No Difference in Average Interdialytic Weight Gain Observed in a Randomized Trial With a Technology-Supported Behavioral Intervention to Reduce Dietary Sodium Intake in Adults Undergoing Maintenance Hemodialysis in the United States: Primary Outcomes of the BalanceWise Study.

OBJECTIVE: To evaluate the efficacy of behavioral counseling combined with technology-based self-monitoring for sodium restriction in hemodialysis (HD) patients. DESIGN: Randomized clinical trial. SUBJECTS: English literate adults undergoing outpatient, in-center intermittent HD for at least 3 months. INTERVENTIONS: Over a 16-week period, both the intervention and the attention control groups were shown 6 educational modules on the HD diet. The intervention group also received social cognitive theory-based behavioral counseling and monitored their diets daily using handheld computers. MAIN OUTCOME MEASURES: Average daily interdialytic weight gain (IDWGA) was calculated for every week of HD treatment over the observation period by subtracting the post-dialysis weight at the previous treatment time (t-1) from the pre-dialysis weight at the current treatment time (t), dividing by the number of days between treatments. Three 24-hour dietary recalls were obtained at baseline, 8 weeks, and 16 weeks and evaluated using the Nutrient Data System for Research. RESULTS: A total of 179 participants were randomized, and 160 (89.4%) completed final measurements. IDWGA did not differ significantly by treatment group at any time point considered (P > .79 for each). A significant differential change in dietary sodium intake observed at 8 weeks (-372 mg/day; P = .05) was not sustained at 16 weeks (-191 mg/day; P = .32). CONCLUSION: The BalanceWise Study intervention appeared to be feasible and acceptable to HD patients although IDWGA was unchanged and the desired behavioral changes observed at 8 weeks were not sustained. Unmeasured factors may have contributed to the mixed findings, and further research is needed to identify the appropriate patients for such interventions.

Dietary Sodium Intake in Type 2 Diabetes.

Patients with type 2 diabetes have an increased risk for cardiovascular and chronic kidney disease. Superimposed hypertension further increases the risk and is associated with increased dietary sodium intake. There are few data available on dietary sodium intake in type 2 diabetes. The aim of this study was to quantify dietary sodium intake in a cohort of self-referred patients with type 2 diabetes and to identify sociodemographic characteristics associated with it. Sodium intake in this cohort was far greater than current recommendations. Increased awareness of sodium intake in this population might lead to target interventions to reduce sodium intake and potentially improve long-term outcomes.

A descriptive study of past experiences with weight-loss treatment.

BACKGROUND: Overweight and obesity affect more than 60% of the adult population in the United States. Most adults who are overweight have a history of previous weight-loss treatment. Exploring individuals' past experiences with weight-loss treatment may allow improvements to the current approach to treatment. OBJECTIVE: To examine individuals' prior experiences with weight-loss treatment, their treatment preferences, and what they found to be most and least satisfying. DESIGN: Cross-sectional descriptive study. SUBJECTS/SETTING: Individuals (N=155) who had registered for a weight-loss study wait list and met standard criteria for a weight-loss program (aged 18 to 55 years and body mass index between 25 and 42). METHODS: Questionnaire packets were mailed to participants. STATISTICAL ANALYSES PERFORMED: Descriptive analyses of the participants' past history with weight-loss treatment, treatment preference, self-efficacy, therapeutic efficacy, barriers to adherence to weight-loss treatment, barriers to healthy eating, and experiences associated with following a low-fat diet. RESULTS: One hundred ten participants (71%) returned completed questionnaire packets. The sample (82% white, 84% female, aged 42.6+/-8.5 years, and body mass index 33.5+/-5.3) was representative of those who seek weight-loss treatment in research settings. Participants were, on average, aged 21.1+/-8.9 years when they first tried a weight-loss program; 96.3% had tried to lose weight since that first time. The two most frequently tried programs were doing it on their own (93.5%) and commercial programs (70.8%). Barriers included having trouble controlling what I eat when hungry (71.3%), difficulty motivating myself to eat appropriately (66.2%), and using food as a reward (59.3%). Preferred weight-loss regimens were doing it on their own (30.6%) and a research program (22.4%). CONCLUSIONS: Participants were not seeking their preferred treatment. These data can be used to improve weight-loss programs by tailoring programs to meet the needs and preferences of participants.

Middle-aged premenopausal women with type 1 diabetes have lower bone mineral density and calcaneal quantitative ultrasound than nondiabetic women.

OBJECTIVE: To determine whether middle-aged premenopausal women with type 1 diabetes had more self-reported fractures and lower bone mineral density (BMD) compared with nondiabetic women. RESEARCH DESIGN AND METHODS: Participants were premenopausal women aged 35-55 years with type 1 diabetes (n = 67; 32.2 +/- 5.3 years duration) and without diabetes (n = 237). Total hip, femoral neck, whole-body, and spine BMD were measured by dual X-ray absorptiometry. Calcaneal broadband ultrasound attenuation (BUA) was assessed with quantitative ultrasound. RESULTS: Women with type 1 diabetes were more likely to report a fracture after age 20 years compared with nondiabetic women (33.3 vs. 22.6%; age-adjusted odds ratio 1.89 [95% CI 1.02-3.49]). Type 1 diabetes was associated with lower total hip BMD (0.890 vs. 0.961 g/cm2; P < 0.001), femoral neck BMD (0.797 vs. 0.847 g/cm2; P = 0.001), whole-body BMD (1.132 vs. 1.165 g/cm2; P < 0.01), and lower calcaneal BUA (71.6 vs. 84.9 dB/MHz; P < 0.001) after multivariate adjustment. BMD was 3-8% lower in type 1 diabetic compared with control women and calcaneal BUA was 15% lower. Spine BMD and biomarkers of bone remodeling were not significantly different between groups. In the type 1 diabetic women, reduced monofilament detection and blindness were both associated with lower BMD. CONCLUSIONS: Lower BMD in premenopausal women with type 1 diabetes may substantially increase their risk of developing osteoporosis after menopause. Type 1 diabetic women should be targeted for osteoporosis screening and possible fracture prevention as they transition through menopause.

Physical activity counseling in overweight and obese primary care patients: Outcomes of the VA-STRIDE randomized controlled trial.

The purpose of this 2-arm randomized clinical trial was to evaluate the effectiveness of a 12-month, expert system-based, print-delivered physical activity intervention in a primary care Veteran population in Pittsburgh, Pennsylvania. Participants were not excluded for many health conditions that typically are exclusionary criteria in physical activity trials. The primary outcome measures were physical activity reported using the Community Healthy Activities Model Program for Seniors (CHAMPS) questionnaire and an accelerometer-based activity assessment at baseline, 6, and 12 months. Of the 232 Veterans enrolled in the study, 208 (89.7%) were retained at the 6-month follow-up and 203 (87.5%) were retained at 12 months. Compared to the attention control, intervention participants had significantly increased odds of meeting the U.S. recommended guideline of ≥ 150 min/week of at least moderate-intensity physical activity at 12 months for the modified CHAMPS (odds ratio [OR] = 2.86; 95% CI: 1.03-7.96; p = 0.04) but not at 6 months (OR = 1.54; 95% CI: 0.56-4.23; p = 0.40). Based on accelerometer data, intervention participants had significantly increased odds of meeting ≥ 150 min/week of moderate-equivalent physical activity at 6 months (OR = 6.26; 95% CI: 1.26-31.22; p = 0.03) and borderline significantly increased odds at 12 months (OR = 4.73; 95% CI: 0.98-22.76; p = 0.053). An expert system physical activity counseling intervention can increase or sustain the proportion of Veterans in primary care meeting current recommendations for moderate-intensity physical activity. Trial Registration Clinical trials.gov identifier: NCT00731094 URL: http://www.clinicaltrials.gov/ct2/show/NCT00731094.

Menstrual cycle differences between women with type 1 diabetes and women without diabetes.

OBJECTIVE: To evaluate menstrual cycle histories among women with type 1 diabetes, their sisters, and unrelated control subjects without diabetes across all reproductive ages. RESEARCH DESIGN AND METHODS: Menstrual and reproductive histories were obtained by questionnaire from 143 women with type 1 diabetes, 186 sisters without diabetes, and 158 unrelated control subjects without diabetes participating in the Familial Autoimmune and Diabetes study. RESULTS: Women with type 1 diabetes had more menstrual problems (long cycles, long menstruation, and heavy menstruation) before age 30 years than sisters and control subjects. These differences were all statistically significant, except for heavy menstruation at age <20 years. No differences were observed after age 30 years. Women with type 1 diabetes experienced later menarche, earlier natural menopause, fewer pregnancies, and more stillbirths than women without diabetes. Multiple regression analyses revealed that type 1 diabetes caused an approximate twofold increased risk of any menstrual problem before age 30 years. These were primarily related to long cycles and long menstruation in women aged <20 and 20-29 years, as well as with heavy menstruation from 20 to 29 years. Oral contraceptives were protective for any menstrual problem and heavy menstruation from 30 to 39 years of age. With history of pregnancy from 20 to 40 years of age, any menstrual problem and long menstruation were more likely. CONCLUSIONS: The results suggest that type 1 diabetes is an independent risk factor for menstrual disturbances in young adults. Future studies may determine whether addressing menstrual disturbances improves quality of life and health for these women.

Infant diet and type 1 diabetes in China.

Infant milk and food introduction may be linked to type 1 diabetes risk in high incidence populations. Dietary data through age 12 months was collected for 247 type 1 diabetic cases and 443 controls in China, a low incidence population, to determine if milk and solid food intake differed. Age range at introduction to milk and formulas was similar in cases and controls but solid food introduction more often occurred before age 3 months in cases. Logistic regression analyses showed soy milk formula consumption at 4-6 (OR = 2.0; 95% CI: 1.1-3.4) and 7-12 months of age (OR = 1.5; 95% CI: 1.0-2.1) was associated with a twofold higher risk of type 1 diabetes, while steamed bread consumption (4-6 months, OR = 0.44; 95% CI: 0.28-0.68; 7-12 months, OR = 0.48; 95% CI: 0.34-0.69) and higher SES (4-6 months, OR = 0.55; 95% CI: 0.39-0.78; 7-12 months, OR = 0.57; 95% CI: 0.40-0.83) were negatively associated. Drinking cow's milk at 7-12 months (OR = 0.60; 95% CI: 0.43-0.85) was negatively associated with type 1 diabetes while consuming vegetables at 4-6 months (OR = 1.5; 95% CI: 1.0-2.2) was positively associated. Results suggest that infant milk and solid food intake are associated with type 1 diabetes in China. Prospective studies may determine how these dietary factors impact disease etiology, particularly for at-risk-populations.

Recruitment of veterans from primary care into a physical activity randomized controlled trial: the experience of the VA-STRIDE study.

BACKGROUND: Much of the existing literature on physical activity (PA) interventions involves physically inactive individuals recruited from community settings rather than clinical practice settings. Recruitment of patients into interventions in clinical practice settings is difficult due to limited time available in the clinic, identification of appropriate personnel to efficiently conduct the process, and time-consuming methods of recruitment. The purpose of this report is to describe the approach used to identify and recruit veterans from the Veterans Affairs (VA) Pittsburgh Healthcare System Primary Care Clinic into a randomized controlled PA study. METHODS: A sampling frame of veterans was developed using the VA electronic medical record. During regularly scheduled clinic appointments, primary care providers (PCPs) screened identified patients for safety to engage in moderate-intensity PA and willingness to discuss the study with research staff members. Research staff determined eligibility with a subsequent telephone screening call and scheduled a research study appointment, at which time signed informed consent and baseline measurements were obtained. RESULTS: Of the 3,482 veterans in the sampling frame who were scheduled for a primary care appointment during the study period, 1,990 (57.2%) were seen in the clinic and screened by the PCP; moderate-intensity PA was deemed safe for 1,293 (37.1%), 871 (25.0%) agreed to be contacted for further screening, 334 (9.6%) were eligible for the study, and 232 (6.7%) enrolled. CONCLUSIONS: Using a semiautomated screening approach that combined an electronically-derived sampling frame with paper and pencil prescreening by PCPs and research staff, VA-STRIDE was able to recruit 1 in 15 veterans in the sampling frame. Using this approach, a high proportion of potentially eligible veterans were screened by their PCPs. TRIAL REGISTRATION: Clinical trials.gov identifier: NCT00731094.

Biophysiologic outcomes of the Enhancing Adherence in Type 2 Diabetes (ENHANCE) trial.

BACKGROUND: Behavioral research to improve lifestyle in broadly defined populations of patients with type 2 diabetes is limited. OBJECTIVE: We evaluated a behavioral intervention featuring technology-based self-monitoring on biophysiologic outcomes of glycemic control and markers of cardiovascular risk. DESIGN: In this single-site, randomized clinical trial, participants were stratified by good and poor glycemic control (glycated hemoglobin <8% or ≥8%) and absence or presence of kidney disease, (estimated glomerular filtration rate ≥60 or <60 mL/min) and randomized within strata. Measurements were obtained at 0, 3, and 6 months. PARTICIPANTS/SETTING: Self-referred, community-dwelling adults with type 2 diabetes mellitus. INTERVENTION: The intervention group received Social Cognitive Theory-based counseling paired with technology-based self-monitoring, and results were compared with an attention control group. MAIN OUTCOME MEASURES: Glycated hemoglobin, fasting serum glucose, lipid levels, blood pressure, weight, body mass index, and waist circumference were evaluated. STATISTICAL ANALYSES PERFORMED: Mean differences within and between randomization groups were compared over time. Intervention effects over time were estimated using random intercept models. RESULTS: Two hundred ninety-six subjects were randomized, 256 (86.5%) completed 3-month and 246 (83.1%) completed 6-month assessments. Glycated hemoglobin was reduced in the intervention group by 0.5% at 3 months and 0.6% at 6 months (P<0.001 for each), and the control group by 0.3% (P<0.001) at 3 months and 0.2% (P<0.05) at 6 months; but between-group differences were not significant. In those with baseline glycated hemoglobin ≥8% and estimated glomerular filtration rate ≥60 mL/min, glycated hemoglobin was reduced in the intervention group by 1.5% at 3 months and 1.8% at 6 months (P<0.001 for each), and the control group by 0.9% (P<0.001) at 3 months and 0.8% (P<0.05) at 6 months; but between-group differences were not significant. In random intercept models, the estimated reduction in glycated hemoglobin of 0.29% was not significant. CONCLUSIONS: Two behavioral approaches to improving general lifestyle management in individuals with type 2 diabetes mellitus were effective in improving glycemic control, but no significant between-group differences were observed.

A randomized clinical trial testing treatment preference and two dietary options in behavioral weight management: preliminary results of the impact of diet at 6 months--PREFER study.

OBJECTIVE: The PREFER study objectives were to examine potential differences in weight loss during a standard behavioral intervention between subjects assigned to one of two calorie- and fat-restricted diets [standard behavior treatment (SBT) and lacto-ovo-vegetarian ([SBT+LOV)], with or without regard to their preferred dietary treatment. This article reports the differences in outcomes between diet groups after the first 6 months of the intervention. RESEARCH METHODS AND PROCEDURES: The study used a four-group design. Subjects (n = 182) were randomized to a treatment preference group and then to a dietary treatment group. For this report, preference groups were combined to permit comparisons by dietary treatment only (SBT, n = 98; SBT+LOV, n = 84). Additional analyses compared SBT+LOV subjects who were 100% adherent (did not consume any meat, fish, or poultry, n = 47) to those who were <100% adherent (n = 24). RESULTS: Significant differences were seen in the baseline to 6-month change scores between the two groups for carbohydrate consumption (p = 0.013), protein consumption (p < 0.001), polyunsaturated-to-saturated fat ratio (p = 0.009), and low-density lipoprotein-cholesterol (LDL-C) level (p = 0.013). Among SBT+LOV subjects, those who were 100% adherent experienced greater reductions in weight (p < 0.001), total cholesterol (p = 0.026), LDL-C (p = 0.034), and glucose (p = 0.002) and consumed less fat (p = 0.030) compared with those who were <100% adherent. DISCUSSION: Differences between dietary treatment groups at 6 months were minimal, most likely because one-third of the SBT+LOV group did not follow the vegetarian diet and because both groups had the same calorie and fat restrictions. SBT+LOV subjects who were 100% adherent were more successful at both weight loss and cholesterol reduction than those who were <100% adherent, suggesting that vegetarian diets are efficacious for weight and cholesterol control.