Prepare, a randomized trial to promote and evaluate weight loss among overweight and obese women planning pregnancy: Study design and rationale.

BACKGROUND: Women who are overweight or have obesity at pregnancy onset, and those who gain excessive weight during pregnancy, are at increased risk of pregnancy-related complications and large for gestational age infants. OBJECTIVE: This report describes methodology for the Prepare study, a randomized, controlled clinical trial testing a preconception and pregnancy weight management program for women who are overweight or have obesity (BMI≥27kg/m(2)). OUTCOMES: This trial examines multiple pregnancy and neonatal outcomes, with the primary outcome being gestational weight gain (GWG). Secondary outcomes include change in weight before conception, offspring birth weight adjusted for gestational age, offspring weight for length, and pregnancy diet quality and physical activity level. METHODS: Nonpregnant women who anticipate becoming pregnant in the next 2years are randomly assigned to an intervention program or a usual care control condition. Intervention participants receive weight management counseling by telephone before and during pregnancy, with weekly contacts during the first 6months and monthly contacts for the next 18months. Intervention participants also have unlimited access to a study website that provides self-management tools. All participants who become pregnant are contacted at 20weeks' gestation to assess physical activity levels and dietary habits. All other outcome data are obtained from medical records. Intervention satisfaction is assessed via questionnaire. SUMMARY: This clinical trial tests the efficacy of an intervention program designed to help overweight and obese women achieve healthy lifestyle changes that will result in a healthy weight prior to pregnancy and appropriate weight gain during pregnancy.

Maternal body mass index before pregnancy is associated with increased bronchodilator dispensing in early childhood: A cross-sectional study.

RATIONALE: Maternal prepregnancy obesity has been associated with early wheeze and childhood asthma in their offspring. Some of these studies have been in minority, urban, and disadvantaged populations using parental recall and questionnaires. The association of maternal prepregnancy obesity with bronchodilator dispensing to their offspring, in a primarily insured, non-urban, White population in the United States is unknown. OBJECTIVES AND METHODS: We conducted a retrospective cohort study using pharmacy dispensing data from the electronic medical records of a large United States health maintenance organization to examine the relationship between maternal prepregnancy body mass index (BMI) and inhaled bronchodilator dispensing in the offspring to 4 years of age. We included infants ≥37 weeks' gestation with birth weight ≥2.5 kg which yielded 6,194 mother-baby pairs. Maternal prepregnancy BMI was categorized as underweight (<18.5 kg/m(2) ), normal (18.5-24.9 kg/m(2) ), overweight (25-29.9 kg/m(2) ), or obese (≥30 kg/m(2) ). RESULTS: In the entire cohort, 27.6% of the offspring received a bronchodilator dispensing. This ranged from 19.2% in the offspring of underweight mothers to 31.3% of those born to obese mothers. In the fully adjusted model using normal BMI as the referent, children of obese mothers had a 22% higher rate of bronchodilator dispensing (adjusted OR = 1.22; 95%CI 1.05-1.41; P = 0.008). CONCLUSIONS: In this insured, non-urban, White population, maternal prepregnancy obesity was associated with bronchodilator dispensing in the offspring in early life. These results extend previous data and reaffirm the potential widespread public health impact that prepregnancy obesity may have on subsequent childhood respiratory health. Pediatr Pulmonol. 2016;51:803-811. © 2016 Wiley Periodicals, Inc.

Do patient or provider characteristics impact management of diabetes?

OBJECTIVES: Patients with diabetes often exceed desired glycated hemoglobin (A1C) levels for months prior to medication adjustments. To determine if provider and patient characteristics predict glycemic control and treatment intensification. STUDY DESIGN: Observational retrospective cohort study using electronic medical record data. METHODS: We studied 149 Kaiser Permanente Northwest primary care providers of 14,430 patients with diabetes, of whom 5823 (40.4%) were in optimal control (all A1Cs < 7%) and 2446 (17%) were in poor control (at least 1 A1C > 9%) in 2011. We also identified a subset of 107 primary care providers of 912 patients with diabetes who were initially in optimal control (A1C < 7%) but had a subsequent A1C > 7.5% from 2010 to 2011. We used hierarchical linear modeling to assess both patient and provider characteristics as predictors of glycemic control and treatment intensification after incident hyperglycemia. RESULTS: Patient characteristics associated with optimal control included older age, lower baseline A1C, shorter diabetes duration, and not using insulin (P < .001 for all). The inverse of these variables predicted poor control. No provider characteristics were associated with glycemic control or intensification. Older patients with a greater change in A1C were more likely to have therapy intensified after loss of glycemic control. CONCLUSIONS: Patient, but not provider characteristics, predicted glycemic control and therapy intensification. Improving systems of care such as disease management services may be a better use of resources than focusing on individual providers.

Evaluation of care management intensity and bariatric surgical weight loss.

OBJECTIVES: To examine the effect of pre- and postoperative care management on weight loss following bariatric surgery. STUDY DESIGN: We conducted a retrospective cohort study supplemented by cross-sectional surveys across 9 bariatric surgery centers. METHODS: Based on the intensity of patient contact, care management intensity (CMI) was defined as high, moderate, or low for preoperative programs, and high or low for postoperative programs. Multivariable linear regression assessed 1- and 2-year post operative weight loss as a function of CMI. RESULTS: In the 9 centers, 4433 individuals underwent Roux-en-Y gastric bypass or adjustable gastric band placement between 2005 and 2009. Two sites had low, 5 had moderate, and 2 had high preoperative CMI; 5 sites had low and 4 had high postoperative CMI. In analyses stratified by procedure and adjusted for multiple covariates including site, we found no statistically significant associations between either preoperative or postoperative CMI and post operative change in body mass index at year 1 or year 2. Results were limited by heterogeneity of care management across sites and an inability to assess adherence to care management programs. CONCLUSIONS: Prospective investigations that incorporate quantifiable measures of CMI and measure individual adherence to components of care management programs are needed to more accurately determine the effect of care management on weight loss. Additional investigations should examine the effect of CMI on other relevant outcomes, such as nutritional status and quality of life, that may be more directly affected by care management.

Provider beliefs about diabetes treatment have little impact on glycemic control of their patients with diabetes.

OBJECTIVE: To improve the health of people with diabetes, it is essential to identify why patients experience extended periods of poor glycemic control before therapeutic intensification. RESEARCH DESIGN AND METHODS: We surveyed 252 primary care providers at Kaiser Permanente Northwest to determine their beliefs about the glycemic goals of their patients, treatment intensification behavior, and barriers to achieving optimal glycemic control. We linked the responses of 149 providers to the health records of their 18 346 patients with diabetes. RESULTS: Patient glycemic levels were not related to either individualized glycemic goals or provider intensification behavior. Providers' beliefs about diabetic treatment and glycated hemoglobin (HbA1c) goals were poorly associated with patient HbA1c levels. Providers identified patients' resistance to lifestyle behaviors and taking insulin, lack of medication adherence, and psychosocial issues as the main barriers to optimal glycemic control. Lack of time to care for complex patients was also a barrier. Providers who agreed that "current research did not support A1C levels <7%" were less likely to have patients with HbA1c levels <7% (OR=0.87, 95% CI 0.78 to 0.97) and patients of providers who disagreed that "some patients will have an A1C >9% no matter what I do" were 16% more likely to have patients with HbA1c <7% (1.16, 1.03 to 1.30) compared with providers who were neutral about those statements. CONCLUSIONS: Given the consistency of HbA1c levels across providers despite differences in beliefs and intensification behaviors, these barriers may be best addressed by instituting changes at the system level (ie, instituting institutional glycemic targets or outreach for dysglycemia) rather than targeting practice patterns of individual providers.

Examining behavioral processes through which lifestyle interventions promote weight loss: results from PREMIER.

OBJECTIVE: To examine the behavioral processes through which lifestyle interventions impacted weight loss. METHODS: The analyses were limited to overweight and obese Black and White adults randomized to a PREMIER lifestyle intervention (N = 501). Structural equation modeling was conducted to test the direct and indirect relationships of session attendance, days of self-monitoring diet and exercise, change in diet composition and exercise, and 6-month weight change. RESULTS: Greater session attendance was associated with increased self-monitoring, which was in turn significantly related to reduction in percent energy from total fat consumed. Change in percent energy from fat and self-monitoring was associated with 6-month percent change in weight. Both a decrease in fat intake and increase in self-monitoring are potential mediators of the relationship between attendance and weight change. CONCLUSIONS: The findings provide a reasonable model that suggests regular session attendance and use of behavioral strategies like self-monitoring are associated with improved behavioral outcomes that are associated with weight loss.

Predictors of dietary change among those who successfully lost weight in phase I of the Weight Loss Maintenance Trial.

AIM: Dietary changes occurring during weight loss interventions can vary. The present study tested if pretreatment psychosocial, dietary and demographic factors were associated with changes in fat intake and fruit and vegetable intake during a weight loss intervention. METHODS: This analysis includes participants who lost at least four kilograms during the initial six month weight loss phase (phase I) of the Weight Loss Maintenance Trial, a group format behavioural intervention emphasising a low-fat diet and increased physical activity. Multiple linear regression was used to determine associations between pretreatment psychosocial, dietary, physical activity, and demographic variables and changes from pretreatment to six months in fat intake and fruit and vegetable intake. RESULTS: Participants (n = 1032) were 63.4% female, 62.4% non-African American, and had a mean age of 55.6 and BMI of 34.1 kg/m2. Being African American (P < 0.0001) and higher baseline kilojoule intake (P < 0.01) were associated with smaller reductions in fat intake. Being African American (p < 0.001) and older age (P = 0.02) were associated with smaller increases in fruit and vegetable intake, whereas a history of 10 or more past weight loss episodes of at least 10 lb (4.5 kg; P < 0.01) was associated with greater increases. CONCLUSIONS: Few psychosocial factors examined contributed to variability in dietary change. Even when achieving meaningful weight losses during a behavioural weight loss intervention, African Americans may make fewer beneficial changes in fat and fruit and vegetable intake than non-African Americans.

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.

Adherence to, and Satisfaction with, the Self-Acupressure Intervention in the LIFE Weight-Loss Maintenance Study.

BACKGROUND: The LIFE study was a randomized controlled trial assessing the impact of a self-acupressure intervention, Tapas Acupressure Technique® (TAT®), on weight-loss maintenance. The primary analysis showed no significant difference between TAT and social support (SS) for weight-loss maintenance, while exploratory post hoc tests suggested that, among participants with highest initial weight-loss, those in the TAT condition regained less weight than those in the SS condition. OBJECTIVE: The aim of the current study was to assess adherence to, and satisfaction with, the experimental self-acupressure intervention in the LIFE weight loss maintenance trial. DESIGN: This was a secondary analysis of adherence and satisfaction patterns in a large randomized controlled trial. SETTING: The study was conducted at a prominent health maintenance organization in the Pacific Northwest. SUBJECTS: This study involved 142 obese participants who had lost >10 pounds in a conventional weight-loss program and who were randomized to the experimental acupressure intervention. INTERVENTIONS: The experimental intervention (n=142) arm consisted of instruction and application of a self-acupressure intervention, the Tapas Acupressure Technique® (TAT®). OUTCOME MEASURES: The outcome sought was self-reported satisfaction and frequency of TAT practice. RESULTS: Sixty-six percent of TAT participants attended at least 6 of 8 intervention sessions. More than 80% of participants reported practicing TAT at home, on average, at least 2 days per week. Sixty two percent reported practicing <10 minutes per session, while 27% reported practicing 10-20 minutes per session. Higher satisfaction scores were significantly correlated with less weight regain (p=0.001). Frequency of TAT practice was not significantly associated with changes in weight, stress, insomnia, depression, or quality of life. CONCLUSIONS: These data suggest moderate acceptance of, and adherence to, the TAT intervention. Further research is required to identify and achieve optimal home-practice levels of self-acupressure techniques.

Randomized trial of Tapas Acupressure Technique for weight loss maintenance.

BACKGROUND: Obesity is an urgent public health problem, yet only a few clinical trials have systematically tested the efficacy of long-term weight-loss maintenance interventions. This randomized clinical trial tested the efficacy of a novel mind and body technique for weight-loss maintenance. METHODS: Participants were obese adults who had completed a six-month behavioral weight-loss program prior to randomization. Those who successfully lost weight were randomized into either an experimental weight-loss maintenance intervention, Tapas Acupressure Technique (TAT®), or a control intervention comprised of social-support group meetings (SS) led by professional facilitators. TAT combines self-applied light pressure to specific acupressure points accompanied by a prescribed sequence of mental steps. Participants in both maintenance conditions attended eight group sessions over six months of active weight loss maintenance intervention, followed by an additional 6 months of no intervention. The main outcome measure was change in weight from the beginning of the weight loss maintenance intervention to 12 months later. Secondary outcomes were change in depression, stress, insomnia, and quality of life. We used analysis of covariance as the primary analysis method. Missing values were replaced using multiple imputation. RESULTS: Among 285 randomized participants, 79% were female, mean age was 56 (standard deviation (sd) = 11), mean BMI at randomization was 34 (sd = 5), and mean initial weight loss was 9.8 kg (sd = 5). In the primary outcome model, there was no significant difference in weight regain between the two arms (1.72 kg (se 0.85) weight regain for TAT and 2.96 kg (se 0.96) weight regain for SS, p < 0.097) Tests of between- arm differences for secondary outcomes were also not significant. A secondary analysis showed a significant interaction between treatment and initial weight loss (p < .036), with exploratory post hoc tests showing that greater initial weight loss was associated with more weight regain for SS but less weight regain for TAT. CONCLUSIONS: The primary analysis showed no significant difference in weight regain between TAT and SS, while secondary and post hoc analyses indicate direction for future research.

Comparison of characteristics and outcomes by initial study contact (website versus staff) for participants enrolled in a weight management study.

BACKGROUND: Traditional recruitment methods for clinical trials, such as telephone, mail, and print media, are often inefficient, costly, and use large amounts of staff time and resources. PURPOSE: This analysis was conducted to determine whether retention, demographics, and outcomes differed between enrolled participants who responded to recruitment outreach using an Internet-based information and registration system and enrollees whose first contact was with study staff via telephone. METHODS: We identified potentially eligible participants from Kaiser Permanente Northwest (KPNW) databases and mailed brochures inviting them to participate in the Life weight loss maintenance study. We also used employee newsletters, a member-directed website, and messages to employee email distribution lists to publicize the study. All outreach methods contained both a website address and a telephone number through which respondents could register for an information session. The website contained the same information as was provided by staff over the telephone. RESULTS: Out of 2122 potential participants who expressed interest in the study, 70% did so through the website. There was no difference in retention rates between enrollees who initiated contact through the website (WEB = 308) and enrollees who contacted the study by telephone (staff = 161). The WEB group was younger (p = 0.01), had higher income (p = 0.01) and education (p < 0.01) levels, and lower body mass index (BMI; p < 0.01). There was a trend toward greater weight loss in the WEB group (p = 0.06). LIMITATIONS: We did not conduct a formal cost analysis of the two methods. Also, the population for this analysis was mostly Caucasian and middle income; thus, we cannot draw conclusions about the generalizability of our findings to more racially and economically diverse populations. CONCLUSION: Enrolled participants who used a website to register for an initial study information session had similar study retention and outcome performance as enrollees who used a more traditional telephone method. For larger clinical trials, a website may help researchers more efficiently and cost-effectively achieve recruitment, eligibility, and randomization goals. More research is needed to determine whether similar recruitment and retention patterns are observed among racially and economically diverse populations when these and similar methods are compared.

Dietary intakes associated with successful weight loss and maintenance during the Weight Loss Maintenance trial.

BACKGROUND: Dietary components effective in weight maintenance efforts have not been adequately identified. OBJECTIVE: To determine the effects of changes in dietary consumption on weight loss and maintenance during the Weight Loss Maintenance clinical trial. DESIGN: Weight Loss Maintenance was a randomized controlled trial. Successful weight loss participants who completed Phase I of the trial and lost 4 kg were randomized to one of three maintenance intervention arms in Phase II and followed for an additional 30 months. PARTICIPANTS/SETTING: The multicenter trial was conducted from 2003 through 2007. This substudy included 828 successful weight loss participants. METHODS: The Block Food Frequency Questionnaire (FFQ) was used to assess nutrient intake levels and food group servings. Carbohydrates, proteins, fats, dietary fiber, fruit/vegetable, and dairy servings were utilized as predictor variables. The FFQ was collected on all participants at study entry (beginning of Phase I). Those randomized to Phase II completed the FFQ at three additional time points: randomization (beginning of Phase II), 12 months, and 30 months. INTERVENTION: The main intervention focused on long-term maintenance of weight loss using the Dietary Approaches to Hypertension diet. This substudy examined if changes to specific dietary variables were associated with weight loss and maintenance. STATISTICAL ANALYSES PERFORMED: Linear regression models that adjusted for change in total energy examined the relationship between changes in dietary intake and weight for each time period. Site, age, race, sex, and a race-sex interaction were included as covariates. RESULTS: Participants who substituted protein for fat lost, on average, 0.33 kg per 6 months during Phase I (P<0.0001) and 0.07 kg per 6 months during Phase II (P<0.0001) per 1% increase in protein. Increased intake of fruits and vegetables was associated with weight loss in Phases I and II: 0.29 kg per 6 months (P<0.0001) and 0.04 kg per 6 months (P=0.0062), respectively, per 1-serving increase. Substitution of carbohydrates for fat and protein for carbohydrates were associated with weight loss during both phases. Increasing dairy intake was associated with significant weight loss during Phase II (-0.17 kg per 6 months per 1-serving increase, P=0.0002), but not during Phase I. Dietary fiber revealed no significant findings. CONCLUSIONS: Increasing fruits, vegetables, and low-fat dairy may help achieve weight loss and maintenance.

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.

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).

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.

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.