Intensive Medical Nutrition Therapy Alone or with Added Metformin to Prevent Gestational Diabetes Mellitus among High-Risk Mexican Women: A Randomized Clinical Trial

The aim of this study was to examine the efficacy of intensive medical nutrition therapy (MNT) plus metformin in preventing gestational diabetes mellitus (GDM) among high-risk Mexican women. An open-label randomized clinical trial was conducted. Inclusion criteria were pregnant women with three or more GDM risk factors: Latino ethnic group, maternal age >35 years, body mass index >25 kg/m², insulin resistance, and a history of previous GDM, prediabetes, a macrosomic neonate, polycystic ovarian syndrome, or a first-degree relative with type 2 diabetes. Women before 15 weeks of gestation were assigned to group 1 (n = 45): intensive MNT-plus metformin (850 mg twice/day) or group 2 (n = 45): intensive MNT without metformin. Intensive MNT included individual dietary counseling, with ≤50% of total energy from high carbohydrates. The primary outcome was the GDM incidence according to the International Association of Diabetes Pregnancy Study Groups criteria. There were no significant differences in baseline characteristics and adverse perinatal outcomes between the groups. The GDM incidence was n = 11 (24.4%) in the MNT plus metformin group versus n = 7 (15.5%) in the MNT without metformin group: p = 0.42 (RR: 1.57 [95% CI: 0.67–3.68]). There is no benefit in adding metformin to intensive MNT to prevent GDM among high-risk Mexican women. Clinical trials registration: {"type":"clinical-trial","attrs":{"text":"NCT01675310","term_id":"NCT01675310"}}NCT01675310.     

Medical Nutrition Therapy Interventions Provided by Dietitians for Adult Overweight and Obesity Management: An Academy of Nutrition and Dietetics Evidence-Based Practice Guideline

Overweight and obesity affect most adults living in the United States and are causally linked to several adverse health outcomes. Registered dietitian nutritionists or international equivalents (dietitians) collaborate with each client and other health care professionals to meet client-centered goals, informed by the best available evidence, and translated through a lens of clinical expertise and client circumstances and preferences. Since the last iteration of the Academy of Nutrition and Dietetics guideline on adult weight management in 2014, considerable research has been conducted and circumstances confronting dietitians have evolved. Thus, updated guidance is needed. The objective of this evidence-based practice guideline is to provide recommendations for dietitians who deliver medical nutrition therapy behavioral interventions for adults (18 years and older) with overweight and obesity to improve cardiometabolic outcomes, quality of life, and weight outcomes, when appropriate for and desired by the client. Recommendations in this guideline highlight the importance of considering complex contributors to overweight and obesity and individualizing interventions to client-centered goals based on specific needs and preferences and shared decision making. The described recommendations have the potential to increase access to care and decrease costs through utilization of telehealth and group counseling as effective delivery methods, and to address other barriers to overweight and obesity management interventions. It is essential for dietitians to collaborate with clients and interprofessional health care teams to provide high-quality medical nutrition therapy interventions using the nutrition care process to promote attainment of client-centered outcomes for adults with overweight or obesity.     

The Effect of Medical Nutrition Therapy by a Registered Dietitian Nutritionist in Patients with Prediabetes Participating in a Randomized Controlled Clinical Research Trial

BackgroundPrior studies have provided evidence that lifestyle change prevents or delays the occurrence of type 2 diabetes mellitus. The challenge is to translate research evidence for type 2 diabetes mellitus prevention into health care settings.ObjectiveWe investigated the effect of medical nutrition therapy (MNT) compared with usual care on fasting plasma glucose values, glycated hemoglobin (HbA1c), serum lipid levels, and Diabetes Risk Score, from baseline to the end of a 12-week intervention in overweight or obese adults with prediabetes.DesignProspective, randomized, parallel group study of 76 adults with impaired fasting plasma glucose or an HbA1c of 5.7% to 6.4%, recruited between April 2010 and May 2011 who completed a 12-week intervention period.Main outcome measuresThe primary outcome measure was fasting plasma glucose. Secondary outcome measures were HbA1c, serum lipid levels, and Diabetes Risk Score.Statistical analysesA factorial repeated measures analysis of variance was used to make comparisons between the two groups (the MNT and usual care groups) and two measures of time (baseline and 12 weeks postintervention). Data analysis was performed using the Statistical Package for the Social Sciences (release 19.0, 2010, SPSS Inc).ResultsThere was a significant interaction for group assignment and HbA1c (P=0.01), with the MNT group experiencing significantly lower HbA1c levels than the usual care group (5.79% vs 6.01%) after the 12-week intervention. There was a significant interaction for group assignment and Diabetes Risk Score (P=0.001). Diabetes Risk Score for the MNT group decreased from 17.54±3.69 to 15.31±3.79 compared with the usual care group score, which went from 17.23±4.69 to 16.83±4.73. Regardless of group assignment, both groups experienced a reduction in total cholesterol (P=0.01) and low-density lipoprotein cholesterol (P=0.04) level.ConclusionsThe results demonstrate that individualized MNT is effective in decreasing HbA1c level in patients diagnosed with prediabetes.     

Safety and Tolerability of Targeted Medical Nutrition for Cachexia in Non-Small-Cell Lung Cancer: A Randomized,Double-Blind,Controlled Pilot Trial

Abstract

Background: This pilot, double-blind, comparator-controlled trial evaluated the safety and tolerability of an oral targeted medical nutrition (TMN) supplement for the management of cachexia in patients with non-small-cell lung cancer (NSCLC).

Methods: Patients receiving first-line chemotherapy for NSCLC with weight loss or low BMI were randomized 1:1 to receive juice-based TMN (～200?kcal; 10?g whey protein; ≥2.0?g eicosapentaenoic acid/docosahexaenoic acid in fish oil; and 10?μg 25-hydroxy-vitamin D3) or a milk-based isocaloric comparator twice daily for 12?weeks (ClinicalTrials.gov: NCT02515032). Primary endpoints included number/type of adverse events and changes in vital signs/laboratory parameters. Secondary endpoints included measures of clinical relevance. Survival was an exploratory endpoint.

Results: The TMN group (n?=?26; mean 64.4?years) experienced fewer adverse events (64 vs. 87) than the comparator group (n?=?29; mean 66.0?years), including fewer cases of neutropenia (0 vs. 4). Compliance was slightly lower in the TMN (58.5%) vs. comparator group (73.6%). There were no statistically significant between-group differences in efficacy endpoints. Fewer (4 vs. 10) patients who received TMN than comparator had died by 1-year post baseline.

Conclusions: TMN was well tolerated. Trends for improved clinical outcomes with TMN identified in this study warrant further investigation.     

The Impact of a Cultural Lifestyle Intervention on Metabolic Parameters After Gestational Diabetes Mellitus A Randomized Controlled Trial

Objectives

The prevalence of type 2 diabetes in Israel is increasing in all ethnic groups but most markedly in the Bedouin population. We aimed to assess the effects of a lifestyle change intervention on risk markers for type 2 diabetes after gestational diabetes mellitus (GDM).

Methods

One hundred eighty Jewish and Bedouin post-GDM women were randomly assigned to a lifestyle intervention group (IG) or a control group (CG) starting 3–4 months after delivery. The IG participated in healthy lifestyle sessions led by a dietician and a sports instructor for 24 months after delivery. The IG participants had three individual 45-min counseling sessions and four 90-min group meetings (10 women each). The dietary and exercise recommendations were culturally adapted. The primary outcome of the study was HOMA-IR. We monitored clinical and chemical biomarkers 1 and 2 years after delivery.

Results

After 1 and 2 years of intervention, the metabolic measures improved substantially. The intervention reduced the insulin, glucose and HOMA-IR levels in the IG compared with those in the CG (p?<?0.001).

Conclusions

This novel culturally tailored lifestyle intervention program significantly improved the metabolic and morphometric indices measured 1 and 2 years after delivery. These results highlight and underscore the importance of effective lifestyle change education following GDM.

     

Effect of Early Full‐Calorie Nutrition Support Following Esophagectomy: A Randomized Controlled Trial

Background: Early use of enteral nutrition (EN) is indicated following surgical resection of esophageal cancer. However, early EN support does not always meet the optimal calorie or protein requirements, and the benefits of supplementary parenteral nutrition (PN) remain unclear. We aimed to evaluate the efficacy and safety of early supplementary PN following esophagectomy. Materials and Methods: We enrolled 80 consecutive patients who underwent esophagectomy. Resting energy expenditure and body composition measurements were performed in all patients preoperatively and postoperatively. EN was administered after surgery, followed by randomization to either EN+PN or EN alone. The amount of PN administered was calculated to meet the full calorie requirement, as measured by indirect calorimetry, and 1.5 g protein/kg fat‐free mass (FFM) per day was added as determined by body composition measurement. The clinical characteristics were compared between the 2 groups. Results: Patients in the EN+PN group but not in the EN group preserved body weight (0.18 ± 3.38 kg vs ?2.15 ± 3.19 kg, P < .05) and FFM (1.46 ± 2.97 kg vs ?2.08 ± 4.16 kg) relative to preoperative measurements. Length of hospital stay, postoperative morbidity rates, and standard blood biochemistry profiles were similar. However, scores for physical functioning (71.5 ± 24.3 vs 60.4 ± 27.4, P < .05) and energy/fatigue (62.9 ± 19.5 vs 54.2 ± 23.5, P < .05) were higher in the EN+PN group 90 days following surgery. Conclusion: Early use of supplemental PN to meet full calorie requirements of patients who underwent esophagectomy led to better quality of life 3 months after surgery. Moreover, increased calorie and protein supplies were associated with preservation of body weight and FFM.     

Effect of Aqueous Cinnamon Extract on the Postprandial Glycemia Levels in Patients with Type 2 Diabetes Mellitus: A Randomized Controlled Trial

Cinnamon is a spice used in traditional cuisine that has been investigated due to hypoglycemic properties. The objective of this study was to investigate the effect of aqueous cinnamon extract on postprandial glycemia levels in type 2 diabetes mellitus (DM2) adults. This clinical trial enrolled 36 adults with DM2, randomly allocated in two groups: the control group (n = 18) took only an oral glucose tolerance test (OGTT) and the intervention group (n = 18) took OGTT immediately followed by aqueous cinnamon extract (6 g/100 mL) ingestion. Blood glucose levels were measured on fasting and after 30, 60, 90 and 120 min in both groups. The chemical analysis of the aqueous cinnamon extract included total phenols content determination and antioxidant activity assessment through FRAP and DPPH methods. The data reveal that aqueous cinnamon extract ingestion did not show a significant difference in the incremental area under the curve (p = 0.834), maximum glucose concentration (p = 0.527) and glucose concentration variation (p = 0.873) compared with the control group. Cinnamon extract possess a total phenol content of 1554.9 mg/L gallic acid equivalent and a strong antioxidant capacity, revealed by the DPPH (5125.0 µmol Trolox/L) and FRAP (3658.8 µmol Trolox/L) tests. Aqueous cinnamon extract did not significantly influence postprandial glucose response in diabetic patients during an OGTT.     

Tibetan Medicated Bathing Therapy for Patients With Post-stroke Limb Spasticity: A Randomized Controlled Clinical Trial

ObjectiveTo determine the short- (4 weeks) and long-term (6 month) effectiveness of Tibetan medicated bathing therapy in patients with post-stroke limb spasticity.DesignProspective, blinded, randomized controlled trial.SubjectsPost-stroke patients with limb spasticity were recruited between December 2013 and February 2017 and randomly assigned 1:1 to a control group that received conventional rehabilitation (n = 222) or an experimental group that received Tibetan medicated bathing therapy in combination with conventional rehabilitation (n = 222).MethodsAll patients received conventional rehabilitation. In addition, the experimental group received Tibetan medicated bathing therapy. The interventions were conducted 5 times per week for 4 weeks. The primary endpoint was changes from baseline after 4 weeks of therapy in muscle tone in the spastic muscles (elbow flexors, wrist flexors, finger flexors, knee extensors, ankle plantar flexors), as measured by the Modified Ashworth Scale (MAS).ResultsThe mean change from baseline after 4 weeks of therapy in the MAS score for the elbow flexors (P = .017), wrist flexors (P < .001), and ankle plantar flexors (P < .001) was significantly greater in patients in the experimental group compared to the control group. The benefit was maintained for 3 muscle groups (elbow flexors P < .001, wrist flexors P = .001, and ankle plantar flexors P < .001) and 6 months (elbow flexors P < .001, wrist flexors P = .002, and ankle plantar flexors P < .001) after therapy. All adverse events were mild, and no serious adverse reactions to Tibetan medicated bathing therapy were recorded.Conclusions and ImplicationsTibetan medicated bathing therapy, in combination with conventional rehabilitation, has potential as a safe, effective treatment for the alleviation of post-stroke upper limb spasticity. Tibetan medicated bathing therapy was most advantageous for patients who had a baseline muscle tone score of 1+ to 2 on the MAS in the affected limb and recent onset of stroke (duration of the disease of 1-3 months).     

A Randomized,Controlled Pragmatic Trial of Telephonic Medication Therapy Management to Reduce Hospitalization in Home Health Patients

Objective

To evaluate the effectiveness of a telephonic medication therapy management (MTM) service on reducing hospitalizations among home health patients.

Setting

Forty randomly selected, geographically diverse home health care centers in the United States.

Design

Two-stage, randomized, controlled trial with 60-day follow-up. All Medicare- insured home health care patients were eligible to participate. Twenty-eight consecutive patients within each care center were recruited and randomized to usual care or MTM intervention. The MTM intervention consisted of the following: (1) initial phone call by a pharmacy technician to verify active medications; (2) pharmacist-provided medication regimen review by telephone; and (3) follow-up pharmacist phone calls at day seven and as needed for 30 days. The primary outcome was 60-day all-cause hospitalization.

Data Collection

Data were collected from in-home nursing assessments using the OASIS-C. Multivariate logistic regression modeled the effect of the MTM intervention on the probability of hospitalization while adjusting for patients’ baseline risk of hospitalization, number of medications taken daily, and other OASIS-C data elements.

Principal Findings

A total of 895 patients (intervention n = 415, control n = 480) were block-randomized to the intervention or usual care. There was no significant difference in the 60-day probability of hospitalization between the MTM intervention and control groups (Adjusted OR: 1.26, 95 percent CI: 0.89–1.77, p = .19). For patients within the lowest baseline risk quartile (n = 232), the intervention group was three times more likely to remain out of the hospital at 60 days (Adjusted OR: 3.79, 95 percent CI: 1.35–10.57, p = .01) compared to the usual care group.

Conclusions

This MTM intervention may not be effective for all home health patients; however, for those patients with the lowest-risk profile, the MTM intervention prevented patients from being hospitalized at 60 days.     

Annals Journal Club: Health Coaching by Medical Assistants to Improve Control of Diabetes,Hypertension, and Hyperlipidemia in Low-Income Patients: A Randomized Controlled Trial

PURPOSE

Health coaching by medical assistants could be a financially viable model for providing self-management support in primary care if its effectiveness were demonstrated. We investigated whether in-clinic health coaching by medical assistants improves control of cardiovascular and metabolic risk factors when compared with usual care.

METHODS

We conducted a 12-month randomized controlled trial of 441 patients at 2 safety net primary care clinics in San Francisco, California. The primary outcome was a composite measure of being at or below goal at 12 months for at least 1 of 3 uncontrolled conditions at baseline as defined by hemoglobin A_1c, systolic blood pressure, and low-density lipoprotein (LDL) cholesterol. Secondary outcomes were meeting all 3 goals and meeting individual goals. Data were analyzed using χ² tests and linear regression models.

RESULTS

Participants in the coaching arm were more likely to achieve both the primary composite measure of 1 of the clinical goals (46.4% vs 34.3%, P = .02) and the secondary composite measure of reaching all clinical goals (34.0% vs 24.7%, P = .05). Almost twice as many coached patients achieved the hemoglobin A_1c goal (48.6% vs 27.6%, P = .01). At the larger study site, coached patients were more likely to achieve the LDL cholesterol goal (41.8% vs 25.4%, P = .04). The proportion of patients meeting the systolic blood pressure goal did not differ significantly.

CONCLUSIONS

Medical assistants serving as in-clinic health coaches improved control of hemoglobin A_1c and LDL levels, but not blood pressure, compared with usual care. Our results highlight the need to understand the relationship between patients’ clinical conditions, interventions, and the contextual features of implementation.     

Vaginal Progesterone Supplementation in the Management of Preterm Labor: A Randomized Controlled Trial

Maternal and Child Health Journal - The primary objective in this study was to evaluate the effects of vaginal progesterone supplementation for the prolongation of the latency period in preterm...     

Consultative Care Coordination Through the Medical Home for CSHCN: A Randomized Controlled Trial

The purpose of this study was to examine the impact of a care coordination intervention aimed at improving the medical home for children with special health care needs (CSHCN). 100 CSHCN referred by a Medicaid managed care plan were randomly assigned to a care coordination intervention or to a wait list comparison group that received standard care. For the intervention group, a care coordinator supported the medical home by consulting with primary care providers at multiple practices to develop an integrated, individualized plan to meet child and family needs. During the second phase of the study, the wait list comparison group received the 6-month intervention. At the end of 12 months, the two groups were combined to examine within subject differences (n = 61). Compared to the control group, participants in the initial intervention group reported a decreased need for information and improved satisfaction with mental health services and specialized therapies. This effect was replicated when the wait list control group received the intervention. Additional benefits were observed in the within subject analysis, including a decline in unmet needs, improved satisfaction with specialty care and care coordination, and improved ratings of child health and family functioning. This intervention improved outcomes for CSHCN and their families by supporting the efforts of primary care physicians to provide comprehensive and coordinated care through the medical home. The consulting care coordinator may provide an efficient and cost effective approach to enhancing the quality of care for CSHCN.     

Mexican American Trial of Community Health Workers: A Randomized Controlled Trial of a Community Health Worker Intervention for Mexican Americans With Type 2 Diabetes Mellitus

Objectives. We assessed whether community health workers (CHWs) could improve glycemic control among Mexican Americans with diabetes.Methods. We recruited 144 Mexican Americans with type 2 diabetes between January 2006 and September 2008 into the single-blinded, randomized controlled Mexican American Trial of Community Health Workers (MATCH) and followed them for 2 years. Participants were assigned to either a CHW intervention, delivering self-management training through 36 home visits over 2 years, or a bilingual control newsletter delivering the same information on the same schedule.Results. Intervention participants showed significantly lower hemoglobin A1c levels than control participants at both year 1 Δ = −0.55; P = .021) and year 2 (Δ = −0.69; P = .005). We observed no effect on blood pressure control, glucose self-monitoring, or adherence to medications or diet. Intervention participants increased physical activity from a mean of 1.63 days per week at baseline to 2.64 days per week after 2 years.Conclusions. A self-management intervention delivered by CHWs resulted in sustained improvements in glycemic control over 2 years among Mexican Americans with diabetes. MATCH adds to the growing body of evidence supporting the use of CHWs to reduce diabetes-related health disparities.The growing prevalence of diabetes mellitus among adults in the United States is well documented, with adverse impact strongest among ethnic minorities and low-income populations. The age-adjusted prevalence of diabetes is 12.6% among non-Hispanic Blacks, 11.8% among Hispanics, and only 7.1% among non-Hispanic Whites.1 Mexican Americans, who make up almost two thirds of US Hispanics,2 have an even higher diabetes prevalence of 13.3%.3 Disparities also persist in both processes of care and clinical outcomes. Mexican Americans with diabetes are significantly less likely than non-Hispanic Whites with the disease to be aware of and treated for comorbid hypertension or dyslipidemia.4 Mexican Americans are less likely to receive recommended clinical services, such as regular ophthalmologic and foot exams,5 and are less likely than non-Hispanic Whites to have well-controlled hemoglobin A1c (HbA1c) and cholesterol levels. In this context, it is not surprising that they are more than twice as likely as non-Hispanic Whites to be hospitalized for uncontrolled diabetes or long-term complications of diabetes5 and that they experience higher diabetes mortality rates.6–8 Although non-Hispanic Whites have experienced reductions in diabetes-related mortality in the past decades, Hispanics have not.8 Thus, unless effective public health strategies are identified and implemented, gaps in health outcomes are likely to grow.Community health workers (CHWs) are frontline public health workers who serve as liaisons between providers and community members, facilitate access to services, and improve both quality and cultural competence of service delivery.9,10 Several characteristics suggest that they may be well suited to addressing diabetes disparities. Because CHWs share culture, language, and knowledge of the community, they engage minority populations more effectively than the formal health care system can.11,12 Living and working in the same community as the people they serve, CHWs are able to provide individualized attention, focus on behavior-related tasks, and deliver regular feedback on the completion of those tasks.13 These qualities should lead to improved diabetes self-management and clinical outcomes. Although much has been written about CHWs in the past decade, few rigorous randomized controlled trials have tested this hypothesis,14–18 and the efficacy of CHWs in improving clinical outcomes in diabetes is not established. Of 6 published randomized controlled trials,19–25 only 2 demonstrated improvements in HbA1c levels among intervention participants, and both of these studies followed participants for only 6 months.19,24 Methodological limitations led the authors of a 2009 Agency for Health Care Research and Quality review to rate the published evidence as fair at best.15The Mexican American Trial of Community Health Workers (MATCH) sought to address these limitations of the literature through a rigorously designed behavioral randomized controlled trial with outcomes measured at 1 and 2 years. The primary study hypothesis was that the CHW intervention, compared with an attention control, would result in improvement in short-term physiological outcomes (mean HbA1c levels and percentage with controlled blood pressure). A secondary hypothesis was that the CHW intervention would improve adherence to self-management behaviors, such as daily self-monitoring of blood glucose, medication taking, and adherence to diet and physical activity recommendations.     

Long Term Physical Activity Improves Quality of Life Perception,Healthy Nutrition,and Daily Life Management in Elderly: A Randomized Controlled Trial

Physical activity (PA) is a key element in the management of successful aging. The aim of this paper was to show the effects of PA on the quality of life perception, nutritional status, and daily life management of 178 older adults (aged 63.87 ± 8.17) randomly assigned to an Experimental Group (EG), which performed moderate-to-high intensity aerobic and strengthening training, and a Control Group (CG) which performed low-impact PA, assessed after 6, 12, and 24 months. The Short-Form Health Survey (SF-36), Mini Nutritional Assessment (MNA), and Physical Activity Scale for the Elderly (PASE) were used for the study. In the SF-36 assessment, EG showed a good quality of life perception maintained after 24 months, while CG showed a worsening in the same period (p = 0.018). The EG reported a significant better nutritional status as compared to pre-intervention assessment (p = 0.003) and to CG (p < 0.001). Regarding the PASE, the EG showed a higher level of weekly activities than the CG after 24 months (p = 0.011), while the CG showed a worsening after 12 months (p = 0.008). The prolonged engagement in moderate-to high-intensity PA allowed the maintenance of a good quality of life perception, a good level of nutritional status, and daily life activities.