was 8.6 kilograms. Participants were encouraged to log in at least weekly and enter a current weight for the 30-month study period. The website contained features that encouraged setting short-term goals, creating action plans, and reinforcing self-management habits. The website also included motivational modules, daily tips, and tailored messages. Based on log-in and weight-entry frequency, we divided participants into three website use categories: consistent, some, and minimal. Results Participants in the consistent user group (n = 212) were more likely to be older (P = .002), other than African American (P = .02), and more educated (P = .01). While there was no significant difference between website use categories in the amount of Phase I change in body weight (P = .45) or income (P = .78), minimal website users (n = 75) were significantly more likely to have attended fewer Phase I sessions (P = .001) and had a higher initial body mass index (BMI) (P < .001). After adjusting for baseline characteristics including initial BMI, variables most associated with less weight regain included: number of log-ins (P = .001), minutes on the website (P < .001), number of weight entries (P = .002), number of exercise entries (P < .001), and sessions with additional use of website features after weight entry (P = .002). Conclusion Participants defined as consistent website users of an interactive behavioral website designed to promote maintenance of weight loss were more successful at maintaining long-term weight loss. Trial Registration NCT00054925; http://clinicaltrials.gov/ct2/show/NCT00054925 (Archived by WebCite at http://www.webcitation.org/5rC7523ue)

Developing a data infrastructure for a learning health system: the PORTAL network

The Kaiser Permanente & Strategic Partners Patient Outcomes Research To Advance Learning (PORTAL) network engages four healthcare delivery systems (Kaiser Permanente, Group Health Cooperative, HealthPartners, and Denver Health) and their affiliated research centers to create a new national network infrastructure that builds on existing relationships among these institutions. PORTAL is enhancing its current capabilities by expanding the scope of the common data model, paying particular attention to incorporating patient-reported data more systematically, implementing new multi-site data governance procedures, and integrating the PCORnet PopMedNet platform across our research centers. PORTAL is partnering with clinical research and patient experts to create cohorts of patients with a common diagnosis (colorectal cancer), a rare diagnosis (adolescents and adults with severe congenital heart disease), and adults who are overweight or obese, including those with pre-diabetes or diabetes, to conduct large-scale observational comparative effectiveness research and pragmatic clinical trials across diverse clinical care settings.

A Harmonized Data Quality Assessment Terminology and Framework for the Secondary Use of Electronic Health Record Data.

Objective: Harmonized data quality (DQ) assessment terms, methods, and reporting practices can establish a common understanding of the strengths and limitations of electronic health record (EHR) data for operational analytics, quality improvement, and research. Existing published DQ terms were harmonized to a comprehensive unified terminology with definitions and examples and organized into a conceptual framework to support a common approach to defining whether EHR data is ‘fit’ for specific uses. Materials and Methods: DQ publications, informatics and analytics experts, managers of established DQ programs, and operational manuals from several mature EHR-based research networks were reviewed to identify potential DQ terms and categories. Two face-to-face stakeholder meetings were used to vet an initial set of DQ terms and definitions that were grouped into an overall conceptual framework. Feedback received from data producers and users was used to construct a draft set of harmonized DQ terms and categories. Multiple rounds of iterative refinement resulted in a set of terms and organizing framework consisting of DQ categories, subcategories, terms, definitions, and examples. The harmonized terminology and logical framework’s inclusiveness was evaluated against ten published DQ terminologies. Results: Existing DQ terms were harmonized and organized into a framework by defining three DQ categories: (1) Conformance (2) Completeness and (3) Plausibility and two DQ assessment contexts: (1) Verification and (2) Validation. Conformance and Plausibility categories were further divided into subcategories. Each category and subcategory was defined with respect to whether the data may be verified with organizational data, or validated against an accepted gold standard, depending on proposed context and uses. The coverage of the harmonized DQ terminology was validated by successfully aligning to multiple published DQ terminologies. Discussion: Existing DQ concepts, community input, and expert review informed the development of a distinct set of terms, organized into categories and subcategories. The resulting DQ terms successfully encompassed a wide range of disparate DQ terminologies. Operational definitions were developed to provide guidance for implementing DQ assessment procedures. The resulting structure is an inclusive DQ framework for standardizing DQ assessment and reporting. While our analysis focused on the DQ issues often found in EHR data, the new terminology may be applicable to a wide range of electronic health data such as administrative, research, and patient-reported data. Conclusion: A consistent, common DQ terminology, organized into a logical framework, is an initial step in enabling data owners and users, patients, and policy makers to evaluate and communicate data quality findings in a well-defined manner with a shared vocabulary. Future work will leverage the framework and terminology to develop reusable data quality assessment and reporting methods.

Development and implementation cost analysis of telephone- and Internet-based interventions for the maintenance of weight loss

OBJECTIVES The Weight Loss Maintenance Trial (WLM) was a multicenter, randomized trial comparing two weight loss maintenance interventions, a personal contact (PC) program with primarily telephone-based monthly contacts, and an Internet-based program (interactive technology, IT), to a self-directed control group, among overweight or obese individuals at high cardiovascular risk. This study describes implementation costs of both interventions as well as IT development costs. METHODS Resources were micro-costed in 2006 dollars from the primary perspective of a sponsoring healthcare system considering adopting an extant intervention, rather than developing its own. Costs were discounted at 3 percent annually. Length of trial participation was 30 months (randomization during February-November 2004). IT development costs were assessed over 36 months. Univariate and multivariate, including probabilistic, sensitivity analyses were performed. RESULTS Total discounted IT development costs over 36 months were

Pragmatic (trial) informatics: a perspective from the NIH Health Care Systems Research Collaboratory

839,949 (

Preparing for the ICD-10-CM Transition: Automated Methods for Translating ICD Codes in Clinical Phenotype Definitions.

2,414 per IT participant). Discounted 30-month implementation costs for 342 PC participants were

The impact of continued intervention on weight: Five-year results from the weight loss maintenance trial

537,242 (

Development and Implementation of a Tailored Self-assessment Tool in an Internet-based Weight Loss Maintenance Program

1,571 per participant), and for 348 IT participants, were