One-year postpartum outcomes following a weight management intervention in pregnant women with obesity.

OBJECTIVE: This analysis was focused on 1-year maternal and infant follow-up of a randomized trial that tested a weight management intervention conducted during pregnancy. METHODS: One hundred fourteen women with obesity (mean BMI 36.7 kg/m(2) ) were randomly assigned at a mean of 15 weeks gestation to a weight management intervention or usual care control condition. The intervention ended at delivery and resulted in less gestational weight gain and a lower proportion of large-for-gestational-age newborns among intervention compared with control participants. The primary outcome at 12 months postpartum was maternal weight. Secondary outcomes included infant weight-for-age and weight-for-length z-scores. RESULTS: At 1 year, mothers in the intervention group weighed 96.3 ± 18.6 kg and those in the control group 99.7 ± 19.2 kg. There was no significant difference between groups in change in weight from randomization to 1 year postpartum (b = -0.47, 95% CI: -4.03 to 3.08). There was a significant main effect of group for infant weight-for-age z-scores (b = -0.40, 95% CI: -0.75 to -0.05) but not infant weight-for-length z-scores (b = -0.20, 95% CI: -0.59 to 0.20). CONCLUSIONS: A gestational weight management intervention did not influence maternal weight or infant weight-for-length at 1 year postpartum. Future studies may be warranted to determine whether extending prenatal interventions into the postpartum period would be beneficial for maternal and infant outcomes.

Efficacy of a group-based dietary intervention for limiting gestational weight gain among obese women: a randomized trial.

OBJECTIVE: Observational studies suggest that minimal gestational weight gain (GWG) may optimize pregnancy outcomes for obese women. This trial tested the efficacy of a group-based weight management intervention for limiting GWG among obese women. METHODS: One hundred and fourteen obese women (BMI [mean ± SD] 36.7 ± 4.9 kg/m(2) ) were randomized between 7 and 21 weeks' (14.9 ± 2.6) gestation to intervention (n = 56) or usual care control conditions (n = 58). The intervention included individualized calorie goals, advice to maintain weight within 3% of randomization and follow the Dietary Approaches to Stop Hypertension dietary pattern without sodium restriction, and attendance at weekly group meetings until delivery. Control participants received one-time dietary advice. Our three main outcomes were maternal weight change from randomization to 2 weeks postpartum and from randomization to 34 weeks gestation, and newborn large-for-gestational age (birth weight >90th percentile, LGA). RESULTS: Intervention participants gained less weight from randomization to 34 weeks gestation (5.0 vs. 8.4 kg, mean difference = -3.4 kg, 95% CI [-5.1-1.8]), and from randomization to 2 weeks postpartum (-2.6 vs. +1.2 kg, mean difference = -3.8 kg, 95% CI [-5.9-1.7]). They also had a lower proportion of LGA babies (9 vs. 26%, odds ratio = 0.28, 95% CI [0.09-0.84]). CONCLUSIONS: The intervention resulted in lower GWG and lower prevalence of LGA newborns.

Healthy Moms, a randomized trial to promote and evaluate weight maintenance among obese pregnant women: study design and rationale.

BACKGROUND: Obesity and excessive weight gain during pregnancy are associated with adverse pregnancy outcomes. Observational studies suggest that minimal or no gestational weight gain (GWG) may minimize the risk of adverse pregnancy outcomes for obese women. OBJECTIVE: This report describes the design of Healthy Moms, a randomized trial testing a weekly, group-based, weight management intervention designed to help limit GWG to 3% of weight (measured at the time of randomization) among obese pregnant women (BMI≥30 kg/m(2)). Participants are randomized at 10-20 weeks gestation to either the intervention or a single dietary advice control condition. PRIMARY OUTCOMES: The study is powered for the primary outcome of total GWG, yielding a target sample size of 160 women. Additional secondary outcomes include weight change between randomization and one-year postpartum and proportion of infants with birth weight>90th percentile for gestational age. Statistical analyses will be based on intention-to-treat. METHODS: Following randomization, all participants receive a 45-minute dietary consultation. They are encouraged to follow the Dietary Approaches to Stop Hypertension diet without sodium restriction. Intervention group participants receive an individualized calorie intake goal, a second individual counseling session and attend weekly group meetings until they give birth. Research staff assesses all participants at 34-weeks gestation and at 2-weeks and one-year postpartum with their infants. SUMMARY: The Healthy Moms study is testing weight management techniques that have been used with non-pregnant adults. We aim to help obese women limit GWG to improve their long-term health and the health of their offspring.

A brief intervention designed to increase breast cancer self-screening.

PURPOSE: To assess the efficacy of an intervention designed to increase appropriate use of breast self-examination (BSE). METHODS: Two-armed randomized clinical trial of cancer-control interventions in women that compared a BSE intervention program to a dietary intervention, which served as the control group. The study was conducted at a large health maintenance organization in Portland, Oregon. Participants were 616 female members of the health maintenance organization who were aged 40 to 70 years. The intervention consisted of a 30- to 45-minute individual counseling session that featured BSE instruction, training and practice with silicone models, identification of barriers to BSE, and problem-solving. This intervention was followed by two brief follow-up telephone calls. The study outcome measure was self-reported BSE practice, which included duration, frequency, and specific elements of exam. RESULTS: The study had a 90% response rate. At the 1-year follow-up, chi2 analyses showed that significantly more individuals in the BSE intervention (59%) reported adequate BSE performance compared with those in the control group (12.2%; p < .001). CONCLUSIONS: This brief intervention was successful in encouraging women to perform adequate BSEs. Although the role of the BSE in patient care remains controversial, these results show that even brief intervention programs can be effective at encouraging self-screening for cancer. This intervention could easily be modified to target other screening practices (e.g., skin or testicular cancer screening) that are associated with reduced cancer morbidity and mortality.

Development and implementation of an integrated, multi-modality, user-centered interactive dietary change program.

Computer-tailored behavior change programs offer the potential for reaching large populations at a much lower cost than individual or group-based programs. However, few of these programs to date appear to integrate behavioral theory with user choice, or combine different electronic modalities. We describe the development of an integrated CD-ROM and interactive voice response dietary change intervention that combines behavioral problem-solving theory with a high degree of user choice. The program, WISE CHOICES, is being evaluated as part of an ongoing trial. This paper describes the program development, emphasizing how user preferences are accommodated, and presents implementation and user satisfaction data. The program was successfully implemented; the linkages among the central database, the CD-ROM and the automated telephone components were robust, and participants liked the program almost as well as a counselor-delivered dietary change condition. Multi-modality programs that emphasize the strengths of each approach appear to be feasible. Future research is needed to determine the program impact and cost-effectiveness compared with counselor-delivered intervention.

Effectiveness of the 5-As tobacco cessation treatments in nine HMOs.

BACKGROUND: Smoking remains the leading cause of preventable mortality in the US. The national clinical guideline recommends an intervention for tobacco use known as the 5-As (Ask, Advise, Assess, Assist, and Arrange). Little is known about the model's effectiveness outside the research setting. OBJECTIVE: To assess the effectiveness of tobacco treatments in HMOs. PARTICIPANTS: Smokers identified from primary care visits in nine nonprofit health plans. DESIGN/METHODS: Smokers were surveyed at baseline and at 12-month follow-up to assess smoking status and tobacco treatments offered by clinicians and used by smokers. RESULTS: Analyses include the 80% of respondents who reported having had a visit in the previous year with their clinician when they were smoking (n = 2,325). Smokers were more often offered Advice (77%) than the more effective Assist treatments-classes/counseling (41%) and pharmacotherapy (33%). One third of smokers reported using pharmacotherapy, but only 16% used classes or counseling. At follow-up, 8.9% were abstinent for >30 days. Smokers who reported being offered pharmacotherapy were more likely to quit than those who did not (adjusted OR = 1.73, CI = 1.22-2.45). Compared with smokers who didn't use classes/counseling or pharmacotherapy, those who did use these services were more likely to quit (adjusted OR = 1.82, CI = 1.16-2.86 and OR = 2.23, CI = 1.56-3.20, respectively). CONCLUSIONS: Smokers were more likely to report quitting if they were offered cessation medications or if they used either medications or counseling. Results are similar to findings from clinical trials and highlight the need for clinicians and health plans to provide more than just advice to quit.

Biobank Recruitment: Motivations for Nonparticipation.

Molecular data, essential for genomics research, can be captured more efficiently in large-scale, population-based biobanks of genetic material rather than by individual studies. Biobanks also offer improved quality and reliability of genetic samples and access through automated sample retrieval. However, it is challenging to adequately inform participants of the broad nature of the research and participation risks and benefits. In addition, recent studies suggest concerns about data sharing and return of research results, or future research topics (eg, stereotypical or potentially stigmatizing traits). We evaluated the interest in participating in a biobank and reasons for nonparticipation.

Using web-based screening to enhance efficiency of HMO clinical trial recruitment in women aged forty and older.

BACKGROUND: Screening potential participants for clinical trials can be labor-intensive, particularly when using long questionnaires administered by telephone. PURPOSE: This report describes the development and use of an interactive recruitment website as a supplemental screening strategy for a study using telephone screening interviews. METHODS: Female HMO members, aged 40 and older, were recruited for a study testing dietary change interventions. Cohorts of potential participants were identified from electronic membership records every two to four weeks; they were sent a letter describing the study and then contacted by telephone. Those interested in the study were asked to complete a 27-question screening interview focused on dietary habits. After 14 cohorts of women were recruited by this method (n=4246), a recruitment website was added and an additional 12 cohorts (n=3000) were contacted. The modified recruitment letter for these later screening cohorts included the website address and a personal password for each woman. The website contained study information, and those who were interested could complete eligibility screening on-line. RESULTS: Proactive participant response (women actively seeking study participation/screening) to the recruitment mailing was 9.5% (95% confidence interval (CI), 8.6-10.4%) in the cohorts without the website option and 11.5% (CI, 10.4-12.7%) after addition of the website option (P=0.004). About half of women screened were ineligible for the study, a proportion that did not statistically differ by recruitment method. LIMITATIONS: The study population was limited to middle-aged and older female members of a non-profit health plan, so the generalizability of these findings to other populations is unknown. The pre-post design used in this study does not control for possible temporal changes unrelated to the study methods. CONCLUSIONS: The addition of the website screening option was associated with a relative 22% increase in recruitment combined with reduced staff time required for screening, thereby increasing screening efficiency. Web-based options for clinical trial recruitment and screening in targeted populations may increase response rates while also reducing staff time.

Natural language processing in the electronic medical record: assessing clinician adherence to tobacco treatment guidelines.

BACKGROUND: Comprehensively assessing care quality with electronic medical records (EMRs) is not currently possible because much data reside in clinicians' free-text notes. METHODS: We evaluated the accuracy of MediClass, an automated, rule-based classifier of the EMR that incorporates natural language processing, in assessing whether clinicians: (1) asked if the patient smoked; (2) advised them to stop; (3) assessed their readiness to quit; (4) assisted them in quitting by providing information or medications; and (5) arranged for appropriate follow-up care (i.e., the 5A's of smoking-cessation care). DESIGN: We analyzed 125 medical records of known smokers at each of four HMOs in 2003 and 2004. One trained abstractor at each HMO manually coded all 500 records according to whether or not each of the 5A's of smoking cessation care was addressed during routine outpatient visits. MEASUREMENTS: For each patient's record, we compared the presence or absence of each of the 5A's as assessed by each human coder and by MediClass. We measured the chance-corrected agreement between the human raters and MediClass using the kappa statistic. RESULTS: For "ask" and "assist," agreement among human coders was indistinguishable from agreement between humans and MediClass (p>0.05). For "assess" and "advise," the human coders agreed more with each other than they did with MediClass (p<0.01); however, MediClass performance was sufficient to assess quality in these areas. The frequency of "arrange" was too low to be analyzed. CONCLUSIONS: MediClass performance appears adequate to replace human coders of the 5A's of smoking-cessation care, allowing for automated assessment of clinician adherence to one of the most important, evidence-based guidelines in preventive health care.

Relationship between tobacco control policies and the delivery of smoking cessation services in nonprofit HMOs.

BACKGROUND: This project examined tobacco policies and delivery of cessation services in nonprofit HMOs that collectively provide comprehensive medical care to more than 8 million members. METHODS: Three annual surveys with health plan managers showed that all of these health plans had written tobacco control guidelines that became more comprehensive over the span of this study. We also surveyed a random sample of 4207 current smokers who had attended a primary care visit in the past year (399-528 at each of nine health plans). RESULTS: Of these smokers, 71% reported advice to quit, 56% were asked about their willingness to quit, 49% were provided some assistance in quitting (mostly self-help material or information about classes or counseling), and 9% were offered some kind of follow-up. Smokers receiving assistance in quitting reported higher satisfaction with their care. CONCLUSIONS: In general, health plans with the most comprehensive policies also showed higher rates of implementing tobacco treatment programs in primary care. Compared with tobacco control efforts of a decade or more ago, considerable progress has been made. However, there is still room for improvement in the proportion of smokers who receive the most effective forms of assistance in quitting.

Tobacco-cessation services and patient satisfaction in nine nonprofit HMOs.

BACKGROUND: The U.S. Public Health Service clinical practice guideline calls for clinicians and healthcare organizations to identify and treat every tobacco user seen in a healthcare setting. There is little information on the extent of compliance with the guideline's treatment model described by the "5A's" (Ask, Advise, Assess, Assist, Arrange). METHODS: In 1999-2000 a survey was mailed to 64,764 members aged 25 to 75 years, of nine nonprofit HMOs participating in the National Cancer Institute-funded Cancer Research Network. These plans provide medical care to more than 8 million Americans including a minority enrollment of 30%. Smokers were asked about tobacco-cessation treatments received during primary care visits in the past year. RESULTS: A 70% response rate identified a smoking prevalence of 10% (n=4207). Results indicated that 90% of smokers were asked about smoking, 71% were advised to quit, 56% were assessed for their willingness to quit, 49% received assistance interventions, and 9% had follow-up arranged. Treatment was provided more often to smokers who asked for help and/or intended to quit. Few and only modest associations were found between other patient characteristics and receipt of 5A's cessation services. In contrast to widely reported concerns about smokers' resistance to tobacco interventions, smokers who received treatment were more satisfied with health plan services. CONCLUSIONS: Results demonstrate substantial clinician compliance with the first two steps-Ask and Advise. Greater efforts are needed in providing the more effective tobacco treatments-Assist and Arrange. Compliance with the guideline is associated with greater patient satisfaction.

Tobacco control efforts in managed care: what do the doctors think?

OBJECTIVES: To use physician reports to evaluate their awareness of health plan tobacco control guidelines and cessation support coverage and to validate the extent to which health plan cessation support material had been disseminated and implemented in clinical settings. STUDY DESIGN: Comparison of survey responses of physicians with tobacco control activities reported by key informants in the health plans with which those physicians were associated. METHODS: A total of 100 primary care physicians in the care delivery organizations associated with 9 nonprofit health plans were randomly selected to receive a survey asking about their health plan's tobacco cessation guidelines, coverage, and support for clinician action. Their responses were compared to data reported by the plan with which they were associated. RESULTS: Responses were obtained from 91%. Although 88% were aware of their health plan's tobacco cessation guidelines, considerably fewer were correctly aware of whether the health plan covered medications and cessation classes or counseling. Physician reports of cessation supports during care bore little relationship to health plan reports of those supports. CONCLUSIONS: Physician reports may be a useful way to verify health plan dissemination and implementation of tobacco control activities. Even these relatively high-performing plans have ample room for further improvement.

One-year results from a brief, computer-assisted intervention to decrease consumption of fat and increase consumption of fruits and vegetables.

BACKGROUND: Current cancer prevention recommendations include reducing consumption of fat and increasing consumption of fruits and vegetables. METHODS: Healthy women health maintenance organization members (n = 616) ages 40-70 were randomly assigned to either a nutrition intervention or a control intervention unrelated to diet. Intervention included two 45-min counseling sessions plus two brief follow-up telephone contacts. Counseling sessions included a 20-min, interactive, computer-based intervention using a touch-screen format. Intervention goals were reducing dietary fat and increasing fruit and vegetable consumption. Outcome measures included a food frequency questionnaire and the Fat and Fiber Behavior Questionnaire (FFBQ). Total serum cholesterol was also measured at baseline and 12 months. RESULTS: Twelve-month follow-up data showed improvements on all dietary outcome variables. Compared to the control, intervention participants reported significantly less fat consumption (3.75 points less for percentage of energy from fat), significantly greater consumption of fruit and vegetables combined (0.93 more servings per day), and a significant reduction in a behavioral measure of fat consumption (0.20 point change in the FFBQ). Group differences in total serum cholesterol, while in the desired direction, were not significant. CONCLUSIONS: In appropriate circumstances, moderate-intensity dietary interventions can show significant effects for periods of at least 1 year.

Randomized trial of a brief dietary intervention to decrease consumption of fat and increase consumption of fruits and vegetables.

PURPOSE: This study tested the efficacy of a computer-assisted counseling intervention to reduce diet-related cancer risk. DESIGN: Randomized controlled trial. SUBJECTS: Healthy women HMO members (n = 616) aged 40 to 70. INTERVENTION: Participants were randomly assigned to nutrition intervention or an attention-control intervention unrelated to diet. Intervention consisted of two 45-minute counseling sessions plus two 5- to 10-minute follow-up telephone contacts. Counseling sessions included a 20-minute, interactive, computer-based intervention using a touchscreen format. Intervention goals were reducing dietary fat and increasing consumption of fruit, vegetables, and whole grains. MEASURES: Twenty-four hour diet recalls and the Fat and Fiber Behavior Questionnaire (FFB). RESULTS: Four-month follow-up data were collected from 94% of the intervention participants and 91% of the controls. Testing with a multivariate general linear models analysis showed improvements on all dietary outcome variables. Compared to the control, intervention participants reported significantly less fat consumption (2.35 percentage points less for percentage of energy from fat), significantly greater consumption of fruit and vegetables combined (1.04 servings per day), and a significant reduction in a behavioral measure of fat consumption (.24 point change in the FFB). CONCLUSIONS: These 4-month results are comparable to several other moderate-intensity studies showing that, in the appropriate circumstances, moderate-intensity dietary interventions can be efficacious. Study limitations include the short follow-up period and the use of self-reported outcome measures.

Screening HMO women overdue for both mammograms and pap tests.

BACKGROUND: Regular screening has the potential to reduce breast and cervical cancer mortality, but despite health plan programs to encourage screening, many women remain unscreened. Tailored communications have been identified as a promising approach to promote mammography and Pap test screening. METHODS: The study used a four-group randomized design to compare with Usual Care the separate and combined effects of two tailored, motivational interventions to increase screening-a clinical office In-reach intervention and a sequential letter/telephone Outreach intervention. Subjects were 510 female HMO members ages 52-69 who had had no mammogram in the past 2 years and no Pap smear in the past 3 years. Primary outcomes were the percentage of women in each condition who received a mammogram, a Pap smear, or both screening tests during the 14-month study period. RESULTS: Thirty-two percent of the Combined group, 39% of the Outreach group, and 26% of the In-reach group obtained both services versus 19% of Usual Care participants. Overall, compared with Usual Care, both Outreach (P = 0.006) and Combined (P = 0.05) screened significantly more women. For subjects ages 65-69, Outreach rates were lower than those of Usual Care. CONCLUSION: A tailored letter-telephone Outreach appears to be more effective at screening women ages 52-64 than a tailored office-based intervention, in large part because most In-reach women did not have clinic visits at which to receive the intervention.