The authors describe the phases (conceptualizing, actualizing, and ensuring success of science) necessary for developing a successful research grant application for funding. Emphasis is on the development of an important and novel research question, clear conceptualization of the study, development of specific aims, theory to guide the study, a well-designed approach, and the role of teamwork to enhance success. The challenges that can occur during these phases of grant writing are also addressed.

Aim. To determine the efficacy and safety of vitamin D3 supplementation in reducing depressive symptoms in women with type 2 diabetes (T2D), depression, and low vitamin D. Methods. In this double-blind randomized active comparator-controlled trial, women with significant depressive symptoms as assessed by the Center for Epidemiologic Studies Depression (CES-D) scale received weekly oral vitamin D3 supplementation (50,000 IU) or an active comparator (5,000 IU) for 6 months. Assessments of vitamin D, 25-hydroxyvitamin D [25 (OH) D], and depression were measured at baseline, 3 months, and 6 months. Results. A total of 129 women were randomized, from which 119 completed the study (57 in lower dose and 62 in higher dose). Participants had an average 25 (OH) D and HbA1c of 20.8 ng/mL and 7.8%, respectively, at baseline. They were diverse (48% Black) and had a mean age of 50 and T2D for about 8 years. Upon completion of vitamin D3 supplementation, serum 25 (OH) D levels increased with 50,000 IU (+34 ng/mL) and 5,000 IU (+10 ng/mL). There was no difference in CES-D scores by treatment dose. Overall, depressive symptoms significantly improved over time with an average CES-D decline of 12.98 points (95% CI: −15.04 to −10.93; p < 0.001 ). Among women with moderate baseline depressive symptoms, those receiving the lower dose had nominally lower depression scores at follow-up than those in the higher dose cohort. Among women with severe baseline depressive symptoms, the improvement in follow-up depression scores was the same regardless of dose. Conclusions. There was no difference in the dosing effect of vitamin D3 supplementation for the treatment of depressive symptoms in women with T2D who present with significant symptoms and low vitamin D. Regardless of the dose, participants’ mood improved over time. Further study of vitamin D to target depressive symptoms in comorbid populations is needed.

Purpose: The purpose of this study was to examine 1) discrepancies between expectations of motherhood and the experience of motherhood in the first 6 to 12 weeks postpartum, 2) relationships between maternal quality of life, mood, parental attitudes, and expectations, and 3) predictors of quality of life. Study Design and Methods: We used a descriptive, correlational design. The sample consisted of first-time mothers who were at or beyond 34 weeks pregnant with no reported history of anxiety or depression. The following questionnaires were administered during pregnancy and 6 to 12 weeks postpartum: Parenting Expectations Measure, General Anxiety Disorder 7, Edinburgh Postnatal Depression Screen, Intensive Parenting Attitudes Questionnaire, and Ferrans and Powers Quality of Life Index. Results: Sixty-one mothers participated. Based on scores from the Parenting Expectations Measure, 44% of participants had expectations of motherhood that were not met. Expectations were a significant predictor of quality of life during pregnancy and postpartum. Clinical Implications: Unmet expectations are important to understand when identifying modifiable risk factors of postpartum anxiety and depression in women without other risk factors. A discussion of expectations during antepartum care may minimize poor quality of life which is associated with anxiety and depression in women without anxiety and depressive symptoms.

OBJECTIVES To assess the potential effect of cholecalciferol supplementation to reduce symptom burden for women with metastatic breast cancer (MBC). SAMPLE & SETTING 11 clinically stable women with estrogen receptor-positive MBC were recruited from a single cancer center for this phase 1, nonrandomized study (NCT02186015). METHODS & VARIABLES Women with insufficient serum 25-hydroxyvitamin D (25[OH]D) levels qualified to receive high-dose repletion therapy. Clinical and questionnaire data on common symptoms and quality of life were obtained prior to and following supplementation. RESULTS Serum 25(OH)D increased significantly pre- versus postintervention. Trends for improvements in endocrine symptoms, bone pain, and fatigue were observed following the intervention. IMPLICATIONS FOR NURSING Women achieved normal serum 25(OH)D levels after eight weeks of supplementation and reported reduced symptom burden. Vitamin D may be a low-cost supportive care therapy; however, future studies should be considered.

PURPOSE:The urinary microbiota in women with type 2 diabetes (T2DM) can have bacterial uropathogens which are more virulent. The primary objective was to describe and compare the characteristics of the microbiota in voided urine of women with and without T2DM. METHODS:Two cohorts of women: those with T2DM (n = 87) and those without T2DM (n = 49) were studied. Demographic data, hemoglobin A1c (HbA1c), fasting serum glucose, and voided urine were collected. To determine the characteristics of the microbiota in the urine, 16S rRNA gene sequencing was used. RESULTS:The genus Lactobacillus was more often present in women with T2DM (75.9%, n = 66) than in the controls (59.2%, n = 30) (p = 0.042), as was the family Enterobacteriaceae (12.6% T2DM versus 2.0% control, p = 0.055). There was evidence of an association between HbA1c and the relative abundance of the various bacteria in the total cohort. The relative abundance of Lactobacillus was positively associated (ρ = 0.19, 95% CI: 0.02, 0.34), while Corynebacterium (ρ = -0.26, 95% CI: -0.41, -0.10) and Prevotella (ρ = -0.23, 95% CI: -0.38, -0.06) were inversely associated with HbA1c. CONCLUSIONS:Enterobacteriaceae (e.g. E. coli) predispose women to urinary tract infections and since T2DM increases this risk, further study is needed. The species of Lactobacillus and its impact needs exploration.

Aim. Type 2 diabetes increases the risk of cognitive decline which adversely impacts self-management of the disease. Evidence also supports a relationship between low serum 25(OH)D levels and poor cognition. The purpose of this trial was to assess vitamin D supplementation on cognitive executive functioning in persons living with type 2 diabetes. Methods. This was a double-blinded RCT where participants were randomized to receive either weekly vitamin D-3 supplementation (50,000 IUs) or a matching comparator (5,000 IUs) for three months. The primary outcome was a battery of neuropsychological tests. Serum 25(OH)D was measured by liquid chromatography/tandem mass spectrometry. Repeated assessments of cognitive measures were collected over 12 weeks using alternative testing forms to minimize practice effects. Results. Thirty participants were randomized to either the low-dose allocation (n=15) or the high-dose allocation (n=15). Most participants were female (83%) and identified as Black (57%). For all cognition measures, there was no statistically significant finding between participants who received high-dose vitamin D supplementation and those who received low-dose supplementation. However, when assessing cognitive function in both groups over time, minimal improvement on the Symbol-Digits, the Stroop Interference Test, and the Trail Making Test Part B was observed. Conclusions. To our knowledge, this is the first randomized control trial to examine the effects of vitamin D supplementation on cognitive function in people with type 2 diabetes. However, no significant differences in cognitive outcomes between participants who received high-dose therapy and those who received low dose were found.

Background In persons with type 1 diabetes (T1D), hypoglycemia is the major limiting factor in achieving optimal glycemic control. All persons with T1D are at risk for hypoglycemia (blood glucose level < 70 mg/dl), which is life-threatening and accompanied by serious physical and psychological symptoms, resulting in profound fear of hypoglycemia (FOH) and reduced quality of life. Young adults with T1D are at risk for FOH and have worse glycemic control and self-management behavior than other age groups with T1D. FOH also results in increased glycemic variability (GV). A major gap exists in how to manage FOH. Our overall objective is to reduce FOH and improve diabetes self-management, glycemic control, and GV in young adults with T1D to reduce or delay diabetes complications and improve quality of life. We aim to (1) determine the feasibility and acceptability of an eight-week cognitive behavioral therapy (CBT)-based Fear Reduction Efficacy Evaluation (FREE) intervention in young adults with T1D who experience FOH; and (2) determine the impact of the FREE intervention, compared to an attention control group, on the outcomes FOH, self-management, glycemic control (A1C), and glycemic variability (continuous glucose monitoring recordings). Methods/design A randomized controlled trial in 50 young adults aged 18 to 35 years with T1D will be used. Eligible subjects will be randomized to the intervention program (Fear Reduction Efficacy Evaluation [FREE]) or attention control group. A one-week run-in phase is planned, with baseline measures of FOH, self-management behavior, A1C, and real-time continuous glucose monitoring recordings (RT-CGM) to calculate GV for both groups. The intervention group will participate in eight weekly individual one-hour sessions using CBT and exposure treatment for specific fears. RT-CGM and a daily FOH diary will be used as feedback cues as part of the FREE program. The attention control group will participate in eight weekly individual one-hour diabetes self-management education (DSME) sessions and wear a RT-CGM device (to measure GV only) over 8 weeks. At completion, FOH will be measured, and RT-CGM recordings will be analyzed to determine differences between the FREE and control groups. Discussion Findings from this proposed pilot study will serve as the foundation for a larger trial to reduce FOH and improve self-management, glycemic control, and GV. Trial registration ClinicalTrials.gov: A cognitive behavioral therapy (CBT) intervention to reduce fear of hypoglycemia in type 1 diabetes, NCT03549104 . Registered June 7, 2018

PurposeTo describe the impact of family functioning on the self-management of type 2 diabetes (T2DM) and depression in a subsample of women who completed a randomized clinical trial using vitamin D3 (5000 or 50,000 IUs weekly) for depression treatment.BackgroundWomen are at higher risk for increased severity of T2DM when experiencing depression.MethodsNarrative inquiry was used. A semi-structured interview was conducted to understand helpful strategies and barriers in managing T2DM and depression. In addition, women were asked their meaning of family quality of life (FQOL).ResultsTwenty-one women participated after completion of the six-month final visit in the randomized clinical trial. The mean age was 55.2 years. Participants were 24% Hispanic, 48% African-American, and 52% Caucasian. The major themes generated related to family issues that impacted their self-management, yet participants did not want to “bring fault” to their families. Three themes emerged: (a) experience of family hardships—“it’s been hard for me,” (b) lack of disclosure to family about being depressed—“no point in talking to them,” and (c) the need for connectedness with family and others—“the way it used to be… close as a family.”ConclusionFamily-centered approaches could address barriers to self-management. A “family lens” for practice and research may improve health outcomes.

Objective. The aim of this study was to determine the effect of vitamin D supplementation on improving mood (depression and anxiety) and health status (mental and physical) in women with type 2 diabetes mellitus (T2DM). Methods. Fifty women with T2DM and significant depressive symptomology were enrolled into the “Sunshine Study,” where weekly vitamin D supplementation (ergocalciferol, 50,000 IU) was given to all participants for six months. The main outcomes included (1) depression (Center for Epidemiologic Studies Depression, CES-D, and Patient Health Questionnaire, PHQ-9), (2) anxiety (State-Trait Anxiety), and (3) health status (Short Form, SF-12). Results. Forty-six women (92%) completed all visits. There was a significant decrease in depression (CES-D and PHQ-9, p<0.001) and anxiety (state and trait, p<0.001). An improvement in mental health status (SF-12, p<0.001) was also found. After controlling for covariates (race, season of enrollment, baseline vitamin D, baseline depression (PHQ-9), and body mass index), the decline in depression remained significant (CES-D, p<0.001). There was a trend for a better response to supplementation for women who were not taking medications for mood (antidepressants or anxiolytics) (p=0.07). Conclusions. Randomized trials to confirm that vitamin D supplementation can improve mood and health status in T2DM women are needed.

Cardiovascular disease (CVD) is the leading cause of death in Hispanic Americans. Social and physical determinants of health unique to this community must be understood before interventions can be designed and implemented. This article describes a CVD risk assessment conducted in a primarily Mexican American community, using Healthy People 2020 as a model. Social (language, culture, awareness of CVD, and socio-economic status) and physical (presence and use of recreation areas, presence of grocery stores, public transportation, and environmental pollution) determinants of health as well as access to health services were assessed. Fifteen community leaders were interviewed using guided interviews. Database searches and direct observations were conducted. Using these methods provided comprehensive assessment of social and physical determinants of health, and access issues that were unique to the community studied. Findings demonstrated greater awareness of diabetes than CVD as a health problem, with little knowledge of CVD risk factors. Lack of access to health services (lack of insurance, lack of a medical home) and presence of cultural and socioeconomic barriers such as language, unemployment, low income, and lack of insurance were identified. The physical determinants such as environment presented fewer barriers, with adequate access to fruits and vegetables, transportation, and parks. Results revealed target areas for intervention.

Purpose: The purpose of this study was to examine how fear of hypoglycemia (FOH) is associated with glycemic variability (GV) and self-management behavior in young adults (aged 18-35) with type 1 diabetes (T1DM).Procedures: Using a prospective repeated-measures design, in 35 young adults, within-and between-person and temporal associations of FOH, specific self-management behaviors, and GV were measured. The data were collected using questionnaires and real-time measures using daily diaries, insulin pump downloads, actigraphy, and continuous glucose monitoring.Findings: FOH was associated with greater glycemic variability. Significant temporal associations emerged. Concurrent day (glucose SD, p = .011) and previous-evening fear levels were associated with GV (glucose SD, p = .007). FOH was also associated with greater calorie intake (r = .492, p = .003) and less physical activity (light activity, r = .341, p = .045).Conclusions: The significant associations of FOH with GV, dietary patterns, and physical activity provide evidence for FOH as an important psychological factor associated with diabetes care. (C) 2017 Elsevier Inc. All rights reserved.

Starting college is a challenging time for first-year students and is often accompanied by emotions such as depression, which can negatively affect academic performance and quality of life. This descriptive correlational study examined stress, coping, depressive symptomology, spirituality, and social support in a convenience sample of first-year students (N = 188) from two private colleges. Results indicated that 45% of students demonstrated greater than average levels of stress and 48% reported clinically significant depressive symptomology. Significant relationships existed between depressive symptoms and stress (p < 0.01) and depressive symptoms and social support (p < 0.01). Less social support was associated with more stress (p < 0.01). The results suggested that interventions targeting stress reduction in first-year students should be considered for decreasing depressive symptoms to enhance their college experience. \

OBJECTIVE:To determine whether women with gestational diabetes mellitus (GDM) had more symptoms of depression than women without GDM. A secondary aim was to determine if factors predictive of symptoms of depression in women with GDM were different than women without GDM.DESIGN:A cross sectional, descriptive design was used.SETTING:An outpatient clinic at an academic medical center.PARTICIPANTS:The sample included 135 pregnant women between 24 and 40 weeks gestation, of which 65 had GDM and 70 did not.METHODS:The Edinburgh Postnatal Depression Screen (EPDS) was used to measure symptoms of depression in pregnant women attending routine prenatal care visits. Descriptive statistics, logistic regression, and multiple regressions were done to analyze the data.RESULTS:Twenty percent of women with GDM and 13% of women without GDM had significant symptoms of depression. Women with GDM were 3.79 times more likely to have a history of depression (95% confidence interval [CI] [1.07, 13.45], p = .04) than women without GDM after controlling for age, income, marital status, body mass index, and gravida. Trait anxiety and perceived stress were significant predictor factors of symptoms of depression (R(2)  = .82, p < .001) for women with and without GDM.CONCLUSIONS:Results suggest that symptoms of depression are common during the antepartum period, thus assessment and education regarding this disorder are important. In addition, a history of depression may be a risk factor for the development of GDM.

The number of individuals aged 65 and older is expected to more than double from 2012 to 2060. The role of vitamin D in the prevention and treatment of diseases associated with aging has not been well studied. Traditionally, the role of vitamin D focused on the maintenance of skeletal health in the older adult. With the discovery of vitamin D receptors in the nervous, cardiovascular and endocrine systems, the role of vitamin D and its impact on these systems has become an important area of research. Older adults are at risk for lower levels of vitamin D as a result of decreased cutaneous synthesis and dietary intake of vitamin D. Epidemiologic evidence indicates an association between low levels of vitamin D and diseases associated with aging such as cognitive decline, depression, osteoporosis, cardiovascular disease, hypertension, type 2 diabetes, and cancer. Clinical trials to determine the benefit of vitamin D supplementation in preventing and treating such diseases are in progress. This paper highlights current evidence regarding the role that vitamin D may play in diseases associated with aging and addresses the need for well-designed randomized trials to examine its benefit on health outcomes in the older adult.

Depression is a significant comorbid condition in diabetes. Individuals with type 2 diabetes (T2DM) are 2 times more likely to experience depression or elevated depressive symptoms compared to those without T2DM. The aims of this state of the science review were to summarize the putative links between diabetes and depression and review empirically supported treatments of depression in diabetes. Findings suggest that a bidirectional association between depression and T2DM exists and that several biological and psychosocial mediators underlie these conditions. Available data indicate that conventional treatments (antidepressant medication, cognitive behavioral therapy, and collaborative care) reduce depression and symptoms of depression; however more controlled studies and development of novel therapies are needed. Glycemic outcomes have most frequently been examined, but findings have been mixed. Self-care and adherence outcomes have been less well studied. Emerging evidence suggests that these outcomes may be important targets for future depression research in T2DM.