The Impact of a Nutritional Intervention on Glycemic Control and Cardiovascular Risk Markers in Type 2 Diabetes.

INTRODUCTION: Nutritional management plays a crucial role in treating patients with type 2 diabetes (T2D), working to prevent and control the progression of chronic non-communicable diseases. OBJECTIVES: To evaluate the effects of individualized nutritional interventions on weight, body mass index (BMI), waist circumference (WC), waist-to-hip ratio (WHR), fasting blood glucose (FBG), hemoglobin A1c (HbA1c), total cholesterol (TC), LDL cholesterol (LDL-C), HDL cholesterol (HDL-C), triglycerides (TGs), systolic blood pressure (SBP), diastolic blood pressure (DBP), and heart rate (HR)} over 12 months and subsequently at follow-up (15 months). METHODS: This longitudinal experimental study (without randomization and blinding) enrolled 84 sedentary participants with T2D (both sexes, aged 18-80 years). They were divided into a control group of 40 participants who received only medical consultations, and an intervention group of 44 participants who received the same medical care along with a nutritional assessment. Consultations occurred quarterly from August 2020 to November 2022 (first-twelfth month), with six to nine patients per session. Subsequently, a follow-up was conducted from December 2022 to November 2023, during which the intervention group had only medical care (during the 12th-15th months). Personalized dietary planning was inspired by the Mediterranean/DASH diets adapted to Brazilian foods and socioeconomic cultures. STATISTICAL ANALYSIS: Normal variables were compared between groups for each time point and also within each group across different time points using a two-way ANOVA (repeated measures for intragroup) followed by the Sídák post hoc test. Non-normal variables were compared between groups for each time point using Kruskal-Wallis followed by the Dunn post hoc test, and within each group across different time points using Friedman followed by the Dunn post hoc test. Data with a Gaussian distribution were presented as mean ± standard deviation (SD), and data with a non-Gaussian distribution were presented as median ± interquartile range (IQR). For all cases, α < 0.05 and p < 0.05 were adopted. RESULTS: In the intervention group, significant reductions were observed between the first and twelfth month for all parameters (p < 0.05), (except for TC), along with an increase in HDL-C (p = 0.0105). Conversely, in the control group, there was a significant increase in HbA1c, weight, BMI, FBG, and WHR (p < 0.05) between the first and twelfth months. Regarding the comparison between groups, there was a significant difference for all analyzed parameters (p < 0.05) from the first to the twelfth month. In the follow-up, differences were also observed (p < 0.05), except for BMI (p > 0.05). CONCLUSION: The individualized nutritional intervention improved eating habits, anthropometric, biochemical, and cardiovascular markers in T2D over 12 months, with sustained results during follow-up. The dietary plan inspired by the Mediterranean and DASH diets demonstrated good adaptation to the Brazilian food culture and the patients' socioeconomic contexts. Consistent monitoring and personalized nutritional management are essential for optimizing long-term outcomes. However, more clinical trials are necessary in order to optimize the level of evidence for longitudinal interventions.

Liver fat as a dietary target by Chinese Medical Nutrition Therapy (CMNT) diet for treating type 2 diabetes with non-alcoholic fatty liver disease: study protocol for a randomised controlled trial.

INTRODUCTION: Type 2 diabetes and non-alcoholic fatty liver disease (NAFLD) often coexist and increase risk for developing liver fibrosis and diabetes complications if no effective measures are taken. Dietary intervention is known to be able to achieve diabetes remission, while evidence regarding the long-term effect on liver fat is limited for comorbidity management of type 2 diabetes and NAFLD. This study aims to investigate the long-term effect of a Chinese Medical Nutrition Therapy (CMNT) diet accompanied by intermittent energy restriction on reducing liver fat and glycated haemoglobin (HbA1c) in patients with type 2 diabetes and NAFLD. METHODS AND ANALYSIS: This is a multicentre two-armed parallel randomised controlled trial study. 120 participants with type 2 diabetes and NAFLD will be recruited from the physical examination centres of multiple hospitals in China. Participants will be randomly allocated 1:1 to either the CMNT group or the usual care group. The CMNT group will be instructed to consume the provided specific meal replacement Chinese medicinal foods consisting of 6 cycles of 5 consecutive days followed by 10 days of regular food intake. The usual care group will be given standard dietary advice. Primary outcomes are changes in the controlled attenuation parameter value by transient elastography and HbA1c level. Secondary outcomes include differences in anthropometrics, clinical blood markers, questionnaires, gut microbiota and metabolomics. Further follow-up will be performed at 6 months, 1 year and 2 years. ETHICS AND DISSEMINATION: The study protocol was approved by the Biomedical Research Ethics Committee of Hunan Agricultural University (BRECHAU20200235).The results will be disseminated via relevant peer-reviewed publications and conference presentations. TRIAL REGISTRATION NUMBER: NCT05439226.

Role of nutritional therapy on dietary habits and glycemic control in insulin-treated kidney transplant patients with diabetes.

AIMS: To evaluate the effect of nutritional therapy on glycemic compensation and key cardio-renal risk markers in patients with diabetes and kidney transplant, on insulin treatment by Multiple Daily Injection (MDI) or Continuous Subcutaneous Insulin Infusion (CSII). METHODS: 34 patients with diabetes on insulin treatment and kidney transplant recipients were enrolled;12 participated in the structured nutritional program (intervention group), 22 patients (control group) did not receive nutritional protocol. Both groups were then divided into subgroups according to the method of insulin administration (MDI and CSII). RESULTS: Statistically significant reduction in fasting blood glucose values, glycosylated hemoglobin (HbA1c) and glycosuria were observed in both groups at the end of the study. The intervention group, significantly reduced total cholesterolemia and the glycemic index, together with reduced dietary intake of lipids, cholesterol, soluble carbohydrates and increased consumption of carbohydrates and fiber. These improvements were even more pronounced in patients treated with CSII. CONCLUSIONS: A proper nutritional approach optimize glycometabolic outcomes and contribute significantly to the reduction of the major cardiovascular risk factors in renal transplant patients.

Gestational Diabetes Mellitus: What Can Medical Nutrition Therapy Do?

Gestational diabetes mellitus (GDM) is one of the common complications during pregnancy. Numerous studies have shown that GDM is associated with a series of adverse effects on both mothers and offspring. Due to the particularity of pregnancy, medical nutrition treatment is considered to be the first choice for the treatment of GDM. This contribution reviews the research progress of medical nutrition treatment in GDM, summarizes the international recommendations on the intake of various nutrients and the influence of nutrients on the prevalence of GDM, and the improvement effect of nutritional intervention on it, in order to provide references for research in related fields of GDM and the targeted development of enteral nutrition.

Evolution of nutritional management in children with cystic fibrosis - a narrative review.

Nutrition has played a central role in the management and outcomes of people with cystic fibrosis (pwCF) since the 1970s. Advances in therapies and practices in recent decades have led to a significant change in the patient landscape with dramatic improvements in life expectancy, as well as quality of life, bringing with it new issues. Historically, cystic fibrosis was a condition associated with childhood and malnutrition; however, changes in patient demographics, nutritional assessment and fundamental nutritional management have evolved, and it has become an increasingly prevalent adult disease with new nutritional challenges, including obesity. This paper aims to describe these changes and the impact and challenges they bring for those working in this field. Nutritional professionals will need to evolve, adapt and remain agile to the wider range of situations and support required for a new generation of pwCF. Specialised nutrition support will continue to be required, and it will be additionally important to improve and optimise quality of life and long-term health.

Ontology-based decision support systems for diabetes nutrition therapy: A systematic literature review.

Diabetes is a non-communicable disease that has reached epidemic proportions, affecting 537 million people globally. Artificial Intelligence can support patients or clinicians in diabetes nutrition therapy - the first medical therapy in most cases of Type 1 and Type 2 diabetes. In particular, ontology-based recommender and decision support systems can deliver a computable representation of experts' knowledge, thus delivering patient-tailored nutritional recommendations or supporting clinical personnel in identifying the most suitable diet. This work proposes a systematic literature review of the domain ontologies describing diabetes in such systems, identifying their underlying conceptualizations, the users targeted by the systems, the type(s) of diabetes tackled, and the nutritional recommendations provided. This review also delves into the structure of the domain ontologies, highlighting several aspects that may hinder (or foster) their adoption in recommender and decision support systems for diabetes nutrition therapy. The results of this review process allow to underline how recommendations are formulated and the role of clinical experts in developing domain ontologies, outlining the research trends characterizing this research area. The results also allow for identifying research directions that can foster a preeminent role for clinical experts and clinical guidelines in a cooperative effort to make ontologies more interoperable - thus enabling them to play a significant role in the decision-making processes about diabetes nutrition therapy.

Nature of the evidence base and approaches to guide nutrition interventions for individuals: a position paper from the Academy of Nutrition Sciences.

This Position Paper from the Academy of Nutrition Sciences is the third in a series which describe the nature of the scientific evidence and frameworks that underpin nutrition recommendations for health. This paper focuses on evidence which guides the application of dietary recommendations for individuals. In some situations, modified nutrient intake becomes essential to prevent deficiency, optimise development and health, or manage symptoms and disease progression. Disease and its treatment can also affect taste, appetite and ability to access and prepare foods, with associated financial impacts. Therefore, the practice of nutrition and dietetics must integrate and apply the sciences of food, nutrition, biology, physiology, behaviour, management, communication and society to achieve and maintain human health. Thus, there is huge complexity in delivering evidence-based nutrition interventions to individuals. This paper examines available frameworks for appraising the quality and certainty of nutrition research evidence, the development nutrition practice guidelines to support evidence implementation in practice and the influence of other sources of nutrition information and misinformation. The paper also considers major challenges in applying research evidence to an individual and suggests consensus recommendations to begin to address these challenges in the future. Our recommendations target three groups; those who deliver nutrition interventions to individuals, those funding, commissioning or undertaking research aimed at delivering evidence-based nutrition practice, and those disseminating nutritional information to individuals.

Are dietitian recommendations followed? A descriptive study of paediatric hospitalised and ambulatory patients.

BACKGROUND: The primary objective of this cross-sectional retrospective study was to describe the implementation of dietitian prescribed nutrition recommendations in malnourished paediatric patients in the hospital and ambulatory settings. We also aimed to investigate other characteristics that could be associated with differences in implementation. METHODS: Data were collected from 186 hospitalised and 565 ambulatory patients between February 2020 and January 2021. Data included age, hospital or ambulatory specialty departments, primary diagnosis, malnutrition status, hospital length of stay (LOS), and medical nutrition therapy recommendations. Implementation by the medical team in the hospital setting and adherence by the family in the outpatient setting were categorised as "Full", "Partial" or "None". "Partial" and "None" were combined for analysis. RESULTS: Dietitian prescribed recommendations were implemented in 79.6% of hospitalised patients. In the ambulatory population, 46.4% of patients were adherent with nutrition recommendations. Within the hospital, there was a significant difference in implementation of nutrition recommendations based on age (p = 0.047), hospital department (p = 0.002) and LOS (p = 0.04), whereas, in the ambulatory population, there were no significant differences in the rate of adherence among any of the studied characteristics. CONCLUSIONS: Dietitian recommendations are frequently implemented in the hospital, whereas adherence to such recommendations is poor in the outpatient population. Interventions to improve adherence to nutrition recommendations in the ambulatory setting are needed.

Effects of nutritional counseling on physical performance and muscle strength in older adults: a systematic review protocol.

OBJECTIVE: The objective of this review is to synthesize the effects of nutritional counseling compared with no intervention (maintaining lifestyle habits) or nutritional counseling in combination with other interventions (eg, nutritional supplementation, physical activity) on physical performance and muscle strength in older adults. INTRODUCTION: Nutritional counseling, which is considered the first line of nutrition therapy, could play an important role in geriatric care programs by helping older adults understand the importance of nutrition and by promoting healthy, sustainable eating habits. However, the effects of nutritional counseling on physical function and muscle strength among older adults are not clear. INCLUSION CRITERIA: This review will consider randomized controlled trials and non-randomized controlled trials. Participants aged 65 years or older, who have received nutritional counseling alone or in combination with another intervention (eg, nutritional supplementation, physical exercise) will be considered for inclusion. Comparators will include another intervention or no intervention, but physical performance (ie, gait, endurance, balance) or muscle strength must be measured. METHODS: This systematic review will be conducted in accordance with the JBI methodology for systematic reviews of effectiveness. The databases to be searched will include MEDLINE (Ovid), Embase, CENTRAL (Ovid), CINAHL (EBSCOhost), and Scopus. Sources of unpublished studies and gray literature will include Google Scholar and protocol registers. Two independent reviewers will select relevant studies, critically appraise the studies, and extract data. Studies will be pooled in a statistical meta-analysis or presented in narrative format. The Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach will be used to grade the certainty of the evidence. REVIEW REGISTRATION: PROSPERO CRD42022374527.

Nutrition support for patients on mechanical circulatory support.

PURPOSE OF REVIEW: No specific guidelines on medical nutrition therapy (MNT) in patients on different types of mechanical circulatory support (MCS) devices yet exist and overall evidence is limited. The purpose of this narrative review is to provide an overview about current existing evidence, which might be of underrecognized importance for the patients' short-term and long-term clinical and functional outcomes. RECENT FINDINGS: Patients on MCS inherit substantial metabolic, endocrinologic, inflammatory, and immunologic alterations, and together with the specificities of MCS therapy, technical modalities of respective devices, and concomitant medication, the consideration of individualized MNT approaches is indicated in routine clinical practice. Exemplarily, the evaluation of the patients' individual nutrition status, determination of nutrition targets, progressive increase of energy and protein supply throughout the different phases of disease, prevention of micronutrient deficiencies, implementation of nutrition protocols, appropriate monitoring strategies, and continuous quality improvement are essential elements of MNT in patients on MCS. SUMMARY: The importance of MNT for patients on MCS still often remains underrecognized, which might be of particular relevance in view of the significant metabolic alterations, the long treatment period, and severity of illness in these patients. Further research on more targeted MNT approaches in those patients is urgently needed for the generation of evidence-based guidelines for this specific cohort of critically ill patients.

The effectiveness of medical nutrition therapy provided by a dietitian in adults with prediabetes: a systematic review and meta-analysis.

BACKGROUND: A total of 374 million adults worldwide are living with prediabetes, 70% of whom will develop type 2 diabetes mellitus (T2DM) in their lifetime. Medical nutrition therapy (MNT) provided by a dietitian, such as that found in lifestyle interventions, has the potential to improve glycemic control and prevent progression to T2DM. OBJECTIVES: The objective of this systematic review was to examine the effectiveness of MNT provided by a dietitian, compared with standard care, on glycemic, cardiometabolic, and anthropometric outcomes in adults with prediabetes. METHODS: Searches were conducted for randomized controlled trials (RCTs) published between 1995 and 2022 using electronic databases MEDLINE, CINHAL, and Cochrane Central. The risk of bias was assessed using version 2 of the Cochrane risk-of-bias tool for RCTs. Meta-analyses were conducted using a random-effects model. The certainty of evidence was assessed for each outcome using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) method, and a summary of findings table was created using the GRADEpro Guideline Development Tool. RESULTS: Thirteen RCTs were included in the analysis, showcasing a variety of MNT interventions delivered by dietitians. Intervention durations ranged from 3 to 24 mo. Compared with standard care, MNT improved hemoglobin A1c (HbA1c) (mean difference [95% confidence interval]: -0.30% [-0.49, -0.12]) and fasting blood glucose (FBG) (-4.97 mg/dL [-6.24, -3.71]). Statistically significant improvements were found in anthropometrics (weight, body mass index, and waist circumference), cholesterol (total, high-, and low-density lipoproteins), and blood pressure (systolic and diastolic). No significant effect was found on T2DM or triglycerides. The certainty of evidence was moderate for FBG and low for HbA1c and incidence of T2DM. CONCLUSIONS: In adults with prediabetes, MNT was effective in improving glycemic outcomes, anthropometrics, blood pressure, and most lipid levels. However, most studies had a risk of bias because of the randomization process or deviations from intended interventions. MNT plays a key role in improving cardiometabolic risk factors in adults with prediabetes. TRIAL REGISTRATION NUMBER: This study was registered with the registration ID #351421, available from https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=351421.

Nutritional education strategies for patients with cirrhosis: A narrative review.

BACKGROUND: Patients with cirrhosis suffer from many complications, including malnutrition, which must be managed promptly and effectively by the healthcare team. Educating patients about their medical condition, the risk of malnutrition and other complications of cirrhosis, could contribute to optimal nutritional status, quality of life and general health. OBJECTIVE: This review provides an overview of the literature on a variety of nutritional education strategies used with patients suffering from cirrhosis. This review also identifies barriers and facilitators which impact the adherence in using these strategies. PATIENT INVOLVEMENT: A patient-partner contributed to this review by providing insights on different issues and concerns that patients with cirrhosis might ask themselves regarding nutritional education strategies. The patient-partner was also involved in the overall revision of the review. METHODS: Articles published between the years 2000-2023 focusing on nutritional education strategies in patients living with cirrhosis were identified using Google Scholar and PubMed and were screened for inclusion in the study. All selected studies were intervention studies. A quality assessment of the included studies was conducted using the Mixed Methods Appraisal Tool (MMAT). RESULTS: Only a few nutritional education strategies in patients with cirrhosis were documented in the literature. The strategies ranged from using traditional printed materials to advanced technologies. These strategies may prove beneficial in complementing routine interventions provided by health professionals, such as registered dietitians, in their clinical practice. DISCUSSION: This narrative review clearly highlights the need for further research to elaborate and evaluate nutritional education strategies for people living with cirrhosis. PRACTICAL VALUE: Elaborating and evaluating educational strategies in nutrition for patients living with cirrhosis will be an adjuvant to health professionals and dietitians in their clinical practice by providing them, and the patients, with targeted education resources.

The feasibility of a 6-month dietary intervention aiming to increase protein intake among community-dwelling older adults with low habitual protein intake: A secondary analysis of the PROMISS randomised controlled trial.

BACKGROUND: The PROMISS randomised controlled trial showed that personalised dietary advice increased protein intake and improved 400-m walk time and leg strength among community-dwelling older adults with a low habitual protein intake. This secondary analysis describes and further evaluates the methods and feasibility of the model used to carry out dietary intervention in the PROMISS randomised controlled trial. METHODS: In total, 185 participants (≥65 years, 54% women) with a habitual low protein intake (<1.0 g/kg adjusted body weight/day) in Finland and the Netherlands received personalised dietary advice and complimentary protein-enriched food products for 6 months with two main objectives: (1) to increase protein intake to ≥1.2 g/kg adjusted body weight/day (energy-neutral) and (2) to include each day a 'high-protein meal' containing ≥ 30-35 g of protein. The feasibility of the model was evaluated by the adoption of the advice, feedback from the participants, and practical experiences by the nutritionists. RESULTS: In all, 174 participants (93.5%) completed the intervention. At the 6-month follow-up, 41.8% reached both main objectives of the advice. The participants' general rating for the dietary advice was 8.6 (SD 1.0) (on a scale of 1-10; 10 indicating very good). Sticking to the advice was (very) easy for 79.2% of the participants. The nutritionists perceived the model feasible for the participants except for those with low food intake. CONCLUSIONS: The methods used in this model are mainly feasible, well-received and effective in increasing protein intake among community-dwelling older adults with low habitual protein intake.

Medical Nutrition Therapy Provided by Dietitians is Effective and Saves Healthcare Costs in the Management of Adults with Dyslipidemia.

PURPOSE OF REVIEW: Referral to nutrition care providers in the USA such as registered dietitian nutritionists (RDNs) for medical nutrition therapy (MNT) remains low. We summarize research on the effectiveness of MNT provided by dietitians versus usual care in the management of adults with dyslipidemia. Improvements in lipids/lipoproteins were examined. If reported, blood pressure (BP), fasting blood glucose (FBG) glycated hemoglobin (A1c), body mass index (BMI), and cost outcomes were also examined. RECENT FINDINGS: The synthesis of three systematic reviews included thirty randomized controlled trials. Multiple MNT visits (3-6) provided by dietitians, compared with usual care, resulted in significant improvements in total cholesterol (mean range: - 4.64 to - 20.84 mg/dl), low-density lipoprotein cholesterol (mean range: - 1.55 to - 11.56 mg/dl), triglycerides (mean range: - 15.9 to - 32.55 mg/dl), SBP (mean range: - 4.7 to - 8.76 mm Hg), BMI (mean: - 0.4 kg/m2), and A1c (- 0.38%). Cost savings from MNT were attributed to a decrease in medication costs and improved quality of life years (QALY). Multiple MNT visits provided by dietitians compared with usual care improved lipids/lipoproteins, BP, A1c, weight status, and QALY with significant cost savings in adults with dyslipidemia and justify a universal nutrition policy for equitable access to MNT.

Nutrition-Related N-of-1 Studies Warrant Further Research to Provide Evidence for Dietitians to Practice Personalized (Precision) Medical Nutrition Therapy: A Systematic Review.

N-of-1 trials provide a higher level of evidence than randomized controlled trials for determining which treatment works best for an individual, and the design readily accommodates testing of personalized nutrition. The aim of this systematic review was to synthesize nutrition-related studies using an N-of-1 design. The inclusion criterion was adult participants; the intervention/exposure was any nutrient, food, beverage, or dietary pattern; the comparators were baseline values, a control condition untreated or placebo, or an alternate treatment, alongside any outcomes such as changes in diet, body weight, biochemical outcomes, symptoms, quality of life, or a disease outcome resulting from differences in nutritional conditions. The information sources used were Medline, Embase, Scopus, Cochrane Central, and PsychInfo. The quality of study reporting was assessed using the Consort Extension for N-of-1 trials (CENT) statement or the STrengthening Reporting of OBservational Studies in Epidemiology (STROBE) guidelines, as appropriate. From 211 articles screened, a total of 7 studies were included and were conducted in 5 countries with a total of 83 participants. The conditions studied included prediabetes, diabetes, irritable bowel syndrome, weight management, and investigation of the effect of diet in healthy people. The quality of reporting was mostly adequate, and dietary assessment quality varied from poor to good. The evidence base is small, but served to illustrate the main characteristics of N-of-1 study designs and considerations for moving research forward in the era of personalized medical nutrition therapy.

Nutritional counseling for patients with incurable cancer: Systematic review and meta-analysis.

BACKGROUND & AIMS: This systematic review aims to determine whether nutritional counseling by registered dietitians and/or nutritional specialists is recommended for adult patients with incurable advanced or recurrent cancer who are refractory to or intolerant of anticancer therapy. METHODS: This systematic review analyzed randomized controlled trials (RCTs) of nutritional counseling in cancer patients older than 18 years, primarily those with stage 4 cancer. Nutrition counseling was performed by registered dietitians and/or nutritional specialists using any method, including group sessions, telephone consultations, written materials, and web-based approaches. We searched the Medline (PubMed), Medline (OVID), EMBASE (OVID), CENTRAL, Emcare, and Web of Science Core Collection databases for articles published from 1981 to 2020. Two independent authors assessed the risk of bias used the Cochrane Risk of Bias 2 tool. Meta-analysis was performed for results and outcomes that allowed quantitative integration. This systematic review protocol was registered with the International Prospective Register of Systematic Reviews (ID: CRD42021288476) and registered in 2021. RESULTS: The search yielded 2376 studies, of which 7 assessed 924 patients with cancer aged 24-95 years. Our primary outcome of quality of life (QoL) was reported in 6 studies, 2 of which showed improvement with nutritional counseling. Our other primary outcome of physical symptoms was reported in two studies, one of which showed improvement with nutritional counseling. Quantitative integration of both QoL and physical symptoms was difficult. A meta-analysis of energy and protein intake and body weight was performed for secondary outcomes. Results showed that nutrition counseling increased energy and protein intake, but total certainty of evidence (CE) was low. Bodyweight was not improved by nutrition counseling. CONCLUSIONS: Nutrition counseling is shown to improve energy and protein intake in patients with incurable cancer. Although neither nutrient intake can be strongly recommended because of low CE, nutrition counseling is a noninvasive treatment strategy that should be introduced early for nutrition intervention for patients with cancer. This review did not find sufficient evidence for the effect of nutrition counseling on QoL, a patient-reported outcome. Overall, low-quality and limited evidence was identified regarding the impact of nutrition counseling for patients with cancer, and further research is needed.

SISTER (Sisters Inspiring Sisters to Engage in Relevant Diabetes Self-Care) Diabetes Study: Protocol for diabetes medical nutrition therapy randomized clinical trial among African American women.

BACKGROUND: African American (AA) women with type 2 diabetes (T2D) carry disproportionate diabetes-related morbidity and mortality burdens. Diabetes medical nutrition therapy (MNT) improves glycemic, blood pressure, and cholesterol control, all critical in preventing and reducing diabetes complications. Yet, MNT does not address low motivation for dietary intake management, which is frequently reported among AA women with T2D living in the Southeastern US. METHODS: A randomized controlled trial will be used to test the central hypothesis that diabetes MNT plus culturally-tailored motivational interviewing (MI) (diabetes MNT plus MI) is more effective than diabetes MNT alone (diabetes MNT). Two hundred ninety-one Southeastern AA women who are at risk for development and/or progression of T2D complications will be randomized to diabetes MNT plus MI or diabetes MNT. Both groups will include: 1) a 3-month active intervention period, consisting of group-based, nutritionist-facilitated MNT sessions; 2) a 3-month maintenance intervention period, including one group-based, nutritionist-facilitated maintenance support session; and 3) a 6-month inactive period. Culturally-adapted MI exercises will be integrated into the diabetes MNT plus MI group only. Primary (HbA1c) and secondary (systolic blood pressure, LDL cholesterol) outcomes will be assessed at baseline and 3, 6, and 12 months following the active intervention period. DISCUSSION: The results from this study, called the SISTER (Sisters Inspiring Sisters to Engage in Relevant Diabetes Self-Care) Diabetes Study, are vital to the adoption and uptake of rigorously-tested MNT interventions that address motivation among AA women with T2D as a way to reduce their risk and/or progression of diabetes-related complications.