Minimal intervention needed for change: definition, use, and value for improving health and health research.

Much research focuses on producing maximal intervention effects. This has generally not resulted in interventions being rapidly or widely adopted or seen as feasible given resources, time, and expertise constraints in the majority of real-world settings. We present a definition and key characteristics of a minimum intervention needed to produce change (MINC). To illustrate use of a MINC condition, we describe a computer-assisted, interactive minimal intervention, titled Healthy Habits, used in three different controlled studies and its effects. This minimal intervention produced modest to sizable health behavior and psychosocial improvements, depending on the intensity of personal contacts, producing larger effects at longer-term assessments. MINC comparison conditions could help to advance both health care and health research, especially comparative effectiveness research. Policy and funding implications of requiring an intervention to be demonstrated more effective than a simpler, less costly MINC alternative are discussed.

Twelve-month outcomes of an Internet-based diabetes self-management support program.

OBJECTIVE: Internet-based programs offer potential for practical, cost-effective chronic illness self-management programs. METHODS: We report 12-month results of an Internet-based diabetes self-management program, with and without additional support, compared to enhanced usual care in a 3-arm practical randomized trial. Patients (n=463) were randomized: 77.3% completed 12-month follow-up. Primary outcomes were changes in health behaviors of healthy eating, physical activity, and medication taking. Secondary outcomes were hemoglobin A1c, body mass index, lipids, blood pressure, and psychosocial factors. RESULTS: Internet conditions improved health behaviors significantly vs. usual care over the 12-month period (d for effect size=.09-.16). All conditions improved moderately on biological and psychosocial outcomes. Latinos, lower literacy, and higher cardiovascular disease risk patients improved as much as other participants. CONCLUSIONS: The Internet intervention meets the reach and feasibility criteria for a potentially broad public health impact. However, 12-month magnitude of effects was small, suggesting that different or more intensive approaches are necessary to support long-term outcomes. Research is needed to understand the linkages between intervention and maintenance processes and downstream outcomes. PRACTICE IMPLICATIONS: Automated self-management interventions should be tailored and integrated into primary care; maintenance of patient self-management can be enhanced through links to community resources.

Intervention costs and cost-effectiveness for a multiple-risk-factor diabetes self-management trial for Latinas: economic analysis of ¡Viva Bien!

Information on cost-effectiveness of multiple-risk-factor lifestyle interventions for Latinas with diabetes is lacking. The aim of this paper is to evaluate costs and cost-effectiveness for ¡Viva Bien!, a randomized trial targeting Latinas with type 2 diabetes. We estimated 6-month costs; calculated incremental costs per behavioral, biologic, and quality-of-life change; and performed sensitivity analyses from health plan and participant perspectives. Recruitment, intervention, and participant costs were estimated at $45,896, $432,433, and $179,697, respectively. This translates to $4,634 in intervention costs per ¡Viva Bien! participant; $7,723 in both per unit reduction in hemoglobin A1c and per unit reduction in body mass index. Although costs may be higher than interventions that address one risk factor, potential risks for longer-term health-care costs are high for this at-risk group. Given the benefits of ¡Viva Bien!, cost reductions are recommended to enhance its efficiency, adoption, and long-term maintenance without diluting its effectiveness.

Starting the conversation performance of a brief dietary assessment and intervention tool for health professionals.

INTRODUCTION: For chronic disease prevention and management, brief but valid dietary assessment tools are needed to determine risk, guide counseling, and monitor progress in a variety of settings. Starting The Conversation (STC) is an eight-item simplified food frequency instrument designed for use in primary care and health-promotion settings. PURPOSE: This report investigates the feasibility, validity, and sensitivity to change of the STC tool, a simplified screener instrument for assessment and counseling. METHODS: Data from an ongoing practical efficacy study of type 2 diabetes patients in a diverse population (N=463) were used to document STC validity, robustness, stability, and sensitivity to change from baseline to 4 months. Data were collected from 2008 to 2010, and they were analyzed for this report in 2010. RESULTS: The eight STC items and summary score performed well. STC items and the summary score were moderately intercorrelated (r =0.39-0.59, p<0.05). The STC summary score was significantly correlated with the NCI fat screener at baseline (r =0.39, p<0.05), and change in the STC summary score correlated with reduction in percentage of calories from fat (r =0.22, p<0.05) from baseline to 4 months. The STC was sensitive to the intervention, with intervention participants improving significantly more than controls on the summary score (M=1.16 vs 0.46, p<0.05). CONCLUSIONS: The brief STC is a relatively simple, valid, and efficient tool for dietary assessment and intervention in the clinical setting. It is available in English and Spanish and is in the public domain. Researchers and practitioners are encouraged to assess its utility in other settings and with other dietary interventions.

A qualitative case study examining intervention tailoring for minorities.

OBJECTIVES: To explore issues of intervention tailoring for ethnic minorities based on information and experiences shared by researchers affiliated with the Health Maintenance Consortium (HMC). METHODS: A qualitative case study methodology was used with the administration of a survey (n = 17 principal investigators) and follow-up telephone interviews. Descriptive and content analyses were conducted, and a synthesis of the findings was developed. RESULTS: A majority of the HMC projects used individual tailoring strategies regardless of the ethnic background of participants. Follow-up interview findings indicated that key considerations in the process of intervention tailoring for minorities included formative research; individually oriented adaptations; and intervention components that were congruent with participants' demographics, cultural norms, and social context. CONCLUSIONS: Future research should examine the extent to which culturally tailoring long-term maintenance interventions for ethnic minorities is efficacious and should be pursued as an effective methodology to reduce health disparities.

Evaluation of a short dietary assessment instrument for percentage energy from fat in an intervention study.

The need for an inexpensive measure of dietary intake in intervention studies led to evaluation of the National Cancer Institute (NCI) Percentage Energy from Fat short instrument (PFat) in a subgroup of the Behavioral Change Consortium (BCC) intervention sites. The PFat's performance was evaluated using multiple nonconsecutive 24-h dietary recalls (24HR) as a reference instrument among participants at baseline in 4 demographically diverse intervention sites of the BCC. Mean estimates of percentage energy from fat for 24HR and PFat were within 2.1 percentage points of each other in all but 2 site/gender comparisons. 24HR and PFat estimates were not significantly different (P < 0.05) among men for 2 of 3 sites, and among women for 2 of 4 sites. Deattenuated Pearson correlation coefficients for the PFat and true intake (as estimated from the 24HR using a measurement error model) were significantly different from 0 (P < 0.05) for men and women in all sites, ranging from 0.52 to 0.77 among men and 0.36 to 0.59 among women. Besides gender and site, no other factors examined (age, education, smoking status, and BMI) consistently moderated validity estimates. If accurate assessment of diet at baseline (and presumably at follow-up) is essential, a more detailed instrument such as multiple 24HR may be warranted. The question of whether the PFat adequately measures change in diet is addressed in another article in this supplement.

Perceived environments as physical activity correlates and moderators of intervention in five studies.

PURPOSE: Few studies have explored how relationships of perceived environment and physical activity vary across different activity domains and populations. This question was explored in five physical activity intervention trials funded by the National Institutes of Health Behavior Change Consortium. DESIGN: Observational. SETTINGS: San Francisco peninsula, California (N = 94); Eugene, Oregon (N = 122); Atlanta, Georgia (N = 256); Kingston, Rhode Island (N = 109); Memphis, Tennessee (N = 64). SUBJECTS: Ethnically diverse community adults ages 18 to 85 years. MEASURES: The Neighborhood Environment Walkability Scale and CHAMPS physical activity questionnaire. Response rate among those invited to complete these measures was 90%. RESULTS: Cross-sectional pooled signal detection analysis indicated that people who reported living in neighborhoods with more attractive scenery and ease of walking were more likely to meet national physical activity recommendations (67%) compared with those without these neighborhood attributes (36%; chi2 = 13.04, p = .0003). Within-site multiple regression identified two additional variables--seeing others when walking and encountering loose dogs that make it difficult to walk--as correlates across multiple sites and activity domains (i.e., minutes of weekly moderate or more vigorous activity, walking for errands, walking leisurely) (incremental R2 = 2.0-7.5; p < .05). Analyses of covariance suggested that traffic safety might be particularly important in facilitating or impeding physical activity in response to a formal intervention (for traffic-arm assignment interactions, F = 3.8-7.0, p < or = .05). CONCLUSIONS: Relationships between perceived environments and physical activity may differ depending upon population groups and activity domains and merit investigation by using stronger prospective designs.

Economic analysis of the Mediterranean Lifestyle Program for postmenopausal women with diabetes.

PURPOSE: The purpose of this study was to evaluate costs associated with the primary intervention of the Mediterranean Lifestyle Program (MLP), which targeted postmenopausal women with type 2 diabetes at risk for coronary heart disease. METHODS: Using retrospective data collected during MLP development and implementation, the authors estimated costs for the first 6 months relative to the usual care condition and incremental costs per behavioral, biologic, and quality-of-life change. Sensitivity analyses were conducted using variations in inflation rates, implementation settings, labor and nonlabor inputs, and market wage rates. RESULTS: Of the sample of 279 study participants, 163 were randomized into the MLP condition. Total intervention costs were estimated at $211 061 ($148 022 direct costs) or $1295 per MLP participant relative to usual care ($908 direct costs). This translates to $3808 per average change in coronary heart disease risk as measured by an average 1-point reduction in hemoglobin A1C. Relative to other measured improvements, this corresponds to $2345 per unit reduction in body mass index and $644 per unit improvement in Problem Areas in Diabetes Quality-of-Life Self-care Summary score, and a $196 per-gram reduction in intake of saturated fatty acids as noted by the Food Frequency Questionnaire. A significant portion of the direct costs were related to the resources used during the recruitment phase. CONCLUSIONS: Providing a relatively intensive lifestyle self-management program for this high-risk group is associated with modest incremental costs compared with usual care, making the program potentially appealing to policy makers.

Assessment of problem-solving: a key to successful diabetes self-management.

Problem-solving skill is important for chronic illness self-management. This project prospectively evaluated a measure of diabetes problem-solving skill for its reliability, convergent validity, sensitivity to intervention, and relationship to change in behavior. Postmenopausal women with type 2 diabetes (N = 279) participated in a RCT to evaluate a lifestyle modification program. The 9-item Diabetes Problem-Solving Inventory (DPSI) was used to assess how patients cope with challenges to diabetes self-care. The DPSI was found to have good inter-rater reliability and internal consistency for a brief scale, be moderately stable over time, and relate significantly to hypothesized variables. DPSI scores improved significantly more in the lifestyle change condition than in controls and were related to improved outcomes. Mediation analyses indicated that the increase in problem-solving was a partial mediator of outcomes. Results support the reliability, predictive ability, and sensitivity to change of the DPSI. Directions for future research on problem-solving and chronic illness are discussed.

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.