Weight Loss in Underserved Patients - A Cluster-Randomized Trial.

BACKGROUND: Evidence of the effectiveness of treatment for obesity delivered in primary care settings in underserved populations is lacking. METHODS: We conducted a cluster-randomized trial to test the effectiveness of a high-intensity, lifestyle-based program for obesity treatment delivered in primary care clinics in which a high percentage of the patients were from low-income populations. We randomly assigned 18 clinics to provide patients with either an intensive lifestyle intervention, which focused on reduced caloric intake and increased physical activity, or usual care. Patients in the intensive-lifestyle group participated in a high-intensity program delivered by health coaches embedded in the clinics. The program consisted of weekly sessions for the first 6 months, followed by monthly sessions for the remaining 18 months. Patients in the usual-care group received standard care from their primary care team. The primary outcome was the percent change from baseline in body weight at 24 months. RESULTS: All 18 clinics (9 assigned to the intensive program and 9 assigned to usual care) completed 24 months of participation; a median of 40.5 patients were enrolled at each clinic. A total of 803 adults with obesity were enrolled: 452 were assigned to the intensive-lifestyle group, and 351 were assigned to the usual-care group; 67.2% of the patients were Black, and 65.5% had an annual household income of less than $40,000. Of the enrolled patients, 83.4% completed the 24-month trial. The percent weight loss at 24 months was significantly greater in the intensive-lifestyle group (change in body weight, -4.99%; 95% confidence interval [CI], -6.02 to -3.96) than in the usual-care group (-0.48%; 95% CI, -1.57 to 0.61), with a mean between-group difference of -4.51 percentage points (95% CI, -5.93 to -3.10) (P<0.001). There were no significant between-group differences in serious adverse events. CONCLUSIONS: A high-intensity, lifestyle-based treatment program for obesity delivered in an underserved primary care population resulted in clinically significant weight loss at 24 months. (Funded by the Patient-Centered Outcomes Research Institute and others; PROPEL ClinicalTrials.gov number, NCT02561221.).

Application of Latent Class Analysis to Identify Behavioral Patterns of Response to Behavioral Lifestyle Interventions in Overweight and Obese Adults.

BACKGROUND: Examining responders and non-responders to behavioral lifestyle interventions among overweight/obese adults with additional comorbidities may aid in refining and tailoring obesity treatment. PURPOSE: The purpose of this study is to demonstrate the use of latent class analysis to identify patterns of response to behavioral lifestyle interventions based on adherence to diet and exercise recommendations. METHOD: Repeated measures latent class analysis was applied to two clinical trial datasets, combination of two active interventions in the PREMIER Trial (n = 501) and phase 1 of the Weight Loss Maintenance Trial (WLM; n = 1685), to identify patterns of response to behavioral lifestyle interventions. Treatment response was based on adherence to daily recommendations for fruit/vegetable, fat, saturated fat, sodium, and exercise at baseline and 6 months. RESULTS: In PREMIER, three distinct latent classes emerged: responders (45.9%), non-responders (23.6%), and early adherers (30.5%). Responders and Early Adherers had greater weight loss at 6 and 18 months and were more likely to meet behavioral recommendations at 18 months than Non-responders. For WLM, there were four latent classes: partial responders (16%), non-responders (40%), early adherers (2%), and fruit/veggie only responders (41%). Non-responders in WLM had significantly less weight loss at 6 months compared to that of the other three latent classes. CONCLUSION: Latent class analysis is a useful method to apply to clinical trial data to identify distinct patterns of response to behavioral interventions. Overweight/ obese participants who respond to behavioral lifestyle treatment (i.e., meet behavioral recommendations) have significantly greater weight loss than that of participants who do not make behavioral changes.

Psychosocial predictors of weight regain in the weight loss maintenance trial.

This study's purpose was to identify psychosocial predictors of weight loss maintenance in a multi-site clinical trial, following a group-based weight loss program. Participants (N = 1025) were predominately women (63%) and 38% were Black (mean age = 55.6 years; SD = 8.7). At 12 months, higher SF-36 mental health composite scores were associated with less weight regain (p < .01). For Black participants, an interaction existed between race and friends' encouragement for exercise, where higher exercise encouragement was related to more weight regain (p < .05). At 30 months, friends' encouragement for healthy eating was associated with more weight regain (p < .05), whereas higher SF-36 mental health composite scores were related to less weight regain (p < .0001). Perceived stress and select health-related quality of life indices were associated with weight regain; this relationship varied across gender, race, and treatment conditions. Temporal changes in these variables should be investigated for their impact on weight maintenance.

Longitudinal Profiling of Fasting Plasma Metabolome in Response to Weight-Loss Interventions in Patients with Morbid Obesity.

It is well recognized that patients with severe obesity exhibit remarkable heterogeneity in response to different types of weight-loss interventions. Those who undergo Roux-en-Y gastric bypass (RYGB) usually exhibit more favorable glycemic outcomes than those who receive adjustable gastric banding (BAND) or intensive medical intervention (IMI). The molecular mechanisms behind these observations, however, remain largely unknown. To identify the plasma metabolites associated with differential glycemic outcomes induced by weight-loss intervention, we studied 75 patients with severe obesity (25 each in RYGB, BAND, or IMI). Using untargeted metabolomics, we repeatedly measured 364 metabolites in plasma samples at baseline and 1-year after intervention. Linear regression was used to examine whether baseline metabolites or changes in metabolites are associated with differential glycemic outcomes in response to different types of weight-loss intervention, adjusting for sex, baseline age, and BMI as well as weight loss. Network analyses were performed to identify differential metabolic pathways involved in the observed associations. After correction for multiple testing (q < 0.05), 33 (RYGB vs. IMI) and 28 (RYGB vs. BAND) baseline metabolites were associated with changes in fasting plasma glucose (FPG) or glycated hemoglobin (HbA1c). Longitudinal changes in 38 (RYGB vs. IMI) and 38 metabolites (RYGB vs. BAND) were significantly associated with changes in FPG or HbA1c. The identified metabolites are enriched in pathways involved in the biosynthesis of aminoacyl-tRNA and branched-chain amino acids. Weight-loss intervention evokes extensive changes in plasma metabolites, and the altered metabolome may underlie the differential glycemic outcomes in response to different types of weight-loss intervention, independent of weight loss itself.

Predictors of racial differences in weight loss: the PROPEL trial.

OBJECTIVE: Studies have consistently shown that African American individuals lose less weight in response to behavioral interventions, but the mechanisms leading to this result have been understudied. METHODS: Data were derived from the PROmoting Successful Weight Loss in Primary CarE in Louisiana (PROPEL) study, which was a cluster-randomized, two-arm trial conducted in primary care clinics. In the PROPEL trial, African American individuals lost less weight compared with patients who belonged to other racial groups after 24 months. In the current study, counterfactual mediation analyses among 445 patients in the intervention arm of PROPEL were used to determine which variables mediated the relationship between race and weight loss. The mediators included treatment engagement, psychosocial, and lifestyle factors. RESULTS: At 6 months, daily weighing mediated 33% (p = 0.008) of the racial differences in weight loss. At 24 months, session attendance and daily weighing mediated 35% (p = 0.027) and 66% (p = 0.005) of the racial differences in weight loss, respectively. None of the psychosocial or lifestyle variables mediated the race-weight loss association. CONCLUSIONS: Strategies specifically targeting engagement, such as improving session attendance and self-weighing behaviors, among African American individuals are needed to support more equitable weight losses over extended time periods.

Weight loss history as a predictor of weight loss: results from Phase I of the weight loss maintenance trial.

Past studies have suggested that weight loss history is associated with subsequent weight loss. However, questions remain whether method and amount of weight lost in previous attempts impacts current weight loss efforts. This study utilized data from the Weight Loss Maintenance Trial to examine the association between weight loss history and weight loss outcomes in a diverse sample of high-risk individuals. Multivariate regression analysis was conducted to determine which specific aspects of weight loss history predict change in weight during a 6-month weight loss intervention. Greater weight loss was predicted by fewer previous weight loss attempts with assistance (p = 0.03), absence of previous dietary/herbal weight loss supplement use (p = 0.01), and greater maximum weight loss in previous attempts (p < 0.001). Future interventions may benefit from assessment of weight loss history and tailoring of interventions based on past weight loss behaviors and outcomes.

DNA methylation is differentially associated with glycemic outcomes by different types of weight-loss interventions: an epigenome-wide association study.

BACKGROUND: Alterations in DNA methylation (DNAm) have been reported to be a mechanism by which bariatric surgeries resulted in considerable metabolic improvements. Previous studies have mostly focused on change in DNAm following weight-loss interventions, yet whether DNAm prior to intervention can explain the variability in glycemic outcomes has not been investigated. Here, we aim to examine whether baseline DNAm is differentially associated with glycemic outcomes induced by different types of weight-loss interventions. METHODS: Participants were 75 adults with severe obesity who underwent non-surgical intensive medical intervention (IMI), adjustable gastric band (BAND) or Roux-en-Y gastric bypass (RYGB) (n = 25 each). Changes in fasting plasma glucose (FPG) and glycated hemoglobin (HbA1c) were measured at 1-year after intervention. DNAm was quantified by Illumina 450 K arrays in baseline peripheral blood DNA. Epigenome-wide association studies were performed to identify CpG probes that modify the effects of different weight-loss interventions on glycemic outcomes, i.e., changes in FPG and HbA1c, by including an interaction term between types of intervention and DNAm. Models were adjusted for weight loss and baseline clinical factors. RESULTS: Baseline DNAm levels at 3216 and 117 CpGs were differentially associated with changes in FPG and HbA1c, respectively, when comparing RYGB versus IMI. Of these, 79 CpGs were significant for both FPG and HbA1c. The identified genes are enriched in adaptive thermogenesis, temperature homeostasis and regulation of cell population proliferation. Additionally, DNAm at 6 CpGs was differentially associated with changes in HbA1c when comparing RYGB versus BAND. CONCLUSIONS: Baseline DNAm is differentially associated with glycemic outcomes in response to different types of weight-loss interventions, independent of weight loss and other clinical factors. Such findings provided initial evidence that baseline DNAm levels may serve as potential biomarkers predictive of differential glycemic outcomes in response to different types of weight-loss interventions.

Actual medical and pharmacy costs for bariatric surgery: 6-year follow-up.

OBJECTIVE: To determine the change in total medical expenditures, total pharmacy expenditures, and subcategories of medical and pharmacy expenditures in obese individuals following weight loss surgery (WLS), and to compare these costs with expenditures in obese individuals not receiving WLS. METHODS: Louisiana Office of Group Benefits (OGB), the state-managed health insurer, invited members to be evaluated for insurance-covered WLS. Of 951 obese members who provided written consent to begin the WLS screening process, 40 were selected for surgery. Medical and pharmaceutical claims cost data of the 911 patients who did not have surgery and the 39 individuals who completed surgery were compared over a 2-year presurgical and 6-year postsurgical period. RESULTS: Total nonpharmacy medical costs were lower for WLS patients compared with non-WLS patients beginning 4 years postsurgery and lasting through 6 years postsurgery. No differences were found between WLS and non-WLS patients in expenditures for most medical subcategories examined, including emergency department, physical and occupational therapy, office visits, and laboratory/pathology; whereas sleep facility and all remaining medical expenditures not represented by a subcategory were lower for WLS patients during some postsurgery years. Total pharmacy costs were lower for WLS participants at 2 and 3 years postsurgery, but these lower costs were not maintained; however, costs remained lower for antidiabetic agents, antihypertensive agents, and dyslipidemic agents through all 6 postsurgery years under study. CONCLUSIONS: The cost of WLS may begin to be recouped within the first 4 years postsurgery with continued effects 6 years postsurgery.

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

BACKGROUND: Using the Internet to replicate client/counselor interactions provides a tremendous opportunity to disseminate interventions at relatively low cost per participant. However, there are substantial challenges with this approach. The Weight Loss Maintenance Trial (WLM) compared two long-term weight-maintenance interventions: (1) a personal contact arm and (2) an Internet arm, to a third self-directed control arm. The Internet arm focused on use of an interactive website for support of long-term weight maintenance. This paper describes a highly interactive self-assessment tool developed for use in the WLM trial Internet intervention arm. METHODS: The Tailored Self-Assessment (TSA) website tool was an interactive resource for those WLM participants assigned to the Internet arm to review their personal weight-management progress and make choices about future weight-management actions. The TSA was highly tailored and ended with a suggested list of personalized action plans. While the participant could complete the TSA at any time, criteria-based reminder messages prompted participation. RESULTS: The TSA was one of 27 interactive tools on the WLM website. Over the course of the 28 months, the TSA was completed 800 times by the 348 randomized participants. Fifty-three percent of the participants (185/348) used the TSA at least once (range: 0, 110) and 72% of the 185 participants who did complete the TSA at least once, completed it more than once. CONCLUSION: The Internet has great potential to impact health behavior by attempting to replicate personal counseling. We learned that while development is complex and appears costly, tailored strategies based on client feedback are likely worthwhile and should be formally tested.

Effects of the PREMIER interventions on health-related quality of life.

BACKGROUND: Health-related quality of life (HRQOL) is an important aspect of well-being that may improve with health behavior interventions. However, health behavior change is difficult with pressure to maintain status quo. PURPOSE: This report examines the effects of two lifestyle interventions and an advice-only condition on HRQOL. Effects of meeting behavioral goals and weight loss also were examined. METHODS: Participants were 295 men and 467 women (34% African American) with pre-hypertension or stage 1 hypertension from the PREMIER trial. HRQOL was assessed by the Short Form-36. Participants were assigned randomly to (1) advice only (ADVICE), (2) established guidelines for blood pressure control (EST), or (3) established guidelines plus the Dietary Approaches to Stop Hypertension (DASH) dietary pattern (EST + DASH). RESULTS: Assignment to EST resulted in improvement in three HRQOL subscales at 6 months and one at 18 months relative to ADVICE. EST + DASH improved in two subscales at 6 and 18 months compared with ADVICE. Across conditions, total fat, saturated fat, fruit, and vegetable intake change, along with ≥ 4-kg weight loss, resulted in HRQOL improvements at 6 and 18 months. No improvement was found for change in physical activity, and only a few HRQOL subscales were associated with change in sodium and low-fat dairy intake. CONCLUSIONS: Intensive lifestyle interventions can result in improvements in HRQOL. Change in dietary intake and weight loss is also important.

Family functioning and weight loss in a sample of african americans and whites.

BACKGROUND: Traditionally, weight management behavioral research has focused on individual-level influences, with little attention given to interpersonal factors that relate to the family behavioral context. PURPOSE: This research examines the association between baseline family functioning scores and weight loss success in a sample of African Americans and Whites enrolled in a 20-week weight loss program with a weight loss goal of ≥ 4 kg. METHODS: Baseline surveys measuring six family functioning constructs were completed by 291 participants in a trial of weight loss maintenance. Analysis was limited to 217 participants in households with at least one other family member, and providing final weight measurements. We evaluated associations of family functioning, family composition, and demographic variables with weight loss success defined as losing ≥ 5% of initial body weight. Baseline predictors of weight loss success were determined using logistic regression analysis. RESULTS: Participants were on average 61 years of age with BMI of 34 kg/m(2); 57% were female and 75% self-identified as African American. Sixty-two percent lost at least 5% of initial body weight. In bivariate analysis, weight loss success was associated with higher income and education (p < 0.01 and p = 0.05, respectively), ethnicity (p < 0.01), and the presence of a spouse (p = 0.01). After adjusting for socio-demographic covariates in a multivariable model, the odds of weight loss success were independently influenced by a significant interaction between ethnicity and family cohesion (p < 0.01). CONCLUSIONS: These findings suggest that family context factors influence weight loss behaviors.

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).

HEADS UP: Design and Methods of a Louisiana State-Funded Surgical and Non-Surgical Weight Loss Program.

This paper describes the methodology, design and procedures used in the HEADS UP Project, an observational study to examine the feasibility of a state-funded weight loss program. HEADS UP offered two weight loss approaches: bariatric surgery or a non-surgical intervention composed of medical management, a low-calorie liquid diet and lifestyle change promotion. Participants were recruited through a multi-stage screening process, in-person interviews, and an initial low-calorie diet program. Eligible participants were entered into a lottery system, with 100 participants selected for the surgical group and 200 selected for the non-surgical group annually for five years. Anthropometric, clinical, and psychosocial assessments were completed at baseline and follow-ups. More than 6800 individuals completed the initial web screening. Screening procedures yielded 1412 participants (490 surgical and 922 non-surgical). Approximately 84% of the total participant population were female and 38% were Black. Participants had an average body mass index of 47.9 and 43 kg/m2 in the surgical and non-surgical groups, respectively. Recruitment and enrollment results of the HEADS UP study demonstrated significant interest in both the surgical and non-surgical treatment programs for obesity. These results support the feasibility of providing a state-funded weight loss program within a healthcare setting.

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 $839,949 ($2,414 per IT participant). Discounted 30-month implementation costs for 342 PC participants were $537,242 ($1,571 per participant), and for 348 IT participants, were $214,879 ($617 per participant). Under all plausible scenarios, PC implementation costs exceeded IT implementation costs. CONCLUSIONS: Costs of implementing and operating an Internet-based intervention for weight loss maintenance were substantially less than analogous costs of an intervention using standard phone and in-person contacts and are of a magnitude that would be attractive to many health systems, subject to demonstration of cost-effectiveness.

The multidimensional health locus of control scales: testing the factorial structure in sample of African American medical patients.

OBJECTIVE: A fifth subscale was recently added to the widely used multidimensional health locus of control (MHLC) measure, and little is known about the factor structure of the MHLC with the new scale among African Americans from disadvantaged backgrounds. Also, few studies have examined differences in Health Locus of Control (HLOC) beliefs across medical patients from similar demographic backgrounds. METHODS: We asked participants to complete a survey about HLOC beliefs and extracted biological markers from their medical charts. Participants were drawn from patients of internal medicine and infectious disease clinics at a charity hospital in Baton Rouge, Louisiana. In total, we surveyed 186 African American patients who were diagnosed with HIV/AIDS or type 2 diabetes. RESULTS: Confirmatory factor analysis could not confirm a 5-factor structure; however, a new 3-factor structure was produced that includes 1) internal health beliefs, 2) external health beliefs, and 3) God health beliefs. Patients with HIV/AIDS reported more external and God HLOC beliefs than did patients with type 2 diabetes. CONCLUSIONS: The factor structures that emerged from previous research may not be appropriate to use when conducting research with individuals from a low SES who are also from an ethnic/racial minority background. Our findings suggest a new 3-factor structure for the MHLC. Future research should examine whether patients with HIV/AIDS may benefit from interventions that target external beliefs to improve health behavior.

Botanicals and the metabolic syndrome.

Metabolic syndrome describes the human condition characterized by the presence of coexisting traditional risk factors for cardiovascular disease, such as hypertension, dyslipidemia, glucose intolerance, and obesity, in addition to nontraditional cardiovascular disease risk factors, such as inflammatory processes and abnormalities of the blood coagulation system. Although the specific etiology for metabolic syndrome is not known, insulin resistance--a clinical state in which a normal or elevated insulin concentration reflects an impaired biological response--is present and is considered a key pathophysiologic abnormality. As such, metabolic syndrome can be considered to be a prediabetic state and contributes greatly to increased morbidity and mortality in humans. Given the public health significance of metabolic syndrome, successful strategies are direly needed to intervene in its development. As such, nutritional supplementation with botanicals that effectively address pathogenic mechanisms, combined with the acceptance and widespread use of botanical supplements by the general public, represents an attractive, novel, and potentially effective approach to the problem. Thus, the overall goal of our botanical research center is to comprehensively evaluate botanicals in addressing the pathophysiologic mechanisms that lead to the development of insulin resistance and metabolic syndrome. Currently, each of the 3 research projects evaluates a specific botanical [Russian tarragon (Artemisia dracunculus L), shilianhua (Sinocrassula indica), and grape (Vitus vinifera) anthocyanins] and assesses the effect on pathogenic mechanisms leading to the development of insulin resistance. With the completion of our research, we anticipate a better understanding of the cellular mechanisms by which insulin resistance develops and the role of botanicals in modulating the progression to metabolic syndrome.

Weight loss during the intensive intervention phase of the weight-loss maintenance trial.

BACKGROUND: To improve methods for long-term weight management, the Weight Loss Maintenance (WLM) trial, a four-center randomized trial, was conducted to compare alternative strategies for maintaining weight loss over a 30-month period. This paper describes methods and results for the initial 6-month weight-loss program (Phase I). METHODS: Eligible adults were aged > or =25, overweight or obese (BMI=25-45 kg/m2), and on medications for hypertension and/or dyslipidemia. Anthropomorphic, demographic, and psychosocial measures were collected at baseline and 6 months. Participants (n=1685) attended 20 weekly group sessions to encourage calorie restriction, moderate-intensity physical activity, and the DASH (dietary approaches to stop hypertension) dietary pattern. Weight-loss predictors with missing data were replaced by multiple imputation. RESULTS: Participants were 44% African American and 67% women; 79% were obese (BMI> or =30), 87% were taking anti-hypertensive medications, and 38% were taking antidyslipidemia medications. Participants attended an average of 72% of 20 group sessions. They self-reported 117 minutes of moderate-intensity physical activity per week, kept 3.7 daily food records per week, and consumed 2.9 servings of fruits and vegetables per day. The Phase-I follow-up rate was 92%. Mean (SD) weight change was -5.8 kg (4.4), and 69% lost at least 4 kg. All race-gender subgroups lost substantial weight: African-American men (-5.4 kg +/- 7.7); African-American women (-4.1 kg +/- 2.9); non-African-American men (-8.5 kg +/- 12.9); and non-African-American women (-5.8 kg +/- 6.1). Behavioral measures (e.g., diet records and physical activity) accounted for most of the weight-loss variation, although the association between behavioral measures and weight loss differed by race and gender groups. CONCLUSIONS: The WLM behavioral intervention successfully achieved clinically significant short-term weight loss in a diverse population of high-risk patients.

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.

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.

PREMIER--a trial of lifestyle interventions for blood pressure control: intervention design and rationale.

Interventions encouraging adoption of healthy diets and increased physical activity are needed to achieve national goals for preventing and treating hypertension, cardiovascular disease, diabetes, and other chronic diseases. PREMIER was a multicenter clinical trial testing the effects of two lifestyle interventions on blood pressure control, compared with advice only. Both interventions implemented established national guidelines for blood pressure control (weight loss, reduced sodium and alcohol intake, and increased physical activity), and one intervention also included the Dietary Approaches to Stop Hypertension (DASH) diet. Both interventions focused on behavioral self-management, motivational enhancement, and personalized feedback. This article describes the design and evaluation approaches for these interventions. Evaluation of multicomponent lifestyle change interventions can help us understand the benefits and difficulties of making multiple lifestyle changes concurrently and the effects such changes can have on blood pressure, particularly in minorities at higher risk for hypertension.