Jack F. Hollis

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.

Social networks as predictors of ischemic heart disease, cancer, stroke and hypertension: Incidence, survival and mortality

Three social network measures were obtained from a randomly sampled cohort of 2603 HMO members in 1970-71. Mortality and first incidence of ischemic heart disease, cancer, stroke, and hypertension were assessed over the next 15 years. Outcome data were adjusted for age, sex, smoking, SES, and baseline health status. Persons with histories of a given morbidity at or prior to baseline were excluded from the analyses of that morbidity. Social network measures, particularly network scope (a measure of the number of different domains in which a person has social contacts), were powerful predictors of 15-year mortality hazard, but weak predictors of incident disease. Only network scope predicted IHD incidence, and none of the other morbidities was predicted by the social network measures. However, social network measures were strong predictors of both cause-specific and all-cause mortality among persons who had incident cases of IHD, cancer, and stroke. These data suggest that social networks may be more effective in supporting recovery after illness has occurred than in preventing the incidence of new disease.

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.

Nurse-Assisted Counseling for Smokers in Primary Care

Physician-delivered, stop-smoking interventions significantly improve quit rates among smoking patients [1-6]. Unfortunately, only about one half of physicians in nonresearch settings consistently counsel smokers [7-11], and fewer than one half of all smokers report that a physician has ever advised them to quit [12-14]. Given the pressures of routine medical practice, it is not surprising that physicians do not take 3 to 5 minutes to counsel every smoking patient they see. Tobacco counseling competes with other pressing clinical tasks; physicians are often too busy to routinely and repeatedly counsel all patients who smoke [11, 15-17]. Physicians will deliver a cessation protocol as part of a study [5, 6, 18], but barriers such as a lack of time, training, and confidence make counseling in nonresearch settings less likely [1, 4, 19, 20]. New approaches [21-23], such as involving other office staff in counseling [17, 24, 25], are needed if tobacco counseling is to become a consistent and sustainable part of medical care delivery [26]. Because physicians see roughly 70%, or 38 million, of the 53 million smokers in the United States each year [15], even a modestly effective physician-driven intervention would have considerable impact on the nations health. This study tested the feasibility and effectiveness of a team counseling approach designed to minimize the burden on physicians by using non-physician clinic staff to provide the more time-consuming parts of cessation counseling. Key features of the team approach were a brief (30-second) physician-delivered cessation message, referral to an on-site nurse or other staff for additional cessation support, and the use of videos to deliver much of the intervention in an efficient and standardized manner. A previous report of process and short-term outcome measures showed that this organized team approach proved practical and sustainable [27]. The participating physicians and other providers delivered brief advice to 86% of identified smokers during the 1-year intake period, and most patients (87%) saw the counselor for materials and additional counseling. Nurse-Assisted counseling led to significantly improved quit rates at 3 months compared with brief physician advice alone. We present the effects of the intervention on long-term abstinence at 1 year. Methods Setting We conducted our study in two large primary care facilities of Kaiser Permanente Northwest Region, a group-practice health maintenance organization (HMO) in Portland, Oregon. Receptionists asked patients between 18 and 70 years of age to complete a health habit survey while waiting for their visit. The patients were seeing 1 of 60 primary care physicians (n = 42), physician assistants (n = 7), or nurse practitioners (n = 11) in outpatient internal medicine and family practice offices. Intervention Regular clinic nurses and clinical assistants collected the surveys as patients were taken to examination rooms and attached a notice to the medical charts of smokers (n = 3161) to alert providers to deliver a brief stop-smoking advice message. Providers were oriented to their role in a 1-hour training session. They were encouraged to use their own words but to not go beyond the following basic 30-second message: The best thing you can do for your health is to stop smoking and I want to advise you to stop as soon as possible. I know it can be hard and many try several times before they finally make it. You may or may not want to stop now, but I want you to talk briefly with our health counselor, who has some tips to make stopping easier when you decide the time is right. The 2707 (86%) smokers who received the provider advice message were considered participants in the study, regardless of whether they were willing to see the counselor or had any interest in quitting smoking. By the end of follow-up, 16 patients died, leaving a total sample of 2691. At the conclusion of the physician consultation, patients were seen by an on-site project nurse or health counselor who described what would be offered and obtained verbal consent to proceed. Patients who would not see the health counselor were mailed materials appropriate to their treatment assignment. Two random digits contained in the patients health record number were used to assign patients to one of the following four interventions: advice, self-quit, group-referral, or combination treatment. Physicians remained blind to treatment assignment. Advice participants received the 30-second provider advice message and a brief pamphlet, Why Do You Smoke?, from the health counselor. This clear and systematic advice would probably be more effective than no treatment or usual care, which were not included for logistic and ethical reasons. The self-quit condition included cessation advice, a carbon monoxide assessment, and a 10-minute How to Quit Smoking video designed specifically for this population. The video focused on the need to make a personal decision to quit, the steps to successful quitting, the frequent need for repeated efforts, and the importance of setting a specific quit date and using substitutes to smoking. The counselor provided a stop-smoking kit including smoking substitutes such as gum, toothpicks, and cinnamon sticks. A choice of one of three stop-smoking manuals was offered. Most participants chose the National Cancer Institutes manual, Quit for Good (54%), although others chose Calling it Quits (17%) or a two-part workbook produced by the American Lung Association titled, Freedom from Smoking in 20 Days and A Lifetime of Freedom from Cigarettes, respectively (29%). Patients were encouraged to set a specific quit date or some other specific plan of action and the counselor arranged to call the patient, usually within 2 to 4 weeks, to check on progress toward cessation. Patients were also mailed a set of stop-smoking tip sheets and a series of six professionally designed bimonthly newsletters devoted to smoking cessation. Group-referral participants also received advice, the carbon monoxide assessment, and a video. In this case, however, the video encouraged patients to join the HMOs intensive stop-smoking group program known as Freedom from Cigarettes. This program entails nine group meetings over 2 months. In a recent study, this program achieved roughly a 35% biochemically verified 1-year quit rate [28]. Patients were provided a brochure, a schedule of group sessions, and a time-limited coupon to waive the program fee. Efforts were made to schedule the patient for an upcoming group. Reminder postcards were sent 1 week before the scheduled meeting, and patients were called several days after the meeting to check on progress and, if necessary, to reschedule. Combination participants also received advice, the carbon monoxide assessment, and a third video, which described both the self-directed and the professionally led group approaches to smoking cessation. Self-directed cessation techniques, as well as the pros and cons of joining a professionally run program, were presented. Participants were asked to choose an approach that made sense for them. The self-help manual, stop-smoking kit, group materials, and fee-waiver coupon were all provided. Participants were encouraged to either set a quit date or sign up for a specific group session, and a telephone call was arranged to check on progress. Tip sheets and the bimonthly newsletters were mailed to all combination participants. Follow-up and Analyses Participants were surveyed by mail 3 and 12 months after their initial visits. Nonresponders were interviewed by telephone by an assessor who was blind to treatment assignment. Participants reporting abstinence from tobacco for at least 7 days before the 12-month assessment were asked to schedule appointments at a convenient clinic location or at their homes to provide saliva samples for biochemical confirmation. The primary end point was a two-point prevalence measure, which was defined as consecutive abstinence at both the 3- and 12-month assessments. Nonrespondents and those lost to follow-up were considered to be smokers. Results As shown in Table 1, participants in the four treatment groups were similar in terms of baseline age, sex, race, education, occupation, cigarettes smoked per day, stage of change, confidence in ability to quit, perceived degree of overweight, and subjective health status [27]. Table 1. Baseline Characteristics by Treatment Group* Self-reported smoking status was obtained on a high percentage of participants at both the 3-month (88%) and 12-month (86%) follow-up assessments. Response rates did not differ significantly across treatment groups. The proportion of participants who reported one or more serious attempts to quit in the year following their clinic visit was significantly higher (P < 0.004) among self-quit participants (53%) relative to advice participants (46%). Group-referral (48%) and combination participants (50%) did not differ from advice participants in terms of quit attempts. All three nurse-assisted interventionsself-quit, group referral, and combinationresulted in higher 3-month point prevalence quit rates than did the advice treatment (Table 2). At the 12-month follow-up, a larger percentage of participants reported abstinence, although differences between treatment arms were reduced. The 12-month point prevalence definition of abstinence, however, includes both long-term ex-smokers and those who quit as little as 1 week before the 1-year follow-up. With the more conservative primary end point, consecutive abstinence at both the 3-month and 12-month assessments, the three nurse-assisted interventions were superior to the advice intervention. Because quit rates for the three nurse-assisted interventions were similar for all analyses (P > 0.2), they were collapsed and compared to the advice intervention. Quit rates in the nurse-assisted groups were significantly higher than advice for the 3-month (6.

Biochemical validation of smoking status: Pros, cons, and data from four low-intensity intervention trials

Biochemical validation of smoking status has long been considered essential, but recent reports have questioned its utility in certain kinds of field trials. We describe efforts to biochemically validate self-reports of smoking cessation from participants in four large-scale randomized trials in outpatient clinics, hospitals, worksites, and dental clinics. These studies included over 5,000 adults smokers who participated in the population-based low-intensity intervention evaluations. At a 1-year follow-up, 798 subjects reported no tobacco use. We attempted to verify these reports using saliva continine/carbon monoxide validation procedures. Overall, there was a moderately high nonparticipation rate (27%), a low disconfirmation rate (4%), and a high self-reported relapse rate (12%) in the interval between survey and biochemical validation. There were no differences between intervention and control conditions on any of the above variables. Longer durations of self-reported abstinence were strongly related to increased probability of biochemical confirmation. Differences in results across projects were related to how biochemical validation was conducted. These results, as well as statistical power considerations, raise questions about whether biochemical validation procedures are practical, informative, or cost-effective in such population-based, low-intensity intervention research.

The effectiveness and cost effectiveness of telephone counselling and the nicotine patch in a state tobacco quitline

Objectives: State and national tobacco quitlines have expanded rapidly and offer a range of services. We examined the effectiveness and cost effectiveness of offering callers single session versus multisession counselling, with or without free nicotine patches. Methods: This 3×2 randomised trial included 4614 Oregon tobacco quitline callers and compared brief (one 15-minute call), moderate (one 30-minute call and a follow-up call) and intensive (five proactive calls) intervention protocols, with or without offers of free nicotine patches (nicotine replacement therapy, NRT). Blinded staff assessed tobacco use by phone at 12 months. Results: Abstinence odds ratios were significant for moderate (OR = 1.22, CI = 1.01 to 1.48) and intensive (OR = 1.29, CI = 1.07 to 1.56) intervention, and for NRT (OR = 1.58, CI = 1.35 to 1.85). Intent to treat quit rates were as follows: brief no NRT (12%); brief NRT (17%); moderate no NRT (14%); moderate NRT (20%); intensive no NRT (14%); and intensive NRT (21%). Relative to brief no NRT, the added costs for each additional quit was

A SMOKING-CESSATION INTERVENTION FOR HOSPITAL PATIENTS

2467 for brief NRT,

Teen Reach: Outcomes From a Randomized, Controlled Trial of a Tobacco Reduction Program for Teens Seen in Primary Medical Care

1912 for moderate no NRT,

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

2109 for moderate NRT,

Preventing smoking relapse, using an individually tailored skills-training technique.

2641 for intensive no NRT, and