Relative contributions of naturalistic and constructed support: two studies of women with type 2 diabetes.

Do distinct sources of social support have differential effects on health? Although previous research has contrasted family and friend support (naturalistic support), research on the relative effects of naturalistic support and constructed support (e.g., support groups) is extremely rare. Two studies of women with type 2 diabetes were conducted that assessed the independent effects of naturalistic and constructed support on physical activity and glycosylated hemoglobin (HbA1c). Participants were women diagnosed with type 2 diabetes from the intervention arms of two randomized controlled trials: primarily European American women (Study 1; N = 163) and exclusively Hispanic women (Study 2; N = 142). Measures assessed physical activity, HbA1c, and friend and family support at baseline and at 6 months, as well as group support after 6 months of intervention. In Study 1, only group support was related to increases in physical activity (ΔR(2) = .036). In Study 2, group support and family support showed independent effects on increases in physical activity (ΔR(2) = .047 and .060, respectively). Also, group support was related to decreases in HbA1c in Study 1 (ΔR(2) = .031) and Study 2 (ΔR(2) = .065). Overall, constructed (group) support was related to outcomes most consistently, but naturalistic (family) support showed some independent relation to physical activity improvement.

Outcomes from a multiple risk factor diabetes self-management trial for Latinas: ¡Viva Bien!

BACKGROUND: Culturally appropriate interventions are needed to assist Latinas in making multiple healthful lifestyle changes. PURPOSE: The purpose of this study was to test a cultural adaptation of a successful multiple health behavior change program, ¡Viva Bien! METHODS: Random assignment of 280 Latinas with type 2 diabetes to usual care only or to usual care + ¡Viva Bien!, which included group meetings for building skills to promote the Mediterranean diet, physical activity, stress management, supportive resources, and smoking cessation. RESULTS: ¡Viva Bien! participants compared to usual care significantly improved psychosocial and behavioral outcomes (fat intake, stress management practice, physical activity, and social-environmental support) at 6 months, and some improvements were maintained at 12 months. Biological improvements included hemoglobin A1c and heart disease risk factors. CONCLUSIONS: The ¡Viva Bien! multiple lifestyle behavior program was effective in improving psychosocial, behavioral, and biological/quality of life outcomes related to heart health for Latinas with type 2 diabetes.

Use of voter registration records to recruit a representative sample.

Research samples are not often compared to broader community samples to evaluate their representativeness, a critical factor in determining the generalizability of study findings. This study evaluated the use of voter-registration records for recruiting a representative sample of community-dwelling, older, and overweight participants for research on improving measures of diet and physical activity. County voter-registration records were used to identify individuals between 45 and 75 years of age and living in the two cities closest to the research lab. The data were collected from July, 2007 through November, 2008. Prospective participants were mailed an introductory letter and opt-out postcard, and received a follow-up recruitment phone call in which they underwent further screening if interested in participating. The representativeness of the final voter-recruited sample (N = 191) was evaluated by comparisons of demographic variables with Behavioral Risk Factor Surveillance System (BRFSS) data at the county and state levels. The voter-recruited sample was only partially comparable to that of the BRFSS sample, with expected differences in variables related to race/ethnicity, the proportion of women, employment status, and educational attainment. Voter-registration records are a relatively low-cost ($75 per participant) method of recruiting a community sample that avoids some biases of other recruitment methods, but may not achieve a fully representative sample.

Methods for the cultural adaptation of a diabetes lifestyle intervention for Latinas: an illustrative project.

Because Latinas experience a high prevalence of type 2 diabetes and its complications, there is an urgent need to reach them with interventions that promote healthful lifestyles. This article illustrates a sequential approach that took an effective multiple-risk-factor behavior-change program and adapted it for Latinas with type 2 diabetes. Adaptation stages include (a) information gathering from literature and focus groups, (b) preliminary adaptation design, and (c) preliminary adaptation test. In this third stage, a pilot study finds that participants were highly satisfied with the intervention and showed improvement across diverse outcomes. Key implications for applications include the importance of a model for guiding cultural adaptations, and the value of procedures for obtaining continuous feedback from staff and participants during the preliminary adaptation test.

Outcomes of minimal and moderate support versions of an internet-based diabetes self-management support program.

OBJECTIVE: Internet and other interactive technology-based programs offer great potential for practical, effective, and cost-efficient diabetes self-management (DSM) programs capable of reaching large numbers of patients. This study evaluated minimal and moderate support versions of an Internet-based diabetes self-management program, compared to an enhanced usual care condition. RESEARCH DESIGN AND METHODS: A three-arm practical randomized trial was conducted to evaluate minimal contact and moderate contact versions of an Internet-based diabetes self-management program, offered in English and Spanish, compared to enhanced usual care. A heterogeneous sample of 463 type 2 patients was randomized and 82.5% completed a 4-month follow-up. Primary outcomes were behavior changes in healthy eating, physical activity, and medication taking. Secondary outcomes included hemoglobin A1c, body mass index, lipids, and blood pressure. RESULTS: The Internet-based intervention produced significantly greater improvements than the enhanced usual care condition on three of four behavioral outcomes (effect sizes [d] for healthy eating = 0.32; fat intake = 0.28; physical activity= 0.19) in both intent-to-treat and complete-cases analyses. These changes did not translate into differential improvements in biological outcomes during the 4-month study period. Added contact did not further enhance outcomes beyond the minimal contact intervention. CONCLUSIONS: The Internet intervention meets several of the RE-AIM criteria for potential public health impact, including reaching a large number of persons, and being practical, feasible, and engaging for participants, but with mixed effectiveness in improving outcomes, and consistent results across different subgroups. Additional research is needed to evaluate longer-term outcomes, enhance effectiveness and cost-effectiveness, and understand the linkages between intervention processes and outcomes.

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.

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.

Performance of a short percentage energy from fat tool in measuring change in dietary intervention studies.

Measurement of percentage energy from fat is important in surveillance of populations and in epidemiologic studies examining relationships between diet and disease as well as for behavioral intervention studies seeking to change dietary behavior. The NCI percentage energy from fat screener (PFat) has adequately predicted percentage of energy from fat compared with 24-h recalls (24HR) in cross-sectional analyses. However, the instrument has not been evaluated for its ability to assess change of percentage energy from fat over time or in response to interventions to change dietary intake of fat. The objective of this analysis is to evaluate the performance of the PFat in assessing change in percentage energy intake from fat in a behavioral intervention setting. Four individual sites participating in the Behavior Change Consortium Nutrition Working Group administered both the PF at and multiple 24HR at baseline and follow-up to 278 participants. A measurement error model was used to assess agreement between the PFat and 24HR at baseline and follow-up. The PFat was consistent with 24HR in finding there was no significant change in percentage energy from fat as a result of the intervention. Both male and female participants in the intervention group demonstrated a significant increase in the correlation between PFat and 24HR from baseline to follow-up. Percentage energy from fat measured by PFat may be useful to provide estimates of change in mean intake of populations over time in longitudinal studies. Further methodologic research is called for in interventions producing significant changes and in diverse populations with adequate sample size.

Accuracy and precision of two short screeners to assess change in fruit and vegetable consumption among diverse populations participating in health promotion intervention trials.

Two short frequency questionnaires, the NCI 19-item Fruit and Vegetable Screener (FVS) and a single question on overall fruit and vegetable consumption (1-item), were evaluated for their ability to assess change in fruit and vegetable (FV) consumption over time and in response to intervention among participants in 5 health promotion trials in the Behavior Change Consortium. Cross-sectional differences and correlations of FV estimates at baseline and at follow-up were compared for the FVS (n = 315) and the 1-item (n = 227), relative to multiple 24-h recall interviews (24HR). The FVS significantly overestimated daily intake by 1.27 servings at baseline among men and by 1.42 and 1.59 servings at baseline and follow-up, respectively, in women, whereas the 1-item measure significantly underestimated intake at both time points in men (0.98 serving at baseline, 0.75 serving at follow-up) and women (0.61 and 0.41 serving). Cross-sectional deattenuated correlations with 24HR at follow-up were 0.48 (FVS) and 0.50 (1-item). To evaluate the capacity of the 2 screeners to assess FV change, we compared mean posttest effects with 24HR by treatment group overall and by gender. Treatment group differences were not significant for either 24HR or 1-item. Among 315 subjects, the FVS treatment group differences were significant both overall and within gender but not when repeated in the sample of 227. Findings suggest multiple 24HR at multiple time points in adequate sample sizes remain the gold standard for FV reports. Biases in FVS estimates may reflect participants' lifestyles and sociodemographic characteristics and require further examination in longitudinal samples representative of diverse populations.

Baseline design elements and sample characteristics for seven sites participating in the Nutrition Working Group of the Behavior Change Consortium.

The purpose of this article is to describe the baseline design elements and sample characteristics of the Behavior Change Consortium (BCC) Dietary Measurement studies for each of the 7 sites that comprised the BCC Nutrition Working Group (NWG). This article summarizes the project designs, including descriptions of diverse study populations, primary assessment methods, and study outcomes. Common measures used across sites included the National Cancer Institute (NCI) Fruit and Vegetable Screener, NCI Percentage Energy from Fat Screener, 24-h dietary recalls, and a single- or 2-item fruit and vegetable measure. Data on sociodemographic characteristics, body weight and height, smoking status, and serum carotenoids were also collected. Study design information such as assessment time points, as well as baseline sample characteristics, is also described. This paper provides the overall framework and descriptive information and serves as the reference for the BCC NWG special supplement.

Correspondence of the NCI Fruit and Vegetable Screener to repeat 24-H recalls and serum carotenoids in behavioral intervention trials.

Five sites participating in the NCI Behavior Change Consortium administered the NCI Fruit and Vegetable Screener (FVS) and multiple, nonconsecutive 24-h dietary recall interviews (24HR) to 590 participants. Three sites also obtained serum carotenoids (n = 295). Participants were primarily female, ethnically diverse, and varied by age and education. Correlations between 24HR and FVS by site ranged from 0.31 (P = 0.07) to 0.47 (P < 0.01) in men and from 0.43 to 0.63 (P < 0.01) in women. Compared with 24HR, FVS significantly (P < 0.05) overestimated intake at 2 of 4 sites for men and all 4 sites for women. Differences in estimated total servings of fruits and vegetables/d ranged from 0.16 to 3.06 servings. On average, the FVS overestimated intake by 1.76 servings in men and 2.11 servings in women. Alternative FVS scoring procedures and a 1-item screener lowered correlations with 24HR as well as serum carotenoids but alternate scoring procedures generally improved estimations of servings.

Use of signal detection methodology to identify subgroups of dietary supplement use in diverse populations.

Despite widespread use of dietary supplements, little is known about correlates and determinants of their use. Using a diverse sample from 7 interventions participating in the Behavior Change Consortium (n = 2539), signal detection methodology (SDM) demonstrated a method for identifying subgroups with varying supplement use. An SDM model was explored with an exploratory half of the entire sample (n = 1268) and used 5 variables to predict dietary supplement use: cigarette smoking, fruit and vegetable intake, dietary fat consumption, BMI, and stage of change for physical activity. A comparison of rates of supplement use between the exploratory model groups and comparably identified groups in the reserved, confirmatory sample (n = 1271) indicates that these analyses may be generalizable. Significant indicators of any supplement use included smoking status, percentage of energy from fat, and fruit and vegetable consumption. Although higher supplement use was associated with healthy behaviors overall, many of the identified groups exhibited mixed combinations of healthy and unhealthy behaviors. The results of this study suggest that patterns of dietary supplement use are complex and support the use of SDM to identify possible population characteristics for targeted and tailored health communication interventions.

Healthy Changes for living with diabetes: an evidence-based community diabetes self-management program.

PURPOSE: This article addresses the gap between research and practice by describing the feasibility and outcomes of an evidence-based diabetes self-management health education program. The Healthy Changes program used a peer-led group format to promote physical activity and healthful eating practices, using culturally relevant materials and measures. METHODS: Older adults (mean age = 69.2 years; SD = 10.7) with type 2 diabetes (N = 243) were recruited from 9 communities to participate in the Healthy Changes program. Components included goal setting, problem solving, group support, and interactive lectures from experts. Measures of eating patterns, physical activity, body weight, community resources, self-rated health, and self-efficacy were administered at baseline, and at 4, 8, and 12 months. RESULTS: Participants attended on average 13 weekly sessions, and showed improvements in health behaviors, supportive resources, and self-efficacy at 4, 8, and 12 months. CONCLUSIONS: The Healthy Changes program can be successfully translated into community settings and led by trained peer leaders, yielding health improvements similar to those reported in efficacy trials. Trained peer leaders are key to effective program implementation. Peer-led groups enhance goal attainment by giving participants a venue to discuss obstacles and strategize solutions.

Problem solving and diabetes self-management: investigation in a large, multiracial sample.

OBJECTIVE: Problem solving is a core aspect of effective diabetes and chronic illness self-management, yet there are relatively few objective evaluations of problem-solving skills, especially in large, multiracial samples. RESEARCH DESIGN AND METHODS: A multiracial sample of 506 adults who have type 2 diabetes were assessed on a variety of patient characteristics, self-management behaviors, and biological and psychosocial measures. They also completed the Diabetes Problem-Solving Interview (DPSI). RESULTS: DPSI scores revealed significant variability across patients in problem-solving skill and were related to a number of comorbid conditions and complications but not to several other demographic factors, including race/ethnicity. Problem solving was also related to self-management behaviors (eating and exercise patterns), biological variables (A1C and lipids), and psychosocial measures (Diabetes Distress Scale) in multivariable analyses controlling for a variety of potential confounding factors. CONCLUSIONS: Diabetes problem solving, as measured by the DPSI, is an important patient skill related to several key diabetes management variables that appears applicable across racial and ethnic groups. Future research is needed to identify the generality versus specificity of diabetes problem solving and practical interventions to enhance problem-solving skills.

Reliability of pedometer data in samples of youth and older women.

BACKGROUND: Pedometers offer researchers a convenient and inexpensive tool for objective measurement of physical activity. However, many unanswered questions remain about expected values for steps/day for different populations, sources of variation in the data, and reliability of pedometer measurements. METHODS: This study documented and compared mean steps/day, demographic predictors of steps/day, and pedometer reliability in two longitudinal investigations, one involving a population-based youth sample (N = 367) and the other targeting postmenopausal women with type 2 diabetes (N = 270). Individuals were asked to wear pedometers (Yamax model SW-701) at the waist for 7 days and record steps/per day. They were also asked to record daily physical activities, duration, and perceived intensity (1 = low/light, 2 = medium/moderate, 3 = high/hard) for the same 7 days. In addition, survey data regarding usual physical activity was collected. Analyses of variance (ANOVA) were conducted to determine whether there were significant differences in pedometer results according to sex, age, and body mass index. Repeated measures ANOVAs were used to examine potential differences in results among differing numbers of days. RESULTS: Mean steps/day were 10,365 steps in the youth sample and 4,352 steps in the sample of older women. Girls took significantly fewer steps than boys, older women took fewer steps than younger women, and both youth and women with greater body mass took fewer steps than those with lower body mass. Reliability coefficients of .80 or greater were obtained with 5 or more days of data collection in the youth sample and 2 or more days in the sample of older women. Youth and older women were more active on weekdays than on weekends. Low but significant associations were found between step counts and self-report measures of physical activity in both samples. CONCLUSION: Mean steps/day and reliability estimates in the two samples were generally consistent with previously published studies of pedometer use. Based on these two studies, unsealed pedometers were found to offer an easy-to-use and cost-effective objective measure of physical activity in both youth and older adult populations.

Long-term effects of the Mediterranean lifestyle program: a randomized clinical trial for postmenopausal women with type 2 diabetes.

BACKGROUND: Multiple-risk-factor interventions offer a promising means for addressing the complex interactions between lifestyle behaviors, psychosocial factors, and the social environment. This report examines the long-term effects of a multiple-risk-factor intervention. METHODS: Postmenopausal women (N = 279) with type 2 diabetes participated in the Mediterranean Lifestyle Program (MLP), a randomized, comprehensive lifestyle intervention study. The intervention targeted healthful eating, physical activity, stress management, smoking cessation, and social support. Outcomes included lifestyle behaviors (i.e., dietary intake, physical activity, stress management, smoking cessation), psychosocial variables (e.g., social support, problem solving, self-efficacy, depression, quality of life), and cost analyses at baseline, and 6, 12, and 24 months. RESULTS: MLP participants showed significant 12- and 24-month improvements in all targeted lifestyle behaviors with one exception (there were too few smokers to analyze tobacco use effects), and in psychosocial measures of use of supportive resources, problem solving, self-efficacy, and quality of life. CONCLUSION: The MLP was more effective than usual care over 24 months in producing improvements on behavioral and psychosocial outcomes. Directions for future research include replication with other populations.

A qualitative study of a nutrition working group.

The Behavioral Change Consortium (BCC) Nutrition Workgroup (NWG) is a multidisciplinary collaboration of representatives from BCC sites and federal agencies. Its mission is to improve measurement of dietary variables. This article presents findings from a qualitative study of perceived effectiveness of the workgroup collaboration. Twelve in-depth interviews were conducted and examined for common themes using the constant comparison method. Themes contributing to perceived effectiveness included: funding and additional resources; invested, committed, and collegial members; strong leadership, clearly articulated goals, and regular communication. Influences seen as reducing effectiveness were: distance, disparate nature of the studies, limited time, and problems associated with starting collaboration after the primary studies had begun data collection. NWG members felt that the workgroup would continue to be successful; however, there were concerns about responsibility for writing and authorship of manuscripts and the need for continued funding to ensure full participation and productivity.

Robustness of a computer-assisted diabetes self-management intervention across patient characteristics, healthcare settings, and intervention staff.

BACKGROUND: A major problem in the dissemination of most interventions found to be efficacious is that they are of limited or unknown generalizability. OBJECTIVE: To document the "robustness," or external validity, of a computer-assisted diabetes self-management program across different patient characteristics, healthcare settings (mixed payer vs health maintenance organization), intervention staff, and outcomes. STUDY DESIGN: A randomized controlled trial evaluating a computer-assisted behavior change program for adult patients with type 2 diabetes mellitus (n = 217) vs a computerized health risk assessment. METHODS: Outcomes were identified using the RE-AIM framework and included program adoption among physicians, reach across patient groups, implementation, and behavioral (fat intake and physical activity) and biological (glycosylated hemoglobin and lipid levels) effectiveness measures. RESULTS: The program achieved 41% patient participation, variable adoption across healthcare settings (76% of health maintenance organization physicians vs 18% of non-health maintenance organization physicians participated), good implementation, and improvement in behavioral outcomes. There were few significant interactions between treatment condition and patient characteristics, type of healthcare setting, or interventionist experience on effectiveness measures. CONCLUSIONS: Patients and physicians were willing to participate in a computer-assisted dietary and physical activity goal-setting intervention, although participation varied by healthcare setting. Interventionists from different backgrounds successfully delivered the intervention, and the results appear robust across various patient and delivery characteristics.

Social support and social-ecological resources as mediators of lifestyle intervention effects for type 2 diabetes.

A study was conducted to determine if an intervention could change social support and social-ecological resources of post-menopausal women diagnosed with type 2 diabetes, and if those changes mediated the intervention's effects on health behaviors and outcomes. Women (N = 279) were randomly assigned to receive a comprehensive 6-month Mediterranean Lifestyle Program (MLP) or usual care from their physicians (UC). MLP was successful in changing social embeddedness and social-ecological resources, but not a measure of perceived support. Changes in social-ecological resources mediated intervention effects on fat consumption, exercise and glycemic control. The experimental manipulation of mediators and the demonstrated mediation effects support the conclusion that social-ecological resources can contribute to improvements in healthful lifestyles for women with type 2 diabetes.

Biologic and quality-of-life outcomes from the Mediterranean Lifestyle Program: a randomized clinical trial.

OBJECTIVE: Few multiple lifestyle behavior change programs have been designed to reduce the risk of coronary heart disease in postmenopausal women with type 2 diabetes. This study tested the effectiveness of the Mediterranean Lifestyle Program (MLP), a comprehensive lifestyle self-management program (Mediterranean low-saturated fat diet, stress management training, exercise, group support, and smoking cessation), in reducing cardiovascular risk factors in postmenopausal women with type 2 diabetes. RESEARCH DESIGN AND METHODS: Postmenopausal women with type 2 diabetes (n = 279) were randomized to either usual care (control) or treatment (MLP) conditions. MLP participants took part in an initial 3-day retreat, followed by 6 months of weekly meetings, to learn and practice program components. Biological end points were changes in HbA(1c), lipid profiles, BMI, blood pressure, plasma fatty acids, and flexibility. Impact on quality of life was assessed. RESULTS: Multivariate ANCOVAs revealed significantly greater improvements in the MLP condition compared with the usual care group on HbA(1c), BMI, plasma fatty acids, and quality of life at the 6-month follow-up. Patterns favoring intervention were seen in lipids, blood pressure, and flexibility but did not reach statistical significance. CONCLUSIONS: These results demonstrate that postmenopausal women with type 2 diabetes can make comprehensive lifestyle changes that may lead to clinically significant improvements in glycemic control, some coronary heart disease risk factors, and quality of life.