Feasibility and acceptability of a remotely-delivered behavioural health coaching intervention to limit gestational weight gain.

INTRODUCTION: Gestational weight gain (GWG) and postpartum weight retention (PPWR) are significant, potentially modifiable, contributors to women's future weight and health trajectories. There is a need for feasible and patient-centered (i.e., convenient, remotely-delivered, technology-enhanced, and accessible through the prenatal care setting) behavioural interventions that limit GWG and PPWR. This study tests the feasibility and acceptability of a remotely-delivered behavioural health coaching intervention to limit gestational weight gain and postpartum weight retention. METHODS: Pregnant women (11-16 weeks gestation) were recruited from two prenatal clinics and randomized to the active intervention or health education comparison group. Completion of the program was monitored and perceived helpfulness was rated (0-100). RESULTS: Twenty-six women were randomized (n = 13 per arm; mean age = 31.6 years, SD = 3.6; mean BMI = 26.7 kg/m2, SD = 7.4). Participants completed a median of 18 coaching calls and 16/19 learning activities during pregnancy, and a median of 6 calls and 5/6 learning activities postpartum. They logged weights at least once/week for a median of 36/38 expected weeks and tracked daily calories and exercise for a median of 154/266 days and 72/266 days, respectively. Median (Q1, Q3) helpfulness ratings of the program during pregnancy were 80 (64, 91) and 62 (50, 81) postpartum; helpfulness ratings of coaching calls were 85 (58, 98). At 37 weeks gestation, 77% of participants achieved IOM weight gain recommendations compared to 54% in the comparison group. CONCLUSIONS: This study provides evidence for the feasibility and acceptability of a remotely-delivered behavioural weight control intervention in pregnancy and postpartum.

Long-term retention in an employer-based, commercial weight-loss programme.

The aim of this study is to examine factors associated with long-term retention in a commercial weight-loss programme. We conducted a retrospective analysis of an employer-based, commercial programme from 2013 to 2016. Our dependent variable was 'long-term retention', defined as continuously enrolled participants who actively engaged through coach calls at 6 and 12 months. Independent variables included baseline demographics, programme engagement and weight change. We conducted multivariate logistic regression analyses assessing for differences in long-term retention by several factors, adjusted for employer clustering. Overall, 68.3% were retained at 6% and 45.9% at 12 months. Greater number of coach calls and website logins during the first 3 months significantly increased the odds of long-term retention, while having chronic conditions significantly decreased the odds. Weight-loss success (≥5% loss at 6 months) was significantly associated with increased odds of retention (12-month: odds ratio [OR] 2.80, P < 0.001), while early weight-loss failure (≥0% weight change at 1 month) significantly decreased odds of retention (12-month: OR 0.66, P = 0.008). In an employer-based, commercial weight loss programme, greater early programme engagement was associated with long-term retention. Given these programmes' popularity and potential reach, our results could be used to develop and test strategies designed to improve retention in commercial weight-loss programmes.

Factors associated with early dropout in an employer-based commercial weight-loss program.

OBJECTIVE: Minimizing program dropout is essential for weight-loss success, but factors that influence dropout among commercial programs are unclear. This study's objective was to determine factors associated with early dropout in a commercial weight-loss program. METHODS: A retrospective analysis of a remotely delivered, employer-based commercial program from 2013 to 2016 was conducted. The dependent variable was 'early dropout', defined as enrollees who disengaged from telephone coaching by month 2's end. Independent variables included demographics, program website engagement and early weight change. Multivariate logistic regression analyses were used to assess for differences in early dropout by several factors, adjusted for employer clustering. RESULTS: Of the 5,274 participants, 26.8% dropped out early. Having ≥1 chronic condition (odds ratio [OR] 1.41, p < 0.001) and 'weight-loss failure' defined as ≥0% weight change at month 1's end (OR 1.86, p < 0.001) had significantly increased odds of early dropout. Increasing age by 10-year intervals (OR 0.90, p = 0.002) and 'meeting the website login goal' defined as ≥90 logins in 3 months (OR 0.13, p < 0.001) significantly decreased the odds of early dropout. CONCLUSIONS: Presence of comorbidities, less online engagement and weight-loss failure were associated with early dropout in a commercial program. Strategies to prevent dropout among high-risk participants, such as increased support or program tailoring, should be developed and tested.

Effects of dietary carbohydrate on 1,5-anhydroglucitol in a population without diabetes: results from the OmniCarb trial.

AIMS: To determine the effects of dietary changes in amount and type of carbohydrate on 1,5-anhydroglucitol levels. METHODS: We conducted an ancillary study to a completed, randomized clinical trial in overweight and obese adults without diabetes (N=159). Using a crossover design, participants were fed each one of four diets in turn for 5 weeks, with 2-week washout periods inbetween. The four diets were: high glycaemic index (≥65) with high proportion of carbohydrate (58% kcal) (GC); low glycaemic index (GI≤45) with low proportion of carbohydrate (40% kcal) (gc); low glycaemic index with high proportion of carbohydrate (gC); and high glycaemic index with low proportion of carbohydrate (Gc). Plasma 1,5-anhydroglucitol levels were measured at baseline and after each feeding period. RESULTS: At baseline, participants had a mean age of 53 years (53% women, 52% non-Hispanic black, 50% obese). Their mean fasting glucose and 1,5-anhydroglucitol levels were 97 mg/dl (5.4 mmol/l) and 18.6 µg/mL (113.3 µmol/l), respectively. Compared with baseline, each of the four diets reduced 1,5-anhydroglucitol by a range of -2.4 to -3.7 µg/mL (-14.6 to -22.5 µmol/l); all P <0.001). Reducing either glycaemic index or proportion of carbohydrate lowered 1,5-anhydroglucitol levels. These effects were additive, such that reducing both glycaemic index and proportion of carbohydrates decreased 1,5-anhydroglucitol by -1.31 µg/mL [95% CI: -1.63, -0.99; P<0.001 or -8.0 (-9.9, -6.0) µmol/l]. Furthermore, these effects were confirmed in a subgroup of participants with 12-h glucose monitoring and no documented hyperglycaemia (fasting glucose <160 mg/dl or 8.9 mmol/l). CONCLUSIONS: Both type and amount of dietary carbohydrate affect 1,5-anhydroglucitol plasma concentrations in adults without diabetes. This finding contradicts the long-standing notion that 1,5-anhydroglucitol remains at constant concentrations in the blood in the absence of hyperglycaemic excursions. (Clinical trials registry number: NCT00051350).

Does vaginal delivery mitigate or strengthen the intergenerational association of overweight and obesity? Findings from the Boston Birth Cohort.

BACKGROUND/OBJECTIVES: The intergenerational association of obesity may be driven by mother-to-newborn transmission of microbiota at birth. Yet cesarean delivery circumvents newborn acquisition of vaginal microbiota, and has been associated with greater childhood adiposity. Here we examined the independent and joint associations of maternal pre-pregnancy body mass index (BMI; kg m-2) and delivery mode with childhood overweight or obesity. SUBJECTS/METHODS: We prospectively followed 1441 racially and ethnically diverse mother-child dyads in the Boston Birth Cohort until age 5 years (range: 2.0-8.0 years). We used logistic regression to examine the independent and joint associations of delivery mode (cesarean and vaginal delivery) and pre-pregnancy BMI with childhood overweight or obesity (age-sex-specific BMI ⩾85th percentile). RESULTS: Of 1441 mothers, 961 delivered vaginally and 480 by cesarean. Compared with vaginally delivered children, cesarean delivered children had 1.4 (95% confidence interval (CI) 1.1-1.8) times greater odds of becoming overweight or obese in childhood, after adjustment for maternal age at delivery, race/ethnicity, education, air pollution exposure, pre-pregnancy BMI, pregnancy weight gain and birth weight. Compared with children born vaginally to normal weight mothers, after multivariable adjustment, odds of childhood overweight or obesity were highest in children born by cesarean delivery to obese mothers (odds ratio (OR): 2.8; 95% CI: 1.9-4.1), followed by children born by cesarean delivery to overweight mothers (OR: 2.2; 95% CI: 1.5-3.2), then children born vaginally to obese mothers (OR: 1.8; 95% CI: 1.3-2.6) and finally children born vaginally to overweight mothers (OR: 1.7; 95% CI: 1.2-2.3). CONCLUSIONS: In our racially and ethnically diverse cohort, cesarean delivery and pre-pregnancy overweight and obesity were associated with childhood overweight or obesity. Needed now are prospective studies that integrate measures of the maternal and infant microbiome, and other potentially explanatory covariates, to elucidate the mechanisms driving this association and to explore whether exposure to vaginal microbiota in cesarean delivered newborns may be an innovative strategy to combat the intergenerational cycle of obesity.

Sex-specific associations of birth weight with measures of adiposity in mid-to-late adulthood: the Brazilian Longitudinal Study of Adult Health (ELSA-Brasil).

BACKGROUND/OBJECTIVES: To investigate sex-specific associations of birth weight with body mass index (BMI), waist circumference (WC) and waist-to-hip ratio (WHR) in mid-to-late adulthood. SUBJECTS/METHODS: ELSA-Brasil is a multicenter cohort study of adults aged 35-74 years affiliated with universities or research institutions of six capital cities in Brazil. After exclusions, we investigated 11 636 participants. Socio-demographic factors and birth weight were obtained by interview. All anthropometry was directly measured at baseline. We categorized birth weight as low (⩽2.5 kg); normal (2.5-4 kg) and high (⩾4 kg). We performed analysis of covariance (ANCOVA) for continuous outcomes and ordinal logistic regression for categorical adiposity outcomes. We examined interaction on the multiplicative scale by sex and by race. RESULTS: High birth weight uniformly predicted greater overall and central obesity in men and women. However, low (vs normal) birth weight, in ANCOVA models adjusted for participant age, family income, race, education, maternal education, and maternal and paternal history of diabetes, was associated with lower BMI, WC and WHR means for men, but not for women (Pinteraction=0.01, <0.0001 and <0.0001, respectively). In similarly adjusted ordinal logistic regression models, odds of obesity (odds ratio (OR)=0.65, 0.46-0.90) and of being in the high (vs low) tertile of WC (OR=0.66, 0.50-0.87) and of WHR (OR=0.79, 0.60-1.03) were lower for low (vs normal) birth weight men, but trended higher (BMI: OR=1.18, 0.92-1.51; WC: OR=1.21, 0.97-1.53; WHR: OR=1.44, 1.15-1.82) for low (vs normal) birth weight women. CONCLUSIONS: In this Brazilian sample of middle-aged and elderly adults who have lived through a rapid nutritional transition, low birth weight was associated with adult adiposity in a sex-specific manner. In men, low birth weight was associated with lower overall and central adult adiposity, while in women low birth weight was generally associated with greater central adiposity.

Perceived helpfulness of the individual components of a behavioural weight loss program: results from the Hopkins POWER Trial.

BACKGROUND: Behavioural weight loss programs are effective first-line treatments for obesity and are recommended by the US Preventive Services Task Force. Gaining an understanding of intervention components that are found helpful by different demographic groups can improve tailoring of weight loss programs. This paper examined the perceived helpfulness of different weight loss program components. METHODS: Participants (n = 236) from the active intervention conditions of the Practice-based Opportunities for Weight Reduction (POWER) Hopkins Trial rated the helpfulness of 15 different components of a multicomponent behavioural weight loss program at 24-month follow-up. These ratings were examined in relation to demographic variables, treatment arm and weight loss success. RESULTS: The components most frequently identified as helpful were individual telephone sessions (88%), tracking weight online (81%) and coach review of tracking (81%). The component least frequently rated as helpful was the primary care providers' general involvement (50%). Groups such as older adults, Blacks and those with lower education levels more frequently reported intervention components as helpful compared with their counterparts. DISCUSSION: Weight loss coaching delivered telephonically with web support was well received. Findings support the use of remote behavioural interventions for a wide variety of individuals.

Effects of the DASH diet on blood pressure in patients with and without metabolic syndrome: results from the DASH trial.

In the Dietary Approach to Stop Hypertension (DASH) trial, the DASH diet reduced blood pressure (BP) in a diverse sample of US adults. Subsequent analyses of this trial documented the efficacy of the DASH diet in several subgroups. Although subgroup analyses in individuals with metabolic syndrome (MS) have not been performed, the DASH diet has been recommended in MS patients. This paper is a subgroup analysis of the DASH trial, in which we examined the effect of study diets on BP in participants with and without MS. Participants were stratified according to MS status (99 with MS, 311 without MS (Non-MS)). The trial was a dietary intervention study in which participants were randomized to receive a control diet, a diet rich in fruits and vegetables, or the DASH diet. Outcomes were (i) the difference in BP between the end and the beginning of intervention and (ii) control of hypertension. We found no significant interaction between MS status and diet assignment on BP (each P-interaction >0.05). In the MS subgroup, the DASH diet compared with the control diet reduced systolic BP by 4.9 mm Hg (P=0.006) and diastolic BP by 1.9 mm Hg (P=0.15). In the Non-MS subgroup, corresponding net BP reductions were 5.2 mm Hg (P<0.001) and 2.9 mm Hg (P<0.001), respectively. The DASH diet controlled hypertension in 75% of hypertensive participants with MS (adjusted odds ratio=9.5 vs the control diet, P=0.05). In conclusion, the DASH diet similarly reduces BP in those with and without MS. Our findings provide direct evidence for existing recommendations.

Behavioral mediators of treatment effects in the weight loss maintenance trial.

BACKGROUND: The Weight Loss Maintenance Trial tested strategies for maintenance of weight loss. Personal contact was superior to interactive technology and self-directed conditions. PURPOSE: We aimed to identify behavioral mediators of the superior effect of personal contact vs. interactive technology and of personal contact vs. self-directed arms. METHODS: Overweight/obese adults at risk for cardiovascular disease (n = 1,032) who lost at least 4 kg were randomized to personal contact, interactive technology, or self-directed. After 30 months, 880 participants had data on weight and behavioral strategies. RESULTS: Reported increase of intake of fruits and vegetables and physical activity and more frequent self-weighing met criteria as mediators of the better outcome of personal contact vs. interactive technology. Increased intake of fruits and vegetables, more frequent self-weighing, and decreased dessert consumption were mediators of the difference between personal contact vs. self-directed. CONCLUSION: Inducing changes in the identified behaviors might yield better outcomes in future weight loss maintenance trials.

Patient-reported outcomes in the practice-based opportunities for weight reduction (POWER) trial.

PURPOSE: To evaluate effects of two behavioral weight-loss interventions (in-person, remote) on health-related quality of life (HRQOL) compared to a control intervention. METHODS: Four hundred and fifty-one obese US adults with at least one cardiovascular risk factor completed five measures of HRQOL and depression: MOS SF-12 physical component summary (PCS) and mental component summary; EuroQoL-5 dimensions single index and visual analog scale; PHQ-8 depression symptoms; and PSQI sleep quality scores at baseline and 6 and 24 months after randomization. Change in each outcome was analyzed using outcome-specific mixed-effects models controlling for participant demographic characteristics. RESULTS: PCS-12 scores over 24 months improved more among participants in the in-person active intervention arm than among control arm participants (P < 0.05, ES = 0.21); there were no other statistically significant treatment arm differences in HRQOL change. Greater weight loss was associated with improvements in most outcomes (P < 0.05 to < 0.0001). CONCLUSIONS: Participants in the in-person active intervention improved more in physical function HRQOL than participants in the control arm did. Greater weight loss during the study was associated with greater improvement in all PRO except for sleep quality, suggesting that weight loss is a key factor in improving HRQOL.

Branched-chain amino acid levels are associated with improvement in insulin resistance with weight loss.

AIMS/HYPOTHESIS: Insulin resistance (IR) improves with weight loss, but this response is heterogeneous. We hypothesised that metabolomic profiling would identify biomarkers predicting changes in IR with weight loss. METHODS: Targeted mass spectrometry-based profiling of 60 metabolites, plus biochemical assays of NEFA, ß-hydroxybutyrate, ketones, insulin and glucose were performed in baseline and 6 month plasma samples from 500 participants who had lost ≥4 kg during Phase I of the Weight Loss Maintenance (WLM) trial. Homeostatic model assessment of insulin resistance (HOMA-IR) and change in HOMA-IR with weight loss (∆HOMA-IR) were calculated. Principal components analysis (PCA) and mixed models adjusted for race, sex, baseline weight, and amount of weight loss were used; findings were validated in an independent cohort of patients (n = 22). RESULTS: Mean weight loss was 8.67 ± 4.28 kg; mean ∆HOMA-IR was -0.80 ± 1.73, range -28.9 to 4.82). Baseline PCA-derived factor 3 (branched chain amino acids [BCAAs] and associated catabolites) correlated with baseline HOMA-IR (r = 0.50, p < 0.0001) and independently associated with ∆HOMA-IR (p < 0.0001). ∆HOMA-IR increased in a linear fashion with increasing baseline factor 3 quartiles. Amount of weight loss was only modestly correlated with ∆HOMA-IR (r = 0.24). These findings were validated in the independent cohort, with a factor composed of BCAAs and related metabolites predicting ∆HOMA-IR (p = 0.007). CONCLUSIONS/INTERPRETATION: A cluster of metabolites comprising BCAAs and related analytes predicts improvement in HOMA-IR independent of the amount of weight lost. These results may help identify individuals most likely to benefit from moderate weight loss and elucidate novel mechanisms of IR in obesity.

The effects of dietary patterns on plasma renin activity: results from the Dietary Approaches to Stop Hypertension trial.

A diet rich in fruits, vegetables and low-fat dairy products, and reduced in saturated fat, total fat and cholesterol (the 'DASH' diet) significantly lowers blood pressure (BP). Previous studies have documented that certain therapies that lower BP increase plasma renin activity (PRA). Using data from the Dietary Approaches to Stop Hypertension (DASH) trial, we assessed the effects of dietary patterns on PRA and determined the relationship of change in PRA with change in BP on each diet. After eating a control diet for 3 weeks, participants were then randomized to receive for 8 weeks: the control diet, a diet rich in fruits and vegetables (F/V), or the DASH diet. Baseline and follow-up levels of PRA were available in 381 participants. Compared with the control diet, the DASH diet increased PRA by 0.37 ng ml(-1) h(-1) (P=0.01). In multivariable linear regression analyses, there was an inverse association of PRA change with systolic BP change on the control diet (slope=-0.35, P=0.001), but PRA did not differ by BP change on the F/V diet (slope=-0.002, P=0.98) or DASH diet (slope=-0.08, P=0.32). These data suggest that a blunted counter-regulatory response of the renin-angiotensin system is associated with the BP-lowering effect of the F/V and DASH diets.

A behavioral weight-loss intervention for persons with serious mental illness in psychiatric rehabilitation centers.

OBJECTIVE: Overweight and obesity are epidemic in populations with serious mental illnesses. We developed and pilot-tested a behavioral weight-loss intervention appropriately tailored for persons with serious mental disorders. METHODS: We conducted a single-arm pilot study in two psychiatric rehabilitation day programs in Maryland, and enrolled 63 overweight or obese adults. The 6-month intervention provided group and individual weight management and group physical activity classes. The primary outcome was weight change from baseline to 6 months. RESULTS: A total of 64% of those potentially eligible enrolled at the centers. The mean age was 43.7 years; 56% were women; 49% were white; and over half had schizophrenia or a schizoaffective disorder. One-third had hypertension and one-fifth had diabetes. In total, 52 (82%) completed the study; others were discharged from psychiatric centers before completion of the study. Average attendance across all weight management sessions was 70% (87% on days participants attended the center) and 59% for physical activity classes (74% on days participants attended the center). From a baseline mean of 210.9 lbs (s.d. 43.9), average weight loss for 52 participants was 4.5 lb (s.d. 12.8) (P<0.014). On average, participants lost 1.9% of body weight. Mean waist circumference change was 3.1 cm (s.d. 5.6). Participants on average increased the distance on the 6-minute walk test by 8%. CONCLUSION: This pilot study documents the feasibility and preliminary efficacy of a behavioral weight-loss intervention in adults with serious mental illness who were attendees at psychiatric rehabilitation centers. The results may have implications for developing weight-loss interventions in other institutional settings such as schools or nursing homes.

Correlates of N-terminal prohormone brain natriuretic peptides in African Americans with hypertensive chronic kidney disease: the African American Study of Kidney Disease and Hypertension.

BACKGROUND/AIMS: The N-amino-terminal fragment of the prohormone B-type natriuretic peptide (NT-proBNP) is a marker of cardiac stress and elevated levels are indicative of heart failure. Few correlates of NT-proBNP levels have been identified in persons with moderate chronic kidney disease (CKD), and data from those without heart failure and from African Americans are especially limited. METHODS: The African American Study of Kidney Disease and Hypertension (AASK) enrolled nondiabetic African Americans with hypertensive kidney disease (glomerular filtration rate [GFR] = 20-65 ml/min/1.73 m(2)) and no evidence of clinical heart failure. NT-proBNP was measured in 982 AASK participants. RESULTS: In unadjusted analyses, GFR (r = -0.39; p < 0.001), hematocrit (r = -0.21; p < 0.001) and body mass index (BMI; r = -0.07; p = 0.04) were inversely correlated, and systolic blood pressure (r = 0.30; p < 0.001) and log UPCR (r = 0.32; p < 0.001) were positively correlated with log NT-proBNP levels. After adjustment for potential confounders, lower GFR and hematocrit and higher systolic blood pressure and protein:creatinine ratio remained significantly associated with higher NT-proBNP. CONCLUSION: Lower GFR and hematocrit, and higher urinary protein excretion may be associated with volume expansion in CKD. These results suggest that these processes are associated with increased NT-proBNP in CKD and may play a role in the development of heart failure.

The relationship between dietary protein intake and blood pressure: results from the PREMIER study.

Observational and clinical studies suggest that high protein intake, particularly protein from plant sources, might reduce blood pressure (BP). To examine the association of dietary protein with BP, we analysed data from PREMIER, an 18-month clinical trial (n=810) that examined the effects of two multi-component lifestyle modifications on BP. We examined the association of protein intake with BP, and in particular the independent relationship of plant and animal protein with BP. Multivariable linear regression analyses were performed with both cross-sectional and longitudinal data. Dietary plant protein was inversely associated with both systolic and diastolic BP in cross-sectional analyses at the 6-month follow-up (P=0.0045 and 0.0096, respectively). Fruit and vegetable intake was also inversely associated with both systolic and diastolic BP cross-sectionally at 6 months (P=0.0003 and 0.0157, respectively). In longitudinal analyses, a high intake of plant protein at 6 months was marginally associated with a reduction of both systolic and diastolic BP from baseline to 6 months only (P=0.0797 and 0.0866, respectively), independent of change in body weight and waist circumference. Furthermore, increased intake of plant protein, and fruits and vegetables was significantly associated with a lower risk of hypertension at 6 but not at 18 months. Results of this study indicate that plant protein had a beneficial effect on BP and was associated with a lower risk of hypertension at 6 months. Our data, in conjunction with other research, suggest that an increased intake of plant protein may be useful as a means to prevent and treat hypertension.

N-terminal prohormone brain natriuretic peptide as a predictor of cardiovascular disease and mortality in blacks with hypertensive kidney disease: the African American Study of Kidney Disease and Hypertension (AASK).

BACKGROUND: Higher levels of N-terminal prohormone brain-type natriuretic peptide (NT-proBNP) predict cardiovascular disease (CVD) in several disease states, but few data are available in patients with chronic kidney disease or in blacks. METHODS AND RESULTS: The African American Study of Kidney Disease and Hypertension trial enrolled hypertensive blacks with a glomerular filtration rate of 20 to 65 mL x min(-1) x 1.73 m(-2) and no other identified cause of kidney disease. NT-proBNP was measured with a sandwich chemiluminescence immunoassay (coefficient of variation 2.9%) in 994 African American Study of Kidney Disease and Hypertension participants. NT-proBNP was categorized as undetectable, low, moderate, or high. Proteinuria was defined as 24-hour urinary protein-creatinine ratio >0.22. A total of 134 first CVD events (CVD death or hospitalization for coronary artery disease, heart failure, or stroke) occurred over a median of 4.3 years. Participants with high NT-proBNP were much more likely to have a CVD event than participants with undetectable NT-proBNP after adjustment (relative hazard 4.0 [95% confidence interval [CI] 2.1 to 7.6]). A doubling of NT-proBNP was associated with a relative hazard of 1.3 (95% CI 1.0 to 1.6) for coronary artery disease, 1.7 (95% CI 1.4 to 2.2) for heart failure, 1.1 (95% CI 0.9 to 1.4) for stroke, and 1.8 (95% CI 1.4 to 2.4) for CVD death. The association of NT-proBNP with CVD events was significantly stronger (P(interaction)=0.05) in participants with than in those without proteinuria. Higher NT-proBNP was not associated with renal disease progression. CONCLUSIONS: These results suggest that elevated NT-proBNP levels are associated with higher CVD risk among blacks with hypertensive kidney disease. This association may be stronger in individuals with significant proteinuria.

One year follow-up of overweight and obese hypertensive adults following intensive lifestyle therapy.

OBJECTIVE: To examine the long-term effect on weight maintenance and dietary habits of participants in a clinical trial for weight loss. SETTING: Community-based residents living in Maryland. PARTICIPANTS: Forty-four hypertensive, overweight adults who participated in a randomized clinical trial of weight loss. Participants were randomized to an intensive 'lifestyle' intervention or a 'monitoring' group. MAIN OUTCOME MEASURES: Weight, self-reported current intake of fat and fruit/fibre and self-reported barriers to maintain weight loss were assessed 1 year after the completion of the Diet, Exercise and Weight-loss Intervention Trial (DEW-IT) trial. ANALYSIS: t-tests were used to compare groups for differences in continuous variables and chi-square tests were used to compare groups for categorical variables. RESULTS: Fourty-two of the 44 DEW-IT subjects participated in the follow-up study. Overall, 55% (12/19) of the lifestyle intervention group remained at or below their baseline weight at 1 year, compared with 48% (11/23) of the monitoring group (P = 0.32). However, during that year, 95% (18/19) of the lifestyle intervention group and 52% (12/23) of the monitoring group gained weight from the end of the study. Both groups reported similar intake of fruits/vegetables (servings day(-1)), dietary fibre (g day(-1)) and fat (g day(-1)). CONCLUSIONS AND IMPLICATIONS: The majority of participants who lost weight during the trial regained weight during the course of 1 year. A successful intensive 2-month programme of lifestyle modification (DEW-IT) was ineffective for long-term maintenance of weight loss.

Effect of lifestyle modifications on blood pressure by race, sex, hypertension status, and age.

Recommendations for control of high blood pressure (BP) emphasize lifestyle modification, including weight loss, reduced sodium intake, increased physical activity, and limited alcohol consumption. The Dietary Approaches to Stop Hypertension (DASH) dietary pattern also lowers BP. The PREMIER randomized trial tested multicomponent lifestyle interventions on BP in demographic and clinical subgroups. Participants with above-optimal BP through stage 1 hypertension were randomized to an Advice Only group or one of two behavioural interventions that implement established recommendations (Est) or established recommendations plus DASH diet (Est plus DASH). The primary outcome was change in systolic BP at 6 months. The study population was 810 individuals with an average age of 50 years, 62% women, 34% African American (AA), 95% overweight/obese, and 38% hypertensive. Participants in all the three groups made lifestyle changes. Mean net reductions in systolic (S) BP in the Est intervention were 1.2 mmHg in AA women, 6.0 in AA men, 4.5 in non-AA women, and 4.2 in non-AA men. The mean effects of the Est Plus DASH intervention were 2.1, 4.6, 4.2, and 5.7 mmHg in the four race-sex subgroups, respectively. BP changes were consistently greater in hypertensives than in nonhypertensives, although interaction tests were nonsignificant. The Est intervention caused statistically significant BP reductions in individuals over and under age 50. The Est Plus DASH intervention lowered BP in both age groups, and significantly more so in older individuals. In conclusion, diverse groups of people can adopt multiple lifestyle changes that can lead to improved BP control and reduced CVD risk.

Comparing office-based and ambulatory blood pressure monitoring in clinical trials.

Ambulatory blood pressure monitoring (ABPM) is commonly used in clinical trials. Yet, its ability to detect blood pressure (BP) change in comparison to multiple office-based measurements has received limited attention. We recorded ambulatory and five daily pairs of random zero (RZ) BPs pre- and post-intervention on 321 adult participants in the multicentre Dietary Approaches to Stop Hypertension trial. Treatment effect estimates measured by ambulatory monitoring were similar to those measured by RZ and did not differ significantly for waking vs 24-h ambulatory measurements. For systolic BP, the standard deviations of change in mean 24-h ambulatory BP (8.0 mmHg among hypertensives and 6.0 mmHg among nonhypertensives) were comparable to or lower than the corresponding standard deviations of change in RZ-BP based on five daily readings (8.9 and 5.9 mmHg). The standard deviations of change for mean waking ambulatory BP (8.7 and 6.7 mmHg) were comparable to those obtained using three to four daily RZ readings. Results for diastolic BP were qualitatively similar. Ambulatory monitoring was more efficient (ie, a smaller sample size could detect a given BP change) than three to four sets of daily RZ readings and required fewer clinic visits. The average of 33 ambulatory BP readings during the waking hours had an efficiency comparable to that from the mean of four daily pairs of RZ-BPs. Participants readily accepted the ABPM devices, and their use requires less staff training. ABPM provides a useful alternative to RZ-BP measurements in clinical trials.