Implementation of a Scalable Online Weight Management Programme in Clinical Settings: Protocol for the PROPS 2.0 Programme (Partnerships for Reducing Overweight and Obesity with Patient-Centered Strategies 2.0).

INTRODUCTION: There is an urgent need for scalable strategies for treating overweight and obesity in clinical settings. PROPS 2.0 (Partnerships for Reducing Overweight and Obesity with Patient-Centered Strategies 2.0) aims to adapt and implement the combined intervention from the PROPS Study at scale, in a diverse cross-section of patients and providers. METHODS AND ANALYSIS: We are implementing PROPS 2.0 across a variety of clinics at Brigham and Women's Hospital, targeting enrolment of 5000 patients. Providers can refer patients or patients can self-refer. Eligible patients must be ≥20 years old and have a body mass index (BMI) of ≥30 kg/m2 or a BMI of 25-29.9 kg/m2 plus another cardiovascular risk factor or obesity-related condition. After enrolment, patients register for the RestoreHealth online programme/app (HealthFleet Inc.) and participate for 12 months. Patients can engage with the programme and receive personalized feedback from a coach. Patient navigators help to enrol patients, enter updates in the electronic health record, and refer patients to additional resources. The RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework is guiding the evaluation. ETHICS AND DISSEMINATION: The Mass General Brigham Human Research Committee approved this protocol. An implementation guide will be created and disseminated, to help other sites adopt the intervention in the future. TRIAL REGISTRATION NUMBER: NCT0555925.

Primary care patients' and providers' perspectives about an online weight management program integrated with population health management: Post-intervention qualitative results from the PROPS study.

Objective: To assess patients' and providers' attitudes about the online weight management program and population health management approach in the PROPS Study, which examined the effectiveness of these strategies in primary care. Methods: We conducted semi-structured interviews with 22 patients and nine providers. Using thematic analysis, we analyzed transcripts of the interviews to identify key themes. Results: Most patients found the online program to be well-structured and easy to use, although a few noted that the information was overwhelming or could be more personalized. Patients mentioned that the support from the population health managers was critical for their success, and several reported that they would have liked more involvement from their primary care provider or a dietitian. Providers also were satisfied with the interventions, and several stated that the population health management support was helpful because it added accountability. Providers suggested that the interventions could be improved by tailoring the information and integrating the online program with the electronic health record. Conclusion: Most patients and providers were satisfied with the interventions, with several recommendations for improvements. Innovation: These findings give additional information about patients' and providers' experience with this innovative approach for managing overweight and obesity in primary care.

In Their Own Words: Parents and Key Informants' Views on Nutrition Education and Family Health Behaviors.

Parents, health professionals, and communities are integral in the development of nutrition behaviors that reduce children's risk for high body mass index (BMI) and chronic disease. The aim of this study was to conduct formative evaluations with key health informants and parents to understand the specific strategies that families use at mealtimes to promote their family's health, along with the barriers they face in attending current nutrition education programming. Focus groups (in English and Spanish) were conducted with parents (n = 22; 63.64% Black/African American, 13.64% Black but not African American, 18.18% Hispanic/Latinx) whose household was located in a community where 50% of residents' gross income was ≤185% of the federal poverty level. Semi-structured interviews were conducted with six key informants with expertise in family health and nutrition. Inductive thematic analysis was used to identify themes across interviews. Six general themes emerged from the interviews including perceptions of health, relationships, health behaviors, facilitators, barriers, and desired changes. Across the six themes, participants responded with suggestions for community-based health promotion programs such as incorporating a broader definition of health to better address the individual and systemic barriers that perpetuate health inequities and make healthy eating difficult. Participants identified stress reduction, health literacy, and cooking knowledge as areas of interest for future programming.

Effect of an Online Weight Management Program Integrated With Population Health Management on Weight Change: A Randomized Clinical Trial.

Importance: Online programs may help with weight loss but have not been widely implemented in routine primary care. Objective: To compare the effectiveness of a combined intervention, including an online weight management program plus population health management, with the online program only and with usual care. Design, Setting, and Participants: Cluster randomized trial with enrollment from July 19, 2016, through August 10, 2017, at 15 primary care practices in the US. Eligible participants had a scheduled primary care visit and were aged 20 to 70 years, had a body mass index between 27 and less than 40, and had a diagnosis of hypertension or type 2 diabetes. Follow-up ended on May 8, 2019. Interventions: Participants in the usual care group (n = 326) were mailed general information about weight management. Participants in the online program only group (n = 216) and the combined intervention group (n = 298) were registered for the online program. The participants in the combined intervention group also received weight-related population health management, which included additional support from nonclinical staff who monitored their progress in the online program and conducted periodic outreach. Main Outcomes and Measures: The primary outcome was weight change at 12 months based on measured weights recorded in the electronic health record. Weight change at 18 months was a secondary outcome. Results: Among the 840 participants who enrolled (mean age, 59.3 years [SD, 8.6 years]; 60% female; 76.8% White), 732 (87.1%) had a recorded weight at 12 months and the missing weights for the remaining participants were imputed. There was a significant difference in weight change at 12 months by group with a mean weight change of -1.2 kg (95% CI, -2.1 to -0.3 kg) in the usual care group, -1.9 kg (95% CI, -2.6 to -1.1 kg) in the online program only group, and -3.1 kg (95% CI, -3.7 to -2.5 kg) in the combined intervention group (P < .001). The difference in weight change between the combined intervention group and the usual care group was -1.9 kg (97.5% CI, -2.9 to -0.9 kg; P < .001) and the difference between the combined intervention group and the online program only group was -1.2 kg (95% CI, -2.2 to -0.3 kg; P = .01). At 18 months, the mean weight change was -1.9 kg (95% CI, -2.8 to -1.0 kg) in the usual care group, -1.1 kg (95% CI, -2.0 to -0.3 kg) in the online program only group, and -2.8 kg (95% CI, -3.5 to -2.0 kg) in the combined intervention group (P < .001). Conclusions and Relevance: Among primary care patients with overweight or obesity and hypertension or type 2 diabetes, combining population health management with an online program resulted in a small but statistically significant greater weight loss at 12 months compared with usual care or the online program only. Further research is needed to understand the generalizability, scalability, and durability of these findings. Trial Registration: ClinicalTrials.gov Identifier: NCT02656693.

Integrating an online weight management program with population health management in primary care: Design, methods, and baseline data from the PROPS randomized controlled trial (Partnerships for Reducing Overweight and Obesity with Patient-centered Strategies).

BACKGROUND: Scalable, low-cost weight management strategies are needed in primary care. We conducted a pragmatic, cluster-randomized controlled trial to examine the effectiveness of an online weight management program integrated with population health management support. METHODS: We adapted an online weight management program and integrated it with population health management support in 15 primary care practices (24 clinics). We randomized the 24 clinics to usual care (UC), online program alone (OP), or combined intervention (CI). Eligible participants had to be ages 20 to 70 and have a recent primary care visit, body mass index (BMI) ≥ 27 and < 40 kg/m2, and a diagnosis of hypertension or type 2 diabetes. Participants attended routine visits and completed surveys over 18 months. The primary outcome is absolute weight change at 12 months (± 90 days) after enrollment, calculated from weights measured at primary care visits and recorded in the electronic health record. RESULTS: We enrolled 840 participants between July 2016 and August 2017 (326 UC, 216 OP, and 298 CI.) At enrollment, participants' mean age was 59.3 years, their mean weight was 203.1 pounds, and their mean BMI was 32.5 kg/m2; 60% of participants were female, 76.8% were white, 96.4% had hypertension, and 24.4% had type 2 diabetes. CONCLUSION: It is feasible to adapt an online weight management program and integrate it with population health management support in primary care. The results of this trial will provide valuable information about the effectiveness of these strategies in primary care settings. ClinicalTrials.govregistration number:NCT02656693.

BWHealthy Weight Pilot Study: A randomized controlled trial to improve weight-loss maintenance using deposit contracts in the workplace.

OBJECTIVE: Deposit contracts, where participants "bet" on achieving a goal and get their money back only if successful, have been shown to be effective for short-term weight-loss. This pilot study examined their effect on weight-loss maintenance. METHODS: From 2016 to 2018, we conducted a pilot, 50-week randomized controlled trial among 42 hospital employees (19 intervention and 23 control), in Boston, Massachusetts, who lost ≥10 lb (4.5 kg) in the two years prior to enrollment. Participants were recruited primarily in-person. Both control and intervention participants were asked to attend a weigh in weekly and received weekly email communication. Intervention participants also entered into a deposit contract to maintain baseline weight within ≤2 lb (0.9 kg). We examined weight change from baseline to 50 weeks (primary outcome) and maintenance of baseline weight at 50 weeks (secondary outcome; binary - yes v. no). Participants completed baseline and follow-up surveys and received incentives for completion. RESULTS: At baseline, mean (SD) weight was 83.2 (15.5 kg) among intervention and 80.7 (14.5 kg) among control participants. After 50 weeks, intervention participants had slightly less but non-significant weight gain (adjusted ß -1.12 kg; 95% CI -5.28, 3.05) than control participants; 73.7% of intervention v. 39.1% of control participants met their weight-loss maintenance goal by study end (adjusted OR 4.78; 95% CI 1.01, 22.71). CONCLUSIONS: A deposit contract was not associated with differences in weight but led to more participants meeting their weight-loss maintenance goals; a deposit contract for weight-loss maintenance should be tested in a full-scale intervention. Most intervention participants viewed the deposit contract as acceptable.

Quality Improvement and Safety in US Pharmacy Schools.

Objective. To catalog the methods in which quality improvement (QI) and safety are taught in schools and colleges of pharmacy in the United States and showcase exemplar QI programs. Methods. This descriptive, multi-phase study included an online questionnaire, syllabi review, and phone interviews. The study was approved by the University of Arizona Institutional Review Board (IRB). One representative from each US pharmacy school accredited by the Accreditation Council for Pharmacy Education (ACPE) was invited to participate. Participants indicated the type of QI education their school provided via online questionnaire. Following questionnaire completion, syllabi were requested from the schools and phone interviews were scheduled with a school representative to obtain additional information. From the data, exemplars were chosen using a predetermined, evidenced-based rubric. Results. Of the 136 schools contacted, 56 (41.2%) completed the survey. Of the responding schools reporting their QI and safety offerings, 41 (73.2%) had a required session/module; 24 (42.9%) had a required course; 21 (37.5%) had an elective course; 21 (37.5%) had an introductory pharmacy practice experience (IPPE), advanced pharmacy practice experience (APPE), or internship; 17 (30.4%) had a required project; 17 (30.4%) had interprofessional education integrated into their course; 15 (26.8%) had an error laboratory; and 11 (19.6%) offered postgraduate training. Conclusion. Many of the responding US schools of pharmacy expose students to some aspect of QI and/or safety, most often via class session or module. The exemplar programs serve as examples of how QI can be further integrated into pharmacy curricula.

Primary Care Patients' and Providers' Perspectives about an Online Weight Management Program: a Qualitative Study.

BACKGROUND: Primary care providers (PCPs) often take the lead role in caring for patients with overweight and obesity; however, few PCPs counsel patients about weight loss. Online weight management programs that are integrated within primary care may help address this gap in care. OBJECTIVE: To identify perceptions of and experience with online weight management programs in general and with a proposed online program, to identify barriers to use, and to improve the design and content of our intervention, which included an online program plus population health management (PHM) support from primary care practices. DESIGN: A mixed qualitative methods study including three patient focus groups and seven semi-structured interviews with healthcare providers. PARTICIPANTS: A total of 13 adult patients (age range, 20-70) with body mass index (BMI) 27-35 kg/m2 attended the focus groups. In-person semi-structured interviews were conducted with seven healthcare providers (three PCPs, two population health managers, one primary care nurse, and one registered dietitian). MAIN MEASURES: We developed and used semi-structured focus groups and interview guides. The focus group and interviews were recorded and transcribed. Using grounded theory, we analyzed the transcripts to identify and extract common concepts and themes. KEY RESULTS: Although patients and healthcare providers expressed positive opinions about online weight management programs, few patients had experience with them, and providers stated that such programs are not being widely implemented in primary care settings. Some participants highlighted the flexibility and low cost as strengths of online weight management tools compared with in-person programs. All participants had favorable opinions about our proposed intervention and were overwhelmingly positive about the combination of an online program and PHM support. CONCLUSIONS: This study highlights the potential value of online weight management programs and PHM support in primary care. CLINICAL TRIALS REGISTRATION: NCT02656693.

Public Health and Mental Health Implications of Environmentally Induced Forced Migration.

ABSTRACTClimate change is increasingly forcing population displacement, better described by the phrase environmentally induced forced migration. Rising global temperatures, rising sea levels, increasing frequency and severity of natural disasters, and progressive depletion of life-sustaining resources are among the drivers that stimulate population mobility. Projections forecast that current trends will rapidly accelerate. This will lead to an estimated 200 million climate migrants by the year 2050 and create dangerous tipping points for public health and security.Among the public health consequences of climate change, environmentally induced forced migration is one of the harshest and most harmful outcomes, always involving a multiplicity of profound resource and social losses and frequently exposing migrants to trauma and violence. Therefore, one particular aspect of forced migration, the effects of population displacement on mental health and psychosocial functioning, deserves dedicated focus. Multiple case examples are provided to elucidate this theme. (Disaster Med Public Health Preparedness. 2019;13:116-122).

Cancer Anorexia and Cachexia: Screening in an Ambulatory Infusion Service and Nutrition Consultation
.

BACKGROUND: Cancer anorexia-cachexia syndrome compromises physical function and nutritional and emotional well-being. Systematic screening followed by nutrition referral for appropriate interventions is rare.
. OBJECTIVES: The purpose of this study was to pilot a screening process followed by nutritional assessment and intervention when warranted for patients with lung malignancies.
. METHODS: Adult patients with lung malignancies were invited to complete the 12-item Anorexia/Cachexia Scale (A/CS-12) on the day of chemotherapy initiation in ambulatory infusion. Those who scored at a preset threshold were referred to nutrition services for a comprehensive assessment and intervention plan. Those who scored better than the threshold completed the A/CS-12 at each infusion visit for as many as 16 weeks. 
. FINDINGS: 90 participants enrolled, and 46 scored in a moderate-to-severe-risk category; of those, 42 were referred to nutrition services.

Characteristics of Ocular Pain Complaints in Patients With Idiopathic Dry Eye Symptoms.

OBJECTIVE: The purpose of this study was to examine the severity and quality of ocular pain complaints in patients with dry eye symptoms. METHODS: Subjects with clinically relevant dry eye symptoms (dryness, discomfort, tearing) of unknown origin seen in the Miami Veterans Affairs eye clinic were administered questionnaires for dry eye symptoms and ocular pain and underwent a standardized ocular examination. Qualities and severity ratings of ocular pain in subjects with idiopathic dry eye were compared with similar measures from published data in other chronic pain populations. RESULTS: The study sample consisted of 154 subjects, of which 91% were men and ranged in age from 27 to 89 (mean age=61). Fifty-three percent of participants reported an average ocular pain of at least moderate intensity (numerical rating scale≥4), with specific characteristics (i.e., "burning" spontaneous pain) reported at frequencies comparable to prevalent chronic neuropathic pain syndromes as reported in the literature. Significant correlations were found between ocular pain metrics and dry eye symptom severity scores (r=0.57-0.66). Dry eye signs, however, did not generally correlate with ocular pain severity. CONCLUSIONS: A significant proportion of subjects with idiopathic dry eye symptoms reported moderate or greater ocular pain intensity, with most endorsing descriptors commonly used by patients with nonocular neuropathic pain conditions. Identifying subgroups of dry eye patients based on the presence and characteristics of ocular pain complaints may improve dry eye subclassification and better individualize treatment strategies.

Assessment of Somatosensory Function in Patients With Idiopathic Dry Eye Symptoms.

IMPORTANCE: Somatosensory dysfunction likely underlies dry eye (DE) symptoms in many individuals yet remains an understudied component of the disease. Its presence has important diagnostic and therapeutic implications. OBJECTIVE: To assess the integrity of nociceptive system processes in persons with DE and ocular pain using quantitative sensory testing (QST) techniques applied at a site remote from the eye. DESIGN, SETTING, AND PARTICIPANTS: A cross-sectional study conducted at Miami Veterans Affairs Hospital included 118 individuals with a wide variety of DE symptoms and signs. The study was conducted from October 31, 2013, to January 28, 2016. INTERVENTIONS: Individuals completed questionnaires regarding ocular symptoms (5-Item Dry Eye Questionnaire [DEQ5], Ocular Surface Disease Index [OSDI], and Neuropathic Pain Symptom Inventory modified for the eye [NPSI-E]), psychological status, and medication use and underwent an ocular surface examination. The QST metrics included measures of vibratory and thermal thresholds and cold and hot pain temporal summation (surrogate measures of central sensitization) on the forearm. MAIN OUTCOMES AND MEASURES: Correlations among DE and ocular pain symptom severity with QST metrics measured on the forearm. The OSDI score ranges from 0 to 100, with 100 indicating the most severe DE symptoms. The DEQ5 score ranges from 0 to 22, with the highest score indicating the most severe symptoms, and the NPSI-E score ranges from 0 to 100, with the highest score indicating the most severe symptoms. Psychological state was measured with the 9-item Patient Health Questionnaire, the PTSD Checklist-Military Version for PTSD, and the Symptom Checklist-90 for anxiety. RESULTS: Of the 118 patients who participated in the study, 105 (88.9%) were men (mean [SD] age, 60 [10] years), and a mean of 41% had PTSD, 10% depression, and 0.93% anxiety. Using stepwise linear regression analyses, significant associations were identified between overall DE symptom severity and posttraumatic stress disorder scores and tear breakup time (DEQ5 model: R = 0.54; OSDI model: R = 0.61, P < .001). All other variables (ie, demographics, comorbidities, medications, tear film factors, and QST metrics) dropped out of these models. When specifically considering neuropathic-like qualities of DE pain, however, anxiety and hot pain temporal summation at the forearm explained 17% of the variability in ocular burning (R = 0.41; P < .001), and PTSD score, tear breakup time, and hot pain temporal summation at the forearm explained 25% of the variability in sensitivity to wind (R = 0.50; P < .001) and 30% of the variability in total NPSI-E scores (R = 0.55; P < .001). CONCLUSIONS AND RELEVANCE: Our findings demonstrate that neuropathic-like DE pain symptom severity correlates with quantitative measures of pain sensitivity at a site remote from the eye. This result provides additional evidence that DE symptoms are not only manifestations of a local disorder but also involve somatosensory dysfunction beyond the trigeminal system.

Neuropathic Ocular Pain due to Dry Eye is Associated with Multiple Comorbid Chronic Pain Syndromes.

UNLABELLED: Recent data show that dry eye (DE) susceptibility and other chronic pain syndromes (CPS) such as chronic widespread pain, irritable bowel syndrome, and pelvic pain, might share common heritable factors. Previously, we showed that DE patients described more severe symptoms and tended to report features of neuropathic ocular pain (NOP). We hypothesized that patients with a greater number of CPS would have a different DE phenotype compared with those with fewer CPS. We recruited a cohort of 154 DE patients from the Miami Veterans Affairs Hospital and defined high and low CPS groups using cluster analysis. In addition to worse nonocular pain complaints and higher post-traumatic stress disorder and depression scores (P < .01), we found that the high CPS group reported more severe neuropathic type DE symptoms compared with the low CPS group, including worse ocular pain assessed via 3 different pain scales (P < .05), with similar objective corneal DE signs. To our knowledge, this was the first study to show that DE patients who manifest a greater number of comorbid CPS reported more severe DE symptoms and features of NOP. These findings provided further evidence that NOP might represent a central pain disorder, and that shared mechanistic factors might underlie vulnerability to some forms of DE and other comorbid CPS. PERSPECTIVE: DE patients reported more frequent CPS (high CPS group) and reported worse DE symptoms and ocular and nonocular pain scores. The high CPS group reported symptoms of NOP that share causal genetic factors with comorbid CPS. These results imply that an NOP evaluation and treatment should be considered for DE patients.

Ocular Inflammation in the Setting of Concomitant Systemic Autoimmune Conditions in an Older Male Population.

PURPOSE: This retrospective cross-sectional study was designed to investigate the frequency and types of inflammatory ocular manifestations of specific systemic autoimmune diseases in a South Florida Veterans Affairs Hospital population. METHODS: Demographic and medical diagnosis information was extracted from the Veterans Administration database for 1225 patients. These patients were seen in Miami and Broward Veterans Affairs hospitals between April 18, 2008, and April 17, 2013, and were diagnosed with at least 1 of the following: systemic lupus erythematosus, sarcoid, rheumatoid arthritis, polymyalgia rheumatica, Takayasu arteritis, giant cell arteritis, Kawasaki disease, polyarteritis nodosa, Buerger disease, Henoch-Schonlein purpura, Behcet syndrome, granulomatosis with polyangiitis, other polyarteritis nodosa-associated vasculitides, or arteritis not otherwise specified. RESULTS: Of 1225 patients, 618 were seen in the VA eye clinic and 25 were diagnosed with concomitant inflammatory ocular conditions. Uveitis was the most common, and included 8 cases of anterior, 1 anterior-intermediate, 1 intermediate, 2 panuveitis, and 3 unspecified. Other manifestations included 7 cases of keratitis and 2 each of scleritis, episcleritis, and acute ischemic optic neuropathy. The overall frequency of inflammatory ocular disease was 2%. The diseases associated with the highest frequency of ocular involvement were granulomatosis with polyangiitis (1/8), sarcoid (9/198), giant cell arteritis (2/68), and rheumatoid arthritis (11/576). Of these 25 patients, 9 were diagnosed with eye disease before systemic disease. CONCLUSIONS: In this population, ocular manifestations were rarely the presenting feature of systemic disease, but autoimmune disorders are an important underlying cause of inflammatory eye disease that should be considered on first evaluation, even in this "nontraditional," predominantly male, autoimmune disease population.

The impact of conjunctivochalasis on dry eye symptoms and signs.

PURPOSE: The purpose of this project was to study the relationship between conjunctivochalasis (Cch) and ocular signs and symptoms of dry eye. METHODS: Ninety-six patients with normal eyelid and corneal anatomy were prospectively recruited from a Veterans Administration hospital over 12 months. Symptoms (via the dry eye questionnaire 5 [DEQ5]) and signs of dry eye were assessed along with quality of life implications. Statistical analyses comparing the above metrics among the three groups included χ(2), analysis of variance, and linear regression tests. RESULTS: Participants were classified into three groups: nasal conjunctivochalasis (NCch; n = 31); nonnasal conjunctivochalasis (non-NCch; n = 41); and no conjunctivochalasis (no-Cch; n = 24). Patients with NCch had more dry eye symptoms than those with non-NCch (DEQ5: NCch = 13.8 ± 5.0, non-NCch = 10.2 ± 5.0, no-Cch = 11.6 ± 5.8; P = 0.014), and more ocular pain than those with Non-NCch and no-Cch (numerical rating scale [NRS]: NCch = 4.5 ± 3.0, non-NCch = 2.3 ± 2.8, no-Cch = 3.3 ± 2.6; P = 0.008). They also had worse dry eye signs compared to those with no-Cch measured by Schirmer score with anesthesia (NCch = 14.5 ± 6.9, non-NCch = 16.8 ± 8.2, no-Cch = 19.9 ± 6.4; P = 0.039); meibomian gland dropout (NCch 1.8 ± 0.9, non-NCch = 1.4 ± 1.0, no-Cch = 1.0 ± 1.0; P = 0.020); and eyelid vascularity (NCch = 0.84 ± 0.8, non-NCch = 0.74 ± 0.7, no-Cch = 0.33 ± 0.6; P = 0.019). Moreover, those with NCch more frequently reported that dry eye symptoms moderately to severely impacted their quality of life (NCch = 87%, non-NCch = 51%, no-Cch = 58%; P = 0.005). CONCLUSIONS: The presence of NCch associates with dry eye symptoms, abnormal tear parameters, and impacts quality of life compared with non-NCch and no-Cch. Based on these data, it is important for clinicians to look for Cch in patients with symptoms of dry eye.

Point-of-purchase price and education intervention to reduce consumption of sugary soft drinks.

OBJECTIVES: We investigated whether a price increase on regular (sugary) soft drinks and an educational intervention would reduce their sales. METHODS: We implemented a 5-phase intervention at the Brigham and Women's Hospital cafeteria in Boston, Massachusetts. After posting existing prices of regular and diet soft drinks and water during baseline, we imposed several interventions in series: a price increase of 35% on regular soft drinks, a reversion to baseline prices (washout), an educational campaign, and a combination price and educational period. We collected data from a comparison site, Beth Israel Deaconess Hospital, also in Boston, for the final 3 phases. RESULTS: Sales of regular soft drinks declined by 26% during the price increase phase. This reduction in sales persisted throughout the study period, with an additional decline of 18% during the combination phase compared with the washout period. Education had no independent effect on sales. Analysis of the comparison site showed no change in regular soft drink sales during the study period. CONCLUSIONS: A price increase may be an effective policy mechanism to decrease sales of regular soda. Further multisite studies in varied populations are warranted to confirm these results.

Early behavioral adherence predicts short and long-term weight loss in the POUNDS LOST study.

The primary aim of this study was to test the association of early (first 6 months) adherence related to diet, self-monitoring, and attendance with changes in adiposity and cardiovascular risk factors. This study used data from the 24-month POUNDS LOST trial that tested the efficacy of four dietary macronutrient compositions for short-and long-term weight loss. A computer tracking system was used to record data on eight indicator variables related to adherence. Using canonical correlations at the 6 and 24 month measurement periods, early behavioral adherence was associated with changes in percent weight loss and waist circumference at 6 months (R = 0.52) and 24 months (R = 0.37), but was not associated with cardiovascular disease risk factor levels. Early dietary adherence was associated with changes in insulin at 6 months (R = 0.19), but not at 24 months (R = 0.08, ns). Early dietary adherence was not associated with changes in adiposity.

Adherence is a multi-dimensional construct in the POUNDS LOST trial.

Research on the conceptualization of adherence to treatment has not addressed a key question: Is adherence best defined as being a uni-dimensional or multi-dimensional behavioral construct? The primary aim of this study was to test which of these conceptual models best described adherence to a weight management program. This ancillary study was conducted as a part of the POUNDS LOST trial that tested the efficacy of four dietary macronutrient compositions for promoting weight loss. A sample of 811 overweight/obese adults was recruited across two clinical sites, and each participant was randomly assigned to one of four macronutrient prescriptions: (1) Low fat (20% of energy), average protein (15% of energy); (2) High fat (40%), average protein (15%); (3) Low fat (20%), high protein (25%); (4) High fat (40%), high protein (25%). Throughout the first 6 months of the study, a computer tracking system collected data on eight indicators of adherence. Computer tracking data from the initial 6 months of the intervention were analyzed using exploratory and confirmatory analyses. Two factors (accounting for 66% of the variance) were identified and confirmed: (1) behavioral adherence and (2) dietary adherence. Behavioral adherence did not differ across the four interventions, but prescription of a high fat diet (vs. a low fat diet) was found to be associated with higher levels of dietary adherence. The findings of this study indicated that adherence to a weight management program was best conceptualized as being multi-dimensional, with two dimensions: behavioral and dietary adherence.

Barriers to purchasing foods for a high-quality, healthy diet in a low-income African American community.

The goal of this project was to assess the cost of purchasing 1-month of nutritionally adequate, familiar, healthy food plans for African American seniors and families in Roxbury, Massachusetts. Model 7-day food plans were developed and tested using focus groups. The food plans were translated into shopping lists and prices were collected at 2 local grocery stores. Results found that the average estimated monthly food cost for both groups exceeded the benefit and food budget set by 2 agencies. It was concluded that many low-income people living in Roxbury have limited access to affordable healthy food options; this issue should be addressed as a matter of public health policy.

Comparison of weight-loss diets with different compositions of fat, protein, and carbohydrates.

BACKGROUND: The possible advantage for weight loss of a diet that emphasizes protein, fat, or carbohydrates has not been established, and there are few studies that extend beyond 1 year. METHODS: We randomly assigned 811 overweight adults to one of four diets; the targeted percentages of energy derived from fat, protein, and carbohydrates in the four diets were 20, 15, and 65%; 20, 25, and 55%; 40, 15, and 45%; and 40, 25, and 35%. The diets consisted of similar foods and met guidelines for cardiovascular health. The participants were offered group and individual instructional sessions for 2 years. The primary outcome was the change in body weight after 2 years in two-by-two factorial comparisons of low fat versus high fat and average protein versus high protein and in the comparison of highest and lowest carbohydrate content. RESULTS: At 6 months, participants assigned to each diet had lost an average of 6 kg, which represented 7% of their initial weight; they began to regain weight after 12 months. By 2 years, weight loss remained similar in those who were assigned to a diet with 15% protein and those assigned to a diet with 25% protein (3.0 and 3.6 kg, respectively); in those assigned to a diet with 20% fat and those assigned to a diet with 40% fat (3.3 kg for both groups); and in those assigned to a diet with 65% carbohydrates and those assigned to a diet with 35% carbohydrates (2.9 and 3.4 kg, respectively) (P>0.20 for all comparisons). Among the 80% of participants who completed the trial, the average weight loss was 4 kg; 14 to 15% of the participants had a reduction of at least 10% of their initial body weight. Satiety, hunger, satisfaction with the diet, and attendance at group sessions were similar for all diets; attendance was strongly associated with weight loss (0.2 kg per session attended). The diets improved lipid-related risk factors and fasting insulin levels. CONCLUSIONS: Reduced-calorie diets result in clinically meaningful weight loss regardless of which macronutrients they emphasize. (ClinicalTrials.gov number, NCT00072995.)