Nangel M. Lindberg

Impact of sleep, screen time, depression and stress on weight change in the intensive weight loss phase of the LIFE study.

Background:The LIFE study is a two-phase randomized clinical trial comparing two approaches to maintaining weight loss following guided weight loss. Phase I provided a nonrandomized intensive 6-month behavioral weight loss intervention to 472 obese (body mass index 30–50) adult participants. Phase II is the randomized weight loss maintenance portion of the study. This paper focuses on Phase I measures of sleep, screen time, depression and stress.Methods:The Phase I intervention consisted of 22 group sessions led over 26 weeks by behavioral counselors. Recommendations included reducing dietary intake by 500 calories per day, adopting the Dietary Approaches to Stop Hypertension (DASH) dietary pattern and increasing physical exercise to at least 180 min per week. Measures reported here are sleep time, insomnia, screen time, depression and stress at entry and post-weight loss intervention follow-up.Results:The mean weight loss for all participants over the intensive Phase I weight loss intervention was 6.3 kg (s.d. 7.1). Sixty percent (N=285) of participants lost at least 4.5 kg (10 lbs) and were randomized into Phase II. Participants (N=472) attended a mean of 73.1% (s.d. 26.7) of sessions, completed 5.1 (s.d. 1.9) daily food records/week, and reported 195.1 min (s.d. 123.1) of exercise per week. Using logistic regression, sleep time (quadratic trend, P=0.030) and lower stress (P=0.024) at entry predicted success in the weight loss program, and lower stress predicted greater weight loss during Phase I (P=0.021). In addition, weight loss was significantly correlated with declines in stress (P=0.048) and depression (P=0.035).Conclusion:Results suggest that clinicians and investigators might consider targeting sleep, depression and stress as part of a behavioral weight loss intervention.

Weight-Loss Interventions for Hispanic Populations: The Role of Culture

In the United States, ethnic minorities are overrepresented among the overweight and obese population, with Hispanic individuals being among the groups most at risk for obesity and obesity-related disease and disability. Most weight-loss interventions designed for the general population have been less successful with individuals from ethnic minorities and there is a pressing need to develop more effective interventions for these groups. This paper examines the importance of culture in the development of “culturally competent” weight-loss interventions for ethnic minority populations, and discusses specific culturally mediated factors that should be considered in the design and implementation of treatment interventions. While specifically focusing on Hispanic populations, we also address issues of relevance to other multiethnic societies.

A Brief Intervention Designed to Increase Breast Cancer Self-Screening

Purpose. To assess the efficacy of an intervention designed to increase appropriate use of breast self-examination (BSE). Methods. Two-armed randomized clinical trial of cancer-control interventions in women that compared a BSE intervention program to a dietary intervention, which served as the control group. The study was conducted at a large health maintenance organization in Portland, Oregon. Participants were 616 female members of the health maintenance organization who were aged 40 to 70 years. The intervention consisted of a 30- to 45-minute individual counseling session that featured BSE instruction, training and practice with silicone models, identification of barriers to BSE, and problem-solving. This intervention was followed by two brief follow-up telephone calls. The study outcome measure was self-reported BSE practice, which included duration, frequency, and specific elements of exam. Results. The study had a 90% response rate. At the 1-year follow-up, χ2 analyses showed that significantly more individuals in the BSE intervention (59%) reported adequate BSE performance compared with those in the control group (12.2%; p < .001). Conclusions. This brief intervention was successful in encouraging women to perform adequate BSEs. Although the role of the BSE in patient care remains controversial, these results show that even brief intervention programs can be effective at encouraging self-screening for cancer. This intervention could easily be modified to target other screening practices (e.g., skin or testicular cancer screening) that are associated with reduced cancer morbidity and mortality.

Racial-Ethnic Differences in Psychiatric Diagnoses and Treatment Across 11 Health Care Systems in the Mental Health Research Network

OBJECTIVE The objective of this study was to characterize racial-ethnic variation in diagnoses and treatment of mental disorders in large not-for-profit health care systems. METHODS Participating systems were 11 private, not-for-profit health care organizations constituting the Mental Health Research Network, with a combined 7,523,956 patients age 18 or older who received care during 2011. Rates of diagnoses, prescription of psychotropic medications, and total formal psychotherapy sessions received were obtained from insurance claims and electronic medical record databases across all health care settings. RESULTS Of the 7.5 million patients in the study, 1.2 million (15.6%) received a psychiatric diagnosis in 2011. This varied significantly by race-ethnicity, with Native American/Alaskan Native patients having the highest rates of any diagnosis (20.6%) and Asians having the lowest rates (7.5%). Among patients with a psychiatric diagnosis, 73% (N=850,585) received a psychotropic medication. Non-Hispanic white patients were significantly more likely (77.8%) than other racial-ethnic groups (odds ratio [OR] range .48-.81) to receive medication. In contrast, only 34% of patients with a psychiatric diagnosis (N=548,837) received formal psychotherapy. Racial-ethnic differences were most pronounced for depression and schizophrenia; compared with whites, non-Hispanic blacks were more likely to receive formal psychotherapy for their depression (OR=1.20) or for their schizophrenia (OR=2.64). CONCLUSIONS There were significant racial-ethnic differences in diagnosis and treatment of psychiatric conditions across 11 U.S. health care systems. Further study is needed to understand underlying causes of these observed differences and whether processes and outcomes of care are equitable across these diverse patient populations.

Randomized trial of Tapas Acupressure Technique for weight loss maintenance: rationale and study design.

OBJECTIVES The aim of this article is to present the rationale, study design, and methods of an ongoing randomized controlled trial assessing the efficacy of an energy psychology intervention, Tapas Acupressure Technique (TAT), to prevent weight regain following successful weight loss. DESIGN This is a randomized controlled trial. SETTINGS/LOCATION The study is being conducted at a large group-model health maintenance organization (HMO). SUBJECTS The study subjects are adult members of an HMO. INTERVENTIONS TAT is being compared to a self-directed social support comparison intervention. OUTCOME MEASURES The primary outcome measure is weight-loss maintenance at 6 and 12 months post-randomization. CONCLUSIONS This randomized controlled trial will test the efficacy of an energy psychology intervention, TAT, by comparing it with a self-directed social support group intervention. This is, to our knowledge, the largest randomized controlled study to date of an energy psychology intervention. Positive findings would support the use of TAT as a tool to prevent weight regain following successful weight loss.

Randomized trial of tapas acupressure technique for weight loss maintenance

BackgroundObesity 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.MethodsParticipants 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.ResultsAmong 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.ConclusionsThe primary analysis showed no significant difference in weight regain between TAT and SS, while secondary and post hoc analyses indicate direction for future research.Trial RegistrationClinicalTrials.gov: NCT00526565

Validity of Medical Chart Weights and Heights for Obese Pregnant Women

Objective: To determine the validity of adult body weights and heights recorded in electronic medical records (EMRs) in the course of routine medical care. Background: EMRs allow the potential use of data collected in the course of routine medical care for a variety of research applications in many fields including epidemiology and comparative effectiveness studies. However, researchers familiar with carefully controlled measurement protocols typically used in clinical trials may question the validity of data collected in the course of routine clinical care. Methods: Weights and heights collected during a research project that focused on weight gain during pregnancy were compared to weight and height measurements coincidently recorded in the research participant’s medical records. For weight measures (N=102), data recorded within ±14 days were compared, and for height measures (N=114), data recorded within ±5 years were compared. We assessed agreement between medical and research measurements using the concordance and intraclass correlation coefficients, and Bland and Altman’s limits of agreement. Findings: The mean research and medical record weight measurements were 99.3 kg and 99.2 kg, respectively. The concordance and intraclass correlation coefficients for weight had similar estimates of .999 and 95 percent confidence intervals [.998, .999]. The 95 percent limits of agreement were −1.5 kg and +1.7 kg. The mean research and medical height measurements were 1.646 m and 1.654 m, respectively, and the concordance and intraclass correlation coefficients for height were .941 and .942, respectively. The 95 percent limits of agreement were −.031 m and +.047 m. Conclusions: For pregnant women, body weights documented in the medical record are exchangeable with body weights recorded in a research setting. Height measurements recorded in the medical records were not in as close agreement as weights, but concordance between medical record and research height measurements are high enough to allow them to be used epidemiological and comparative effectiveness 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.

From sea to shining sea and the great plains to patagonia: A review on current knowledge of diabetes mellitus in hispanics/Latinos in the US and Latin America

The past two decades have witnessed many advances in the prevention, treatment, and control of diabetes mellitus (DM) and its complications. Increased screening has led to a greater recognition of type 2 diabetes mellitus (type 2 DM) and prediabetes; however, Hispanics/Latinos, the largest minority group in the US, have not fully benefited from these advances. The Hispanic/Latino population is highly diverse in ancestries, birth places, cultures, languages, and socioeconomic backgrounds, and it populates most of the Western Hemisphere. In the US, the prevalence of DM varies among Hispanic/Latino heritage groups, being higher among Mexicans, Puerto Ricans, and Dominicans, and lower among South Americans. The risk and prevalence of diabetes among Hispanics/Latinos are significantly higher than in non-Hispanic Whites, and nearly 40% of Hispanics/Latinos with diabetes have not been formally diagnosed. Despite these striking facts, the representation of Hispanics/Latinos in pharmacological and non-pharmacological clinical trials has been suboptimal, while the prevalence of diabetes in these populations continues to rise. This review will focus on the epidemiology, etiology and prevention of type 2 DM in populations of Latin American origin. We will set the stage by defining the terms Hispanic, Latino, and Latin American, explaining the challenges identifying Hispanics/Latinos in the scientific literature and databases, describing the epidemiology of diabetes—including type 2 DM and gestational diabetes mellitus (GDM)—and cardiovascular risk factors in Hispanics/Latinos in the US and Latin America, and discussing trends, and commonalities and differences across studies and populations, including methodology to ascertain diabetes. We will discuss studies on mechanisms of disease, and research on prevention of type 2 DM in Hispanics/Latinos, including women with GDM, youth and adults; and finalize with a discussion on lessons learned and opportunities to enhance research, and, consequently, clinical care oriented toward preventing type 2 DM in Hispanics/Latinos in the US and Latin America.

Personalized medicine and Hispanic health: Improving health outcomes and reducing health disparities - A National Heart, Lung, and Blood Institute workshop report

Persons of Hispanic/Latino descent may represent different ancestries, ethnic and cultural groups and countries of birth. In the U.S., the Hispanic/Latino population is projected to constitute 29% of the population by 2060. A personalized approach focusing on individual variability in genetics, environment, lifestyle and socioeconomic determinants of health may advance the understanding of some of the major factors contributing to the health disparities experienced by Hispanics/Latinos and other groups in the U.S., thus leading to new strategies that improve health care outcomes. However, there are major gaps in our current knowledge about how personalized medicine can shape health outcomes among Hispanics/Latinos and address the potential factors that may explain the observed differences within this heterogeneous group, and between this group and other U.S. demographic groups. For that purpose, the National Heart, Lung, and Blood Institute (NHLBI), in collaboration with the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), and the Food and Drug Administration (FDA), held a workshop in which experts discussed (1) potential approaches to study medical treatments and health outcomes among Hispanics/Latinos and garner the necessary evidence to fill gaps of efficacy, effectiveness and safety of therapies for heart, lung, blood and sleep (HLBS) disorders and conditions--and their risk factors; (2) research opportunities related to personalized medicine to improve knowledge and develop effective interventions to reduce health disparities among Hispanics/Latinos in the U.S.; and (3) the incorporation of expanded sociocultural and socioeconomic data collection and genetic/genomic/epigenetic information of Hispanic/Latino patients into their clinical assessments, to account for individual variability in ancestry; physiology or disease risk; culture; environment; lifestyle; and socioeconomic determinants of health. The experts also provided recommendations on: sources of Hispanic/Latino health data and strategies to enhance its collection; policy; genetics, genomics and epigenetics research; and integrating Hispanic/Latino health research within clinical settings.