Ulcerative Colitis-Symptom Questionnaire: Valid for Use in Adults with Moderately to Severely Active Ulcerative Colitis.

BACKGROUND: Due to wide-ranging impacts of Ulcerative Colitis (UC), regulatory authorities emphasize the importance of including validated patient-reported symptom severity measures in clinical trials. AIM: To describe the development and validation of the Ulcerative Colitis-Symptom Questionnaire (UC-SQ). METHODS: The UC-SQ was developed in a qualitative study involving a targeted literature review, semi-structured concept elicitation interviews, and combined concept elicitation/cognitive interviews. Measurement properties, including item-level analyses, factor structure, reliability, validity, responsiveness, and clinically meaningful change were evaluated using data from a phase 2b, randomized trial in adults with UC (N = 113). RESULTS: Fourteen symptom concepts were elicited across 22 interviews, with saturation at the fifth interview. Twenty-two items were unmodified as cognitive interview participants interpreted underlying concepts correctly. Instructions were clear and items were relevant, with appropriate response options and recall periods. Reduction to 17 items was completed prior to psychometric testing. Two items (joint pain/constipation) did not contribute to reliability in initial testing and were included as non-scored items. The 15-item UC-SQ showed evidence of internal consistency (α = 0.86) and test-retest reliability (intraclass correlation coefficient = 0.88). The UC-SQ discriminated by disease severity as defined by Mayo and Inflammatory Bowel Disease Questionnaire scores (p < 0.0001). Convergent validity was supported by strong correlations with criterion measures. The UC-SQ was responsive in patients indicating change in other measures. A 10-point decrease from baseline indicated within-patient meaningful improvement. CONCLUSIONS: The UC-SQ is reliable, valid and responsive, with a 10-point improvement estimating within-patient clinically meaningful improvement. The tool is fit-for-purpose as a key endpoint in pivotal UC trials.

Psychometric properties of the Alzheimer's Disease Cooperative Study - Activities of Daily Living for Mild Cognitive Impairment (ADCS-MCI-ADL) scale: a post hoc analysis of the ADCS ADC-008 trial.

BACKGROUND: The Alzheimer's Disease Cooperative Study - Activities of Daily Living Scale for use in Mild Cognitive Impairment (MCI), the ADCS-ADL-MCI, is an evaluation scale with information provided by an informant/caregiver to describe the functional impairment of patients with MCI. As the ADCS-ADL-MCI has yet to undergo a full psychometric evaluation, this study aimed to evaluate the measurement properties of the ADCS-ADL-MCI in subjects with amnestic MCI. METHODS: Measurement properties, including item-level analysis, internal consistency reliability, test-retest reliability, construct validity (convergent/discriminant, known-groups validity), and responsiveness were evaluated using data from the ADCS ADC-008 trial, a 36-month, multicenter, placebo-controlled study in 769 subjects with amnestic MCI (defined by clinical criteria and a global clinical dementia rating, CDR, score of 0.5). Due to most subjects' mild condition at baseline and resulting low variance in scores, psychometric properties were assessed using both baseline and 36-month data. RESULTS: Ceiling effects were not apparent at the total score level, with 3% of the cohort reaching the maximum score of 53, despite most subjects having a relatively high score at baseline (mean score = 46.0 [standard deviation = 4.8]). Item-total correlations were overall weak at baseline, most likely due to low variability in responses; however, at month 36, good item homogeneity was found. Cronbach's alpha values ranged from acceptable (0.64 at baseline) to good (0.87 at month 36), indicating overall very good internal consistency reliability. Further, moderate to good test-retest reliability was found (intraclass correlation coefficients ranging from 0.62-0.73). The analyses also largely supported convergent/discriminant validity, especially at month 36. Finally, the ADCS-ADL-MCI discriminated well between groups showing good known-groups validity, and was responsive in patients who indicated a longitudinal change in other instruments. CONCLUSIONS: This study provides a comprehensive psychometric evaluation of the ADCS-ADL-MCI. Findings suggest that the ADCS-ADL-MCI is a reliable, valid and responsive measure capable of capturing functional abilities in patients with amnestic MCI. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT00000173.

Diet quality and periodontal disease: Results from the oral infections, glucose intolerance and insulin resistance study (ORIGINS).

AIMS: This study examined the cross-sectional association between diet quality and periodontal disease. MATERIALS AND METHODS: In the Oral Infections, Glucose Intolerance and Insulin Resistance Study (ORIGINS), 923 individuals completed the National Cancer Institute's validated Diet History Questionnaire 1, from which the Alternative Healthy Eating Index (AHEI) scores and A Priori Diet Quality Scores (APDQS) were calculated. Mean probing depth (MPD), mean clinical attachment loss (MAL) and % of sites bleeding on probing (%BOP) were derived from full-mouth periodontal exams. Multivariable adjusted linear and logistic regression models assessed the associations between diet quality and MPD, MAL, %BOP, and the odds of periodontitis (defined via the CDC/AAP classification). RESULTS: Alternative Healthy Eating Index and APDQS were not associated with MPD, MAL, or periodontitis. While AHEI was also not associated with %BOP, the APDQS was associated with %BOP (p = .03). Higher nut consumption was related to lower MPD (p = .03) and periodontitis odds (p = .03). Higher red meat consumption was associated with higher MPD (p = .01) and %BOP (p = .05). Higher trans-fatty acid consumption was also associated with increased %BOP (p = .05). CONCLUSION: Overall diet quality scores were not associated with periodontal status. Future studies are necessary to replicate the associations observed in this study to minimize the risk of false discovery.

Designing online grocery stores to support healthy eating for weight loss.

OBJECTIVES: The current study aimed to identify features to include in online grocery stores to support healthful food purchasing by those striving to lose weight. DESIGN: A Value Proposition Design approach was used to gain shopper insights, devise potential online grocery store features and obtain feedback on these features. SETTING: Telephone interviews were conducted to gain insight into shoppers' needs and perceptions. Results were used by the research team to identify potential online grocery shopping features that may support healthful purchase decisions, and interviews were conducted with a different sample of shoppers to gather feedback on features. PARTICIPANTS: Insight (n 25) and feedback (n 25) interviews were conducted with convenience samples of adults trying to lose weight. RESULTS: Participants were primarily female, white, college educated and with obesity or overweight. Online grocery features devised by the research team based on findings from the insight interviews included (1) shopping cart nutrition rating tool; (2) healthy meal planning tool; (3) interactive healthy eating inspiration aisle and (4) healthy shopping preference settings option. Findings from the feedback interviews indicated that the healthy meal planning tool, healthy shopping preference settings option and shopping cart nutrition rating tool features were positively rated by most participants. CONCLUSIONS: There are multiple features grocers should consider including in their online stores to attract and support customers striving to eat healthy for weight loss.

Associations of breastfeeding or formula feeding with infant anthropometry and body composition at 6 months.

The objective of this study was to investigate the associations of mode of feeding with infant anthropometric and body composition variables at 6 months of age. We studied 259 infants whose exclusive mode of feeding (breast or formula) to 1 month was confirmed. Standard anthropometric characteristics of the infants (weight, length and weight-for-length z scores) were obtained, and body composition (total fat mass, fat-free mass, trunk fat mass and body fat percent) was measured using dual-energy X-ray absorptiometry (DXA) at 6 months (±12 days). General linear models were used to test the associations of mode of feeding with infant anthropometric and body composition variables at 6 months after adjustment for maternal and infant covariates. In this cohort of predominantly breastfed, White infants of highly educated mothers, fat-free mass was lower (P = .002), and trunk fat mass (P = .032) and body fat percent (P < .001) were greater in breastfed infants than in formula-fed infants at 6 months of age. After adjustment for covariates, total fat-free mass was significantly lower (ß = -372 g, [SE = 125, P = .003]), and body fat percent was significantly greater (ß = 3.30, [SE = 0.91, P < .001]) in breastfed infants than in formula-fed infants. No other significant associations were observed. These findings support those of previous studies reporting greater fat-free mass in formula-fed infants during the first 6 months of life. Additional research is warranted to explore whether differences in infant body composition by mode of feeding persist throughout the life course and to assess causality.

The Association of Television Viewing in Childhood With Overweight and Obesity Throughout the Life Course.

Few studies have addressed the association between television viewing time in childhood and overweight/obesity across the life course. Among 30,921 mother-daughter dyads from the Nurses' Mothers' Cohort (2001) and the Nurses' Health Study II (1989 and 1991), the following information was collected: daughter's television viewing time and physical activity (PA) level at ages 3-5 and 5-10 years, somatotype at ages 5 and 10 years, and body mass index at age 18 years and in adulthood (ages 26-45 years). According to multivariable-adjusted logistic regression models, television viewing at least 4 hours/day versus no television at ages 3-5 years was associated with odds ratios of overweight/obesity of 1.61 (95% confidence interval (CI): 1.20, 2.17) at age 5 years, 1.46 (95% CI: 1.14, 1.86) at age 10 years, 1.31 (95% CI: 1.00, 1.70) at age 18 years, and 1.32 (95% CI: 1.10, 1.59) in adulthood. A composite variable of high television viewing time/low PA level versus low television viewing time/high PA level at ages 3-5 years was associated with odds ratios of overweight/obesity ranging from 3.22 (95% CI: 2.23, 4.65) at age 5 years to 1.82 (95% CI: 1.36, 2.45) in adulthood. Findings were similar at ages 5-10 years. Long hours of television viewing in childhood alone and in combination with low PA levels were consistently associated with overweight/obesity throughout life.

Quality of Life after Dietary Self-Management Intervention for Persons with Early Stage CKD.

Dietary recommendations that potentially delay the progression of chronic kidney disease (CKD) can be perceived as restrictive and unpalatable, negatively impacting quality of life (QOL). This pilot study examined the effect of a six-week small group intervention, "Self-Management of Dietary Intake Using Mindful Eating," on QOL, health literacy, and dietary self-efficacy among persons with CKD Stages 1-3. Improvements (n=19) were found from pre-test to post-test in total scores for Kidney Disease Quality of Life Short Form-36 (p=0.003), health literacy (p=0.001), and self-efficacy (p=0.003). The intervention had promising results for improving both diet management and QOL, which supports further testing in randomized control trials.

Self-management of dietary intake using mindful eating to improve dietary intake for individuals with early stage chronic kidney disease.

Using mindful eating to improve specific dietary recommendations has not been adequately studied. This feasibility study examined an intervention, self-management of dietary intake using mindful eating, with 19 participants that had mild to moderate chronic kidney disease, using a prospective, single group, pretest-posttest design. The intervention had six weekly classes focused on self-management using mindful eating, goal-setting, problem-solving, and food label reading. Weight, body mass index (BMI), 3-day 24-h dietary recalls and fasting blood samples were measured. Participants improved significantly in mean weight (203.21 ± 42.98 vs 199.91 ± 40.36 lbs; P = 0.03) and BMI (32.02 ± 5.22 vs 31.57 ± 5.27 kg/m2; P = 0.04), but not in dietary intake nor blood measures with the exception of cis-beta-carotene levels (0.020 + 0.012 vs 0.026 + 0.012 mcg/mL; P = 0.008), which correlates to fruit and vegetable servings. These promising results warrant further testing of the intervention in randomized control trials.

Development and Validation of a Canine Health-Related Quality of Life Questionnaire and a Human-Canine Bond Questionnaire for Use in Veterinary Practice.

The use of valid questionnaires to assess dogs' health-related quality of life (HRQoL) in veterinary practice can improve canine health outcomes and communications between veterinarians and caretakers of dogs. The Canine HRQoL Questionnaire (Canine HRQoL-Q) and the Human-Canine Bond Questionnaire (HCBQ) were developed and validated to fulfill this need. A literature review, interviews with veterinarians, and focus groups with caretakers were conducted to generate questionnaire items and develop draft questionnaires, which were piloted with caretakers to establish their content validity. Measurement properties were evaluated using data from a prospective survey study (N = 327). Draft Canine HRQoL-Q and HCBQ measures were developed, including a domain structure, items, recall period, and scale/response options. Refinements were made via iterative cognitive interviews with caretakers. When no additional revisions were indicated and content validity was established, the questionnaires were psychometrically tested. Ceiling effects were observed for all items, and factor analyses indicated that the pre-specified domains are appropriate. Internal consistency was demonstrated for the HCBQ (α = 0.79-0.86) and all but the social functioning domain of the Canine HRQoL-Q (α = 0.60). Test-retest reliability for the Canine HRQoL-Q was generally moderate-to-good (with intraclass correlation coefficients (ICCs) > 0.79). Test-retest reliability for the HCBQ was moderate (ICCs: 0.70-0.79) except for the trust domain (ICC: 0.58). Known-groups validity was demonstrated via significant differences (p < 0.05) in scores for health/bonding groups. Convergent validity was supported (r > 0.40) between all domains and the total scores for both questionnaires. The Canine HRQoL-Q and the HCBQ are valid, reliable measures of canine HRQoL for use in veterinary clinics and appear to measure related but distinct concepts that contribute to canine health and wellness.

Associations of Physical Activity and Lactation Duration With Cardiometabolic Risk Factors: The CARDIA Study.

BACKGROUND: Physical activity (PA) and lactation benefit cardiometabolic health. OBJECTIVES: The purpose of this study was to describe the joint associations of PA and lactation with cardiometabolic risk. METHODS: We averaged PA across exams and summed lifetime lactation in Black and White parous women in the Coronary Artery Risk Development in Young Adults Study. Categories were created for PA (-PA:

Higher Maternal Diet Quality during Pregnancy and Lactation Is Associated with Lower Infant Weight-For-Length, Body Fat Percent, and Fat Mass in Early Postnatal Life.

Maternal pregnancy nutrition influences fetal growth. Evidence is limited, however, on the relationship of maternal diet during pregnancy and lactation on infant postnatal growth and adiposity. Our purpose was to examine associations between maternal diet quality during pregnancy and lactation with offspring growth and body composition from birth to six months. Maternal diet quality was serially assessed in pregnancy and at one and three months postpartum, using the Healthy Eating Index⁻2015 in a cohort of 354 fully breastfeeding mother⁻infant dyads. Infant length-for-age (LAZ), weight-for-age (WAZ), and weight-for-length (WLZ) Z-scores were assessed at birth, one, three, and six months. Infant body fat percent (BF%), fat mass (FM), and fat-free mass (FFM) were measured at six months using dual-energy X-ray absorptiometry. Higher maternal diet quality from pregnancy through three months postpartum was associated with lower infant WLZ from birth to six months (p = 0.02) and BF% at six months (p ≤ 0.05). Higher maternal diet quality at one and three months postpartum was also associated with lower infant FM at six months (p < 0.01). In summary, maternal diet quality during pregnancy and lactation was inversely associated with infant relative weight and adiposity in early postnatal life. Additional research is needed to explore whether associations persist across the life course.

Association of Full Breastfeeding Duration with Postpartum Weight Retention in a Cohort of Predominantly Breastfeeding Women.

Full breastfeeding (FBF) is promoted as effective for losing pregnancy weight during the postpartum period. This study evaluated whether longer FBF is associated with lower maternal postpartum weight retention (PPWR) as compared to a shorter FBF duration. The MILK (Mothers and Infants Linked for Healthy Growth) study is an ongoing prospective cohort of 370 mother-infant dyads, all of whom fully breastfed their infants for at least 1 month. Breastfeeding status was subsequently self-reported by mothers at 3 and 6 months postpartum. Maternal PPWR was calculated as maternal weight measured at 1, 3, and 6 months postpartum minus maternal prepregnancy weight. Using linear mixed effects models, by 6 months postpartum, adjusted means ± standard errors for weight retention among mothers who fully breastfed for 1-3 (3.40 ± 1.16 kg), 3-6 (1.41 ± 0.69 kg), and ≥6 months (0.97 ± 0.32 kg) were estimated. Compared to mothers who reported FBF for 1-3 months, those who reported FBF for 3-6 months and ≥6 months both had lower PPWR over the period from 1 to 6 months postpartum (p = 0.04 and p < 0.01, respectively). However, PPWR from 3 to 6 months was not significantly different among those who reported FBF for 3-6 versus ≥6 months (p > 0.05). Interventions to promote FBF past 3 months may increase the likelihood of postpartum return to prepregnancy weight.

Age at Introduction of Solid Food and Obesity Throughout the Life Course.

OBJECTIVE: This study aimed to examine the association between age at solid food (SF) introduction and obesity throughout the life course. METHODS: Among 31,816 mother- nurse daughter dyads in the Nurses' Mothers' Cohort Study and the Nurses' Health Study II, information was collected on age at SF introduction, body somatotype at ages 5 and 10, and Body Mass Index at age 18 and in adulthood. Odds ratios (ORs) and 95% confidence intervals (95% CIs) for obesity throughout life were estimated using logistic regression models with adjustment for parental and nurse daughter covariates. RESULTS: Nurse daughters introduced to SF at ≥ 9 months versus 6 to 9 months had marginally higher age-adjusted (OR: 1.21; 95% CI: 1.01, 1.47) and covariate-adjusted (OR: 1.22; 95% CI: 1.01, 1.47) odds of obesity at age 5. Age at SF introduction was not related to obesity at ages 10 and 18 or in adulthood. CONCLUSIONS: Late age at SF introduction was marginally associated with obesity at age 5, but this association did not persist throughout the life course.