A Randomized Controlled Trial of a Theoretically-Based Behavioral Nutrition Intervention for Community Elders: Lessons Learned from the Behavioral Nutrition Intervention for Community Elders Study

Older adults with multiple comorbidities are often undernourished or at high risk for becoming so, especially after a recent hospitalization. Randomized controlled trials of effective, innovative interventions are needed to support evidence-based approaches for solving nutritional problems in this population. Self-management approaches where participants select their own behavioral goals can enhance success of interventions. The purpose of this study was to evaluate the feasibility and efficacy of a multilevel self-management intervention to improve nutritional status in a group of high-risk older adults. The Behavioral Nutrition Intervention for Community Elders (B-NICE) trial used a prospective randomized controlled design to determine whether the intervention, compared to standard care, maintained or increased caloric intake (depending on baseline body mass index) and, consequently, stabilized or increased body weight. Participants were 34 Medicare-eligible, age 65 years old or older, homebound adults who were consuming insufficient calories and/or had a history of weight loss ≥2.5% over 6 months. The intervention took place within participants' homes. Outcome measures, including energy intake (based on collection of three 24-hour dietary recalls) and body weights were assessed at baseline and at 60 days post randomization. The primary analyses included analyses of covariance and Pearson's χ². We hypothesized that the intervention would result in increased caloric intake and weight gain in underweight older adults and increased or stabilized caloric intake and weight for everyone else. The intervention was feasible; however, it did not result in differences between groups for desired outcomes of either caloric intake or body weight. Future interventions might either deliberately involve caregivers or reduce burden for both patients and caregivers.     

Cognitive-Behavioral Group Therapy as an Early Intervention for Insomnia: A Randomized Controlled Trial

A randomized controlled design was used with a 1-yr follow-up. The purpose was to compare the effects of two early interventions, a cognitive-behavioral group intervention and a self-help information package, in patients with insomnia. In sum, 165 individuals seeking care for insomnia of 3–12 months duration were randomized to either a group receiving a CBT intervention or a group receiving a self-help information package. At the 1-yr follow-up, 136 participants had completed the entire study. At the 1-yr follow-up, the CBT group intervention was, compared with the control group, effective in producing reductions in dysfunctional beliefs and attitudes about sleep, negative daytime symptoms, as well as vital improvements in sleep (i.e. sleep onset latency, time awake after sleep onset, total sleep time, sleep quality, and sleep efficiency). In comparison with the control group, significantly more participants in the CBT group met criteria at the 1-yr follow-up for clinically meaningful improvements in sleep onset latency, time awake after sleep onset, and sleep efficiency. A CBT group intervention may well be a viable early intervention for patients with insomnia in a wide range of health services.     

A Comprehensive Report of Child Care Providers' Perceptions of a Statewide Early Care and Education Initiative

As the call to improve early care and education environments heightens across the United States, individual states have developed an array of approaches to enhance out-of-home care experiences for young children. As a part of the larger evaluation study of Kentucky's early childhood initiative, KIDS NOW, the current study gains perspectives from child care providers regarding their experiences with a comprehensive statewide early care and education initiative. Through a series of focus groups, child care providers highlighted their need for adequate information regarding the initiative as well as their varying perceptions of different types of initiative components. These findings highlight the need for continual stakeholder involvement as policy changes unfold within a state. Additionally, providers' perspectives on the implementation of the initiative underscore the complexity inherent to affecting change in early care and education.     

A Mediterranean-Diet-Based Nutritional Intervention for Children with Prediabetes in a Rural Town: A Pilot Randomized Controlled Trial

Prediabetes is a pathological condition in which the blood glucose concentration is higher than normal concentrations but lower than those considered necessary for a type 2 diabetes mellitus diagnosis. Various authors have indicated that the Mediterranean Diet is one of the dietary patterns with the most healthy outcomes, reducing high levels of HbA1c, triglycerides, BMI, and other anthropometric parameters. The main objective of this study was to determine the efficacy of the nutritional intervention for children with prediabetes, including the effectiveness of this nutritional education regarding anthropometric parameters. A randomized pilot trial with two groups, an experimental group (EG) and a control group (CG), using intervention in dietary habits with nutritional reinforcement was carried out on 29 children with prediabetes from a rural area. The nutritional intervention was analyzed through astrophotometric and glycemic measurements and validated surveys. Results: The results indicated improvement in eating habits, adherence to the Mediterranean diet, anthropometric measurements, mainly body mass index and perimeters, and analytical parameters, with a significant decrease in glycated hemoglobin in the EG compared to the CG (p < 0.001). Although the results showed that both groups’ anthropometric parameters improved, a more significant decrease was observed in the experimental group compared to the control.     

Changes in Dietary Patterns through a Nutritional Intervention with a Traditional Atlantic Diet: The Galiat Randomized Controlled Trial

Unhealthy dietary patterns (DPs) can lead to cardiovascular and other chronic diseases. We assessed the effects of a community-focused intervention with a traditional Atlantic diet on changes in DPs in families and the associations of these changes with weight loss. The Galiat study is a randomized, controlled trial conducted in 250 families (720 adults and children) and performed at a primary care setting with the cooperation of multiple society sectors. Over 6 months, families randomized to the intervention group received educational sessions, cooking classes, written supporting material, and foods that form part of the Atlantic diet, whereas those randomized to the control group followed their habitual lifestyle. At baseline, five DPs that explained 30.1% of variance were identified: “Caloric”, “Frieds”, “Fruits, vegetables, and dairy products”, “Alcohol”, and “Fish and boiled meals.” Compared to the controls, the intervention group showed significant improvements in “Fruits, vegetables, and dairy products” and “Fish and boiled meals” and reductions in the “Caloric” and “Frieds”. Changes in bodyweight per unit increment of “Frieds” and “Fruits, vegetables, and dairy products” scores were 0.240 kg (95% CI, 0.050–0.429) and −0.184 kg (95% CI, −0.379–0.012), respectively. We found that a culturally appropriate diet improved DPs associated with weight loss.     

A Theoretically Based Behavioral Nutrition Intervention for Community Elders at High Risk: The B-NICE Randomized Controlled Clinical Trial

We conducted a study designed to evaluate the efficacy and feasibility of a multilevel self-management intervention to improve nutritional intake in a group of older adults receiving Medicare home health services who were at especially high risk for experiencing undernutrition. The Behavioral Nutrition Intervention for Community Elders (B-NICE) trial used a prospective randomized controlled design to determine whether individually tailored counseling focused on social and behavioral aspects of eating resulted in increased caloric intake and improved nutrition-related health outcomes in a high-risk population of older adults. The study was guided by the theoretical approaches of the Ecological Model and Social Cognitive Theory. The development and implementation of the B-NICE protocol, including the theoretical framework, methodology, specific elements of the behavioral intervention, and assurances of the treatment fidelity, as well as the health policy implications of the trial results, are presented in this article.     

A Home-Based Nutrition and Physical Activity Intervention for Grandparents Raising Grandchildren: A Pilot Study

Five African American grandparents raising their grandchildren participated in a home-based nutrition and physical activity intervention. The primary goals were to increase grandparents' knowledge and skills in selecting and preparing healthy foods and to increase the grandparents' and grandchildren's physical activity levels. Results revealed that grandparents' concerns regarding their chronic diseases and desire to prevent health problems in their grandchildren served as motivators. Following the intervention, grandparents scored higher on nutrition and physical activity knowledge and their self-efficacy improved, although most health status indicators remained unchanged. Self-reported changes included walking more, reading food labels, and switching to a healthier type of fat.     

Impact of a School-Based Gardening,Cooking, Nutrition Intervention on Diet Intake and Quality: The TX Sprouts Randomized Controlled Trial

School gardens have become common school-based health promotion strategies to enhance dietary behaviors in the United States. The goal of this study was to examine the effects of TX Sprouts, a one-year school-based gardening, cooking, and nutrition cluster randomized controlled trial, on students’ dietary intake and quality. Eight schools were randomly assigned to the TX Sprouts intervention and eight schools to control (i.e., delayed intervention) over three years (2016–2019). The intervention arm received: formation and training of Garden Leadership Committees; a 0.25-acre outdoor teaching garden; 18 student lessons including gardening, nutrition, and cooking activities, taught weekly in the teaching garden during school hours; and nine parent lessons, taught monthly. Dietary intake data via two 24 h dietary recalls (24 hDR) were collected on a random subsample (n = 468). Dietary quality was calculated using the Healthy Eating Index 2015 (HEI-2015). The intervention group compared to control resulted in a modest increase in protein intake as a percentage of total energy (0.4% vs. −0.3%, p = 0.021) and in HEI-2015 total vegetables component scores (+4% vs. −2%, p = 0.003). When stratified by ethnicity/race, non-Hispanic children had a significant increase in HEI-2015 total vegetable scores in the intervention group compared to the control group (+4% vs. −8%, p = 0.026). Both the intervention and control groups increased added sugar intake; however, to a lesser extent within the intervention group (0.3 vs. 2.6 g/day, p = 0.050). School-based gardening, cooking, and nutrition interventions can result in significant improvements in dietary intake. Further research on ways to scale and sustain nutrition education programs in schools is warranted. The trial is registered at ClinicalTrials.gov ({"type":"clinical-trial","attrs":{"text":"NCT02668744","term_id":"NCT02668744"}}NCT02668744).     

Feasibility and Acceptability of a Healthy Nordic Diet Intervention for the Treatment of Depression: A Randomized Controlled Pilot Trial

Healthy diet interventions have been shown to improve depressive symptoms, but there is a need for randomized controlled trials (RCTs) that are double blind and investigate biological mechanisms. The primary objectives of this randomized controlled pilot trial were to test the palatability of the meals and the acceptability of the intervention in preparation for an 8-week RCT in the future, which will investigate whether a healthy Nordic diet improves depressive symptoms in individuals with major depressive disorder, and associated biological mechanisms. Depressed (n = 10) and non-depressed (n = 6) women and men were randomized to receive either a healthy Nordic diet (ND) or a control diet (CD) for 8 days. Participants were blinded to their diet allocation and the study hypotheses. Health questionnaires were completed before and after the intervention and, throughout the study, questionnaires assessed participants’ liking for the meals, their sensory properties, adherence, and open-ended feedback. In the ND group, 75% of participants consumed only the provided foods, as instructed, compared to 50% of CD participants. The meals of both diets, on average, received good ratings for liking and sensory properties, though the ND ratings were somewhat higher. Overall, results were positive and informative, indicating that the planned RCT will be feasible and well-accepted, with some proposed modifications.     

Dietary Effects of Introducing Salt-Reduced Bread with and without Dietary Counselling—A Cluster Randomized Controlled Trial

Successful strategies for policy makers and the food industry are required to reduce population salt intake. A 4-month cluster randomized controlled trial was conducted to evaluate whether the provision of salt-reduced bread with or without dietary counselling affected the dietary intake of selected food groups, energy, macronutrients, sodium, and potassium. Eighty-nine families (n = 309) consisting of minimum one parent and one child were assigned to receive bread gradually reduced in salt content alone (Intervention A), combined with dietary counselling (Intervention B), or bread with regular salt content (control). Food intake was recorded for seven consecutive days at baseline and follow-up. Salt intake was reduced in both Intervention A (−1.0 g salt/10 MJ, p = 0.027) and Intervention B (−1.0 g salt/10 MJ, p = 0.026) compared to the control. Consumption of bread and both total and salt-rich bread fillings remained similar between groups, while ‘cheese and cheese products’ were reduced in Intervention A (−38%, p = 0.011). Energy intake and macronutrient distribution were not affected in Intervention A, but Intervention B resulted in a higher energy intake (512 kJ, p = 0.019) and a lower energy % (E%) from saturated fat (−1.0 E%, p = 0.031) compared to the control. In conclusion, provision of salt-reduced bread both with and without dietary counselling successfully reduced dietary salt intake without adversely affecting the dietary nutritional quality.     

Postoperative Dietary Intake Achievement: A Secondary Analysis of a Randomized Controlled Trial

Sufficient postoperative dietary intake is crucial for ensuring a better surgical outcome. This study aimed to investigate the postoperative dietary intake achievement and predictors of postoperative dietary intake among gynecologic cancer patients. A total of 118 participants were included in this secondary analysis. Postoperative dietary data was pooled and re-classified into early postoperative dietary intake achievement (EDIA) (daily energy intake (DEI) ≥ 75% from the estimated energy requirement (EER)) and delay dietary intake achievement (DDIA) (DEI < 75% EER) There was a significant difference in postoperative changes in weight (p = 0.002), muscle mass (p = 0.018), and handgrip strength (p = 0.010) between the groups. Postoperative daily energy and protein intake in the EDIA was significantly greater than DDIA from operation day to discharged (p = 0.000 and p = 0.036). Four significant independent postoperative dietary intake predictors were found: preoperative whey protein-infused carbohydrate loading (p = 0.000), postoperative nausea vomiting (p = 0.001), age (p = 0.010), and time to tolerate clear fluid (p = 0.016). The multilinear regression model significantly predicted postoperative dietary intake, F (4, 116) = 68.013, p = 0.000, adj. R² = 0.698. With the four predictors’ recognition, the integration of a more specific and comprehensive dietitian-led supportive care with individualized nutrition intervention ought to be considered to promote functional recovery.     

Effects of a Rice Bran Dietary Intervention on the Composition of the Intestinal Microbiota of Adults with a High Risk of Colorectal Cancer: A Pilot Randomised-Controlled Trial

Rice bran exhibits chemopreventive properties that may help to prevent colorectal cancer (CRC), and a short-term rice bran dietary intervention may promote intestinal health via modification of the intestinal microbiota. We conducted a pilot, double-blind, randomised placebo-controlled trial to assess the feasibility of implementing a long-term (24-week) rice bran dietary intervention in Chinese subjects with a high risk of CRC, and to examine its effects on the composition of their intestinal microbiota. Forty subjects were randomised into the intervention group (n = 19) or the control group (n = 20). The intervention participants consumed 30 g of rice bran over 24-h intervals for 24 weeks, whilst the control participants consumed 30 g of rice powder on the same schedule. High rates of retention (97.5%) and compliance (≥91.3%) were observed. No adverse effects were reported. The intervention significantly enhanced the intestinal abundance of Firmicutes and Lactobacillus, and tended to increase the Firmicutes/Bacteroidetes ratio and the intestinal abundance of Prevotella_9 and the health-promoting Lactobacillales and Bifidobacteria, but had no effect on bacterial diversity. Overall, a 24-week rice bran dietary intervention was feasible, and may increase intestinal health by inducing health-promoting modification of the intestinal microbiota. Further larger-scale studies involving a longer intervention duration and multiple follow-up outcome assessments are recommended.     

A Participatory Workplace Intervention for Employees With Distress and Lost Time: A Feasibility Evaluation Within a Randomized Controlled Trial

Introduction Little is known about feasibility and acceptability of return to work (RTW) interventions for mental health problems. RTW for mental health problems is more complicated than for musculoskeletal problems due to stigmatization at the workplace. A participatory workplace intervention was developed in which an employee and supervisor identify and prioritize obstacles and solutions for RTW guided by a RTW coordinator. This paper is a feasibility study of this innovative intervention for employees with distress. The aims of this study were to describe the reach and extent of implementation of the workplace intervention, the satisfaction and expectations of all stakeholders, and the intention to use the workplace intervention in the future. Methods Eligible for this study were employees who had been on sick leave from regular work for 2–8 weeks with distress. Data were collected from the employees, their supervisors, RTW coordinators, and occupational physicians by means of standardized matrices and questionnaires at baseline and 3 months follow-up. Reach, implementation, satisfaction, expectations, and maintenance regarding the workplace intervention were described. Results Of the 56 employees with distress eligible to receive the workplace intervention, 40 employees, their supervisors and RTW coordinators actually participated in the intervention. They identified 151 obstacles for RTW mostly related to job design, communication, mental workload and person-related stress factors. The 281 consensus-based solutions identified were mostly related to job design, communication and training. Of those solutions, 72% was realized at the evaluation with the employee and supervisor. Overall, employees, supervisors and occupational health professionals were satisfied with the workplace intervention and occupational health professionals rated it with a 7.1. Time-investment was the only barrier for implementation reported by the occupational health professionals. Conclusions The results of this study indicate a high feasibility for a broad implementation of a participatory workplace intervention for employees with distress and lost time, and their supervisors.     

Effects of Individual Dietary Intervention on Nutrient Intake in Postpartum Japanese Women: A Randomized Controlled Trial

No dietary intervention that focuses on the diet quality of postpartum women has been developed in Japan, although most postpartum women experience an insufficient intake of vitamins and minerals. We aimed to examine whether dietary intervention, based on the health belief model, at both 1 and 3 months postpartum affects nutrient intake and food group consumption at 6 months postpartum. A randomized controlled trial was conducted at a university hospital in Tokyo between 2015 and 2016. Healthy women at 1 month postpartum were randomly allocated to either an intervention group (n = 100) or a control group (n = 94). Dietary intervention included dietary assessment, individual feedback, and dietary guidance. The dietary intakes between the two groups were compared using the Mann-Whitney U test. At 6 months postpartum, the energy-adjusted intakes of protein, total dietary fiber, potassium, magnesium, phosphorus, zinc, vitamin B₆, and β-carotene were significantly higher in the intervention group than in the control group. The changes in energy-adjusted intakes of total dietary fiber and iron from 1 month postpartum to 6 months postpartum were significantly different between the two groups. Dietary intervention based on the health belief model improved nutrition at 6 months postpartum, although the impact was limited.     

A Randomized Controlled Trial of a Community-Based Nutrition Education Program for Low-Income Parents

ObjectiveAssess effectiveness of the Expanded Food and Nutrition Education Program on nutrition behaviors post-education and longitudinally.DesignSwitching replications randomized experimental design. Participants randomly assigned to immediate education (IE) or delayed education (DE). Participants in IE received intervention the first 8 weeks, and those in DE the second 8 weeks, with no intervention during alternate periods. Data were collected in 3 repeated measures.ParticipantsParents (n = 168 randomized; n = 134 completed) of children in 2 Head Start and 6 low-income schools.InterventionEight weekly workshops, based on Eating Right is Basic-Enhanced adapted to incorporate dialogue approach with experiential learning.Main Outcome MeasuresTen-item self-reported behavior checklist on nutrition, food resource management, food safety, and food security; responses on a 5-point scale reporting frequency of behavior.AnalysisChi-square, analysis of variance, and multiple regression.ResultsGroups were demographically similar. Both groups reported improved behaviors pre- to post-education (P < .05). There was no significant difference between groups at Time 1 (T1) or DE control period (T1 vs T2). Changed IE behavior was retained T2 to T3. A multiple regression model of overall change, controlling for T1 score and educator, showed significant improvement (n = 134, β = 5.72, P < .001).Conclusions and ImplicationsPositive outcomes were supported by this experimental study in a usual program context, with reported behavior changes retained at least 2 months.