Laura P. Svetkey

2014 Evidence-Based Guideline for the Management of High Blood Pressure in Adults: Report From the Panel Members Appointed to the Eighth Joint National Committee (JNC 8)

Hypertension is the most common condition seen in primary care and leads to myocardial infarction, stroke, renal failure, and death if not detected early and treated appropriately. Patients want to be assured that blood pressure (BP) treatment will reduce their disease burden, while clinicians want guidance on hypertension management using the best scientific evidence. This report takes a rigorous, evidence-based approach to recommend treatment thresholds, goals, and medications in the management of hypertension in adults. Evidence was drawn from randomized controlled trials, which represent the gold standard for determining efficacy and effectiveness. Evidence quality and recommendations were graded based on their effect on important outcomes. There is strong evidence to support treating hypertensive persons aged 60 years or older to a BP goal of less than 150/90 mm Hg and hypertensive persons 30 through 59 years of age to a diastolic goal of less than 90 mm Hg; however, there is insufficient evidence in hypertensive persons younger than 60 years for a systolic goal, or in those younger than 30 years for a diastolic goal, so the panel recommends a BP of less than 140/90 mm Hg for those groups based on expert opinion. The same thresholds and goals are recommended for hypertensive adults with diabetes or nondiabetic chronic kidney disease (CKD) as for the general hypertensive population younger than 60 years. There is moderate evidence to support initiating drug treatment with an angiotensin-converting enzyme inhibitor, angiotensin receptor blocker, calcium channel blocker, or thiazide-type diuretic in the nonblack hypertensive population, including those with diabetes. In the black hypertensive population, including those with diabetes, a calcium channel blocker or thiazide-type diuretic is recommended as initial therapy. There is moderate evidence to support initial or add-on antihypertensive therapy with an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker in persons with CKD to improve kidney outcomes. Although this guideline provides evidence-based recommendations for the management of high BP and should meet the clinical needs of most patients, these recommendations are not a substitute for clinical judgment, and decisions about care must carefully consider and incorporate the clinical characteristics and circumstances of each individual patient.

Effects on Blood Pressure of Reduced Dietary Sodium and the Dietary Approaches to Stop Hypertension (DASH) Diet

Background The effect of dietary composition on blood pressure is a subject of public health importance. We studied the effect of different levels of dietary sodium, in conjunction with the Dietary Approaches to Stop Hypertension (DASH) diet, which is rich in vegetables, fruits, and low-fat dairy products, in persons with and in those without hypertension. Methods A total of 412 participants were randomly assigned to eat either a control diet typical of intake in the United States or the DASH diet. Within the assigned diet, participants ate foods with high, intermediate, and low levels of sodium for 30 consecutive days each, in random order. Results Reducing the sodium intake from the high to the intermediate level reduced the systolic blood pressure by 2.1 mm Hg (P<0.001) during the control diet and by 1.3 mm Hg (P=0.03) during the DASH diet. Reducing the sodium intake from the intermediate to the low level caused additional reductions of 4.6 mm Hg during the control diet (P<0.001) and 1.7 mm Hg during t...

A Branched-Chain Amino Acid-Related Metabolic Signature that Differentiates Obese and Lean Humans and Contributes to Insulin Resistance

Metabolomic profiling of obese versus lean humans reveals a branched-chain amino acid (BCAA)-related metabolite signature that is suggestive of increased catabolism of BCAA and correlated with insulin resistance. To test its impact on metabolic homeostasis, we fed rats on high-fat (HF), HF with supplemented BCAA (HF/BCAA), or standard chow (SC) diets. Despite having reduced food intake and a low rate of weight gain equivalent to the SC group, HF/BCAA rats were as insulin resistant as HF rats. Pair-feeding of HF diet to match the HF/BCAA animals or BCAA addition to SC diet did not cause insulin resistance. Insulin resistance induced by HF/BCAA feeding was accompanied by chronic phosphorylation of mTOR, JNK, and IRS1Ser307 and by accumulation of multiple acylcarnitines in muscle, and it was reversed by the mTOR inhibitor, rapamycin. Our findings show that in the context of a dietary pattern that includes high fat consumption, BCAA contributes to development of obesity-associated insulin resistance.

2013 AHA/ACC Guideline on Lifestyle Management to Reduce Cardiovascular Risk

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Comparison of Strategies for Sustaining Weight Loss: The Weight Loss Maintenance Randomized Controlled Trial

CONTEXT Behavioral weight loss interventions achieve short-term success, but re-gain is common. OBJECTIVE To compare 2 weight loss maintenance interventions with a self-directed control group. DESIGN, SETTING, AND PARTICIPANTS Two-phase trial in which 1032 overweight or obese adults (38% African American, 63% women) with hypertension, dyslipidemia, or both who had lost at least 4 kg during a 6-month weight loss program (phase 1) were randomized to a weight-loss maintenance intervention (phase 2). Enrollment at 4 academic centers occurred August 2003-July 2004 and randomization, February-December 2004. Data collection was completed in June 2007. INTERVENTIONS After the phase 1 weight-loss program, participants were randomized to one of the following groups for 30 months: monthly personal contact, unlimited access to an interactive technology-based intervention, or self-directed control. Main Outcome Changes in weight from randomization. RESULTS Mean entry weight was 96.7 kg. During the initial 6-month program, mean weight loss was 8.5 kg. After randomization, weight regain occurred. Participants in the personal-contact group regained less weight (4.0 kg) than those in the self-directed group (5.5 kg; mean difference at 30 months, -1.5 kg; 95% confidence interval [CI], -2.4 to -0.6 kg; P = .001). At 30 months, weight regain did not differ between the interactive technology-based (5.2 kg) and self-directed groups (5.5 kg; mean difference -0.3 kg; 95% CI, -1.2 to 0.6 kg; P = .51); however, weight regain was lower in the interactive technology-based than in the self-directed group at 18 months (mean difference, -1.1 kg; 95% CI, -1.9 to -0.4 kg; P = .003) and at 24 months (mean difference, -0.9 kg; 95% CI, -1.7 to -0.02 kg; P = .04). At 30 months, the difference between the personal-contact and interactive technology-based group was -1.2 kg (95% CI -2.1 to -0.3; P = .008). Effects did not differ significantly by sex, race, age, and body mass index subgroups. Overall, 71% of study participants remained below entry weight. CONCLUSIONS The majority of individuals who successfully completed an initial behavioral weight loss program maintained a weight below their initial level. Monthly brief personal contact provided modest benefit in sustaining weight loss, whereas an interactive technology-based intervention provided early but transient benefit. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00054925.

Effects of comprehensive lifestyle modification on diet, weight, physical fitness, and blood pressure control: 18-month results of a randomized trial.

Context Can adults make sustained changes in unhealthy lifestyle behaviors? Content In this multicenter trial, 810 adult volunteers with prehypertension or stage 1 hypertension were randomly assigned to a multicomponent behavioral intervention group, a group combining the behavioral intervention plus the Dietary Approaches to Stop Hypertension (DASH) diet, or an advice only group. At 18 months, participants in both behavioral intervention groups had less hypertension, more weight loss, and better reduction in sodium and fat intake than those receiving advice only. The participants in the DASH diet group also increased their intake of fruits, vegetables, and fiber. Implications Motivated adults can sustain several lifestyle changes over 18 months, which might reduce their risk for cardiovascular disease. The Editors The public health burden of chronic diseases related to suboptimal diet and physical inactivity is enormous. It has been estimated that these lifestyle factors contribute to approximately 20% of deaths in the United States (1). Incidence of atherosclerotic cardiovascular disease, overweight and obesity, elevated blood pressure and lipid levels, diabetes, osteoporosis, and cancer is increased by unhealthy lifestyles (2-8). Multiple lifestyle factors, such as physical inactivity; excessive intake of calories, sodium, saturated fat, and cholesterol; and inadequate intake of fruits, vegetables, and low-fat dairy products, are etiologically related to the development of these diseases (4, 5, 8-10). To reduce the burden of chronic disease, increased physical activity and changes in diet are needed, yet few intervention studies have attempted to achieve many lifestyle changes simultaneously. The PREMIER randomized trial tested the effects of 2 multicomponent behavioral interventions on blood pressure (11). Both interventions promoted increased physical activity, weight loss, and reduced sodium intake, each of which is recommended by the 2005 Dietary Guidelines Scientific Advisory Committee (12). One intervention also added the Dietary Approaches to Stop Hypertension (DASH) diet (13). This diet, which is high in fruits, vegetables, and low-fat dairy products and low in saturated fat, total fat, and cholesterol, meets each of the major nutrient recommendations that were established by the Institute of Medicine (14-18). We report the effects of the PREMIER interventions on lifestyle changes and blood pressure status at 18 months. The main results of PREMIER, namely change in blood pressure at 6 months, were reported previously (11). Methods The PREMIER study design and rationale (19) and intervention methods (11) have been described previously. The institutional review boards at each clinical center; an external protocol review committee appointed by the National Heart, Lung, and Blood Institute (NHLBI); and the NHLBI reviewed and approved the protocol (available at www.kpchr.org/public/premier/intervention/default.asp). The NHLBI also appointed a data and safety monitoring board to monitor the trial. Each participant provided written informed consent. The trial was conducted from January 2000 through November 2002. Study Participants Participants were generally healthy adults, age 25 years or older, who had prehypertension or stage 1 hypertension and met the Joint National Committee VI (JNC VI) criteria for a 6-month trial of nonpharmacologic therapy (2). Targeted recruitment methods were used to ensure adequate representation of clinically important subgroups, in particular, African-American persons. Specific methods varied from site to site but included direct mailings, radio and newspaper advertisements, and networking within the local African-American communities. Eligibility criteria included not taking antihypertensive medication and having a systolic blood pressure of 120 to 159 mm Hg and a diastolic blood pressure of 80 to 95 mm Hg, based on the average of 3 screening visits. Persons with prehypertension (systolic blood pressure of 120 to 139 mm Hg or diastolic blood pressure of 80 to 89 mm Hg) were included because of the excess risk for cardiovascular disease in those with blood pressure within this range (20). Major exclusion criteria were a body mass index less than 18.5 kg/mg2 or greater than 45.0 kg/m2, use of antihypertensive drugs or other drugs that affect blood pressure, JNC VI risk category C (target organ damage or diabetes), use of prescription weight loss medications, previous cardiovascular event, congestive heart failure, angina, cancer, and consumption of more than 21 alcoholic drinks per week. Trial Conduct Eligible participants were randomly assigned, with equal probability, to 1 of 3 groups: an advice only comparison group (advice only); an intervention group that targeted established, guideline-recommended lifestyle recommendations (established) (2); or an intervention group targeting the established recommendations and adding the DASH dietary pattern (established plus DASH) (13). Computer-generated treatment assignments were stratified by clinic and hypertension status and were assigned in blocks of varying sizes to provide balance over time. The actual assignments were administered by using a password-protected, Web-based application developed by the coordinating center and accessible only by authorized individuals. All clinic measurement staff were blinded to treatment assignment, and all intervention staff were blinded to clinic measurements. Hypertension was defined by using the JNC VI criteria for hypertension treatment: an average systolic blood pressure of 140 mm Hg, a diastolic blood pressure greater than 90 mm Hg, or use of antihypertensive medication. Normal blood pressure was defined as systolic blood pressure less than 120 mm Hg, diastolic blood pressure less than 80 mm Hg, and no use of antihypertensive medication (21) (Figure). Intervention was provided by masters degreelevel counselors (dietitians and health educators trained in behavioral methods). The counselors were centrally trained before the start of the study, attended annual 3-day training sessions, and participated in monthly conference calls. Figure. Flow diagram of enrollment, measurements, and visit completion. Advice Only Group Participants in the advice group received advice to follow the National High Blood Pressure Education Program lifestyle recommendations for blood pressure control (2). Lifestyle recommendations included reducing weight (if overweight), following a reduced-sodium diet, engaging in regular moderate-intensity physical activity, and eating a heart-healthy diet, including the DASH diet. This advice was provided in two 30-minute individual sessions, 1 immediately after random assignment and 1 after the 6-month data collection visit. A PREMIER counselor reviewed the guidelines with the participant and provided printed educational materials and information about community resources. This intervention did not include advice to keep a food or exercise diary. Behavioral Interventions in the Established and Established plus DASH Groups Participant goals for the established and established plus DASH groups included weight loss of at least 6.8 kg (15 lb) for those with a body mass index of 25 kg/m2 or greater, at least 180 minutes per week of moderate-intensity physical activity, no more than 100 mmol per day of dietary sodium, and alcohol consumption of no more than 30 mL (1 oz) per day (2 drinks) for men and 15 mL (0.5) oz per day (1 drink) for women. Participants assigned to the established plus DASH group (but not those in the established group) also received counseling on the DASH diet, with goals for increased consumption of fruits and vegetables (9 to 12 servings/d) and low-fat dairy products (2 to 3 servings/d) and reduced consumption of saturated fat ( 7% of energy) and total fat ( 25% of energy). The intervention format, contact pattern, and behavior change strategies for the established and established plus DASH groups were identical. During the first 6 months, participants in both behavioral intervention groups attended 14 group sessions and 4 individual sessions; during months 7 to 18, they attended monthly group sessions supplemented with 3 individual counseling sessions. Throughout the trial, participants in the established and established plus DASH groups (but not those in the advice group) kept food diaries, monitored dietary calorie and sodium intakes, and recorded minutes of physical activity. Self-monitoring was used to provide individualized feedback, reinforcement, problem solving, and support. Social support for initial behavior changes and maintenance of change was provided during the group sessions. More detailed descriptions of the behavorial intervention methods are available (22). Measurements Blood pressure was assessed twice at each measurement, and systolic and diastolic blood pressures were calculated by using the mean of all available measurements (4 sets before random assignment, 3 sets at 6 and 18 months, and 1 set at 3 and 12 months). For 4 participants who were started on antihypertensive drug therapy between the 12- and 18-month visits, we obtained an official set of blood pressure measurements before initiation of therapy and used these as our 18-month blood pressure values for analysis. A similar procedure was used to obtain the 6-month blood pressure value for the 1 participant who began taking antihypertensive drugs between the 3- and 6-month visits. Two 24-hour dietary recalls, 1 obtained on a weekday and the other obtained on a weekend, were collected at baseline and at 6 and 18 months by telephone interview (23). Intakes of nutrients and food groups were calculated by using the Nutrition Data System for Research, version NDS-R 1998 (University of Minnesota, Minneapolis, Minnesota). Urinary excretion of sodium (reflecting salt intake) and potassium (reflecting fruit and vegetable intake) was obtained from 24-hour urinary collections at baseline a

Practice Guideline2013 AHA/ACC Guideline on Lifestyle Management to Reduce Cardiovascular Risk: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines☆

This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.

Effects of Diet and Sodium Intake on Blood Pressure: Subgroup Analysis of the DASH-Sodium Trial

Although epidemiologic data show a direct relation between dietary sodium intake and blood pressure at the population level (1, 2), some experts question the universality of the findings and oppose public health recommendations to decrease sodium intake in the general population (3). Certainly, results from reports on the relationship between sodium and blood pressure among major subgroups vary considerably. Several studies suggest that African Americans and older adults have heightened salt sensitivity (greater blood pressure response to sodium intake) (4-6). Some evidence also indicates increased salt sensitivity in women (7), although other studies do not support this claim (4, 5). The association of sodium intake with cardiovascular morbidity and mortality varies by overweight status (8), perhaps reflecting a differential effect of sodium on blood pressure in overweight persons. Finally, higher dietary intakes of potassium and calcium have been shown to blunt the pressor effects of dietary sodium (9, 10). Dietary factors other than sodium also directly affect blood pressure, and these effects also appear to vary across subgroups. In the Dietary Approaches to Stop Hypertension (DASH) Trial, for example, a diet that had reduced total and saturated fat and was rich in fruits, vegetables, and low-fat dairy foods (the DASH diet) substantially decreased blood pressure compared with a more typical U.S. diet, in the absence of weight change and at sodium intakes approximating current U.S. consumption (11, 12). These effects persisted across all subgroups and were especially pronounced among hypertensive persons, African Americans, and persons who did not drink alcohol (13). The DASH-Sodium Trial examined the effects of reduced sodium intake in the context of the DASH diet and a more typical U.S. diet (14). In that study, highly significant decreases in blood pressure were observed with decreased sodium intake in participants following either diet, and the DASH diet decreased blood pressure at sodium intakes well below the current U.S. average. These results were observed overall and in subgroups defined by ethnicity, sex, and hypertension status (15). We report on more detailed subgroup analyses from the DASH-Sodium Trial, including results for subgroups defined by age, obesity, waist circumference, alcohol intake, and baseline sodium intake. We also report the results of multivariate analyses that demonstrate how these effects vary across subgroups defined jointly by age, ethnicity, sex, and hypertension status. Methods Study Design The DASH-Sodium Trial was a multicenter, randomized feeding trial comparing the effects on blood pressure of three levels of sodium intake and two dietary patterns. The 412 participants were 22 years of age or older and had systolic blood pressures of 120 to 159 mm Hg and diastolic blood pressures of 80 to 95 mm Hg (15). The three levels of sodium intake (lower, intermediate, and higher) varied according to energy intake in a ratio of 1:2:3; target intakes were 50, 100, and 150 mmol/d, respectively, for a 2100-kcal diet. The dietary patterns were a control diet, typical of what many Americans eat, and the DASH diet, which emphasizes fruits, vegetables, and low-fat dairy foods; includes whole grains, poultry, fish, and nuts; and is reduced in fats, red meat, sweets, and sugar-containing beverages (11, 14). Participants were recruited in four separate feeding cohorts and were randomly assigned to one of the two dietary patterns by using a parallel-group design. They then ate their assigned diet for three consecutive 30-day intervention feeding periods, during which sodium intake varied among the three levels by a randomly assigned sequence (Figure). Participants ate the control diet at the higher sodium intake during a 2-week run-in period. During the three intervention periods, participants received all their food in the context of the study and were asked not to eat any nonstudy food. Individual energy intake was adjusted to keep body weight stable. Figure. Design of the Dietary Approaches to Stop Hypertension (DASH)-Sodium Trial. Exclusion criteria were heart disease, renal insufficiency, poorly controlled hyperlipidemia or diabetes mellitus, diabetes requiring insulin, special dietary requirements, intake of more than 14 alcoholic drinks/wk, or use of antihypertensive drugs or other medications that would affect blood pressure or nutrient metabolism. The study was approved by the human subjects committees of the clinical centers and coordinating center, and participants gave informed consent. Measurement Protocol Trained staff measured blood pressure at each of three screening visits, on 2 days during the run-in period, and on 5 of the last 9 days of each intervention feeding period. Interim blood pressures were assessed once during each of the first 3 weeks of each intervention feeding period. During screening and the last week of each intervention feeding period, a 24-hour urine collection was obtained. Height and weight were measured, and body mass index was calculated. Baseline physical activity was measured by using a 7-day physical activity recall interview (16). Information on education level, income, alcohol consumption, and family history was obtained by using a questionnaire. Baseline blood pressure was defined as the average of the five preintervention blood pressures. End-of-feeding blood pressures were defined as the average of the five blood pressures at the end of each 30-day intervention feeding period. If no end-of-feeding blood pressure values were available (49 of 1236 possible cases), interim (n = 9) or screening (n = 40) blood pressures were used to impute end-of-feeding blood pressures. Definitions of Subgroups Ethnicity was categorized as African American versus other (primarily non-Hispanic white). Participants were considered hypertensive if their untreated baseline systolic blood pressure was 140 mm Hg or greater and their diastolic blood pressure was 90 mm Hg or greater. (Use of antihypertensive agents was an exclusion criterion [17].) Obesity was defined as body mass index of 30 kg/m2 or greater, and high-risk waist circumference was defined as greater than 102 cm in men and greater than 88 cm in women (18). Age, physical activity, baseline alcohol intake, baseline 24-hour urinary sodium level, and family income were dichotomized at the approximate median. Level of education was dichotomized as high school or less versus more than high school. Statistical Analysis The data were analyzed on an intention-to-treat basis. Given the differential effects of sodium on blood pressure observed in previous analyses among participants eating the DASH diet versus the control diet (15) and because power for subgroup analyses is more limited than for overall analysis, we focused our comparisons on the maximum contrasts (higher versus lower sodium intake with the control diet, DASH diet versus control diet at the higher sodium intake, and the combined effect of DASH diet and lower sodium intake versus control diet and higher sodium intake). We used generalized estimating equations (19) to fit linear models that predicted baseline and end-of-feeding blood pressures as a function of diet (DASH vs. control), sodium level, and subgroup indicators. Different ways of modeling the dietsodium effects and their interactions with the subgroup indicators were used to test specific hypotheses. In particular, two-way interactions of the various dietsodium effects with ethnicity, sex, hypertension status, and age were analyzed to determine the incremental effect on blood pressure in each of these subgroups while controlling for the main and incremental effects of the other subgroups. This model allowed us to estimate various diet-sodium contrasts for each of the 16 subgroups defined by hypertension status, ethnicity, sex, and age. A second set of models examined subgroup variables in a bivariate manner and did not assume simple additivity of subgroup effects. Finally, unadjusted subgroup analyses included main effects and interactions for a single subgroup indicator. All analyses were performed by using the xtgee procedure in Stata software, version 5 (Stata Corp., College Station, Texas) (20) and included adjustment for baseline blood pressure, site, feeding cohort, and carryover effects. An exchangeable covariance matrix was assumed for the repeated measurements for each participant. Unless otherwise stated, a P value less than 0.05 was significant, and all confidence intervals are 95% confidence intervals. Because subgroup analyses were planned to interpret and elucidate the overall study results, they are not adjusted for multiple comparisons. Results Of the 412 participants who underwent randomization, 390 (95%) completed the 12-week intervention feeding period. Adherence to the study diets seemed excellent, and body weight remained stable over time (15). Table 1 shows baseline characteristics of the 412 participants. Mean urinary sodium excretion at screening was 155 mmol/d, a value higher than that found while participants ate higher-sodium diets (142 mmol/d). Table 1. Characteristics of Study Sample Several key subgroups were highly interrelated. Women made up 70% of African-American participants but only 39% of non-African-American participants. Women were more likely to be hypertensive than were men. The percentage of both men and women with hypertension increased sharply with age among non-African-American participants (21% of those 45 years of age vs. 47% of those >45 years of age) but was equally high among older and younger African Americans (43% of those 45 years of age vs. 45% of those >45 years of age). These correlations highlight the potential for confounding in our results and, hence, the importance of the multivariate-adjusted analyses. Effects of the DASH Diet Table 2 shows the effect on systolic blood pressure of the DASH diet compared with the control diet du

Predictors of blood pressure response in the SYMPLICITY HTN-3 trial

AIMS The SYMPLICITY HTN-3 randomized, blinded, sham-controlled trial confirmed the safety of renal denervation (RDN), but did not meet its primary efficacy endpoint. Prior RDN studies have demonstrated significant and durable reductions in blood pressure. This analysis investigated factors that may help explain these disparate results. METHODS AND RESULTS Patients with resistant hypertension were randomized 2 : 1 to RDN (n = 364) or sham (n = 171). The primary endpoint was the difference in office systolic blood pressure (SBP) change at 6 months. A multivariable analysis identified predictors of SBP change. Additional analyses examined the influence of medication changes, results in selected subgroups and procedural factors. Between randomization and the 6-month endpoint, 39% of patients underwent medication changes. Predictors of office SBP reduction at 6 months were baseline office SBP ≥ 180 mmHg, aldosterone antagonist use, and non-use of vasodilators; number of ablations was a predictor in the RDN group. Non-African-American patients receiving RDN had a significantly greater change in office SBP than those receiving sham; -15.2 ± 23.5 vs. -8.6 ± 24.8 mmHg, respectively (P = 0.012). Greater reductions in office and ambulatory SBP, and heart rate were observed with a higher number of ablations and energy delivery in a four-quadrant pattern. CONCLUSIONS Post hoc analyses, although derived from limited patient cohorts, reveal several potential confounding factors that may partially explain the unexpected blood pressure responses in both the sham control and RDN groups. These hypothesis-generating data further inform the design of subsequent research to evaluate the potential role of RDN in the treatment of resistant hypertension. CLINICALTRIALS.GOV IDENTIFIER: NCT01418261.

Weight Loss During the Intensive Intervention Phase of the Weight-Loss Maintenance Trial

BACKGROUND To improve methods for long-term weight management, the Weight Loss Maintenance (WLM) trial, a four-center randomized trial, was conducted to compare alternative strategies for maintaining weight loss over a 30-month period. This paper describes methods and results for the initial 6-month weight-loss program (Phase I). METHODS Eligible adults were aged > or =25, overweight or obese (BMI=25-45 kg/m2), and on medications for hypertension and/or dyslipidemia. Anthropomorphic, demographic, and psychosocial measures were collected at baseline and 6 months. Participants (n=1685) attended 20 weekly group sessions to encourage calorie restriction, moderate-intensity physical activity, and the DASH (dietary approaches to stop hypertension) dietary pattern. Weight-loss predictors with missing data were replaced by multiple imputation. RESULTS Participants were 44% African American and 67% women; 79% were obese (BMI> or =30), 87% were taking anti-hypertensive medications, and 38% were taking antidyslipidemia medications. Participants attended an average of 72% of 20 group sessions. They self-reported 117 minutes of moderate-intensity physical activity per week, kept 3.7 daily food records per week, and consumed 2.9 servings of fruits and vegetables per day. The Phase-I follow-up rate was 92%. Mean (SD) weight change was -5.8 kg (4.4), and 69% lost at least 4 kg. All race-gender subgroups lost substantial weight: African-American men (-5.4 kg +/- 7.7); African-American women (-4.1 kg +/- 2.9); non-African-American men (-8.5 kg +/- 12.9); and non-African-American women (-5.8 kg +/- 6.1). Behavioral measures (e.g., diet records and physical activity) accounted for most of the weight-loss variation, although the association between behavioral measures and weight loss differed by race and gender groups. CONCLUSIONS The WLM behavioral intervention successfully achieved clinically significant short-term weight loss in a diverse population of high-risk patients.