Randomized controlled trial of behavioral treatment for comorbid obesity and depression in women: the Be Active Trial.

OBJECTIVE: Depression is associated with increased risk for obesity and worse weight loss treatment outcomes. The purpose of the present study was to test the hypothesis that delivering evidence-based behavior therapy for depression before a lifestyle weight loss intervention improves both weight loss and depression. DESIGN: In a randomized controlled trial, obese women with major depressive disorder (N=161, mean age=45.9 (s.d.: 10.8) years) were randomized to brief behavior therapy for depression treatment followed by a lifestyle intervention (BA) or a lifestyle intervention only (LI). Follow-up occurred at 6 and 12 months. Main outcome measures included weight loss and depression symptoms. RESULTS: Intention-to-treat analyses revealed both conditions lost significant weight, but no differences between conditions in weight change at 6 months (BA=-3.0%, s.e.=-0.65%; LI=-3.7%, s.e.=0.63%; P=0.48) or 12 months (BA=-2.6%, s.e.=0.77%; LI=-3.1%, s.e.=0.74%; P=0.72). However, the BA condition evidenced significantly greater improvement in Beck Depression Inventory-II scores relative to the LI condition at both 6 months (BA mean change=-12.5, s.d.=0.85; LI mean change=-9.2, s.d.=0.80, P=0.005) and 12 months (BA mean change=-12.6, s.d.=0.97; LI mean change=-9.9, s.d.=0.93; P=0.045). Participants who experienced depression remission by 6 months (61.2%) lost greater weight (mean=-4.31%; s.e.=0.052) than those who did not (39.7%; mean=-2.47%, s.e.=0.53; P=.001). CONCLUSION: Adding behavior therapy to a lifestyle intervention results in greater depression remission but does not improve weight loss within 1 year. Improvement in depression is associated with greater weight loss.

PDA-assisted low glycemic index dietary intervention for type II diabetes: a pilot study.

BACKGROUND: Epidemiological and dietary intervention studies suggest that a low-glycemic index (GI) diet is beneficial for blood glucose control; however, long-term clinical utility of the low GI diet has not been fully investigated. OBJECTIVES: To evaluate the feasibility and efficacy of a nutritionist-delivered low-GI dietary intervention, with the support of a personal digital assistant (PDA), for adult patients with poorly controlled type II diabetes. METHOD: The low-GI intervention consisted of six counseling sessions and the use of a PDA-based food database with GI scores for 6 months. Study outcomes included feasibility measures, glycosylated hemoglobin levels (HbA1c), GI and glycemic load (GL) score of self-reported dietary intake, body weight, depression and quality of life (QOL). Measures were obtained at baseline, 3 and 6 months. RESULTS: Of 31 adult patients approached, 15 met study eligibility criteria and were enrolled in the study. Thirteen patients (87%) completed all study assessments. Findings included decreases in average HbA1c (-0.5% P = 0.02), body weight, hip circumference, blood pressure, dietary GI and daily caloric intake. Diabetes impact scores also decreased. All but one participant completed all components of the intervention. There were mixed reports regarding the usefulness of the PDAs; however, participants offered helpful suggestions for further development. CONCLUSIONS: Results of this pilot study support the feasibility of implementing a nutritionist-delivered, PDA-assisted low-GI dietary intervention for patients with poorly controlled type II diabetes. Encouraging initial efficacy data require further testing in the context of a randomized clinical trial.

Seasonal variation in food intake, physical activity, and body weight in a predominantly overweight population.

OBJECTIVE: To describe seasonal variation in food intake, physical activity, and body weight in a predominantly overweight population. DESIGN: A longitudinal observational study. SETTING: Most of the study participants were recruited from a health maintenance organization (HMO) in central Massachusetts, USA. Additional individuals of Hispanic descent were recruited from outside of the HMO population to increase the ethnic diversity of this sample. SUBJECTS: Data from 593 participants, aged 20-70, were used for this investigation. Each participant was followed quarterly (five sampling points: baseline and four consecutive quarters) for 1-year period. Body weight measurements and three 24-h dietary and physical activity recalls were obtained on randomly selected days (including 2 weekdays and 1 weekend day) per quarter. Sinusoidal regression models were used to estimate peak-to-trough amplitude and phase of the peaks. RESULTS: Daily caloric intake was higher by 86 kcal/day during the fall compared to the spring. Percentage of calories from carbohydrate, fat and saturated fat showed slight seasonal variation, with a peak in the spring for carbohydrate and in the fall for total fat and saturated fat intake. The lowest physical activity level was observed in the winter and the highest in the spring. Body weight varied by about 1/2 kg throughout the year, with a peak in the winter (P<0.001 winter versus summer). Greater seasonal variation was observed in subjects who were male, middle aged, nonwhite, and less educated. CONCLUSIONS: Although there is seasonal variation in diet, physical activity and body weight, the magnitude of the change is generally small in this population. SPONSORSHIP: US National Heart, Lung and Blood Institute.

Behavioral risk factors among members of a health maintenance organization.

BACKGROUND: Co-occurrence of risk behaviors (RBs) substantially increases the risk of disease. This study examines the co-occurrence of four health risk behaviors (i.e., smoking, high-fat diet, sedentariness, and high-risk drinking) and demographic and psychosocial variables associated with number of RBs in a sample of members of a health maintenance organization who participated in the Seasonal Variation in Cholesterol (Seasons) study. METHODS: Seasons study baseline data were used. Subjects completed a self-administered questionnaire packet containing questions on demographics, smoking history, and leisure-time physical activity, a 7-day dietary recall instrument, and various psychosocial measures. Results presented here are based on 496 subjects with complete data on all RBs. RESULTS: Forty-three percent of participants had > or = two RBs. The most prevalent RB combination was high-fat diet/sedentariness, with 30% of subjects reporting both RBs. Associations between RBs were observed. A greater number of RBs were observed among younger and less-educated subjects, those with higher depression scores, and subjects who perceived their health as poor. CONCLUSIONS: Findings highlight the importance of designing and evaluating primary care-based screening programs and interventions for multiple RBs.

Sources of variance in daily physical activity levels in the seasonal variation of blood cholesterol study.

The authors examined sources of variance in self-reported physical activity in a cohort of healthy adults (n = 580) from Worcester, Massachusetts (the Seasonal Variation of Blood Cholesterol Study, 1994-1998). Fifteen 24-hour physical activity recalls of total, occupational, and nonoccupational activity (metabolic equivalent-hours/day) were obtained over 12 months. Random effects models were employed to estimate variance components for subject, season, day of the week, and residual error, from which the number of days of assessment required to achieve 80% reliability was estimated. The largest proportional source of variance in total and nonoccupational activity was within-subject variance (50-60% of the total). Differences between subjects accounted for 20-30% of the overall variance in total activity, and seasonal and day-of-the-week effects accounted for 6% and 15%, respectively. For total activity, 7-10 days of assessment in men and 14-21 days of assessment in women were required to achieve 80% reliability. For nonoccupational activity, 21-28 days of assessment were required. This study is among the first to have examined the sources of variance in daily physical activity levels in a large population of adults using 24-hour physical activity recall. These findings provide insight for understanding the strengths and limitations of short term and long term physical activity assessments employed in epidemiologic studies.

Facilitating dietary change: the patient-centered counseling model.

Recent data indicate that the patient-centered counseling model enhances long-term dietary adherence. This model facilitates change by assessing patient needs and subsequently tailoring the intervention to the patient's stage in the process of change, personal goals, and unique challenges. This article describes this model, including its theoretical foundations, a 4-step counseling process, and applications. This behavioral counseling model can help nutrition professionals enhance patient adherence to nutrition care plans and dietary guidelines.

Variability and classification accuracy of serial high-sensitivity C-reactive protein measurements in healthy adults.

BACKGROUND: Increased concentrations of high-sensitivity C-reactive protein (hs-CRP), a marker of systemic inflammation, are associated with increased risk for coronary heart disease. Because of its relationship to inflammation, hs-CRP has considerable biologic variation. This study was carried out to characterize CRP variation and to compare it to another risk factor, total serum cholesterol. METHODS: One hundred thirteen individuals were scheduled to have five measurements each of hs-CRP and total cholesterol carried out at quarterly intervals over a 1-year period. Variations of hs-CRP and total cholesterol were characterized, and classification accuracy was described and compared for both. RESULTS: The relative variation was comparable for hs-CRP and total cholesterol. When classified by quartile, 63% of first and second hs-CRP measurements were in agreement; for total cholesterol it was 60%. Ninety percent of hs-CRP measurements were within one quartile of each other. This relationship was not altered by the use of log-transformed hs-CRP data. CONCLUSION: hs-CRP has a degree of measurement stability that is similar to that of total cholesterol.

Seasonal variation in household, occupational, and leisure time physical activity: longitudinal analyses from the seasonal variation of blood cholesterol study.

The authors examined seasonal variation in physical activity in longitudinal analyses of 580 healthy adults from Worcester, Massachusetts (the Seasonal Variation of Blood Cholesterol Study, 1994-1998). Three 24-hour physical activity recalls administered five times during 12 months of follow-up were used to estimate household, occupational, leisure time, and total physical activity levels in metabolic equivalent (MET)-hours/day. Trigonometric models were used to estimate the peak-to-trough amplitude and phase of the peaks in activity during the year. Total activity increased by 1.4 MET-hours/day (121 kcal/day) in men and 1.0 MET-hours/day (70 kcal/day) in women during the summer in comparison with winter. Moderate intensity nonoccupational activity increased by 2.0-2.4 MET-hours/day in the summer. During the summer, objectively measured mean physical activity increased by 51 minutes/day (95% confidence interval: 20, 82) in men and by 16 minutes/day (95% confidence interval: -12, 45) in women. The authors observed complex patterns of seasonal change that varied in amplitude and phase by type and intensity of activity and by subject characteristics (i.e., age, obesity, and exercise). These findings have important implications for clinical research studies examining the health effects of physical activity and for health promotion efforts designed to increase population levels of physical activity.

Seasonal variation of depression and other moods: a longitudinal approach.

The present study examined the effect of season of the year on depression and other moods. Previous work, primarily cross sectional or retrospective in design and involving clinically depressed or seasonally affective disordered samples, has suggested that mood changes as a function of season. However, the literature also shows conflicting and/or inconsistent findings about the extent and nature of this relationship. Importantly, these prior studies have not adequately answered the question of whether there is a seasonal effect in nondepressed people. The present study employed a longitudinal design and a large sample drawn from a normal population. The results, based on those participants for whom mood measures were collected in each season, demonstrated strong seasonal effects. Beck Depression Inventory (BDI) scores were highest in winter and lowest in summer. Ratings on scales of hostility, anger, irritability, and anxiety also showed very strong seasonal effects. Further analyses revealed that seasonal variation in BDI scores differed for females and males. Females had higher BDI scores that showed strong seasonal variation, whereas males had lower BDI scores that did not vary significantly across season of the year.

Comparing physical activity assessment methods in the Seasonal Variation of Blood Cholesterol Study.

PURPOSE: This paper evaluated three measures of physical activity employed in the Seasonal Variation of Blood Cholesterol Study (Seasons), and it had two objectives: 1) To examine the laboratory validity of the Actillume activity monitor, and 2) To examine the relative validity of three 24-h physical activity recalls (24HR) in quantifying short-term physical activity behaviors. METHODS: Nineteen healthy middle-age adults completed seven activity trials (reading, typing, box moving, stepping, and walking (3.5, 4.25, 5.0 km x h(-1))) while oxygen consumption and Actillume measures were obtained. ANOVA, linear regression, and a scatter plot were employed to examine the validity of the Actillume. In relative validity analyses of the 24HR in the Seasons study, participants (N = 481) completed two or three 24HR (MET-h x d(-1)) and a modified Baecke Questionnaire. A subset of the cohort (N = 41) wore the Actillume for 3-8 d (counts x min(-1) x d(-1)). The relative validity of the 24HR method was examined by comparison to these criterion measures. RESULTS: In laboratory validation analyses, the monitor was found to discriminate between sedentary and moderate intensity activities, changes in walking speed, and to account for 79% of the variance in oxygen consumption across sedentary and walking trials. In relative validity analyses, correlations between the 24HR and the modified Baecke ranged from 0.29 to 0.52 (P < 0.01) across total, household, occupational, and leisure-time activities. CONCLUSIONS: In laboratory testing, the Actillume monitor discriminated between sedentary and moderate intensity activities and was highly correlated with oxygen consumption. Three 24HR of physical activity were observed to have a relative validity that was comparable to published data from other short-term activity assessments that also employed the Baecke Questionnaire and activity monitors as criterion measures.

Sequence and seasonal effects of salivary cortisol.

Assessments of cortisol levels in saliva have been widely used by both researchers and clinicians as an index of adrenal functioning. Quarterly measurements of morning and evening cortisol levels were determined in a longitudinal study of 147 participants (72 women and 75 men) followed for 1 year each. The analysis of salivary cortisol revealed no significant gender or age differences in the sample. There was a sequence effect in quarterly cortisol values with a progressive decrease in serial measurements, especially notable in the morning values; as well as a seasonal variation in cortisol levels with significantly higher levels found in winter and fall, compared with spring and summer. The findings in this study suggest that repeated saliva sampling and seasonal variation in cortisol levels may independently affect adrenal response and, therefore, need to be accounted for in longitudinal studies.

Comparing food intake using the Dietary Risk Assessment with multiple 24-hour dietary recalls and the 7-Day Dietary Recall.

The Dietary Risk Assessment (DRA) is a brief dietary assessment tool used to identify dietary behaviors associated with cardiovascular disease. Intended for use by physicians and other nondietitians, the DRA identifies healthful and problematic dietary behaviors and alerts the physician to patients who require further nutrition counseling. To determine the relative validity of this tool, we compared it to the 7-Day Dietary Recall (an instrument developed to assess intake of dietary fat) and to the average of 7 telephone-administered 24-hour dietary recalls. Forty-two free-living subjects were recruited into the study. The 7-Day Dietary Recall and DRA were administered to each subject twice, at the beginning and the end of the study period, and the 24-hour recalls were conducted during the intervening time period. Correlation coefficients were computed to compare the food scores derived from the 3 assessment methods. Correlations between the DRA and 7-Day Dietary Recall data were moderate (r = .47, on average, for postmeasures); correlations between the DRA and 24-hour recalls were lower. The ability of the DRA to assess dietary fat consumption and ease of administration make it a clinically useful screening instrument for the physician when counseling patients about dietary fat reduction.

Why not routinely use best linear unbiased predictors (BLUPs) as estimates of cholesterol, per cent fat from kcal and physical activity?

Measures of biologic and behavioural variables on a patient often estimate longer term latent values, with the two connected by a simple response error model. For example, a subject's measured total cholesterol is an estimate (equal to the best linear unbiased estimate (BLUE)) of a subject's latent total cholesterol. With known (or estimated) variances, an alternative estimate is the best linear unbiased predictor (BLUP). We illustrate and discuss when the BLUE or BLUP will be a better estimate of a subject's latent value given a single measure on a subject, concluding that the BLUP estimator should be routinely used for total cholesterol and per cent kcal from fat, with a modified BLUP estimator used for large observed values of leisure time activity. Data from a large longitudinal study of seasonal variation in serum cholesterol forms the backdrop for the illustrations. Simulations which mimic the empirical and response error distributions are used to guide choice of an estimator. We use the simulations to describe criteria for estimator choice, to identify parameter ranges where BLUE or BLUP estimates are superior, and discuss key ideas that underlie the results.

Seasonal variation of blood cholesterol levels: study methodology.

This manuscript provides a description of the methodology used in the Seasonal Variation of Blood Cholesterol Levels (SEASON) study, with the intent of informing the scientific community of the available data sets and to invite a dialogue with scientists in complementary fields. The primary aim of the SEASON study is to describe and delineate the causes of seasonal variation of blood lipid levels in the general population. This research project is designed specifically to systematically collect and analyze a number of important variables necessary to study the role of seasonality in blood lipids and relevant covariates.

A dietitian-delivered group nutrition program leads to reductions in dietary fat, serum cholesterol, and body weight: the Worcester Area Trial for Counseling in Hyperlipidemia (WATCH).

OBJECTIVE: To assess the effectiveness of a dietitian-based nutrition counseling and education program for patients with hyperlipidemia. DESIGN: A 4-session program implemented as a complement to a randomized physician-delivered intervention. SUBJECTS/SETTING: From 12 practice sites of the Fallon Clinic, 1,162 subjects with hyperlipidemia were recruited, 645 of whom had data sufficient for our primary analyses. INTERVENTION: Two individual and 2 group sessions conducted over 6 weeks. MAIN OUTCOME MEASURES: Total and saturated fat levels; serum low-density lipoprotein cholesterol levels; and body weight, measured at baseline and after 1 year. STATISTICAL ANALYSES: Multiple linear regression was used to evaluate changes in outcome measures. RESULTS: After 1 year, there were significant reductions in outcome measures for subjects attending 3 or 4 nutrition sessions vs subjects attending fewer than 3 sessions or those never referred to a nutrition session. Reductions (mean +/- standard error) in saturated fat (measured as percent of energy) were 2.7 +/- 0.5%, 2.1 +/- 0.5%, and 0.3 +/- 0.1%, respectively. These reductions correspond to roughly a 22% relative change from baseline in those attending 3 or 4 sessions. Corollary reductions were observed for total fat (measured as percent of energy): 8.2 +/- 1.4%, 5.0 +/- 1.4%, and 0.7 +/- 0.4%; low-density lipoprotein cholesterol: 0.48 +/- 0.11 mmol/L, 0.13 +/- 0.11 mmol/L, and 0.02 +/- 0.03 mmol/L; and body weight: 4.5 +/- 0.9 kg, 2.1 +/- 0.8 kg, and 1.1 +/- 0.2 kg. The specified changes were additive to those of the physician-delivered intervention. APPLICATIONS/CONCLUSIONS: This investigation provides empirical data demonstrating the effectiveness of a dietitian-delivered intervention in the care of patients with hyperlipidemia.

Effect of physician-delivered nutrition counseling training and an office-support program on saturated fat intake, weight, and serum lipid measurements in a hyperlipidemic population: Worcester Area Trial for Counseling in Hyperlipidemia (WATCH).

OBJECTIVE: To evaluate the effectiveness of a training program for physician-delivered nutrition counseling, alone and in combination with an office-support program, on dietary fat intake, weight, and blood low-density lipoprotein cholesterol levels in patients with hyperlipidemia. PARTICIPANTS AND METHODS: Forty-five primary care internists at the Fallon Community Health Plan, a central Massachusetts health maintenance organization, were randomized by site into 3 groups: (1) usual care; (2) physician nutrition counseling training; and (3) physician nutrition counseling training plus an office-support program. Eleven hundred sixty-two of their patients with blood total cholesterol levels in the highest 25th percentile, having previously scheduled physician visits, were recruited. Physicians in groups 2 and 3 attended a 3-hour training program on the use of brief patient-centered interactive counseling and the use of an office-support program that included in-office prompts, algorithms, and simple dietary assessment tools. Primary outcome measures included change at 1-year of follow-up in percentage of energy intake from saturated fat; weight; and blood low-density lipoprotein cholesterol levels. RESULTS: Improvement was seen in all 3 primary outcome measures, but was limited to patients in group 3. Compared with group 1, patients in group 3 had average reductions of 1.1 percentage points in percent of energy from saturated fat (a 10.3% decrease) (P = .01); a reduction in weight of 2.3 kg (P<.001); and a decrease of 0.10 mmol/L (3.8 mg/dL) in low-density lipoprotein cholesterol level (P = .10). Average time for the initial counseling intervention in group 3 was 8.2 minutes, 5.5 minutes more than in the control group. CONCLUSION: Brief supported physician nutrition counseling can produce beneficial changes in diet, weight, and blood lipids.

Nutrient Intake Report: a coordination of patient dietary assessment between physicians and registered dietitians.

The Nutrient Intake Report (NIR) is based on a 7-day dietary recall questionnaire used previously in research for dietary assessment and adapted for clinical use. Used to provide information and counseling as part of total patient care, the NIR acts as a cornerstone for dietary education and interaction between physician, registered dietitian, and patient. The NIR is ordered by physicians or registered dietitians, scanned and assessed by a registered dietitian, and incorporated into the laboratory section of the medical record. It documents the patient's dietary intake in the context of his or her diagnosis and general health status. The NIR also opens a dialogue between physicians and registered dietitians. Incorporation of the NIR into the medical record makes the work of the registered dietitian available to other health practitioners, which is welcome in an era when licensing and reimbursement are contingent on systematic documentation of dietary assessment and its role in patient care.