Phillip J. Brantley

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

A Daily Stress Inventory: development, reliability, and validity.

This article describes the development of the Daily Stress Inventory, a measure introduced to provide researchers and clinicians with a psychometrically sound self-report instrument for the daily assessment of the sources and individualized impact of relatively minor stressful events. It was designed to assess sources of stress not typically assessed by major life-event scales. Generalizability coefficients indicate that the scale has significant homogeneity and a useful degree of stability. Several studies investigating the concurrent and construct validities suggest that the scale measures the construct commonly referred to as “stress”. Implications for uses in theoretical and basic research as well as clinical assessment are discussed.

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.

Postconcussion symptoms and daily stress in normal and head-injured college populations.

The postconcussion syndrome is a term invoked to describe a constellation of cognitive (decreased memory and concentration), emotional (increased irritability and nervousness or anxiety), and physical (increased headaches and dizziness) changes that are commonly reported following minor or severe head injuries. The first section presents the development and validation of the Postconcussion Syndrome Checklist. The second section describes the daily changes in symptom reports as a function of daily stress levels. A population of head-injured subjects and controls monitored postconcussion symptoms and stress across a 6-week period. The frequency, intensity, and duration of symptoms reported were correlated with daily stress levels as measured by the Daily Stress Inventory for both groups. Yet, the number of symptoms reported by our head-injured group did not vary significantly from the normal subjects. The data support models which predict that postconcussion syndrome varies with stress, but the evidence for a reduction in the cerebral reserve capacity after head injury was not supported with this population. Explanations for this finding are presented and implications of this research and directions for future research are outlined.

The Utility of the Ces-D as a Depression Screening Measure among Low-Income Women Attending Primary Care Clinics

Objective: Depressive disorders are among the most common medical disorders seen in primary care practice. The Center for Epidemiologic Studies-Depression (CES-D) scale is one of the measures commonly suggested for detecting depression in these clinics. However, to our knowledge, there have been no previous studies examining the validity of the CES-D among low-income women attending primary care clinics. Method: Low-income women attending public primary care clinics (n = 179, ages 20–77) completed the CES-D and the Diagnostic Interview Schedule for the DSM-IV (DIS-IV). Results: The results supported the validity of the CES-D. The standard cut-score of 16 and above yielded a sensitivity of .95 and specificity of .70 in predicting Major Depressive Disorder (MDD). However, over two-thirds of those who screened positive did not meet criteria for MDD (positive predictive value = .28). The standard cut-score appears valid, but inefficient for depression screening in this population. An elevated cut-score of 34 yielded a higher specificity (.95) and over 50 percent of the patients who screened positive had a MDD (positive predictive value = .53), but at great cost to sensitivity (.45). Conclusion: Results indicated that the CES-D appears to be as valid for low-income, minority women as for any other demographic group examined in the literature. Despite similar validity, the CES-D appears to be inadequate for routine screening in this population. The positive predictive value remains very low no matter which cut-scores are used. The costs of the false positive rates could be prohibitive, especially in similar public primary care settings.

Validation of the Beck Depression Inventory-II in a Low-Income African American Sample of Medical Outpatients.

The psychometric properties of the Beck Depression Inventory-II (BDI-II) are well established with primarily Caucasian samples. However, little is known about its reliability and validity with minority groups. This study evaluated the psychometric properties of the BDI-II in a sample of low-income African American medical outpatients (N=220). Reliability was demonstrated with high internal consistency (.90) and good item-total intercorrelations. Criterion-related validity was demonstrated. A confirmatory factor analysis supported a hierarchical factor structure in which the BDI-II reflected 2 first-order factors (Cognitive and Somatic) that in turn reflected a second-order factor (Depression). These results are consistent with previous findings and thus support the use of the BDI-II in assessing depressive symptoms for African American patients in a medical setting.

Design and Implementation of an Interactive Website to Support Long-Term Maintenance of Weight Loss

Background For most individuals, long-term maintenance of weight loss requires long-term, supportive intervention. Internet-based weight loss maintenance programs offer considerable potential for meeting this need. Careful design processes are required to maximize adherence and minimize attrition. Objective This paper describes the development, implementation and use of a Web-based intervention program designed to help those who have recently lost weight sustain their weight loss over 1 year. Methods The weight loss maintenance website was developed over a 1-year period by an interdisciplinary team of public health researchers, behavior change intervention experts, applications developers, and interface designers. Key interactive features of the final site include social support, self-monitoring, written guidelines for diet and physical activity, links to appropriate websites, supportive tools for behavior change, check-in accountability, tailored reinforcement messages, and problem solving and relapse prevention training. The weight loss maintenance program included a reminder system (automated email and telephone messages) that prompted participants to return to the website if they missed their check-in date. If there was no log-in response to the email and telephone automated prompts, a staff member called the participant. We tracked the proportion of participants with at least one log-in per month, and analyzed log-ins as a result of automated prompts. Results The mean age of the 348 participants enrolled in an ongoing randomized trial and assigned to use the website was 56 years; 63% were female, and 38% were African American. While weight loss data will not be available until mid-2008, website use remained high during the first year with over 80% of the participants still using the website during month 12. During the first 52 weeks, participants averaged 35 weeks with at least one log-in. Email and telephone prompts appear to be very effective at helping participants sustain ongoing website use. Conclusions Developing interactive websites is expensive, complex, and time consuming. We found that extensive paper prototyping well in advance of programming and a versatile product manager who could work with project staff at all levels of detail were essential to keeping the development process efficient. Trial Registration clinicaltrials.gov NCT00054925

The relation between stress and disease activity in rheumatoid arthritis

This study investigated the relation between stress and current disease activity in rheumatoid arthritis (RA). During a routine clinic appointment, subjects were given ratings of global disease status by their physicians and completed self-report measures of major stress and minor stress. In addition, each subjects erythrocyte sedimentation rate was taken. After controlling for disease severity and major stress, minor stress accounted for a significant amount of the variance in inflammation level. These results suggest that minor stress is associated with current disease activity in RA.

Predicting medical regimen adherence: the interactions of health locus of control beliefs

The present study examined the interactions between five dimensions of health locus of control beliefs and their relationships with medical regimen adherence in low-income individuals diagnosed with type 2 diabetes. One hundred and nine patients were administered an expanded Multidimensional Health Locus of Control (MHLC) scale. HbA1c was used as a biological indicator of medical regimen adherence. Multivariate regression analyses demonstrated that three interactions were significantly related to HbA1c. The present findings suggest that HLOC may be meaningfully related to medical outcomes. However, these relationships may not be captured through the examination of main effects and may be only found when interactions are considered.