Folate fortification of food: Insufficient for women with epilepsy.

OBJECTIVE: Folic acid supplementation during the periconceptual period has been shown to improve cognitive outcomes in children of women with epilepsy taking anti-seizure medications (ASMs). The dose of folic acid necessary to provide positive cognitive outcomes is unclear. In many countries including the United States, food is fortified with folic acid, but no data exist on how food fortification may affect cognition in children with fetal-ASM exposure. This study evaluated the effect of dietary folate from natural folates plus folic acid fortification, separate from folic acid vitamin supplements, on age-6 year IQ in children with fetal-ASM exposure. METHODS: Data from the Neurodevelopmental Effects of Antiepileptic Drugs (NEAD) study were retrospectively analyzed for this investigation. Assessment of nutrient intake was conducted using the Block Food Frequency Questionnaire-98. The primary outcome of the present study was to assess association of maternal prepregnancy nutrient levels to child age-6 IQ. RESULTS: Folate from food alone without supplement was not associated with improvement of age-6 IQ in children with fetal ASM exposure (95% CI: -11.7-2.3, p = 0.187). Periconceptual folate supplement use was associated with a 10.1-point higher age-6 IQ (95% CI: 5.2-15.0, p < .001). Total combined folate from food plus supplement also showed that higher intake of folate was associated with higher age-6 IQ (Coefficient: 4.5, 95% CI: 2.0-6.9, p < .001). Six other nutrients from food and supplements were analyzed (Vitamin C, Vitamin D, Vitamin E, Omega 3, Gamma Tocopherol, and Vitamin B12) and had no significant association with age 6-IQ. SIGNIFICANCE: Dietary content of folate, even in a country where food is fortified with folic acid, is not sufficient to provide improved cognitive outcomes for children of women taking ASMs during pregnancy. Folate supplementation is needed for significant improvement in cognitive outcomes, specifically age-6 IQ.

Diabetes Prevention and Weight Loss with a Fully Automated Behavioral Intervention by Email, Web, and Mobile Phone: A Randomized Controlled Trial Among Persons with Prediabetes.

BACKGROUND: One-third of US adults, 86 million people, have prediabetes. Two-thirds of adults are overweight or obese and at risk for diabetes. Effective and affordable interventions are needed that can reach these 86 million, and others at high risk, to reduce their progression to diagnosed diabetes. OBJECTIVE: The aim was to evaluate the effectiveness of a fully automated algorithm-driven behavioral intervention for diabetes prevention, Alive-PD, delivered via the Web, Internet, mobile phone, and automated phone calls. METHODS: Alive-PD provided tailored behavioral support for improvements in physical activity, eating habits, and factors such as weight loss, stress, and sleep. Weekly emails suggested small-step goals and linked to an individual Web page with tools for tracking, coaching, social support through virtual teams, competition, and health information. A mobile phone app and automated phone calls provided further support. The trial randomly assigned 339 persons to the Alive-PD intervention (n=163) or a 6-month wait-list usual-care control group (n=176). Participants were eligible if either fasting glucose or glycated hemoglobin A1c (HbA1c) was in the prediabetic range. Primary outcome measures were changes in fasting glucose and HbA1c at 6 months. Secondary outcome measures included clinic-measured changes in body weight, body mass index (BMI), waist circumference, triglyceride/high-density lipoprotein cholesterol (TG/HDL) ratio, and Framingham diabetes risk score. Analysis was by intention-to-treat. RESULTS: Participants' mean age was 55 (SD 8.9) years, mean BMI was 31.2 (SD 4.4) kg/m(2), and 68.7% (233/339) were male. Mean fasting glucose was in the prediabetic range (mean 109.9, SD 8.4 mg/dL), whereas the mean HbA1c was 5.6% (SD 0.3), in the normal range. In intention-to-treat analyses, Alive-PD participants achieved significantly greater reductions than controls in fasting glucose (mean -7.36 mg/dL, 95% CI -7.85 to -6.87 vs mean -2.19, 95% CI -2.64 to -1.73, P<.001), HbA1c (mean -0.26%, 95% CI -0.27 to -0.24 vs mean -0.18%, 95% CI -0.19 to -0.16, P<.001), and body weight (mean -3.26 kg, 95% CI -3.26 to -3.25 vs mean -1.26 kg, 95% CI -1.27 to -1.26, P<.001). Reductions in BMI, waist circumference, and TG/HDL were also significantly greater in Alive-PD participants than in the control group. At 6 months, the Alive-PD group reduced their Framingham 8-year diabetes risk from 16% to 11%, significantly more than the control group (P<.001). Participation and retention was good; intervention participants interacted with the program a median of 17 (IQR 14) of 24 weeks and 71.1% (116/163) were still interacting with the program in month 6. CONCLUSIONS: Alive-PD improved glycemic control, body weight, BMI, waist circumference, TG/HDL ratio, and diabetes risk. As a fully automated system, the program has high potential for scalability and could potentially reach many of the 86 million US adults who have prediabetes as well as other at-risk groups. TRIAL REGISTRATION: Clinicaltrials.gov NCT01479062; https://clinicaltrials.gov/ct2/show/NCT01479062 (Archived by WebCite at http://www.webcitation.org/6bt4V20NR).

Relative validation of Block Kids Food Screener for dietary assessment in children and adolescents.

Food frequency questionnaires (FFQs) are less time consuming and inexpensive instruments for collecting dietary intake when compared with 24-h dietary recalls or double-labelled water; however, the validation of FFQ is important as incorrect information may lead to biased conclusions about associations. Therefore, the relative validity of the Block Kids Food Screener (BKFS) developed for use with children was examined in a convenience sample of 99 youth recruited from the Portland, OR metropolitan area. Three 24-h dietary recalls served as the reference. The relative validity was analysed after natural log transformation of all variables except glycaemic index prior to correlation analysis. Daily cup equivalent totals from the BKFS and 'servings' from 24-h recalls were used to compute average daily intake of fruits, vegetables, potatoes, whole grains, legumes, meat/fish/poultry and dairy. Protein grams (g), total kcalories, glycaemic index (glucose reference), glycaemic load (glucose reference), total saturated fat (g) and added sugar (g) were also calculated by each instrument. The correlation between data obtained from the two instruments was corrected for the within-subject variation in food intake reported by the 24-h recalls using standard nutritional assessment methodology. The de-attenuated correlations in nutritional intake between the two dietary assessment instruments ranged from 0.526 for vegetables, to 0.878 for potatoes. The 24-h recall estimated higher levels of saturated fat and added sugar consumption, higher glycaemic loads and glycaemic indices; the de-attenuatted correlations of these measures ranged from 0.478 to 0.768. Assessment of Bland-Altman plots indicated no systematic difference between the two instruments for vegetable, dairy and meat/fish/poultry fat consumption. BKFS is a useful dietary assessment instrument for the nutrients and food groups it was designed to assess in children age 10-17 years.

Calibration of the brief food frequency questionnaire among patients on dialysis.

OBJECTIVE: Estimating dietary intake is challenging in patients with chronic diseases. The aim of this study was to calibrate the Block Brief 2000 food frequency questionnaire (BFFQ) using 3-day food diary records among patients on dialysis. METHODS: Data from 3-day food diary records from 146 patients new to dialysis were reviewed and entered into National Cancer Institute self-administered 24-hour dietary recall (ASA24), a web-based dietary interview system. The information was then re-entered omitting foods reported in the diaries that were not in the BFFQ to generate a "BFFQ-restricted" set of intakes. We modeled each major dietary component (i.e., energy [total calories], protein, carbohydrate, fat) separately using linear regression. The main independent variables were BFFQ-restricted food diary estimates computed as the average of the 3 days of diaries, restricted to items included in the BFFQ, with the unrestricted 3-day food diary averages as dependent variables. RESULTS: The BFFQ-restricted diary energy estimate of 1,325 ± 545 kcal was 87% of the energy intake in the full food diary (1,510.3 ± 510.4, P < .0001). The BFFQ-restricted diary carbohydrate intake was 83% of the full food diary (156.7 ± 78.7 g vs. 190.4 ± 72.7, P < .0001). The BFFQ-restricted fat intake was 90% of the full-diary-reported fat intake (50.1 ± 24.1 g vs. 56.4 ± 21.6 g, P < .0001). Daily protein intake assessments were not statistically different by BFFQ-restricted diary and full diary assessment (63.1 ± 28.5 vs. 64.1 ± 21.4 g, P = .60). The associations between BFFQ-restricted diary intake and unrestricted intake were linear. Three-day diary-reported intake could be estimated from BFFQ-restricted intake with r2 ranging from 0.36 to 0.56 (P < .0001 for energy [total calories], protein, carbohydrate, and fat). Final equations did not include adjustments for age, sex, or race because the patterns of associations were not significantly different. CONCLUSION: Energy and macronutrient estimates by BFFQ are lower than estimates from 3-day food diaries, but simple calibration equations can be used to approximate total intake from BFFQ responses.

Community Health workers United to Reduce Colorectal cancer and cardiovascular disease among people at Higher risk (CHURCH): study protocol for a randomized controlled trial.

BACKGROUND: Colorectal cancer (CRC) is the second most lethal cancer in the United States (U.S.) with the highest incidence and mortality rates among African Americans (AAs) compared to other racial groups. Despite these disparities, AAs are the least likely to undergo CRC screening, have precancerous colorectal polyps removed, and have CRC detected at stages early enough for curative excision. In addition, compelling evidence links inflammatory dietary patterns to increased CRC and cardiovascular disease risk. Studies show that AA churches can successfully engage in health promotion activities including those related to cancer control. The current study seeks to leverage church-placed Community Health Workers (CHWs) to increase CRC screening and reduce CRC risk. DESIGN AND METHODS: We aim to (1) increase guideline concordant CRC screening uptake using church-placed CHWs trained in screening with a validated instrument, Brief Intervention using Motivational Interviewing, and Referral to Treatment (SBIRT); and (2) reduce dietary risk factors (inflammatory dietary patterns) linked to CRC. The latter will be addressed by culturally adapting an existing, web-based lifestyle program called Alive!. Using a Hybrid Type 1 Implementation-Effectiveness cluster randomized design, we will randomize 22 AA churches into either the dual intervention arm (CHW-led SBIRT intervention plus Alive!) or a usual care arm comprised of CRC prevention educational pamphlets and a list of CRC screening sites. We will recruit 440 subjects and evaluate the effects of both arms on screening uptake (colonoscopy, fecal DNA) (primary outcome) and dietary inflammation score (secondary outcome) at 6-month follow-up, and Life Simple7 (LS7)-a cardiovascular disease (CVD) risk score-at 6 months and 1 year (secondary outcome). Finally, guided by a racism-conscious adaptation of the Consolidated Framework for Implementation Research (CFIR), we will conduct a mixed-methods process evaluation with key stakeholders to understand multi-level influences on CRC screening and CVD risk behaviors. DISCUSSION: Church-placed CHWs are trusted influential connectors between communities and health systems. Studies have shown that these CHWs can successfully implement health prevention protocols in churches, including those related to cancer control, making them potentially important community mediators of CRC screening uptake and CRC/CVD risk reduction. TRIAL REGISTRATION: NCT05174286; clinicaltrials.gov; August 31st, 2023.

Community Health workers United to Reduce Colorectal cancer and cardiovascular disease among people at Higher risk (CHURCH): study protocol for a randomized controlled trial.

Background: Colorectal cancer (CRC) is the second most lethal cancer in the United States (U.S.) with the highest incidence and mortality rates among African Americans (AAs) compared to other racial groups. Despite these disparities, AAs are the least likely to undergo CRC screening, have precancerous colorectal polys removed, and have CRC detected at stages early enough for curative excision. In addition, compelling evidence links inflammatory dietary patterns to increased CRC and cardiovascular disease risk. Studies show that AA churches can successfully engage in health promotion activities including those related to cancer control. The current study seeks to leverage church-placed Community Health Workers (CHWs) to increase CRC screening and reduce CRC risk. Design and Methods: We aim to (1) increase guideline concordant CRC screening uptake using church-placed CHWs trained in screening with a validated instrument, Brief Intervention using Motivational Interviewing, and Referral to Treatment (SBIRT); and (2) reduce dietary risk factors (inflammatory dietary patterns) linked to CRC. The latter will be addressed by culturally adapting an existing, web-based lifestyle program called Alive!. Using a Hybrid Type 1 Implementation-Effectiveness cluster randomized design, we will randomize 22 AA churches into either the dual intervention arm (CHW-led SBIRT intervention plus Alive!) or a usual care arm comprised of CRC prevention educational pamphlets and a list of CRC screening sites. We will recruit 440 subjects and evaluate the effects of both arms on screening uptake (colonoscopy, fecal DNA) (primary outcome) and dietary inflammation score (secondary outcome) at 6-months follow up, and Life Simple7 (LS7) - a cardiovascular disease (CVD) risk score - at 6 months and 1-year (secondary outcome). Finally, guided by a racism-conscious adaptation of the Consolidated Framework for Implementation Research (CFIR), we will conduct a mixed-methods process evaluation with key stakeholders to understand multi-level influences on CRC screening and CVD risk behaviors. Discussion: Church-placed CHWs are trusted influential connectors between communities and health systems. Studies have shown that these CHWs can successfully implement health prevention protocols in churches, including those related to cancer control, making them potentially important community mediators of CRC screening uptake and CRC/CVD risk reduction. Trial registration: NCT05174286.

Development of an updated phytoestrogen database for use with the SWAN food frequency questionnaire: intakes and food sources in a community-based, multiethnic cohort study.

Phytoestrogens, heterocyclic phenols found in plants, may benefit several health outcomes. However, epidemiologic studies of the health effects of dietary phytoestrogens have yielded mixed results, in part due to challenges inherent in estimating dietary intakes. The goal of this study was to improve the estimates of dietary phytoestrogen consumption using a modified Block Food Frequency Questionnaire (FFQ), a 137-item FFQ created for the Study of Women's Health Across the Nation (SWAN) in 1994. To expand the database of sources from which phytonutrient intakes were computed, we conducted a comprehensive PubMed/Medline search covering January 1994 through September 2008. The expanded database included 4 isoflavones, coumestrol, and 4 lignans. The new database estimated isoflavone content of 105 food items (76.6%) vs. 14 (10.2%) in the 1994 version and computed coumestrol content of 52 food items (38.0%), compared to 1 (0.7%) in the original version. Newly added were lignans; values for 104 FFQ food items (75.9%) were calculated. In addition, we report here the phytonutrient intakes for each racial and language group in the SWAN sample and present major food sources from which the phytonutrients came. This enhanced ascertainment of phytoestrogens will permit improved studies of their health effects.

Improving quality of Food Frequency Questionnaire response in low-income Mexican American children.

The authors evaluated the validity and reliability of the Block Kids Food Frequency Questionnaire (BKFFQ) and the Block Kid Screener (BKScreener) in Mexican American children living along the Texas-Mexico border who participated in the National Institutes of Health-funded Proyecto Bienestar Laredo. The Bienestar/NEEMA health program is a school-based diabetes and obesity control program, and the Proyecto Bienestar Laredo is the translation of the Bienestar/NEEMA health program to 38 elementary schools in Laredo, Texas. Par ticipants included 2,376 eight-year-old boys (48%) and girls (52%) from two school districts in Laredo. Two Food Frequency Questionnaire (BKFFQ and BKScreener) dietary intakes were collected, and an expert panel of nutritionist assigned a classification response quality of "Good," "Questionable," and "Poor," based on playfulness (systematic or nonrandom) patterns and completion rates. In addition, both instruments were assessed for reliability (test-retest) in 138 students from a San Antonio School District. Children's height, weight, percentage body fat, reported family history of diabetes, and Texas Assessments of Knowledge and Skills in reading and mathematics scores were collected. This study showed that for Mexican American children living along the Texas-Mexico border, within the time constraints of the classroom, BKScreener yielded better data than the BKFFQ.

Sustained Minimal Residual Disease Negativity in Multiple Myeloma is Associated with Stool Butyrate and Healthier Plant-Based Diets.

PURPOSE: Sustained minimal residual disease (MRD) negativity is associated with long-term survival in multiple myeloma. The gut microbiome is affected by diet, and in turn can modulate host immunity, for example through production of short-chain fatty acids including butyrate. We hypothesized that dietary factors affect the microbiome (abundance of butyrate-producing bacteria or stool butyrate concentration) and may be associated with multiple myeloma outcomes. EXPERIMENTAL DESIGN: We examined the relationship of dietary factors (via a food frequency questionnaire), stool metabolites (via gas chromatography-mass spectrometry), and the stool microbiome (via 16S sequencing - α-diversity and relative abundance of butyrate-producing bacteria) with sustained MRD negativity (via flow cytometry at two timepoints 1 year apart) in myeloma patients on lenalidomide maintenance. The Healthy Eating Index 2015 score and flavonoid nutrient values were calculated from the food frequency questionnaire. The Wilcoxon rank sum test was used to evaluate associations with two-sided P < 0.05 considered significant. RESULTS: At 3 months, higher stool butyrate concentration (P = 0.037), butyrate producers (P = 0.025), and α-diversity (P = 0.0035) were associated with sustained MRD negativity. Healthier dietary proteins, (from seafood and plants), correlated with butyrate at 3 months (P = 0.009) and sustained MRD negativity (P = 0.05). Consumption of dietary flavonoids, plant nutrients with antioxidant effects, correlated with stool butyrate concentration (anthocyanidins P = 0.01, flavones P = 0.01, and flavanols P = 0.02). CONCLUSIONS: This is the first study to demonstrate an association between a plant-based dietary pattern, stool butyrate production, and sustained MRD negativity in multiple myeloma, providing rationale to evaluate a prospective dietary intervention.

Design and development of a dialysis food frequency questionnaire.

OBJECTIVES: Periodic assessment of dietary intake across a given dialysis population may help to improve the clinical outcomes related to nutrients such as dietary protein, phosphorus, or potassium. Although dietary recalls and food records are used to assess dietary intake at individual level and over shorter periods, food frequency questionnaires (FFQ) are used to rank subjects of a given population according to their nutrient intake over longer periods. DESIGN: To modify and refine the conventional Block FFQ to develop a specific FFQ for dialysis patients. SETTING: A total of 8 DaVita outpatient dialysis clinics in Los Angeles area, which participated in the "Nutrition and Inflammation in Dialysis Patients" study. PATIENTS: The study included 154 patients undergoing maintenance hemodialysis (MHD). MAIN OUTCOME MEASURE: Dietary intake of participating MHD patients using a 3-day food record, supplemented by a person-to-person dietary interview, to capture food intake over the last hemodialysis treatment day of the week and the 2 subsequent nondialysis days. RESULTS: Analyses of the food records identified the key contributors to the daily nutrient intake in the 154 participating MHD patients. A "Dialysis-FFQ" was developed to include approximately 100 food items representing the total food intake of 90% of the patients of the "Nutrition and Inflammation in Dialysis Patients" study population. Distinctions were made in several food items on the basis of key nutritional issues, such as protein, phosphorus, and potassium, in dialysis patients. CONCLUSIONS: We have developed a "Dialysis FFQ" to compare and rank dialysis patients according to their diverse nutrient intake. Although the Dialysis-FFQ may be a valuable tool to compare dialysis patients and to identify those who ingest higher or lower amounts of a given nutrient, studies are needed to examine the utility of the Dialysis-FFQ for nutritional assessment of dialysis patients.

Intake of Lycopene and other Carotenoids and Incidence of Uterine Leiomyomata: A Prospective Ultrasound Study.

BACKGROUND: Uterine leiomyomata (UL) are the leading indication for hysterectomy in the United States. Dietary supplementation with lycopene was associated with reduced size and incidence of oviduct leiomyoma in the Japanese quail. Two US prospective cohort studies of women reported little association between intake of lycopene, or other carotenoids, and UL incidence. However, these studies relied on self-reported physician-diagnosed UL, which is prone to misclassification. OBJECTIVE: This study examines the association between dietary intake of carotenoids and UL incidence. DESIGN: Data were derived from the Study of the Environment, Lifestyle, and Fibroids, a prospective cohort study. Women completed self-administered baseline questionnaires on demographic characteristics, reproductive history, and lifestyle, including a 110-item validated food frequency questionnaire, from which dietary intakes of carotenoids-including alpha carotene, beta carotene, cryptoxanthin, lutein-zeaxanthin, and lycopene-and vitamin A were estimated. PARTICIPANTS/SETTING: One thousand two hundred thirty Black women aged 23 to 35 years who did not have a previous diagnosis of UL, cancer, or autoimmune disease were eligible for enrollment (2010-2012). Participants were residents of the Detroit, MI, metropolitan area. MAIN OUTCOME MEASURES: Transvaginal ultrasound was used to assess UL at baseline and 20, 40, and 60 months of follow-up. STATISTICAL ANALYSES PERFORMED: Cox regression was used to estimate hazard ratios and 95% CIs, adjusted for energy intake, age at menarche, education, body mass index, parity, age at first birth, years since last birth, current use of oral contraceptives or progestin-only injectables, alcohol intake, and cigarette smoking. RESULTS: Among 1,230 women without prevalent UL at baseline, 301 incident UL cases during follow-up were identified. Intakes of lycopene, other carotenoids, and vitamin A were not appreciably associated with UL incidence. Hazard ratios comparing quartiles 2 (2,376 to 3,397 µg/day), 3 (3,398 to 4,817 µg/day), and 4 (≥4,818 µg/day) with quartile 1 (<2,376 µg/day) of lycopene intake were 1.03 (95% CI 0.72 to 1.47), 1.22 (95% CI 0.86 to 1.72), and 0.95 (95% CI 0.67 to 1.36), respectively. CONCLUSIONS: Study findings do not support the hypothesis that greater carotenoid intake is associated with reduced UL incidence.

Vitamin D intake from food and supplements among Ontario women based on the US block food frequency questionnaire with and without modification for Canadian food values.

OBJECTIVES: To measure and compare dietary vitamin D intake among women in Ontario using a modified Block 1998 (US) food frequency questionnaire (FFQ) before and after modification for Canadian-specific vitamin D food fortification. METHODS: An age-stratified random sample of 3,471 women in Ontario (aged 25-74) was identified using random digit dialing methods. Standard US food values and a modified Canadian-specific vitamin D nutrient analysis were applied to the FFQ. RESULTS: Intake of vitamin D from foods (Canadian nutrient analysis) was 5.3 +/- 3.4 microg/day (mean +/- SD) and 45% of women reported vitamin D intake from supplements. Total vitamin D intakes met the current Adequate Intakes of 5, 10 and 15 microg/day for only 62%, 47%, and 28% of women aged < or = 50, 51-70 and > or = 71, respectively. Relatively high agreement was found between the US and Canadian nutrient analysis methods of measuring vitamin D from food (weighted kappa = 0.74, 95% CI 0.72-0.76). Intake differences (US minus Canadian) ranged from -5.0 microg/day to +2.0 microg/day (1st-99th percentile); however, the mean difference was only -0.54 microg/day (95% CI: -0.58 to -0.50). CONCLUSIONS: Lower than recommended total vitamin D intakes were observed among our study participants which may negatively impact the health status of women. Adjustment for Canadian food fortification and the inclusion of fatty fish had little impact on the measurement of vitamin D from food.

Development of Alive! (A Lifestyle Intervention Via Email), and its effect on health-related quality of life, presenteeism, and other behavioral outcomes: randomized controlled trial.

BACKGROUND: Cost-effective interventions to improve diet and physical activity are a public health priority. Alive! is an email-based intervention to increase physical activity, reduce saturated and trans fats and added sugars, and increase fruit and vegetable consumption. It was shown to improve these behaviors in a large randomized controlled trial. OBJECTIVE: (1) To describe the components and behavioral principles underlying Alive!, and (2) to report effects of the intervention on the secondary outcomes: health-related quality of life, presenteeism, self-efficacy, and stage of change. METHODS: The Alive! behavior change model is designed to elicit healthy behaviors and promote their maintenance. Behavioral strategies include assessments followed by individualized feedback, weekly goal-setting, individually tailored goals and tips, reminders, and promotion of social support. Alive! was tested among non-medical employees of Kaiser Permanente of Northern California, who were randomized to either the intervention group or the wait-list control group. After randomization, intervention group participants chose one topic to undertake for the intervention period: increasing physical activity, increasing fruits and vegetables, or decreasing saturated and trans fats and added sugars. Pre-post questionnaires assessed changes in SF-8 health-related quality of life, presenteeism, self-efficacy, and stage of change. Mixed effects multiple linear regression and ordinal logistic regression models were used, with department as a random effect factor. Analyses were by intention to treat: the 30% (238/787) who did not respond to the follow-up questionnaires were assigned change scores of zero. RESULTS: Participants were 19 to 65 years (mean 44.0 +/- 10.6), and 74.3% (585/787) were female. Mean SF-8 Physical quality of life score increased significantly more in the intervention group than in the control group, 1.84 (95% CI 0.96-2.72) vs 0.72 (95% CI -0.15-1.58) respectively, P = .02. SF8 Mental score also improved significantly more in the intervention group than in the control group (P = .02). The odds ratio for improvement in self-assessed health status was 1.57 (95% CI 1.21-2.04, P < .001) for the intervention group compared to the control group. The odds ratio for having a reduction in difficulty accomplishing work tasks because of physical or emotional problems, a measure of presenteeism, was 1.47 (95% CI 1.05-2.05, P = .02) for the intervention group compared to the control group. The odds of having an improvement in self-efficacy for changing diet was 2.05 (95% CI 1.44-2.93) for the intervention vs the control group (P < .001). Greater improvement in stage of change for physical activity (P = .05), fats (P = .06), and fruits/vegetables (P = .006) was seen in the intervention group compared to the control group. Significant effects on diet and physical activity behavior change are reported elsewhere. CONCLUSIONS: Cost-effective methods that can reach large populations with science-based interventions are urgently needed. Alive! is a fully automated low-cost intervention shown to effect significant improvements in important health parameters. TRIAL REGISTRATION: Clinicaltrials.gov NCT00607009; http://clinicaltrials.gov/ct2/show/NCT00607009 (Archived by WebCite at http://www.webcitation.org/5cLpCWcT6).

Relative validation of a short questionnaire to assess the dietary habits of pregnant American Indian women.

The objective of this study was to compare a short dietary screener developed to assess diet quality with interviewer-administered telephone 24-hour dietary recalls in a population of pregnant Northern Plains (NP) American Indian women. Participants were recruited from NP clinical sites of the Prenatal Alcohol and SIDS and Stillbirth (PASS) Network, as part of a large, prospective, multidisciplinary study. Prenatal PASS participants who enrolled prior to 24 weeks gestation were eligible to participate. Repeated 24-hour dietary recalls were collected using the Nutrition Data System for Research (NDSR) software and a short dietary screener was administered intended to capture usual dietary intake during pregnancy. The available recalls were averaged across days for analysis. Items were grouped from the recalls to match the food group data estimates for the screener (e.g., total vegetables, total fruit, total dairy, total and whole grains). Deattenuated Pearson correlation coefficients were calculated between the two data sources after correcting for the within-person variation in the 24-hour recall data. A total of 164 eligible women completed the screener and at least two 24-hour dietary recalls and were included in the analyses. Pearson deattenuated correlation coefficients between the diet screener and the dietary recalls for the majority of food groups were 0.40 or higher. This short diet screener to assess usual diet appears to be a valid instrument for use in evaluating diet quality among pregnant American Indian women.

A Lifestyle Intervention via Email in Minority Breast Cancer Survivors: Randomized Parallel-Group Feasibility Study.

BACKGROUND: Our data have indicated that minority breast cancer survivors are receptive to participating in lifestyle interventions delivered via email or the Web, yet few Web-based studies exist in this population. OBJECTIVE: The aim of this study was to examine the feasibility and preliminary results of an email-delivered diet and activity intervention program, "A Lifestyle Intervention Via Email (ALIVE)," delivered to a sample of racial and ethnic minority breast cancer survivors. METHODS: Survivors (mean age: 52 years, 83% [59/71] African American) were recruited and randomized to receive either the ALIVE program's 3-month physical activity track or its 3-month dietary track. The fully automated system provided tools for self-monitoring and goal setting, tailored content, and automated phone calls. Descriptive statistics and mixed-effects models were computed to examine the outcomes of the study. RESULTS: Upon completion, 44 of 71 survivors completed the study. Our "intention-to-treat" analysis revealed that participants in the physical activity track made greater improvements in moderate to vigorous activity than those in the dietary track (+97 vs. +49 min/week, P<.001). Similarly, reductions in total sedentary time among those in the physical activity track (-304 vs. -59 min/week, P<.001) was nearly 5 times greater than that for participants in the dietary track. Our completers case analysis indicated that participants in the dietary track made improvements in the intake of fiber (+4.4 g/day), fruits and vegetables (+1.0 cup equivalents/day), and reductions in saturated fat (-2.3 g/day) and trans fat (-0.3 g/day) (all P<.05). However, these improvements in dietary intake were not significantly different from the changes observed by participants in the physical activity track (all P>.05). Process evaluation data indicated that most survivors would recommend ALIVE to other cancer survivors (97%), were satisfied with ALIVE (82%), and felt that ALIVE was effective (73%). However, survivors expressed concerns about the functionality of the interactive emails. CONCLUSIONS: ALIVE appears to be feasible for racial and ethnic minority cancer survivors and showed promising results for larger implementation. Although survivors favored the educational content, a mobile phone app and interactive emails that work on multiple email domains may help to boost adherence rates and to improve satisfaction with the Web-based platform. TRIAL REGISTRATION: ClinicalTrials.gov NCT02722850; https://clinicaltrials.gov/ct2/show/NCT02722850 (Archived by WebCite at http://www.webcitation.org/6tHN9VsPh).

A Fully Automated Diabetes Prevention Program, Alive-PD: Program Design and Randomized Controlled Trial Protocol.

BACKGROUND: In the United States, 86 million adults have pre-diabetes. Evidence-based interventions that are both cost effective and widely scalable are needed to prevent diabetes. OBJECTIVE: Our goal was to develop a fully automated diabetes prevention program and determine its effectiveness in a randomized controlled trial. METHODS: Subjects with verified pre-diabetes were recruited to participate in a trial of the effectiveness of Alive-PD, a newly developed, 1-year, fully automated behavior change program delivered by email and Web. The program involves weekly tailored goal-setting, team-based and individual challenges, gamification, and other opportunities for interaction. An accompanying mobile phone app supports goal-setting and activity planning. For the trial, participants were randomized by computer algorithm to start the program immediately or after a 6-month delay. The primary outcome measures are change in HbA1c and fasting glucose from baseline to 6 months. The secondary outcome measures are change in HbA1c, glucose, lipids, body mass index (BMI), weight, waist circumference, and blood pressure at 3, 6, 9, and 12 months. Randomization and delivery of the intervention are independent of clinic staff, who are blinded to treatment assignment. Outcomes will be evaluated for the intention-to-treat and per-protocol populations. RESULTS: A total of 340 subjects with pre-diabetes were randomized to the intervention (n=164) or delayed-entry control group (n=176). Baseline characteristics were as follows: mean age 55 (SD 8.9); mean BMI 31.1 (SD 4.3); male 68.5%; mean fasting glucose 109.9 (SD 8.4) mg/dL; and mean HbA1c 5.6 (SD 0.3)%. Data collection and analysis are in progress. We hypothesize that participants in the intervention group will achieve statistically significant reductions in fasting glucose and HbA1c as compared to the control group at 6 months post baseline. CONCLUSIONS: The randomized trial will provide rigorous evidence regarding the efficacy of this Web- and Internet-based program in reducing or preventing progression of glycemic markers and indirectly in preventing progression to diabetes. TRIAL REGISTRATION: ClinicalTrials.gov NCT01479062; http://clinicaltrials.gov/show/NCT01479062 (Archived by WebCite at http://www.webcitation.org/6U8ODy1vo).

Demonstration of an E-mailed worksite nutrition intervention program.

INTRODUCTION: Dietary fat and low fruit and vegetable intake are linked to many chronic diseases, and U.S. population intake does not meet recommendations. Interventions are needed that incorporate effective behavior-change principles and that can be delivered inexpensively to large segments of the population. METHODS: Employees at a corporate worksite were invited to participate in a program, delivered entirely by e-mail, to reduce dietary fat and increase fruit and vegetable intake. Behavior-change principles underlying the intervention included tailoring to the participant's dietary lifestyle, baseline assessment and feedback about dietary intake, family participation, and goal setting. Assessment, tailoring, and delivery was fully automated. The program was delivered weekly to participants' e-mail inboxes for 12 weeks. Each e-mail included information on nutrition or on the relationship between diet and health, dietary tips tailored to the individual, and small goals to try for the next week. In this nonrandomized pilot study, we assessed technical feasibility, acceptability to employees, improvement in Stage of Change, increase in fruit and vegetable consumption, and decrease in fat intake. RESULTS: Approximately one third (n = 84) of employees who were offered the 12-week program signed up for it, and satisfaction was high. There was significant improvement in Stage of Change: 74% of those not already at the top had forward movement (P < .001). In addition, results suggest significant increase in fruit and vegetable consumption (0.73 times/day, P < .001) and significant decrease in intake of fat sources (-0.39 times/day, P < .001). CONCLUSION: This inexpensive program is feasible and appears to be effective. A randomized controlled trial is needed.

Use and reliability of the World Wide Web version of the Block Health Habits and History Questionnaire with older rural women.

OBJECTIVE: To estimate the parallel forms reliability of the paper and pencil and World Wide Web versions of the 1998 Block Health Habits and History Questionnaire (HHHQ) and to examine the feasibility of older women using the Web version. DESIGN: Within a 2-week period, participants completed both the paper and pencil and Web versions of the HHHQ and pre- and postsurveys about their comfort level and experience in using the computer. SUBJECTS: A convenience sample of 31 white women, aged 58.2 6.3 years, from a rural location were recruited via direct mail, public service announcements, and public posters. VARIABLES MEASURED: The parallel forms reliability of the HHHQ administered in two different ways and the perceptions of the women on their computer use were measured. ANALYSIS: Dietary data were analyzed using Pearson correlations and paired t tests. Alpha significance level was set at P .70), with only vitamin C (r =.54) and iron (r =.65) falling below the acceptable standard. Eleven women indicated initial discomfort with the computer, but after the study, only three said they were uncomfortable completing the on-line survey. IMPLICATIONS: Internet dietary assessment tools could be a feasible assessment tool for older women to self-administer.

The work and home activities questionnaire: energy expenditure estimates and association with percent body fat.

BACKGROUND: Understanding and increasing physical activity requires assessment of occupational, home, leisure and sedentary activities. METHODS: A physical activity questionnaire was developed using data from a large representative U.S. sample; includes occupational, leisure and home-based domains; and produces estimates of energy expenditure, percent body fat, minutes in various domains, and meeting recommendations. It was tested in 396 persons, mean age 44 years. Estimates were evaluated in relation to percent body fat measured by dual-energy x-ray absorptiometry. RESULTS: Median energy expenditure was 2365 kcal (women) and 2960 kcal (men). Women spent 35.1 minutes/day in moderate household activities, 13.0 minutes in moderate leisure and 4.0 minutes in vigorous activities. Men spent 18.0, 22.5 and 15.6 minutes/day in those activities, respectively. Men and women spent 276.4 and 257.0 minutes/day in sedentary activities. Respondents who met recommendations through vigorous activities had significantly lower percent body fat than those who did not, while meeting recommendations only through moderate activities was not associated with percent body fat. Predicted and observed percent body fat correlated at r = .73 and r = .82 for men and women respectively, P < .0001. CONCLUSIONS: This questionnaire may be useful for understanding health effects of different components of activity, and for interventions to increase activity levels.

Improving diet and physical activity with ALIVE: a worksite randomized trial.

CONTEXT: Healthy diets and regular physical activity confer many health benefits, but the prevalence of these behaviors is relatively low. BACKGROUND: Cost-effective strategies are needed to increase healthy eating and physical activity in the population. DESIGN: An RCT, conducted in 2006, of a 16-week e-mail program offered individually tailored, small-step goals; a personal homepage with tips; educational materials; and tracking and simulation tools. SETTING/POPULATION: Seven hundred eighty-seven employees in the administrative offices of a large healthcare organization volunteered to participate. MAIN OUTCOME MEASURES: Changes were self-reported for total physical activity; moderate physical activity (MPA); vigorous physical activity (VPA); walking; sedentary behavior; and intake of fruits and vegetables, saturated and trans fats, and added sugars in the intervention group compared to the control group. RESULTS: In intent-to-treat analyses (conducted in 2007 and 2008) that set change in nonresponders to the follow-up questionnaire to zero, the intervention group reported increases of 28.0 minutes/week (min/wk) of MPA (SE=7.4, p=0.0002); 12.5 min/wk of VPA (SE=5.7, p=0.03); and 21.5 min/wk of walking (SE=5.5, p=0.0003) relative to the control group. Intake of both saturated and trans fats (grams/day [g/day]) declined (beta=-0.95, SE=0.36, p=0.01; beta=-0.29, SE=0.12, p=0.02, respectively). The consumption of fruits and vegetables increased significantly (p=0.03), and the consumption of added sugars decreased marginally (p=0.08). The largest changes were in participants who did not meet behavioral recommendations at baseline (increase of 55.4 min/wk of MPA and decrease of 1.15 g/day of trans fats, relative to the control group). Differences between the intervention and control groups were still observed 4 months after the intervention ended. CONCLUSIONS: ALIVE is an effective program for achieving significant improvement in diet and physical activity. TRIAL REGISTRATION: NCT00607009.