K. Sabina Smith

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.

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

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.

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.

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

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.

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, χ2 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.

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

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.

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.